Study to Identify and Determine Best Implementation Practices for Injectable Cabotegravir+Rilpivirine in the United States (US)

• Sponsor: ViiV Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04001803
• Collaborator: (none)
• Enrollment: 115
• Locations: 9
• Arm: 1
• Actual Duration (Months): 32.3
• Patients Per Site: 12.8
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

Chronic human immunodeficiency virus (HIV) infection in adults continues to be characterized by increased development of resistant virus, increased transmission of resistant virus and issues associated with the long-term toxicity of anti-retroviral therapy (ART), despite advances in development of new ART, which provides extensive insight in management of HIV-infected individuals. Cabotegravir (CAB) is a potent integrase inhibitor (INI) and rilpivirine (RPV) is a potent non-nucleoside reverse transcriptase inhibitor (NNRTI). A two-drug regimen (DR)with CAB plus RPV long acting (LA) product offers many potential advantages over daily oral regimens including better tolerability, improved compliance, adherence, less likely to develop resistance, and overall treatment satisfaction in virologically suppressed subjects. This is a single-arm, open-label, multicenter, short term facilitation study to evaluate the effect of an implementation strategy on the degree of acceptability, appropriateness, feasibility, fidelity and sustainability of clinical practices to deliver the CAB+RPV LA regimen to HIV infected subjects and to also measure subject satisfaction by recording timeliness of visits, length of visit and their education. Approximately 135 subjects will be enrolled in the study and the total duration of the study will be approximately 52-weeks.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: CAB LA+RPV LA	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 115 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Qualitative Hybrid III Implementation Study to Identify and Evaluate Strategies for Successful Implementation of the Cabotegravir + Rilpivirine Long-acting Injectable Regimen in the US
• Actual Study Start Date: Jul 8, 2019
• Actual Primary Completion Date: Oct 5, 2020
• Actual Study Completion Date: Mar 18, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subjects with HIV infection HIV-infected subjects receiving CAB LA+RPV LA will be included in this arm.	Drug: CAB LA+RPV LA; Subjects will receive one tablet of CAB 30 milligram(mg) + RPV 25 mg once daily from Day 1 for 1 month. During month 1, subjects will receive 600 mg of CAB LA injection+ 900 mg of RPV LA injection. Following Month 1, subjects will receive 400mg of CAB LA + 600mg of RPV LA at each subsequent injection.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in the Acceptability of Intervention Measure (AIM) Total Score in Staff Study Participants at Month 4 [Baseline and Month 4]

   AIM is a four item survey that assessed the acceptability of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the AIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

2. Change From Baseline in AIM Total Score in Staff Study Participants at Month 12 [Baseline and Month 12]

   AIM is a four item survey that assessed the acceptability of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the AIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

3. Change From Baseline in AIM Total Score in Participants With HIV Infection at Month 4 [Baseline and Month 4]

   AIM is a four item survey that assessed the acceptability of an implementation process. The participants were asked about their impressions of the CAB LA + RPV LA injection treatment for treating HIV on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

4. Change From Baseline in AIM Total Score in Participants With HIV Infection at Month 12 [Baseline and Month 12]

   AIM is a four item survey that assessed the acceptability of an implementation process. The participants were asked about their impressions of the CAB LA + RPV LA injection treatment for treating HIV on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

5. Change From Baseline in Intervention Appropriateness Measure (IAM) Score in Staff Study Participants at Month 4 [Baseline and Month 4]

   IAM is a four item survey that assessed the appropriateness of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

6. Change From Baseline in IAM Score in Staff Study Participants at Month 12 [Baseline and Month 12]

   IAM is a four item survey that assessed the appropriateness of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

7. Change From Baseline in IAM Score in Participants With HIV Infection at Month 4 [Baseline and Month 4]

   IAM is a four item survey that assessed the appropriateness of an implementation process. The participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

8. Change From Baseline in IAM Score in Participants With HIV Infection at Month 12 [Baseline and Month 12]

   IAM is a four item survey that assessed the appropriateness of an implementation process. The participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

9. Change From Baseline in Feasibility of Intervention Measure (FIM) Total Score in Staff Study Participants at Month 4 [Baseline and Month 4]

   FIM is a four item survey that assessed the feasibility of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the FIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The FIM total score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

10. Change From Baseline for FIM Total Score in Staff Study Participants at Month 12 [Baseline and Month 12]

    FIM is a four item survey that assessed the feasibility of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the FIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The FIM total score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

Secondary Outcome Measures

1. Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 [At Month 4]

   The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Not Applicable (NA) in the categories mean response was not offered. The toolkit resources consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs. The number of participants with the rating on helpfulness for each toolkit resources at Month 4 is presented.

2. Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 [At Month 12]

   The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Not Applicable (NA) in the categories mean response was not offered. The toolkit resources consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, WB treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs. The number of participants with the rating on helpfulness for each toolkit resources at Month 12 is presented.

3. Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants [Baseline and Month 4]

   BIM is a 23-item survey which assessed barriers (that is, difficulties and challenges) to successful implementation of the CAB LA + RPV LA injection treatment in the study clinic/practices. For each item, providers were asked to rate how much they agreed or disagreed that the issue is a barrier based on their experiences with implementing the CAB + RPV treatment on a five point rating scale (1=completely disagree to 5=completely agree). It is presented as fewer perceived barriers (FPB)=all negative change in scores from Baseline, same perceived barriers (SPB)=change in score of 0 from Baseline, and greater/more perceived barriers (MPB)=all positive change in scores from Baseline.

4. Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants [Baseline and Month 12]

   BIM is a 23-item survey which assessed barriers (i.e., difficulties and challenges) to successful implementation of the CAB LA + RPV LA injection treatment in the study clinic/practices. For each item, providers were asked to rate how much they agreed or disagreed that the issue is a barrier based on their experiences with implementing the CAB + RPV treatment on a five point rating scale (1=completely disagree to 5=completely agree). It is presented as fewer perceived barriers (FPB)=all negative change in scores from Baseline, same perceived barriers (SPB)=change in score of 0 from Baseline, and greater/more perceived barriers (MPB)=all positive change in scores from Baseline.

5. Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 [At Month 12]

   The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Categories for did not receive (DNR) and recevied but did not use (RBDNU) were presented as well. Not Applicable (NA) in the data means participants were not offered the response option. The toolkit resources consisted of information and resources, hot and cold pack, written materials, website for participants, video, verbal information, reminder calls, reminder text messages, reminder app, peer group information session and appointments outside work time. The number of participants with the rating on helpfulness for each toolkit resources is presented.

6. Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12 [At Month 12]

   Participants were asked to report any factors that were interfering with their ability to get the monthly CAB LA + RPV LA injection treatment. Number of participants along with the reasons for interference in ability to get CAB LA + RPV LA is presented.

7. Number of Barriers Assessed Among Clinics Using Short-term Facilitation [Up to 6 months]

   The barriers were analyzed using semi-structured interviews from the validated consolidated framework for implementation research (CFIR) across 7 calls. An implementation science approach was used to understand the barriers for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants.

8. Number of Facilitators Assessed Among Clinics Using Short-term Facilitation [Up to 6 months]

   The facilitators were analyzed using semi-structured interviews from the validated CFIR across 7 calls. An implementation science approach was used to understand the facilitators for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants.

9. Number of Best Practices Assessed Among Clinics Using Short-term Facilitation [Up to 6 months]

   The best practices were analyzed using short-term facilitation calls. An implementation science approach was used to understand the best practices for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants.

10. Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 [At Month 4]

    Number of staff study participants using support materials/toolkit at Month 4 was assessed by variables: Not used, Used similar resource, used the support materials/toolkit. The support materials/toolkit consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs.

11. Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 [At Month 12]

    Number of staff study participants using support materials/toolkit at Month 12 was assessed by variables: Not used, Used similar resource, used the support materials/toolkit. The support materials/toolkit consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs.

12. Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 [At Month 4]

    Participants with HIV infection were asked about their utilization of each element of the support materials/toolkit and were asked to categorize it as Extremely helpful (EH) Very helpful (VH), Somewhat helpful (SH), A little helpful (ALH), Not at all helpful (NAAH), did not receive (DNR), Received but did not use (RBDNU) and missing. Not Applicable (NA) in the data means participants were not offered the response option. The support materials/toolkit consisted of information and resources, hot and cold pack, written materials, website for participants, video, verbal information, reminder calls, reminder text messages, reminder app, peer group information session and appointments outside work time. Percentage of participants with the rating on helpfulness for each toolkit resources is presented.

13. Number of Participants Receiving Injections Within Target Window at Month 4 [At Month 4]

    Number of participants receiving injections within target window at Month 4 is presented. The target window is +/- 7 days from the target injection visit date.

14. Number of Participants Receiving Injections Within Target Window at Month 12 [At Month 12]

    Number of participants receiving injections within target window at Month 12 is presented. The target window is +/- 7 days from the target injection visit date.

15. Implementation Sustainability Assessed in Staff Study Participants Using Program Sustainability Assessment Tool (PSAT) Scores [At Month 12]

    Implementation sustainability in staff study participants was assessed using PSAT tool that evaluated capability of clinics to maintain processes developed to administer CAB+RPV injection in routine clinical settings after study conclusion.It consisted of 6 domains(1.Environmental support,2.Organizational capacity,3.Program evaluation,4.Program adaptation,5.Communications and 6.Strategic planning).Each domain consisted of 5 items,each assessed using 7-point numerical rating scale:1=to not extent at all,7=to a very great extent and an eighth not applicable/not able to answer response(NA).Score ranges for total domain scores are 5 to 35 for each of 6 domains(5 items in each domain on 1 to 7 scale).Numeric response to each item within specific domain is summed to produce a total domain score then mean domain score is calculated(excluding any NA responses).Higher scores indicate better outcome(higher endorsement/more positive impressions by staff-study with sustainability survey concepts)

16. HIV Treatment Satisfaction Questionnaire Status Version (HIV-TSQs) Scores at Month 1 [At Month 1]

    Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment.

17. HIV-TSQs Scores at Month 4 [At Month 4]

    Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment.

18. HIV-TSQs Scores at Month 12 [At Month 12]

    Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment.

19. Number of Participants With Reported Acceptability of the Amount of Time Spent in the Clinic for Each Injection Visit [At Month 12]

    The results for participant reported acceptability of the amount of time spent in the clinic for each injection visit is presented. Participants were asked to rate the acceptability of the amount of time spent in the clinic for each injection visit as extremely acceptable, very acceptable, somewhat acceptable, a little acceptable and not at all acceptable.

20. Number of Participants With the Reported Time Spent in Clinic/Practice for Each Injection Visit [At Month 12]

    Number of participants with the reported time spent in clinic/practice for each injection visit is presented.

21. Number of Participants With Extent of Knowledge About the CAB + RPV LA Treatment [At Month 12]

    Participants were asked to rate how knowledgeable they feel about the CAB LA + RPV LA treatment as extremely knowledgeable, very knowledgeable, somewhat knowledgeable, a little knowledgeable and not at all knowledgeable.

22. Length of Participant Visit [At Months 1, 5 and 11]

    Length of visit was calculated by subtracting the arrival time (Lead time [actual start time of appointment - arrival time] + process time [actual end time of appointment - actual start time of appointment]) from actual end time of appointment.

23. Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies/Milliliter (c/mL) [Up to Month 12]

    Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA <50 c/mL (virologic success) was evaluated using the modified Food and Drug Administration (FDA) snapshot algorithm with Coronavirus Disease 2019 (COVID-19) related missing value imputed using the last observation carried forward (LOCF) approach.

24. Percentage of Participants With Confirmed Virologic Failure (CVF) [Up to Month 12]

    Plasma samples were collected for quantitative analysis of HIV-1 RNA. The CVF is defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels greater than or equal to (>=)200 copies/mL after prior suppression to <200 copies/mL.

25. Number of Participants With Treatment Emergent Genotypic Resistance to CAB and RPV [Up to Month 12]

    Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1 RNA levels >=200 copies/mL after prior suppression to <200 copies/mL) with emergent genotypic resistance is summarized.

26. Number of Participants With Treatment Emergent Phenotypic Resistance to CAB and RPV [Up to Month 12]

    Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1 RNA levels >=200 copies/mL after prior suppression to <200 copies/mL) with emergent phenotypic resistance is summarized.

27. Number of Participants With Serious Adverse Events (SAEs) and Common (>=5 Percent [%]) Non-serious Adverse Events (Non-SAEs) [Up to Month 12]

    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Number of participants with any SAE and common (>=5%) non-SAEs are presented.

28. Percentage of Participants Who Discontinue Treatment or Withdraw From Study Due to AEs Over Time [Up to Month 12]

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Percentage of participants with adverse events leading to study treatment or study withdrawal has been presented. The percentage value presented has been rounded off.

29. Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline [Up to Month 12]

    Blood samples were collected for the analysis of following hematology parameters: leukocytes, neutrophils and platelets. The parameters were graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scale from Grade 1 to 4, where Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms.

30. Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline [Up to Month 12]

    Blood samples were collected up to the Month 12 visit for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), creatine kinase (CK), creatinine, direct bilirubin, glucose, lipase, phosphate, potassium and sodium. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms.

31. Number of Participants With Urinalysis Result of Potential Clinical Importance [Up to Month 12]

    Urine samples were collected to analyze the urine parameters: Protein, occult blood or glucose. Potential clinical importance is defined as an increase in protein (dipstick) or occult blood (dipstick) post-Baseline relative to Baseline. Number of participants with results of potential clinical importance in any of the urine parameters is presented.

32. Number of Participants With Injection Site Reactions (ISRs) Over Time [Up to Month 12]

    Local tolerability was measured by injection site reaction (ISR), for example; bruise at the site of injection and/or itching, pain, blistering or skin damage. ISRs were assigned to the most recent planned injection visit prior to/on the onset date of the ISR. Number of participants with ISRs by each assigned injection visit is presented.

33. Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count [Baseline and up to Month 12]

    Blood samples were collected to analyze the hematology parameters: Platelets, WBCs, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

34. Change From Baseline in Hematology Parameter: Red Blood Cell (RBC) Count [Baseline and up to Month 12]

    Blood samples were collected to analyze the hematology parameter: RBC count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

35. Change From Baseline in Hematology Parameter: Hemoglobin [Baseline and up to Month 12]

    Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

36. Change From Baseline in Hematology Parameter: Hematocrit [Baseline and up to Month 12]

    Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1). Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

37. Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume (MCV) [Baseline and up to Month 12]

    Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

38. Absolute Values of the Hematology Parameters: Platelet Count, WBC Count , Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils [Up to Month 12]

    Blood samples were collected for the analysis of hematology parameters including platelet count, WBCs, basophils, eosinophils, lymphocytes, monocytes and neutrophils

39. Absolute Values of Hematology Parameter: RBC Count [Up to Month 12]

    Blood samples were collected to analyze the hematology parameter: RBC count.

40. Absolute Values of Hematology Parameter: Hemoglobin [Up to Month 12]

    Blood samples were collected to analyze the hematology parameter: Hemoglobin

41. Absolute Values of Hematology Parameter: Hematocrit [Up to Month 12]

    Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1)

42. Absolute Values of Hematology Parameter: Erythrocytes MCV [Up to Month 12]

    Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV.

43. Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate [Baseline and up to Month 12]

    Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

44. Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin [Baseline and up to Month 12]

    Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

45. Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase [Baseline and up to Month 12]

    Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

46. Change From Baseline in Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) [Baseline and up to Month 12]

    Blood samples were collected from participants at indicated time points to analyze the clinical chemistry parameter: GFR from creatinine adjusted for BSA. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

47. Change From Baseline in Clinical Laboratory Parameter: Lipase [Baseline and up to Month 12]

    Blood samples were collected for the analysis of clinical chemistry parameter: Lipase. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

48. Change From Baseline in Clinical Laboratory Parameter: Albumin [Baseline and up to Month 12]

    Blood samples were collected for the analysis of clinical chemistry parameter: Albumin. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

49. Absolute Values of Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate. [Up to Month 12]

    Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate.

50. Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin [Up to Month 12]

    Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin.

51. Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase [Up to Month 12]

    Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase.

52. Absolute Values of Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) [Up to Month 12]

    Blood samples were collected from participants to analyze the clinical chemistry parameter: GFR from Creatinine adjusted for BSA

53. Absolute Values of Clinical Laboratory Parameter: Lipase [Up to Month 12]

    Blood samples were collected for the analysis of clinical chemistry parameter: Lipase.

54. Absolute Values of Clinical Laboratory Parameter: Albumin [Up to Month 12]

    Blood samples were collected for the analysis of clinical chemistry parameter: Albumin.

Other Outcome Measures

1. Change From Baseline in Urinalysis Parameters: Urine Albumin to Creatinine Ratio [Baseline and up to Month 12]

   Urine samples were not planned to be collected for the analysis of urine albumin to creatinine ratio. The results for this outcome measure will never be posted.

2. Change From Baseline in Urinalysis Parameters: Urine Protein to Creatinine Ratio [Baseline and up to Month 12]

   Urine samples were not planned to be collected for the analysis of urine protein to creatinine ratio. The results for this outcome measure will never be posted.

3. Change From Baseline in Urinalysis Parameters: Urine Phosphate [Baseline and up to Month 12]

   Urine samples were not planned to be collected for the analysis of urine phosphate. The results for this outcome measure will never be posted.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Be able to understand and comply with protocol requirements, instructions, and restrictions;

• Understand the long-term commitment to the study and be likely to complete the study as planned;

• Be considered appropriate candidates for participation in an investigative clinical trial with oral and intramuscularly injectable medications (e.g., no active substance use disorder, acute major organ disease, or planned long-term work assignments out of the country, etc.).

All Participants eligible for enrolment in the study must meet all of the following criteria:

• Aged 18 years or older at the time of signing the informed consent.

• HIV-1 infected and must be on an active highly active antiretroviral therapy (HAART) (2 or 3 drug) regimen for at least 6 months prior to Screening. Any prior switch, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for treatment failure (HIV-1 RNA >=200 c/mL).

Acceptable stable ARV regimens prior to Screening include 2 NRTIs plus:

• INI (either the initial or second Combination antiretroviral therapy (cART) regimen)

• NNRTI (either the initial or second cART regimen)

• Boosted prediction interval (PI) (or atazanavir [ATV] unboosted) (must be either the initial cART regimen or one historical within class switch is permitted due to safety/tolerability)

• Any suppressed participants on a triple ART regimen for at least 6 months who had their regimen switched to a 2DR of dolutegravir (DTG)/RPV

• Documented evidence of at least two plasma HIV-1 RNA measurements <50 c/mL in the 12 months prior to Screening: at least one within 6 months prior to Screening;

• Plasma HIV-1 RNA <50 c/mL at Screening;

• A female participant is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin (hCG) test at screen and at Day 1), not lactating, and at least one of the following conditions applies:

1. Non-reproductive potential defined as:

• Pre-menopausal females with one of the following:

• Documented tubal ligation

• Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion

• Hysterectomy

• Documented Bilateral Oophorectomy

• Postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.

1. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication, throughout the study, and for at least 30 days after discontinuation of all oral study medications and for at least 52 weeks after discontinuation of CAB LA and RPV LA. The investigator is responsible for ensuring that participants understand how to properly use these methods of contraception.

• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. Eligible participants or their legal guardians (and next of kin when locally required), must sign a written Informed Consent Form before any protocol-specified assessments are conducted. Enrolment of participants who are unable to provide direct informed consent is optional and will be based on local legal/regulatory requirements and site feasibility to conduct protocol procedures.

Exclusion Criteria:

• Within 6 months prior to Screening, plasma HIV-1 RNA measurement >=50 c/mL;

• During the previous 12 months, any confirmed HIV-1 RNA measurement >=200 c/mL Exclusionary medical conditions

• Women who are pregnant, breastfeeding, or plan to become pregnant or breastfeed during the study

• Any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy, and Cluster of Differentiation (CD4+) counts <200 cells/microliter are not exclusionary

• Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.

• Participants determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant with a prior history of seizure may be considered for enrolment if the Investigator believes the risk of seizure recurrence is low.

• Participants who, in the investigator's judgment, pose a significant suicide risk. Participant's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk.

• The participant has a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions.

• Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV Deoxyribonucleic acid (DNA) as follows:

• Participants positive for HBsAg are excluded;

• Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded Note: Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded.

• Participants who are anticipated to require HCV treatment within 12 months must be excluded. Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded; investigators must carefully assess if therapy specific for HCV infection is required. (HCV treatment on study may be permitted, following consultation and approval of the direct acting antiviral (DAA) drug based therapy being considered with the medical monitor).

• Participants with HCV co-infection will be allowed entry into this study if:

• Liver enzymes meet entry criteria

• HCV Disease has undergone appropriate work-up, and is not advanced. Additional information (where available) on participants with HCV coinfection at screening should include results from any liver biopsy, Fibroscan, ultrasound, or other fibrosis evaluation, history of cirrhosis or other decompensated liver disease, prior treatment, and timing/plan for HCV treatment.

• In the event that recent biopsy or imaging data is not available or inconclusive, the Fib-4 score will be used to verify eligibility

• Fib-4 score >3.25 is exclusionary

• Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation Fibrosis 4 Score Formula: (Age x AST) / (Platelets x ( sqr [ ALT ])

• Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).

• History of liver cirrhosis with or without hepatitis viral co-infection.

• Ongoing or clinically relevant pancreatitis.

• Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease.

• Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the participant prior to inclusion.

• Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to receive study medication.

• History or presence of allergy or intolerance to the study drugs or their components or drugs of their class.

• Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (<=325 milligram (mg) per day) or hereditary coagulation and platelet disorders such as haemophilia or Von Willebrand Disease.

• Corrected QT interval (QTc [Bazett]) >450 milli second (msec) or QTc (Bazett) >480 msec for subjects with bundle branch block). Exclusionary Laboratory Values or Clinical Assessments (a single repeat to determine eligibility is allowed).

• Any evidence of primary resistance based on the presence of any major known INI or NNRTI resistance-associated mutation, except for K103N, (International acquired immune deficiency syndrome [AIDS] Society [IAS]-USA) by any historical resistance test result.

• ALT >=5 × Upper Limit Normal (ULN) or ALT >=3xULN and bilirubin >=1.5xULN (with >35% direct bilirubin) over the last 6 months.

• Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening phase to verify a result.

• Participant has estimated creatinine clearance <50 mL/min/1.73meter^2 via the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.

Concomitant Medications

• Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to Day 1 of this study;

• Treatment with any of the following agents within 28 days of Day 1:

• radiation therapy;

• cytotoxic chemotherapeutic agents;

• tuberculosis therapy with the exception of isoniazid (isonicotinylhydrazid [INH]);

• anti-coagulation agents;

• Immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons. Note: Participants using short-term (e.g. <=21 days) systemic corticosteroid treatment; topical, inhaled and intranasal corticosteroids are eligible for enrolment.

• Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.

• Use of medications which are associated with Torsade de Pointes must be discussed with the Medical Monitor to determine eligibility.

• Subjects receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication. Note: Any prohibited medications that decrease CAB or RPV concentrations should be discontinued for a minimum of four weeks or a minimum of three half-lives (whichever is longer) prior to the first dose and any other prohibited medications should be discontinued for a minimum of two weeks or a minimum of three half-lives (whichever is longer) prior to the first dose.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Sacramento	California	United States	95825
2	GSK Investigational Site	Washington	District of Columbia	United States	20017
3	GSK Investigational Site	Jacksonville	Florida	United States	32209
4	GSK Investigational Site	Miami Beach	Florida	United States	33140
5	GSK Investigational Site	Atlanta	Georgia	United States	30309
6	GSK Investigational Site	Berkley	Michigan	United States	48072
7	GSK Investigational Site	Jackson	Mississippi	United States	39216-4505
8	GSK Investigational Site	Kansas City	Missouri	United States	64111
9	GSK Investigational Site	Dallas	Texas	United States	75208

Sponsors and Collaborators

• ViiV Healthcare

Investigators

• Study Director: GSK Clinical Trials, ViiV Healthcare

Study Documents (Full-Text)

• Study Protocol - Nov 16, 2020
• Statistical Analysis Plan - Oct 29, 2020

More Information

Publications

None provided.

• Responsible Party: ViiV Healthcare
• ClinicalTrials.gov Identifier: NCT04001803
• Other Study ID Numbers: 209493
• First Posted: Jun 28, 2019
• Last Update Posted: May 17, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by ViiV Healthcare: Antiretroviral therapy, HIV infections, cabotegravir, rilpivirine, long-acting intramuscular injection,
• Additional relevant MeSH terms: HIV Infections

Study Results

Participant Flow

Recruitment Details

Total 115 participants were enrolled in study and received study treatment. The 24 study staff population (HIV care providers,nurses/staff performing CAB+LA injections administrators/clinic managers)is not considered participants in the study and were not counted in the enrolment number nor reported in any modules that are considered for enrolled participants as study staff didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections.

Pre-assignment Detail

Study staff participants only provided input through the completion of surveys, semi-structured interviews and facilitation calls. Participant flow, Baseline characteristics or adverse events for study staff participants were not collected because it was not required per study design. Results are presented based on primary analysis up to Month 12. Data collection is ongoing and additional results will be provided after study completion

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Period Title: Overall Study
STARTED	115
COMPLETED	1
NOT COMPLETED	114

Baseline Characteristics

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Overall Participants	115
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	38.8 (11.71)
Sex: Female, Male (Count of Participants)
Female	16 13.9%
Male	99 86.1%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaskan native	5 4.3%
Black or African American	42 36.5%
White-White/Caucasian/European heritage	66 57.4%
Black or African American and White	2 1.7%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in the Acceptability of Intervention Measure (AIM) Total Score in Staff Study Participants at Month 4
Description	AIM is a four item survey that assessed the acceptability of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the AIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline and Month 4

Outcome Measure Data

Analysis Population Description

All Staff study participants population

Arm/Group Title	Staff Study Participants
Arm/Group Description	Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
Measure Participants	24
Mean (Standard Deviation) [Scores on a scale]	0.00 (0.42)

2. Primary Outcome

Title	Change From Baseline in AIM Total Score in Staff Study Participants at Month 12
Description	AIM is a four item survey that assessed the acceptability of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the AIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline and Month 12

Outcome Measure Data

Analysis Population Description

All staff study participants population. Only those staff study participants who completed the survey were included in the analysis.

Arm/Group Title	Staff Study Participants
Arm/Group Description	Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
Measure Participants	23
Mean (Standard Deviation) [Scores on a scale]	0.02 (0.52)

3. Primary Outcome

Title	Change From Baseline in AIM Total Score in Participants With HIV Infection at Month 4
Description	AIM is a four item survey that assessed the acceptability of an implementation process. The participants were asked about their impressions of the CAB LA + RPV LA injection treatment for treating HIV on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline and Month 4

Outcome Measure Data

Analysis Population Description

Safety population consisted of all participants who were enrolled and received atleast one dose of CAB LA + RPV LA. Only those participants who completed the survey were included in the analysis

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	105
Mean (Standard Deviation) [Scores on a scale]	0.03 (0.74)

4. Primary Outcome

Title	Change From Baseline in AIM Total Score in Participants With HIV Infection at Month 12
Description	AIM is a four item survey that assessed the acceptability of an implementation process. The participants were asked about their impressions of the CAB LA + RPV LA injection treatment for treating HIV on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline and Month 12

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants who completed the survey were included in the analysis

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	102
Mean (Standard Deviation) [Scores on a scale]	0.19 (0.52)

5. Primary Outcome

Title	Change From Baseline in Intervention Appropriateness Measure (IAM) Score in Staff Study Participants at Month 4
Description	IAM is a four item survey that assessed the appropriateness of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline and Month 4

Outcome Measure Data

Analysis Population Description

All Staff study participants population

Arm/Group Title	Staff Study Participants
Arm/Group Description	Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
Measure Participants	24
Mean (Standard Deviation) [Scores on a scale]	-0.03 (0.50)

6. Primary Outcome

Title	Change From Baseline in IAM Score in Staff Study Participants at Month 12
Description	IAM is a four item survey that assessed the appropriateness of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline and Month 12

Outcome Measure Data

Analysis Population Description

All Staff study participant population. Only those staff study participants who completed the survey were included in the analysis.

Arm/Group Title	Staff Study Participants
Arm/Group Description	Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
Measure Participants	23
Mean (Standard Deviation) [Scores on a scale]	0.10 (0.43)

7. Primary Outcome

Title	Change From Baseline in IAM Score in Participants With HIV Infection at Month 4
Description	IAM is a four item survey that assessed the appropriateness of an implementation process. The participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline and Month 4

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants who completed the survey were included in the analysis.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	105
Mean (Standard Deviation) [Scores on a scale]	0.05 (0.78)

8. Primary Outcome

Title	Change From Baseline in IAM Score in Participants With HIV Infection at Month 12
Description	IAM is a four item survey that assessed the appropriateness of an implementation process. The participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline and Month 12

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	102
Mean (Standard Deviation) [Scores on a scale]	0.19 (0.58)

9. Primary Outcome

Title	Change From Baseline in Feasibility of Intervention Measure (FIM) Total Score in Staff Study Participants at Month 4
Description	FIM is a four item survey that assessed the feasibility of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the FIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The FIM total score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline and Month 4

Outcome Measure Data

Analysis Population Description

All staff study participants.

Arm/Group Title	Staff Study Participants
Arm/Group Description	Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
Measure Participants	24
Mean (Standard Deviation) [Scores on a scale]	-0.02 (0.63)

10. Primary Outcome

Title	Change From Baseline for FIM Total Score in Staff Study Participants at Month 12
Description	FIM is a four item survey that assessed the feasibility of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the FIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The FIM total score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline and Month 12

Outcome Measure Data

Analysis Population Description

All staff study participants population. Only those staff study participants who completed the survey were included in the analysis.

Arm/Group Title	Staff Study Participants
Arm/Group Description	Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
Measure Participants	23
Mean (Standard Deviation) [Scores on a scale]	0.07 (0.69)

11. Secondary Outcome

Title	Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Description	The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Not Applicable (NA) in the categories mean response was not offered. The toolkit resources consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs. The number of participants with the rating on helpfulness for each toolkit resources at Month 4 is presented.
Time Frame	At Month 4

Outcome Measure Data

Analysis Population Description

All staff study participants population.

Arm/Group Title	Staff Study Participants
Arm/Group Description	Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
Measure Participants	24
Website for clinical staff, EH	2 1.7%
Website for clinical staff, VH	3 2.6%
Website for clinical staff, SH	3 2.6%
Website for clinical staff, ALH	5 4.3%
Website for clinical staff, NAAH	1 0.9%
Website for clinical staff, NA	10 8.7%
Video on giving CAB + RPV LA injection, EH	3 2.6%
Video on giving CAB + RPV LA injection, VH	6 5.2%
Video on giving CAB + RPV LA injection, SH	4 3.5%
Video on giving CAB + RPV LA injection, ALH	2 1.7%
Video on giving CAB + RPV LA injection, NAAH	0 0%
Video on giving CAB + RPV LA injection, NA	9 7.8%
How to use new packaging card, EH	0 0%
How to use new packaging card, VH	6 5.2%
How to use new packaging card, SH	3 2.6%
How to use new packaging card, ALH	3 2.6%
How to use new packaging card, NAAH	1 0.9%
How to use new packaging card, NA	11 9.6%
Study factsheet for healthcare providers, EH	1 0.9%
Study factsheet for healthcare providers, VH	4 3.5%
Study factsheet for healthcare providers, SH	8 7%
Study factsheet for healthcare providers, ALH	1 0.9%
Study factsheet for healthcare providers, NAAH	1 0.9%
Study factsheet for healthcare providers, NA	9 7.8%
Consultation aid, EH	0 0%
Consultation aid, VH	4 3.5%
Consultation aid, SH	4 3.5%
Consultation aid, ALH	2 1.7%
Consultation aid, NAAH	1 0.9%
Consultation aid, NA	13 11.3%
Reminder-electronic (e)-application (app), EH	1 0.9%
Reminder e-app, VH	2 1.7%
Reminder e-app, SH	1 0.9%
Reminder e-app, ALH	2 1.7%
Reminder e-app, NAAH	0 0%
Reminder e-app, NA	18 15.7%
Reminder short message service (SMS)/text, EH	1 0.9%
Reminder SMS/text, VH	1 0.9%
Reminder SMS/text, SH	1 0.9%
Reminder SMS/text, ALH	2 1.7%
Reminder SMS/text, NAAH	0 0%
Reminder SMS/text, NA	19 16.5%
Face to face (F2F) training by healthcare staff, EH	5 4.3%
F2F training by healthcare staff, VH	6 5.2%
F2F training by healthcare staff, SH	3 2.6%
F2F training by healthcare staff, ALH	1 0.9%
F2F training by healthcare staff, NAAH	0 0%
F2F training by healthcare staff, NA	9 7.8%
Facilitation group calls, EH	0 0%
Facilitation group calls, VH	0 0%
Facilitation group calls, SH	7 6.1%
Facilitation group calls, ALH	8 7%
Facilitation group calls, NAAH	4 3.5%
Facilitation group calls, NA	5 4.3%
Web-based (WB) treatment planner, EH	4 3.5%
WB treatment planner, VH	5 4.3%
WB treatment planner, SH	1 0.9%
WB treatment planner, ALH	1 0.9%
WB treatment planner, NAAH	1 0.9%
WB treatment planner, NA	12 10.4%
WB health clinic capacity planning tool, EH	0 0%
WB health clinic capacity planning tool, VH	1 0.9%
WB health clinic capacity planning tool, SH	0 0%
WB health clinic capacity planning tool, ALH	0 0%
WB health clinic capacity planning tool, NAAH	1 0.9%
WB health clinic capacity planning tool, NA	22 19.1%
Injection flashcard for participants, EH	2 1.7%
Injection flashcard for participants, VH	2 1.7%
Injection flashcard for participants, SH	5 4.3%
Injection flashcard for participants, ALH	3 2.6%
Injection flashcard for participants, NAAH	0 0%
Injection flashcard for participants, NA	12 10.4%
Website for participants, EH	0 0%
Website for participants, VH	3 2.6%
Website for participants, SH	4 3.5%
Website for participants, ALH	2 1.7%
Website for participants, NAAH	0 0%
Website for participants, NA	15 13%
What to expect factsheet for participants, EH	1 0.9%
What to expect factsheet for participants, VH	5 4.3%
What to expect factsheet for participants, SH	7 6.1%
What to expect factsheet for participants, ALH	2 1.7%
What to expect factsheet for participants, NAAH	0 0%
What to expect factsheet for participants, NA	9 7.8%
Participant handbook, EH	3 2.6%
Participant handbook, VH	3 2.6%
Participant handbook, SH	5 4.3%
Participant handbook, ALH	0 0%
Participant handbook, NAAH	1 0.9%
Participant handbook, NA	12 10.4%
Frequently asked questions (FAQs) chatbot, EH	0 0%
FAQs chatbot, VH	1 0.9%
FAQs chatbot, SH	3 2.6%
FAQs chatbot, ALH	1 0.9%
FAQs chatbot, NAAH	1 0.9%
FAQs chatbot, NA	18 15.7%
Trial guide app, EH	0 0%
Trial guide app, VH	1 0.9%
Trial guide app, SH	2 1.7%
Trial guide app, ALH	1 0.9%
Trial guide app, NAAH	1 0.9%
Trial guide app, NA	19 16.5%
Video-what to expect, EH	7 6.1%
Video-what to expect, VH	4 3.5%
Video-what to expect, SH	1 0.9%
Video-what to expect, ALH	3 2.6%
Video-what to expect, NAAH	1 0.9%
Video-what to expect, NA	8 7%
Hot and cold packs for participants, EH	5 4.3%
Hot and cold packs for participants, VH	5 4.3%
Hot and cold packs for participants, SH	6 5.2%
Hot and cold packs for participants, ALH	2 1.7%
Hot and cold packs for participants, NAAH	0 0%
Hot and cold packs for participants, NA	6 5.2%

12. Secondary Outcome

Title	Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Description	The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Not Applicable (NA) in the categories mean response was not offered. The toolkit resources consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, WB treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs. The number of participants with the rating on helpfulness for each toolkit resources at Month 12 is presented.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

All staff study participants population. Only those staff study participants who completed the survey were included in the analysis.

Arm/Group Title	Staff Study Participants
Arm/Group Description	Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
Measure Participants	23
Website for clinical staff, EH	2 1.7%
Website for clinical staff, VH	2 1.7%
Website for clinical staff, SH	6 5.2%
Website for clinical staff, ALH	0 0%
Website for clinical staff, NAAH	0 0%
Website for clinical staff, NA	13 11.3%
Video on giving CAB + RPV LA injection, EH	4 3.5%
Video on giving CAB + RPV LA injection, VH	6 5.2%
Video on giving CAB + RPV LA injection, SH	7 6.1%
Video on giving CAB + RPV LA injection, ALH	0 0%
Video on giving CAB + RPV LA injection, NAAH	0 0%
Video on giving CAB + RPV LA injection, NA	6 5.2%
How to use new packaging card, EH	1 0.9%
How to use new packaging card, VH	3 2.6%
How to use new packaging card, SH	5 4.3%
How to use new packaging card, ALH	0 0%
How to use new packaging card, NAAH	0 0%
How to use new packaging card, NA	14 12.2%
Study factsheet for healthcare providers, EH	1 0.9%
Study factsheet for healthcare providers, VH	6 5.2%
Study factsheet for healthcare providers, SH	4 3.5%
Study factsheet for healthcare providers, ALH	1 0.9%
Study factsheet for healthcare providers, NAAH	0 0%
Study factsheet for healthcare providers, NA	11 9.6%
Consultation aid, EH	1 0.9%
Consultation aid, VH	1 0.9%
Consultation aid, SH	2 1.7%
Consultation aid, ALH	5 4.3%
Consultation aid, NAAH	0 0%
Consultation aid, NA	14 12.2%
Reminder e-app, EH	0 0%
Reminder e-app, VH	1 0.9%
Reminder e-app, SH	0 0%
Reminder e-app, ALH	0 0%
Reminder e-app, NAAH	1 0.9%
Reminder e-app, NA	21 18.3%
Reminder SMS/text, EH	1 0.9%
Reminder SMS/text, VH	1 0.9%
Reminder SMS/text, SH	0 0%
Reminder SMS/text, ALH	1 0.9%
Reminder SMS/text, NAAH	2 1.7%
Reminder SMS/text, NA	18 15.7%
F2F training by healthcare staff, EH	6 5.2%
F2F training by healthcare staff, VH	10 8.7%
F2F training by healthcare staff, SH	3 2.6%
F2F training by healthcare staff, ALH	0 0%
F2F training by healthcare staff, NAAH	0 0%
F2F training by healthcare staff, NA	4 3.5%
Facilitation group calls, EH	1 0.9%
Facilitation group calls, VH	1 0.9%
Facilitation group calls, SH	5 4.3%
Facilitation group calls, ALH	5 4.3%
Facilitation group calls, NAAH	4 3.5%
Facilitation group calls, NA	7 6.1%
WB treatment planner, EH	4 3.5%
WB treatment planner, VH	1 0.9%
WB treatment planner, SH	4 3.5%
WB treatment planner, ALH	0 0%
WB treatment planner, NAAH	1 0.9%
WB treatment planner, NA	13 11.3%
WB health clinic capacity planning tool, EH	0 0%
WB health clinic capacity planning tool, VH	0 0%
WB health clinic capacity planning tool, SH	2 1.7%
WB health clinic capacity planning tool, ALH	1 0.9%
WB health clinic capacity planning tool, NAAH	0 0%
WB health clinic capacity planning tool, NA	20 17.4%
Injection flashcard for participants, EH	2 1.7%
Injection flashcard for participants, VH	7 6.1%
Injection flashcard for participants, SH	2 1.7%
Injection flashcard for participants, ALH	1 0.9%
Injection flashcard for participants, NAAH	0 0%
Injection flashcard for participants, NA	11 9.6%
Website for participants, EH	0 0%
Website for participants, VH	3 2.6%
Website for participants, SH	3 2.6%
Website for participants, ALH	0 0%
Website for participants, NAAH	0 0%
Website for participants, NA	17 14.8%
What to expect factsheet for participants, EH	2 1.7%
What to expect factsheet for participants, VH	7 6.1%
What to expect factsheet for participants, SH	6 5.2%
What to expect factsheet for participants, ALH	1 0.9%
What to expect factsheet for participants, NAAH	0 0%
What to expect factsheet for participants, NA	7 6.1%
Participant handbook, EH	1 0.9%
Participant handbook, VH	5 4.3%
Participant handbook, SH	5 4.3%
Participant handbook, ALH	2 1.7%
Participant handbook, NAAH	0 0%
Participant handbook, NA	10 8.7%
FAQs chatbot, EH	0 0%
FAQs chatbot, VH	1 0.9%
FAQs chatbot, SH	0 0%
FAQs chatbot, ALH	1 0.9%
FAQs chatbot, NAAH	1 0.9%
FAQs chatbot, NA	20 17.4%
Trial guide app, EH	0 0%
Trial guide app, VH	0 0%
Trial guide app, SH	0 0%
Trial guide app, ALH	0 0%
Trial guide app, NAAH	1 0.9%
Trial guide app, NA	22 19.1%
Video-what to expect, EH	4 3.5%
Video-what to expect, VH	7 6.1%
Video-what to expect, SH	3 2.6%
Video-what to expect, ALH	0 0%
Video-what to expect, NAAH	0 0%
Video-what to expect, NA	9 7.8%
Hot and cold packs for participants, EH	6 5.2%
Hot and cold packs for participants, VH	6 5.2%
Hot and cold packs for participants, SH	6 5.2%
Hot and cold packs for participants, ALH	3 2.6%
Hot and cold packs for participants, NAAH	0 0%
Hot and cold packs for participants, NA	2 1.7%

13. Secondary Outcome

Title	Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Description	BIM is a 23-item survey which assessed barriers (that is, difficulties and challenges) to successful implementation of the CAB LA + RPV LA injection treatment in the study clinic/practices. For each item, providers were asked to rate how much they agreed or disagreed that the issue is a barrier based on their experiences with implementing the CAB + RPV treatment on a five point rating scale (1=completely disagree to 5=completely agree). It is presented as fewer perceived barriers (FPB)=all negative change in scores from Baseline, same perceived barriers (SPB)=change in score of 0 from Baseline, and greater/more perceived barriers (MPB)=all positive change in scores from Baseline.
Time Frame	Baseline and Month 4

Outcome Measure Data

Analysis Population Description

All staff study participants population.

Arm/Group Title	Staff Study Participants
Arm/Group Description	Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
Measure Participants	24
Interest in the new treatment, FPB	15 13%
Interest in the new treatment, SPB	6 5.2%
Interest in the new treatment, MPB	3 2.6%
Incentives for clinical practice change, FPB	15 13%
Incentives for clinical practice change, SPB	3 2.6%
Incentives for clinical practice change, MPB	6 5.2%
Ability to keep monthly appointments (apts), FPB	14 12.2%
Ability to keep monthly appointments, SPB	5 4.3%
Ability to keep monthly appointments, MPB	5 4.3%
Failing due to missed doses/injection apts, FPB	13 11.3%
Failing due to missed doses/injection apts, SPB	9 7.8%
Failing due to missed doses/injection apts, MPB	2 1.7%
Lack of familiarity with tools/resources, FPB	13 11.3%
Lack of familiarity with tools/resources, SPB	8 7%
Lack of familiarity with tools/resources, MPB	3 2.6%
Transportation for monthly apts, FPB	12 10.4%
Transportation for monthly apts, SPB	10 8.7%
Transportation for monthly apts, MPB	2 1.7%
Injection (Inj)/pain soreness, FPB	12 10.4%
Injection/pain soreness, SPB	10 8.7%
Injection/pain soreness, MPB	2 1.7%
Rescheduling missed injections, FPB	12 10.4%
Rescheduling missed injections, SPB	9 7.8%
Rescheduling missed injections, MPB	3 2.6%
Time for new method implementation CAB+RPV LA, FPB	12 10.4%
Time for new method implementation CAB+RPV LA, SPB	11 9.6%
Time for new method implementation CAB+RPV LA, MPB	1 0.9%
Flagging/awareness of missed injection visits, FPB	11 9.6%
Flagging/awareness of missed injection visits, SPB	9 7.8%
Flagging/awareness of missed injection visits, MPB	4 3.5%
Competing clinic priorities, FPB	11 9.6%
Competing clinic priorities, SPB	10 8.7%
Competing clinic priorities, MPB	3 2.6%
Manage for inj visits with other care need, FPB	10 8.7%
Manage for inj visits with other care need,SPB	8 7%
Manage for inj visit with other care need, MPB	6 5.2%
Transition from oral to injection treatment, FPB	10 8.7%
Transition from oral to injection treatment, SPB	13 11.3%
Transition from oral to injection treatment, MPB	1 0.9%
Time to administer the injection, FPB	10 8.7%
Time to administer the injection, SPB	10 8.7%
Time to administer the injection, MPB	4 3.5%
Number of exam rooms for injection, FPB	9 7.8%
Number of exam rooms for injection, SPB	9 7.8%
Number of exam rooms for injection, MPB	6 5.2%
Staff resourcing for clinic flow, FPB	9 7.8%
Staff resourcing for clinic flow, SPB	8 7%
Staff resourcing for clinic flow, MPB	7 6.1%
Staff buy-in, FPB	9 7.8%
Staff buy-in, SPB	13 11.3%
Staff buy-in, MPB	2 1.7%
Staff preparation, FPB	9 7.8%
Staff preparation, SPB	13 11.3%
Staff preparation, MPB	2 1.7%
Scheduling of apt reminders, FPB	8 7%
Scheduling of apt reminders, SPB	12 10.4%
Scheduling of apt reminders, MPB	4 3.5%
Answering questions between visits, FPB	7 6.1%
Answering questions between visits, SPB	11 9.6%
Answering questions between visits, MPB	6 5.2%
Scheduling of monthly apts, FPB	7 6.1%
Scheduling of monthly apts, SPB	13 11.3%
Scheduling of monthly apts, MPB	4 3.5%
Leadership support, FPB	6 5.2%
Leadership support, SPB	14 12.2%
Leadership support, MPB	4 3.5%
Storage/refrigeration, FPB	5 4.3%
Storage/refrigeration, SPB	11 9.6%
Storage/refrigeration, MPB	8 7%

14. Secondary Outcome

Title	Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Description	BIM is a 23-item survey which assessed barriers (i.e., difficulties and challenges) to successful implementation of the CAB LA + RPV LA injection treatment in the study clinic/practices. For each item, providers were asked to rate how much they agreed or disagreed that the issue is a barrier based on their experiences with implementing the CAB + RPV treatment on a five point rating scale (1=completely disagree to 5=completely agree). It is presented as fewer perceived barriers (FPB)=all negative change in scores from Baseline, same perceived barriers (SPB)=change in score of 0 from Baseline, and greater/more perceived barriers (MPB)=all positive change in scores from Baseline.
Time Frame	Baseline and Month 12

Outcome Measure Data

Analysis Population Description

All staff study participants population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Staff Study Participants
Arm/Group Description	Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
Measure Participants	23
Failing due to missed doses/injection apts, FPB	78.1 67.9%
Failing due to missed doses/injection apts, SPB	13.0 11.3%
Failing due to missed doses/injection apts, MPB	8.7 7.6%
Flagging/awareness of missed injection visits, FPB	69.5 60.4%
Flagging/awareness of missed injection visits, SPB	26.1 22.7%
Flagging/awareness of missed injection visits, MPB	4.3 3.7%
Ability to keep monthly appointments, FPB	65.2 56.7%
Ability to keep monthly appointments, SPB	34.8 30.3%
Ability to keep monthly appointments, MPB	0.0 0%
Transportation for monthly apts, FPB	60.8 52.9%
Transportation for monthly apts, SPB	34.8 30.3%
Transportation for monthly apts, MPB	4.3 3.7%
Time for new method implementation CAB+RPV LA, FPB	60.8 52.9%
Time for new method implementation CAB+RPV LA, SPB	26.1 22.7%
Time for new method implementation CAB+RPV LA, MPB	13.0 11.3%
Incentives for clinical practice change, FPB	60.7 52.8%
Incentives for clinical practice change, SPB	21.7 18.9%
Incentives for clinical practice change, MPB	17.4 15.1%
Interest in the new treatment, FPB	56.5 49.1%
Interest in the new treatment, SPB	26.1 22.7%
Interest in the new treatment, MPB	17.4 15.1%
Transition from oral to injection treatment, FPB	56.5 49.1%
Transition from oral to injection treatment, SPB	39.1 34%
Transition from oral to injection treatment, MPB	4.3 3.7%
Competing clinic priorities, FPB	52.1 45.3%
Competing clinic priorities, SPB	43.5 37.8%
Competing clinic priorities, MPB	4.3 3.7%
Manage for inj visits with other care need, FPB	52.1 45.3%
Manage for inj visits with other care need,SPB	43.5 37.8%
Manage for inj visit with other care need, MPB	4.3 3.7%
Number of exam rooms for injection, FPB	52.1 45.3%
Number of exam rooms for injection, SPB	21.7 18.9%
Number of exam rooms for injection, MPB	26.1 22.7%
Staff resourcing for clinic flow, FPB	52.1 45.3%
Staff resourcing for clinic flow, SPB	30.4 26.4%
Staff resourcing for clinic flow, MPB	17.4 15.1%
Scheduling of apt reminders, FPB	52.1 45.3%
Scheduling of apt reminders, SPB	34.8 30.3%
Scheduling of apt reminders, MPB	13.0 11.3%
Time to administer the injection, FPB	47.8 41.6%
Time to administer the injection, SPB	43.5 37.8%
Time to administer the injection, MPB	8.7 7.6%
Lack of familiarity with tools/resources, FPB	47.7 41.5%
Lack of familiarity with tools/resources, SPB	39.1 34%
Lack of familiarity with tools/resources, MPB	13.0 11.3%
Rescheduling missed injections, FPB	47.7 41.5%
Rescheduling missed injections, SPB	39.1 34%
Rescheduling missed injections, MPB	13.0 11.3%
Staff preparation, FPB	43.4 37.7%
Staff preparation, SPB	47.8 41.6%
Staff preparation, MPB	8.7 7.6%
Scheduling of monthly apts, FPB	43.4 37.7%
Scheduling of monthly apts, SPB	30.4 26.4%
Scheduling of monthly apts, MPB	8.7 7.6%
Answering questions between visits, FPB	39.1 34%
Answering questions between visits, SPB	43.5 37.8%
Answering questions between visits, MPB	17.4 15.1%
Leadership support, FPB	39.0 33.9%
Leadership support, SPB	43.5 37.8%
Leadership support, MPB	17.4 15.1%
Injection/pain soreness, FPB	34.8 30.3%
Injection/pain soreness, SPB	56.5 49.1%
Injection/pain soreness, MPB	8.7 7.6%
Staff buy-in, FPB	34.8 30.3%
Staff buy-in, SPB	56.5 49.1%
Staff buy-in, MPB	8.6 7.5%
Storage/refrigeration, FPB	34.8 30.3%
Storage/refrigeration, SPB	43.5 37.8%
Storage/refrigeration, MPB	21.7 18.9%

15. Secondary Outcome

Title	Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Description	The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Categories for did not receive (DNR) and recevied but did not use (RBDNU) were presented as well. Not Applicable (NA) in the data means participants were not offered the response option. The toolkit resources consisted of information and resources, hot and cold pack, written materials, website for participants, video, verbal information, reminder calls, reminder text messages, reminder app, peer group information session and appointments outside work time. The number of participants with the rating on helpfulness for each toolkit resources is presented.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	102
Information and resources, EH	50 43.5%
Information and resources, VH	40 34.8%
Information and resources, SH	4 3.5%
Information and resources, ALH	2 1.7%
Information and resources, NAAH	0 0%
Information and resources, DNR	6 5.2%
Information and resources, RBDNU	0 0%
Information and resources, Missing	0 0%
Hot and cold pack, EH	18 15.7%
Hot and cold pack, VH	20 17.4%
Hot and cold pack, SH	14 12.2%
Hot and cold pack, ALH	6 5.2%
Hot and cold pack, NAAH	8 7%
Hot and cold pack, DNR	9 7.8%
Hot and cold pack, RBDNU	27 23.5%
Hot and cold pack, Missing	0 0%
Written materials, EH	37 32.2%
Written materials, VH	37 32.2%
Written materials, SH	11 9.6%
Written materials, ALH	2 1.7%
Written materials, NAAH	0 0%
Written materials, DNR	1 0.9%
Written materials, RBDNU	14 12.2%
Written materials, Missing	0 0%
Website for participants, EH	25 21.7%
Website for participants, VH	28 24.3%
Website for participants, SH	11 9.6%
Website for participants, ALH	2 1.7%
Website for participants, NAAH	1 0.9%
Website for participants, DNR	4 3.5%
Website for participants, RBDNU	31 27%
Website for participants, Missing	0 0%
Video, EH	29 25.2%
Video, VH	38 33%
Video, SH	13 11.3%
Video, ALH	5 4.3%
Video, NAAH	1 0.9%
Video, DNR	9 7.8%
Video, RBDNU	6 5.2%
Video, Missing	1 0.9%
Verbal information, EH	69 60%
Verbal information, VH	31 27%
Verbal information, SH	2 1.7%
Verbal information, ALH	0 0%
Verbal information, NAAH	0 0%
Verbal information, DNR	0 0%
Verbal information, RBDNU	0 0%
Verbal information, Missing	0 0%
Reminder calls, EH	67 58.3%
Reminder calls, VH	24 20.9%
Reminder calls, SH	5 4.3%
Reminder calls, ALH	1 0.9%
Reminder calls, NAAH	1 0.9%
Reminder calls, DNR	4 3.5%
Reminder calls, RBDNU	0 0%
Reminder calls, Missing	0 0%
Reminder text messages, EH	63 54.8%
Reminder text messages, VH	19 16.5%
Reminder text messages, SH	4 3.5%
Reminder text messages, ALH	1 0.9%
Reminder text messages, NAAH	0 0%
Reminder text messages, DNR	15 13%
Reminder text messages, RBDNU	0 0%
Reminder text messages, Missing	0 0%
Reminder app, EH	26 22.6%
Reminder app, VH	14 12.2%
Reminder app, SH	3 2.6%
Reminder app, ALH	0 0%
Reminder app, NAAH	0 0%
Reminder app, DNR	28 24.3%
Reminder app, RBDNU	31 27%
Reminder app, Missing	0 0%
Peer group informational (info) session, EH	24 20.9%
Peer group info session, VH	27 23.5%
Peer group info session, SH	25 21.7%
Peer group info session, ALH	6 5.2%
Peer group info session, NAAH	20 17.4%
Peer group info session, DNR	NA NaN
Peer group info session, RBDNU	NA NaN
Peer group info session, Missing	0 0%
Apts outside work time, EH	63 54.8%
Apts outside work time, VH	22 19.1%
Apts outside work time, SH	13 11.3%
Apts outside work time, ALH	1 0.9%
Apts outside work time, NAAH	3 2.6%
Apts outside work time, DNR	NA NaN
Apts outside work time, RBDNU	NA NaN
Apts outside work time, Missing	0 0%

16. Secondary Outcome

Title	Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12
Description	Participants were asked to report any factors that were interfering with their ability to get the monthly CAB LA + RPV LA injection treatment. Number of participants along with the reasons for interference in ability to get CAB LA + RPV LA is presented.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	102
Pain or soreness from the injection	15 13%
Scheduling upcoming injection visits	2 1.7%
Rescheduling missed injection visits	1 0.9%
Forgetting appointment for the injection visits	2 1.7%
Frequency of required visits to clinic for inj	6 5.2%
Missing work too frequently for the injection	7 6.1%
Transportation to clinic/practice for inj visit	3 2.6%
Ease of parking at clinic/practice for inj visit	4 3.5%
Limited clinic/practice hours for inj visits	3 2.6%
Less privacy for inj visits than daily HIV medicine	1 0.9%
Nothing is interfering with getting this treatment	75 65.2%

17. Secondary Outcome

Title	Number of Barriers Assessed Among Clinics Using Short-term Facilitation
Description	The barriers were analyzed using semi-structured interviews from the validated consolidated framework for implementation research (CFIR) across 7 calls. An implementation science approach was used to understand the barriers for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants.
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	115
Facilitation call 1	5
Facilitation call 2	3
Facilitation call 3	7
Facilitation call 4	6
Facilitation call 5	4
Facilitation call 6	7
Facilitation call 7	3

18. Secondary Outcome

Title	Number of Facilitators Assessed Among Clinics Using Short-term Facilitation
Description	The facilitators were analyzed using semi-structured interviews from the validated CFIR across 7 calls. An implementation science approach was used to understand the facilitators for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants.
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	115
Facilitation call 1	7
Facilitation call 2	3
Facilitation call 3	3
Facilitation call 4	5
Facilitation call 5	9
Facilitation call 6	9
Facilitation call 7	8

19. Secondary Outcome

Title	Number of Best Practices Assessed Among Clinics Using Short-term Facilitation
Description	The best practices were analyzed using short-term facilitation calls. An implementation science approach was used to understand the best practices for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants.
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	115
Facilitation call 1	5
Facilitation call 2	2
Facilitation call 3	2
Facilitation call 4	5
Facilitation call 5	6
Facilitation call 6	6
Facilitation call 7	8

20. Secondary Outcome

Title	Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Description	Number of staff study participants using support materials/toolkit at Month 4 was assessed by variables: Not used, Used similar resource, used the support materials/toolkit. The support materials/toolkit consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs.
Time Frame	At Month 4

Outcome Measure Data

Analysis Population Description

All Staff study participants population

Arm/Group Title	Staff Study Participants
Arm/Group Description	Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
Measure Participants	24
Website for clinical staff, not used	9 7.8%
Website for clinical staff, used similar	1 0.9%
Website for clinical staff, used	14 12.2%
Video on giving CAB + RPV LA injection, not used	8 7%
Video on giving CAB + RPV LA injection, used similar	1 0.9%
Video on giving CAB + RPV LA injection, used	15 13%
How to use new packaging card, not used	11 9.6%
How to use new packaging card, used similar	0 0%
How to use new packaging card, used	13 11.3%
Study factsheet for HCP, not used	8 7%
Study factsheet for HCP, used similar	1 0.9%
Study factsheet for HCP, used	15 13%
Consultation aid, not used	12 10.4%
Consultation aid, used similar	1 0.9%
Consultation aid, used	11 9.6%
Reminder, e-app, not used	16 13.9%
Reminder e-app, used similar	2 1.7%
Reminder e-app, used	6 5.2%
Reminder SMS/text, not used	15 13%
Reminder SMS/text, used similar	4 3.5%
Reminder SMS/text, used	5 4.3%
F2F training, not used	8 7%
F2F training, used similar	1 0.9%
F2F training, used	15 13%
Facilitation group calls, not used	4 3.5%
Facilitation group calls, used similar	1 0.9%
Facilitation group calls, used	19 16.5%
WB treatment planner, not used	12 10.4%
WB treatment planner, used similar	0 0%
WB treatment planner, used	12 10.4%
WB health clinic capacity planning tool, not used	20 17.4%
WB health clinic planning tool, used similar	2 1.7%
WB health clinic capacity planning tool, used	2 1.7%
Injection flashcard, not used	10 8.7%
Injection flashcard, used similar	2 1.7%
Injection flashcard, used	12 10.4%
Website for participants, not used	14 12.2%
Website for participants, used similar	1 0.9%
Website for participants, used	9 7.8%
What to expect factsheet, not used	8 7%
What to expect factsheet, used similar	1 0.9%
What to expect factsheet, used	15 13%
Participant handbook, not used	12 10.4%
Participant handbook, used similar	0 0%
Participant handbook, used	12 10.4%
FAQ chatbot, not used	18 15.7%
FAQ chatbot, used similar	0 0%
FAQ chatbot, used	6 5.2%
Trial guide app, not used	19 16.5%
Trail guide app, used similar	0 0%
Trial guide app, used	5 4.3%
Video-what to expect, not used	8 7%
Video-what to expect, used similar	0 0%
Video-what to expect, used	16 13.9%
Hot and cold pack, not used	6 5.2%
Hot and cold pack, used similar	0 0%
Hot and cold pack, used	18 15.7%

21. Secondary Outcome

Title	Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Description	Number of staff study participants using support materials/toolkit at Month 12 was assessed by variables: Not used, Used similar resource, used the support materials/toolkit. The support materials/toolkit consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

All staff study participants population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Staff Study Participants
Arm/Group Description	Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
Measure Participants	23
Website for clinical staff, not used	13 11.3%
Website for clinical staff, used similar	0 0%
Website for clinical staff, used	10 8.7%
Video on giving CAB + RPV LA injection, not used	6 5.2%
Video on giving CAB + RPV LA injection, used similar	0 0%
Video on giving CAB + RPV LA injection, used	17 14.8%
How to use new packaging card, not used	14 12.2%
How to use new packaging card, used similar	0 0%
How to use new packaging card, used	9 7.8%
Study factsheet for HCP, not used	10 8.7%
Study factsheet for HCP, used similar	1 0.9%
Study factsheet for HCP, used	12 10.4%
Consultation aid, not used	14 12.2%
Consultation aid, used similar	0 0%
Consultation aid, used	9 7.8%
Reminder, e-app, not used	15 13%
Reminder e-app, used similar	6 5.2%
Reminder e-app, used	2 1.7%
Reminder SMS/text, not used	8 7%
Reminder SMS/text, used similar	10 8.7%
Reminder SMS/text, used	5 4.3%
F2F training, not used	3 2.6%
F2F training, used similar	1 0.9%
F2F training, used	19 16.5%
Facilitation group calls, not used	6 5.2%
Facilitation group calls, used similar	1 0.9%
Facilitation group calls, used	16 13.9%
WB treatment planner, not used	11 9.6%
WB treatment planner, used similar	2 1.7%
WB treatment planner, used	10 8.7%
WB health clinic capacity planning tool, not used	16 13.9%
WB health clinic planning tool, used similar	4 3.5%
WB health clinic capacity planning tool, used	3 2.6%
Injection flashcard, not used	9 7.8%
Injection flashcard, used similar	2 1.7%
Injection flashcard, used	12 10.4%
Website for participants, not used	15 13%
Website for participants, used similar	2 1.7%
Website for participants, used	6 5.2%
What to expect factsheet, not used	5 4.3%
What to expect factsheet, used similar	2 1.7%
What to expect factsheet, used	16 13.9%
Participant handbook, not used	8 7%
Participant handbook, used similar	2 1.7%
Participant handbook, used	13 11.3%
FAQ chatbot, not used	18 15.7%
FAQ chatbot, used similar	2 1.7%
FAQ chatbot, used	3 2.6%
Trial guide app, not used	20 17.4%
Trail guide app, used similar	2 1.7%
Trial guide app, used	1 0.9%
Video-what to expect, not used	8 7%
Video-what to expect, used similar	1 0.9%
Video-what to expect, used	14 12.2%
Hot and cold pack, not used	2 1.7%
Hot and cold pack, used similar	0 0%
Hot and cold pack, used	21 18.3%

22. Secondary Outcome

Title	Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Description	Participants with HIV infection were asked about their utilization of each element of the support materials/toolkit and were asked to categorize it as Extremely helpful (EH) Very helpful (VH), Somewhat helpful (SH), A little helpful (ALH), Not at all helpful (NAAH), did not receive (DNR), Received but did not use (RBDNU) and missing. Not Applicable (NA) in the data means participants were not offered the response option. The support materials/toolkit consisted of information and resources, hot and cold pack, written materials, website for participants, video, verbal information, reminder calls, reminder text messages, reminder app, peer group information session and appointments outside work time. Percentage of participants with the rating on helpfulness for each toolkit resources is presented.
Time Frame	At Month 4

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	105
Information and resources, EH	49.5 43%
Information and resources, VH	38.1 33.1%
Information and resources, SH	6.7 5.8%
Information and resources, ALH	1.9 1.7%
Information and resources, NAAH	0.0 0%
Information and resources, DNR	3.8 3.3%
Information and resources, RBDNU	0.0 0%
Information and resources, Missing	0.0 0%
Hot and cold pack, EH	19.0 16.5%
Hot and cold pack, VH	8.6 7.5%
Hot and cold pack, SH	21.9 19%
Hot and cold pack, ALH	8.6 7.5%
Hot and cold pack, NAAH	2.9 2.5%
Hot and cold pack, DNR	14.3 12.4%
Hot and cold pack, RBDNU	23.8 20.7%
Hot and cold pack, Missing	1.0 0.9%
Written materials, EH	38.1 33.1%
Written materials, VH	35.2 30.6%
Written materials, SH	12.4 10.8%
Written materials, ALH	1.9 1.7%
Written materials, NAAH	1.0 0.9%
Written materials, DNR	1.9 1.7%
Written materials, RBDNU	9.5 8.3%
Written materials, Missing	0.0 0%
Website, EH	21.0 18.3%
Website, VH	28.6 24.9%
Website, SH	5.7 5%
Website, ALH	1.9 1.7%
Website, NAAH	1.9 1.7%
Website, DNR	6.7 5.8%
Website, RBDNU	34.3 29.8%
Website, Missing	0.0 0%
Video, EH	28.6 24.9%
Video, VH	41.0 35.7%
Video, SH	12.4 10.8%
Video, ALH	4.8 4.2%
Video, NAAH	1.9 1.7%
Video, DNR	8.6 7.5%
Video, RBDNU	2.9 2.5%
Video, Missing	0.0 0%
Verbal information, EH	62.9 54.7%
Verbal information, VH	32.4 28.2%
Verbal information, SH	3.8 3.3%
Verbal information, ALH	0.0 0%
Verbal information, NAAH	0.0 0%
Verbal information, DNR	0.0 0%
Verbal information, RBDNU	0.0 0%
Verbal information, Missing	1.0 0.9%
Reminder calls, EH	61.0 53%
Reminder calls, VH	23.8 20.7%
Reminder calls, SH	4.8 4.2%
Reminder calls, ALH	4.8 4.2%
Reminder calls, NAAH	0.0 0%
Reminder calls, DNR	4.8 4.2%
Reminder calls, RBDNU	0.0 0%
Reminder calls, Missing	1.0 0.9%
Reminder text messages, EH	56.2 48.9%
Reminder text messages, VH	19.0 16.5%
Reminder text messages, SH	4.8 4.2%
Reminder text messages, ALH	1.0 0.9%
Reminder text messages, NAAH	0.0 0%
Reminder text messages, DNR	18.1 15.7%
Reminder text messages, RBDNU	0.0 0%
Reminder text messages, Missing	1.0 0.9%
Reminder app, EH	23.8 20.7%
Reminder app, VH	16.2 14.1%
Reminder app, SH	2.9 2.5%
Reminder app, ALH	1.9 1.7%
Reminder app, NAAH	0.0 0%
Reminder app, DNR	26.7 23.2%
Reminder app, RBDNU	28.6 24.9%
Reminder app, Missing	0.0 0%
Peer group informational (info) session, EH	22.9 19.9%
Peer group info session, VH	20.0 17.4%
Peer group info session, SH	33.3 29%
Peer group info session, ALH	8.6 7.5%
Peer group info session, NAAH	14.3 12.4%
Peer group info session, DNR	NA NaN
Peer group info session, RBDNU	NA NaN
Peer group info session, Missing	1.0 0.9%
Apts outside work time, EH	57.1 49.7%
Apts outside work time, VH	26.7 23.2%
Apts outside work time, SH	6.7 5.8%
Apts outside work time, ALH	4.8 4.2%
Apts outside work time, NAAH	4.8 4.2%
Apts outside work time, DNR	NA NaN
Apts outside work time, RBDNU	NA NaN
Apts outside work time, Missing	0.0 0%

23. Secondary Outcome

Title	Number of Participants Receiving Injections Within Target Window at Month 4
Description	Number of participants receiving injections within target window at Month 4 is presented. The target window is +/- 7 days from the target injection visit date.
Time Frame	At Month 4

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	105
Count of Participants [Participants]	100 87%

24. Secondary Outcome

Title	Number of Participants Receiving Injections Within Target Window at Month 12
Description	Number of participants receiving injections within target window at Month 12 is presented. The target window is +/- 7 days from the target injection visit date.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	102
Count of Participants [Participants]	96 83.5%

25. Secondary Outcome

Title	Implementation Sustainability Assessed in Staff Study Participants Using Program Sustainability Assessment Tool (PSAT) Scores
Description	Implementation sustainability in staff study participants was assessed using PSAT tool that evaluated capability of clinics to maintain processes developed to administer CAB+RPV injection in routine clinical settings after study conclusion.It consisted of 6 domains(1.Environmental support,2.Organizational capacity,3.Program evaluation,4.Program adaptation,5.Communications and 6.Strategic planning).Each domain consisted of 5 items,each assessed using 7-point numerical rating scale:1=to not extent at all,7=to a very great extent and an eighth not applicable/not able to answer response(NA).Score ranges for total domain scores are 5 to 35 for each of 6 domains(5 items in each domain on 1 to 7 scale).Numeric response to each item within specific domain is summed to produce a total domain score then mean domain score is calculated(excluding any NA responses).Higher scores indicate better outcome(higher endorsement/more positive impressions by staff-study with sustainability survey concepts)
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

All staff study participants population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Staff Study Participants
Arm/Group Description	Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
Measure Participants	23
Environmental support	5.82 (0.20)
Organizational capacity	5.74 (0.28)
Program evaluation	5.83 (0.49)
Program adaptation	5.98 (0.15)
Communications	6.09 (0.06)
Strategic planning	5.50 (0.34)

26. Secondary Outcome

Title	HIV Treatment Satisfaction Questionnaire Status Version (HIV-TSQs) Scores at Month 1
Description	Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment.
Time Frame	At Month 1

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	109
Mean (Standard Deviation) [Scores on a scale]	60.7 (6.3)

27. Secondary Outcome

Title	HIV-TSQs Scores at Month 4
Description	Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment.
Time Frame	At Month 4

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	105
Mean (Standard Deviation) [Scores on a scale]	62.12 (5.79)

28. Secondary Outcome

Title	HIV-TSQs Scores at Month 12
Description	Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	102
Mean (Standard Deviation) [Scores on a scale]	63.30 (3.81)

29. Secondary Outcome

Title	Number of Participants With Reported Acceptability of the Amount of Time Spent in the Clinic for Each Injection Visit
Description	The results for participant reported acceptability of the amount of time spent in the clinic for each injection visit is presented. Participants were asked to rate the acceptability of the amount of time spent in the clinic for each injection visit as extremely acceptable, very acceptable, somewhat acceptable, a little acceptable and not at all acceptable.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	102
Extremely acceptable	62 53.9%
Very acceptable	33 28.7%
Somewhat acceptable	7 6.1%
A little acceptable	0 0%
Not at all acceptable	0 0%

30. Secondary Outcome

Title	Number of Participants With the Reported Time Spent in Clinic/Practice for Each Injection Visit
Description	Number of participants with the reported time spent in clinic/practice for each injection visit is presented.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	101
1-15 minutes	14 12.2%
16-30 minutes	51 44.3%
31-45 minutes	23 20%
46-60 minutes	12 10.4%
More than 60 minutes	1 0.9%

31. Secondary Outcome

Title	Number of Participants With Extent of Knowledge About the CAB + RPV LA Treatment
Description	Participants were asked to rate how knowledgeable they feel about the CAB LA + RPV LA treatment as extremely knowledgeable, very knowledgeable, somewhat knowledgeable, a little knowledgeable and not at all knowledgeable.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	102
Extremely knowledgeable	34 29.6%
Very knowledgeable	40 34.8%
Somewhat knowledgeable	25 21.7%
A little knowledgeable	2 1.7%
Not at all knowledgeable	1 0.9%

32. Secondary Outcome

Title	Length of Participant Visit
Description	Length of visit was calculated by subtracting the arrival time (Lead time [actual start time of appointment - arrival time] + process time [actual end time of appointment - actual start time of appointment]) from actual end time of appointment.
Time Frame	At Months 1, 5 and 11

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	115
At Month 1, n=109	63.4 (29.51)
At Month 5, n=104	38.7 (19.91)
At Month 11, n=100	36.3 (16.85)

33. Secondary Outcome

Title	Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies/Milliliter (c/mL)
Description	Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA <50 c/mL (virologic success) was evaluated using the modified Food and Drug Administration (FDA) snapshot algorithm with Coronavirus Disease 2019 (COVID-19) related missing value imputed using the last observation carried forward (LOCF) approach.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	115
Month 1	93.9 81.7%
Month 2	94.8 82.4%
Month 4	91.3 79.4%
Month 6	90.4 78.6%
Month 8	88.7 77.1%
Month 10	87.8 76.3%
Month 12	88.7 77.1%

34. Secondary Outcome

Title	Percentage of Participants With Confirmed Virologic Failure (CVF)
Description	Plasma samples were collected for quantitative analysis of HIV-1 RNA. The CVF is defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels greater than or equal to (>=)200 copies/mL after prior suppression to <200 copies/mL.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	115
Number [Percentage of participants]	0 0%

35. Secondary Outcome

Title	Number of Participants With Treatment Emergent Genotypic Resistance to CAB and RPV
Description	Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1 RNA levels >=200 copies/mL after prior suppression to <200 copies/mL) with emergent genotypic resistance is summarized.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population. Only participants with CVF were included in the analysis

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	0

36. Secondary Outcome

Title	Number of Participants With Treatment Emergent Phenotypic Resistance to CAB and RPV
Description	Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1 RNA levels >=200 copies/mL after prior suppression to <200 copies/mL) with emergent phenotypic resistance is summarized.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population. Only participants with CVF were included in the analysis

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	0

37. Secondary Outcome

Title	Number of Participants With Serious Adverse Events (SAEs) and Common (>=5 Percent [%]) Non-serious Adverse Events (Non-SAEs)
Description	An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Number of participants with any SAE and common (>=5%) non-SAEs are presented.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	115
Common (>=5%) non-SAEs	96 83.5%
SAEs	5 4.3%

38. Secondary Outcome

Title	Percentage of Participants Who Discontinue Treatment or Withdraw From Study Due to AEs Over Time
Description	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Percentage of participants with adverse events leading to study treatment or study withdrawal has been presented. The percentage value presented has been rounded off.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	115
Number [Percentage of participants]	5 4.3%

39. Secondary Outcome

Title	Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Description	Blood samples were collected for the analysis of following hematology parameters: leukocytes, neutrophils and platelets. The parameters were graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scale from Grade 1 to 4, where Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	115
Leukocytes, increase from Grade 1 to 4	5 4.3%
Leukocytes, increase from Grade 2 to 4	2 1.7%
Leukocytes, increase from Grade 3 to 4	1 0.9%
Neutrophils, increase from Grade 1 to 4	8 7%
Neutrophils, increase from Grade 2 to 4	3 2.6%
Neutrophils, increase from Grade 3 to 4	1 0.9%
Platelets, increase from Grade 1 to 4	1 0.9%
Platelets, increase from Grade 2 to 4	0 0%
Platelets, increase from Grade 3 to 4	0 0%

40. Secondary Outcome

Title	Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Description	Blood samples were collected up to the Month 12 visit for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), creatine kinase (CK), creatinine, direct bilirubin, glucose, lipase, phosphate, potassium and sodium. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	115
ALT, increase from Grade 1 to 4	15 13%
ALT, increase from Grade 2 to 4	3 2.6%
ALT, increase from Grade 3 to 4	0 0%
ALP, increase from Grade 1 to 4	3 2.6%
ALP, increase from Grade 2 to 4	0 0%
ALP, increase from Grade 3 to 4	0 0%
AST, increase from Grade 1 to 4	8 7%
AST, increase from Grade 2 to 4	4 3.5%
AST, increase from Grade 3 to 4	0 0%
Bilirubin, increase from Grade 1 to 4	4 3.5%
Bilirubin, increase from Grade 2 to 4	1 0.9%
Bilirubin, increase from Grade 3 to 4	0 0%
CO2, increase from Grade 1 to 4	16 13.9%
CO2, increase from Grade 2 to 4	0 0%
CO2, increase from Grade 3 to 4	0 0%
CK, increase from Grade 1 to 4	11 9.6%
CK, increase from Grade 2 to 4	4 3.5%
CK, increase from Grade 3 to 4	1 0.9%
Creatinine, increase from Grade 1 to 4	2 1.7%
Creatinine, increase from Grade 2 to 4	1 0.9%
Creatinine, increase from Grade 3 to 4	0 0%
Direct bilirubin, increase from Grade 1 to 4	1 0.9%
Direct bilirubin, increase from Grade 2 to 4	1 0.9%
Direct bilirubin, increase from Grade 3 to 4	1 0.9%
Glucose, increase from Grade 1 to 4	18 15.7%
Glucose, increase from Grade 2 to 4	8 7%
Glucose, increase from Grade 3 to 4	0 0%
Lipase, increase from Grade 1 to 4	17 14.8%
Lipase, increase from Grade 2 to 4	11 9.6%
Lipase, increase from Grade 3 to 4	0 0%
Phosphate, increase from Grade 1 to 4	16 13.9%
Phosphate, increase from Grade 2 to 4	4 3.5%
Phosphate, increase from Grade 3 to 4	0 0%
Potassium, increase from Grade 1 to 4	4 3.5%
Potassium, increase from Grade 2 to 4	0 0%
Potassium, increase from Grade 3 to 4	0 0%
Sodium, increase from Grade 1 to 4	6 5.2%
Sodium, increase from Grade 2 to 4	0 0%
Sodium, increase from Grade 3 to 4	0 0%

41. Secondary Outcome

Title	Number of Participants With Urinalysis Result of Potential Clinical Importance
Description	Urine samples were collected to analyze the urine parameters: Protein, occult blood or glucose. Potential clinical importance is defined as an increase in protein (dipstick) or occult blood (dipstick) post-Baseline relative to Baseline. Number of participants with results of potential clinical importance in any of the urine parameters is presented.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	115
Count of Participants [Participants]	8 7%

42. Secondary Outcome

Title	Number of Participants With Injection Site Reactions (ISRs) Over Time
Description	Local tolerability was measured by injection site reaction (ISR), for example; bruise at the site of injection and/or itching, pain, blistering or skin damage. ISRs were assigned to the most recent planned injection visit prior to/on the onset date of the ISR. Number of participants with ISRs by each assigned injection visit is presented.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	115
Month 1	109 94.8%
Month 2	108 93.9%
Month 3	106 92.2%
Month 4	105 91.3%
Month 5	104 90.4%
Month 6	103 89.6%
Month 7	103 89.6%
Month 8	102 88.7%
Month 9	100 87%
Month 10	100 87%
Month 11	100 87%
Month 12	101 87.8%

43. Secondary Outcome

Title	Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count
Description	Blood samples were collected to analyze the hematology parameters: Platelets, WBCs, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline and up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	115
Platelets, n=100	-0.66 (33.512)
WBC count, n=101	0.27 (1.412)
Basophil count, n=101	0.006 (0.0232)
Eosinophil count, n=101	0.018 (0.1632)
Lymphocyte count, n=101	-0.0005 (0.49237)
Monocyte count, n=101	0.029 (0.1434)
Neutrophil count, n=101	0.214 (1.1746)

44. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Red Blood Cell (RBC) Count
Description	Blood samples were collected to analyze the hematology parameter: RBC count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline and up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	101
Mean (Standard Deviation) [10^12 cells per liter]	0.18 (0.260)

45. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Hemoglobin
Description	Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline and up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	101
Mean (Standard Deviation) [Grams per liter]	-1.11 (7.221)

46. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Hematocrit
Description	Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1). Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline and up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	101
Mean (Standard Deviation) [Percentage of red blood cells in blood]	-0.0022 (0.02554)

47. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume (MCV)
Description	Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline and up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	101
Mean (Standard Deviation) [Femtoliter]	-3.90 (2.961)

48. Secondary Outcome

Title	Absolute Values of the Hematology Parameters: Platelet Count, WBC Count , Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Description	Blood samples were collected for the analysis of hematology parameters including platelet count, WBCs, basophils, eosinophils, lymphocytes, monocytes and neutrophils
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	115
Platelets, n=100	238.78 (56.321)
WBC count, n=101	5.81 (1.606)
Basophil count, n=101	0.042 (0.0239)
Eosinophil count, n=101	0.160 (0.1305)
Lymphocyte count, n=101	1.9528 (0.58037)
Monocyte count, n=101	0.388 (0.1352)
Neutrophil count, n=101	3.269 (1.3055)

49. Secondary Outcome

Title	Absolute Values of Hematology Parameter: RBC Count
Description	Blood samples were collected to analyze the hematology parameter: RBC count.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	101
Mean (Standard Deviation) [10^12 cells per liter]	4.84 (0.504)

50. Secondary Outcome

Title	Absolute Values of Hematology Parameter: Hemoglobin
Description	Blood samples were collected to analyze the hematology parameter: Hemoglobin
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	101
Mean (Standard Deviation) [Grams per liter]	145.19 (11.121)

51. Secondary Outcome

Title	Absolute Values of Hematology Parameter: Hematocrit
Description	Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1)
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	101
Mean (Standard Deviation) [Percentage of red blood cells in blood]	0.4445 (0.03412)

52. Secondary Outcome

Title	Absolute Values of Hematology Parameter: Erythrocytes MCV
Description	Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	101
Mean (Standard Deviation) [Femtoliter]	92.37 (5.546)

53. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate
Description	Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline and up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	101
Sodium	0.2 (2.00)
Potassium	0.02 (0.295)
Carbon dioxide	-0.0 (2.20)
Chloride	-0.8 (2.34)
Glucose	-0.37 (1.636)
Urea	0.13 (1.324)
Phosphate	-0.005 (0.1853)

54. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin
Description	Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline and up to Month 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	101
Creatinine	-1.59 (14.736)
Bilirubin	0.9 (4.24)

55. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase
Description	Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline and up to Month 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	101
ALT	1.1 (14.17)
AST	0.5 (11.59)
ALP	0.3 (12.27)
Creatine kinase	-29.1 (278.65)

56. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA)
Description	Blood samples were collected from participants at indicated time points to analyze the clinical chemistry parameter: GFR from creatinine adjusted for BSA. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline and up to Month 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	101
Mean (Standard Deviation) [Milliliters/seconds/1.73 meter square]	0.00520 (0.221404)

57. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Lipase
Description	Blood samples were collected for the analysis of clinical chemistry parameter: Lipase. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline and up to Month 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	101
Mean (Standard Deviation) [Units per liter]	-2.3 (21.54)

58. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Albumin
Description	Blood samples were collected for the analysis of clinical chemistry parameter: Albumin. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline and up to Month 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	101
Mean (Standard Deviation) [Grams per liter]	0.2 (2.54)

59. Secondary Outcome

Title	Absolute Values of Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate.
Description	Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	101
Sodium	139.7 (1.67)
Potassium	4.15 (0.309)
Carbon dioxide	23.1 (2.02)
Chloride	103.8 (2.18)
Glucose	5.26 (1.425)
Urea	5.08 (1.588)
Phosphate	1.087 (0.1687)

60. Secondary Outcome

Title	Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin
Description	Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	101
Creatinine	89.10 (15.229)
Bilirubin	10.0 (5.10)

61. Secondary Outcome

Title	Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase
Description	Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	101
ALT	24.6 (17.52)
AST	21.7 (14.31)
ALP	69.0 (19.42)
Creatine kinase	181.4 (153.58)

62. Secondary Outcome

Title	Absolute Values of Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA)
Description	Blood samples were collected from participants to analyze the clinical chemistry parameter: GFR from Creatinine adjusted for BSA
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	101
Mean (Standard Deviation) [Milliliters/seconds/1.73 meter square]	1.60853 (0.305979)

63. Secondary Outcome

Title	Absolute Values of Clinical Laboratory Parameter: Lipase
Description	Blood samples were collected for the analysis of clinical chemistry parameter: Lipase.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	101
Mean (Standard Deviation) [Units per liter]	31.6 (25.92)

64. Secondary Outcome

Title	Absolute Values of Clinical Laboratory Parameter: Albumin
Description	Blood samples were collected for the analysis of clinical chemistry parameter: Albumin.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	101
Mean (Standard Deviation) [Grams per liter]	44.7 (2.74)

65. Other Pre-specified Outcome

Title	Change From Baseline in Urinalysis Parameters: Urine Albumin to Creatinine Ratio
Description	Urine samples were not planned to be collected for the analysis of urine albumin to creatinine ratio. The results for this outcome measure will never be posted.
Time Frame	Baseline and up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	0

66. Other Pre-specified Outcome

Title	Change From Baseline in Urinalysis Parameters: Urine Protein to Creatinine Ratio
Description	Urine samples were not planned to be collected for the analysis of urine protein to creatinine ratio. The results for this outcome measure will never be posted.
Time Frame	Baseline and up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	0

67. Other Pre-specified Outcome

Title	Change From Baseline in Urinalysis Parameters: Urine Phosphate
Description	Urine samples were not planned to be collected for the analysis of urine phosphate. The results for this outcome measure will never be posted.
Time Frame	Baseline and up to Month 12

Outcome Measure Data

Analysis Population Description

Safety population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.

Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
Measure Participants	0

Adverse Events

Time Frame	Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected from the start of study treatment until Month 12 analysis. The results presented are based on the Primary Analysis. Data collection is still on-going and additional results will be provided after study completion.
Adverse Event Reporting Description	Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
Arm/Group Title	Participants With HIV Infection
Arm/Group Description	Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
All Cause Mortality
	Participants With HIV Infection
	Affected / at Risk (%)	# Events
Total	1/115 (0.9%)
Serious Adverse Events
	Participants With HIV Infection
	Affected / at Risk (%)	# Events
Total	5/115 (4.3%)
General disorders
Chest pain	1/115 (0.9%)	1
Infections and infestations
Abscess limb	1/115 (0.9%)	1
Staphylococcal infection	1/115 (0.9%)	1
Injury, poisoning and procedural complications
Gun shot wound	1/115 (0.9%)	1
Overdose	1/115 (0.9%)	1
Metabolism and nutrition disorders
Diabetic ketoacidosis	1/115 (0.9%)	1
Psychiatric disorders
Mental status changes	2/115 (1.7%)	2
Drug abuse	1/115 (0.9%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/115 (0.9%)	1
Pneumonia aspiration	1/115 (0.9%)	1
Other (Not Including Serious) Adverse Events
	Participants With HIV Infection
	Affected / at Risk (%)	# Events
Total	96/115 (83.5%)
Gastrointestinal disorders
Diarrhoea	16/115 (13.9%)	17
Nausea	11/115 (9.6%)	11
General disorders
Injection site pain	61/115 (53%)	494
Injection site discomfort	28/115 (24.3%)	144
Fatigue	14/115 (12.2%)	38
Injection site induration	14/115 (12.2%)	26
Injection site nodule	13/115 (11.3%)	20
Injection site swelling	11/115 (9.6%)	16
Injection site bruising	9/115 (7.8%)	9
Pyrexia	6/115 (5.2%)	21
Infections and infestations
Nasopharyngitis	10/115 (8.7%)	10
Pharyngitis	8/115 (7%)	8
COVID-19	7/115 (6.1%)	7
Influenza	7/115 (6.1%)	7
Proctitis gonococcal	6/115 (5.2%)	7
Sinusitis	6/115 (5.2%)	6
Musculoskeletal and connective tissue disorders
Arthralgia	16/115 (13.9%)	20
Back pain	9/115 (7.8%)	10
Pain in extremity	7/115 (6.1%)	9
Nervous system disorders
Headache	13/115 (11.3%)	14
Psychiatric disorders
Insomnia	11/115 (9.6%)	11
Respiratory, thoracic and mediastinal disorders
Cough	9/115 (7.8%)	9
Skin and subcutaneous tissue disorders
Rash	9/115 (7.8%)	11

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.