PILLAR: A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States
Study Details
Study Description
Brief Summary
This is a two-arm study evaluating the impact of two implementation strategy conditions, dynamic implementation and routine implementation on the feasibility of delivering of Cabotegravir PrEP in low and high-volume PrEP sites in the United States for men who have sex with men (MSM) and Transgender men ≥ 18 years of age. There are two types of participants in the study. Patient Study Participants (PSPs) will refer to individuals who are enrolled in the study and who will receive commercially available Cabotegravir PrEP via prescription from the PrEP provider at the corresponding site. Staff Study Participants (SSPs) will refer to site staff who are involved in administrative and clinical aspects of offering and administering PrEP to PSPs and will participate in the staff study assessments.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Routine Implementation (RI) PSPs will receive APRETUDE injection and optional Cabotegravir tablets as oral lead in (OLI) . PSPs and SSPs will have access to standard toolkits for APRETUDE to use as needed. |
Drug: APRETUDE
Available as intramuscular injection.
Drug: Cabotegravir OLI
Available as marketed orally administered tablets.
|
| Experimental: Dynamic Implementation (DI) PSPs will receive APRETUDE injection and optional Cabotegravir tablets as oral lead in (OLI). PSPs and SSPs will have access to enhanced toolkits, a digital health end to end implementation strategy and implementation facilitation for APRETUDE to use. |
Drug: APRETUDE
Available as intramuscular injection.
Drug: Cabotegravir OLI
Available as marketed orally administered tablets.
|
Outcome Measures
Primary Outcome Measures
- Mean Feasibility of Intervention Measure (FIM) Score Based on Study Arm in SSPs [Month 13]
The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Mean FIM Score Based on Clinic Characteristics in SSPs [Month 13]
The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
Secondary Outcome Measures
- Change from Baseline in FIM Score Based on Study Arm in SSPs [Baseline (Month 1), Month 5 and 13]
The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Change from Baseline in FIM Score Based on Clinic Characteristics in SSPs [Baseline (Month 1), Month 5 and 13]
The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Perceptions of Facilitators and Barriers to RI, DI, and Overall Implementation of PrEP into Routine Care Assessed by Semi-Structured Qualitative Interviews (SSIs) in SSPs [Up to Month 13]
Perception of facilitators and barriers to RI, DI and overall implementation of PrEP measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) framework guided semi-structured qualitative interview.
- Perceptions of Facilitators and Barriers to RI, DI, and Overall Implementation of PrEP into Routine Care Assessed by Implementation Science Questionnaire (ISQ) in SSPs [Up to Month 13]
ISQ measures a range, including acceptability, feasibility and utility
- Perceptions of Facilitators and Barriers to RI, DI, and Overall Implementation of PrEP into Routine Care Assessed by FRAME-IS Responses in SSPs [Up to Month 13]
The Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) is a measure that will provide a precise understanding of modifications, the process of modifying or adapting, and the relationship between different forms of modification and subsequent health and implementation outcomes.
- Perceptions of Facilitators and Barriers to RI, DI, and Overall Implementation of PrEP into Routine Care Assessed by Implementation Monitoring Calls (IMC) in SSPs [Up to Month 13]
Perception of facilitators and barriers measured from themes emerged from IMC with sites using an interview guide.
- Perceptions of Facilitators and Barriers to RI, DI, and Overall Implementation of PrEP into Routine Care Assessed by Facilitation Calls in SSPs [Up to Month 13]
Perception of facilitators and barriers measured from themes emerged from facilitation calls with sites using an interview guide.
- Mean FIM Score Based on Study Arm in PSPs [Baseline (Month 1), Month 6, 7, 12 and 13]
The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Mean FIM Score Based on Clinic Characteristics in PSPs [Baseline (Month 1), Month 6, 7, 12 and 13]
The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Mean FIM Score Based on Initiation Method in PSPs [Baseline (Month 1), Month 6, 7, 12 and 13]
The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Mean FIM Score Based on Patient Subgroups [Baseline (Month 1), Month 6, 7, 12 and 13]
The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Mean Acceptability of Implementation Measure (AIM) Score Based on Study Arm in PSPs [Baseline (Month 1), Month 6, 7, 12 and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Mean AIM Score Based on Clinical Characteristics in PSPs [Baseline (Month 1), Month 6, 7, 12 and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Mean AIM Score Based on Initiation Method in PSPs [Baseline (Month 1), Month 6, 7, 12 and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Mean AIM Score Based on Patient Subgroups [Baseline (Month 1), Month 6, 7, 12 and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- ISQ Responses Based on Study Arm in PSPs [Baseline (Month 1), Month 6, 7, 12 and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- ISQ Responses Based on Clinical Characteristics in PSPs [Baseline (Month 1), Month 6, 7, 12 and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- ISQ Responses Based on Initiation Method in PSPs [Baseline (Month 1), Month 6, 7, 12 and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- ISQ Responses Based on Patient Subgroups [Baseline (Month 1), Month 6, 7, 12 and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Change from Baseline in AIM Score Based on Study Arm in PSPs [Baseline (Month 1) and Month 6, 7, 12 and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Change from Baseline in AIM Score Based on Clinic Characteristics in PSPs [Baseline (Month 1) and Month 6, 7, 12 and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Change from Baseline in AIM Score Based on Patient Subgroups [Baseline (Month 1) and Month 6, 7, 12 and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Change from Baseline in FIM Score Based on Study Arm in PSPs [Baseline (Month 1) and Month 6, 7, 12 and 13]
The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Change from Baseline in FIM Score Based on Clinic Characteristics in PSPs [Baseline (Month 1) and Month 6, 7, 12 and 13]
The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Change from Baseline in FIM Score Based on Patient Subgroup [Baseline (Month 1) and Month 6, 7, 12 and 13]
The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Change from Baseline in ISQ Responses Under Study Arm in PSPs [Baseline (Month 1) and Month 6, 7, 12 and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Change from Baseline in ISQ Responses Under Clinic Characteristics in PSPs [Baseline (Month 1) and Month 6, 7, 12 and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Change from Baseline in ISQ Responses Under Patient Subgroup [Baseline (Month 1) and Month 6, 7, 12 and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Perception of Facilitators and Barriers to Feasibility and Acceptability of APRETUDE Assessed by Semi-Structured Qualitative Interviews (SSIs) Based on Patient Subgroups [Up to Month 13]
Facilitators and barriers to feasibility and acceptability of APRETUDE measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) framework guided semi-structured qualitative interviews.
- Mean FIM Score for Telehealth Delivery Based on Study Arm in SSPs [Baseline (Month 1), Month 5, and 13]
The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Mean FIM Score for Telehealth Delivery Based on Clinic Characteristics in SSPs [Baseline (Month 1), Month 5, and 13]
The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Mean AIM Score for Telehealth Delivery Based on Study Arm in SSPs [Baseline (Month 1), Month 5, and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Mean AIM Score for Telehealth Delivery Based on Clinic Characteristics in SSPs [Baseline (Month 1), Month 5, and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- ISQ Responses for Telehealth Delivery Based on Study Arm in SSPs [Baseline (Month 1), Month 5, and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- ISQ Responses for Telehealth Delivery Based on Clinic Characteristics in SSPs [Baseline (Month 1), Month 5, and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Change from Baseline in FIM Score for Telehealth Delivery Based on Study Arm in SSPs [Baseline (Month 1) and Month 5, and 13]
The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Change from Baseline in FIM Score for Telehealth Delivery Based on Clinic Characteristics in SSPs [Baseline (Month 1) and Month 5, and 13]
The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Change from Baseline in AIM Score for Telehealth Delivery Under Study Arm in SSPs [Baseline (Month 1) and Month 5, and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Change from Baseline in AIM Score for Telehealth Delivery Under Clinic Characteristics in SSPs [Baseline (Month 1) and Month 5, and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Change from Baseline in ISQ Responses for Telehealth Delivery Under Study Arm in SSPs [Baseline (Month 1) and Month 5, and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Change from Baseline in ISQ Responses for Telehealth Delivery Under Clinic Characteristics in SSPs [Baseline (Month 1) and Month 5, and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Mean FIM Score for Telehealth Delivery Based on Study Arm in PSPs [Baseline (Month 1), Month 6, 7, 12 and 13]
The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Mean FIM Score for Telehealth Delivery Based on Clinic Characteristics in PSPs [Baseline (Month 1), Month 6, 7, 12 and 13]
The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Mean FIM Score for Telehealth Delivery Based on Patient Subgroups [Baseline (Month 1), Month 6, 7, 12 and 13]
The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Mean AIM Score for Telehealth Delivery Based on Study Arm in PSPs [Baseline (Month 1), Month 6, 7, 12 and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Mean AIM Score for Telehealth Delivery Based on Clinical Characteristics in PSPs [Baseline (Month 1), Month 6, 7, 12 and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Mean AIM Score for Telehealth Delivery Based on Patient Subgroups [Baseline (Month 1), Month 6, 7, 12 and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- ISQ Responses for Telehealth Delivery Based on Study Arm in PSPs [Baseline (Month 1), Month 6, 7, 12 and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- ISQ Responses for Telehealth Delivery Based on Clinic Characteristics in PSPs [Baseline (Month 1), Month 6, 7, 12 and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- ISQ Responses for Telehealth Delivery Based on Patient Subgroup [Baseline (Month 1), Month 6, 7, 12 and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Change from Baseline in FIM Score for Telehealth Delivery Based on Study Arm in PSPs [Baseline (Month 1) and Month 6, 7, 12 and 13]
The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Change from Baseline in FIM Score for Telehealth Delivery Based on Clinic Characteristics in PSPs [Baseline (Month 1) and Month 6, 7, 12 and 13]
The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Change from Baseline in FIM Score for Telehealth Delivery Based on Patient Subgroup [Baseline (Month 1) and Month 6, 7, 12 and 13]
The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Change from Baseline in AIM Score for Telehealth Delivery Based on Study Arm in PSPs [Baseline (Month 1) and Month 6, 7, 12 and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Change from Baseline in AIM Score for Telehealth Delivery Based on Clinic Characteristics in PSPs [Baseline (Month 1) and Month 6, 7, 12 and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Change from Baseline in AIM Score for Telehealth Delivery Based on Patient Subgroups [Baseline (Month 1) and Month 6, 7, 12 and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Change from Baseline in ISQ Responses for Telehealth Delivery Based on Study Arm in PSPs [Baseline (Month 1) and Month 6, 7, 12 and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Change from Baseline in ISQ Responses for Telehealth Delivery Based on Clinic Characteristics in PSPs [Baseline (Month 1) and Month 6, 7, 12 and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Change from Baseline in ISQ Responses for Telehealth Delivery Based on Patient Subgroups [Baseline (Month 1) and Month 6, 7, 12 and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery Assessed by SSIs in SSPs [Month 13]
Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.
- Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery Assessed by SSIs Based on Patient Subgroups [Up to Month 13]
Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.
- Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery Assessed by FRAME-IS Responses in SSPs [Month 13]
The FRAME-IS is a measure that will provide a precise understanding of modifications, the process of modifying or adapting, and the relationship between different forms of modification and subsequent health and implementation outcomes.
- Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery Assessed by FRAME-IS Responses Based on Patient Subgroups [Up to Month 13]
The FRAME-IS is a measure that will provide a precise understanding of modifications, the process of modifying or adapting, and the relationship between different forms of modification and subsequent health and implementation outcomes.
- Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery Assessed by Facilitation Calls in SSPs [Month 13]
Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery will be measured from themes emerged from calls with sites using an interview guide.
- Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery Assessed by Facilitation Calls Based on Patient Subgroups [Up to Month 13]
Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery will be measured from themes emerged from calls with sites using an interview guide.
- Mean AIM Score Based on Study Arm in SSPs [Baseline (Month 1), Month 5 and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Mean AIM Score Based on Clinic Characteristics in SSPs [Baseline (Month 1), Month 5 and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Mean AIM Score Based on Implementation Strategy in SSPs [Baseline (Month 1), Month 5 and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- IS Questionnaire Responses Based on Study Arm in SSPs [Baseline (Month 1), Month 5 and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- IS Questionnaire Responses Based on Clinical Characteristics in SSPs [Baseline (Month 1), Month 5 and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- IS Questionnaire Responses Based on Implementation Strategy in SSPs [Baseline (Month 1), Month 5 and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Change From Baseline in AIM Score Based on Study Arm in SSPs [Baseline (Month 1) and Month 5 and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes
- Change From Baseline in AIM Score Based on Clinical Characteristics in SSPs [Baseline (Month 1) and Month 5 and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Change From Baseline in AIM Score Based on Implementation Strategy in SSPs [Baseline (Month 1) and Month 5 and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Change From Baseline in ISQ Based on Study Arm in SSPs [Baseline (Month 1) and Month 5 and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Change From Baseline in ISQ Based on Clinical Characteristics in SSPs [Baseline (Month 1) and Month 5 and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Change From Baseline in ISQ Based on Implementation Strategy in SSPs [Baseline (Month 1) and Month 5 and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Mean AIM Score Based on Implementation Strategy in PSPs [Baseline (Month 1), Month 5 and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- ISQ Responses Based on Implementation Strategy in PSPs [Baseline (Month 1), Month 5 and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Change from Baseline in AIM Score Under Implementation Strategy in PSPs [Baseline (Month 1), and Month 5 and 13]
The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Change from Baseline in ISQ Responses Under Implementation Strategy in PSPs [Baseline (Month 1), and Month 5 and 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Proportion of SSPs that Respond in Agreement on Relevant Items on the ISQ that each Implementation Strategy is Fit for Based on Study Arm [Month 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Proportion of SSPs that Respond in Agreement on Relevant Items on the ISQ that each Implementation Strategy is Fit for Use Based on Clinic Characteristics [Month 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Proportion of PSPs that Respond in Agreement on Relevant Items on the ISQ that each Implementation Strategy is Fit for Use Based on Study Arm [Up to Month 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Proportion of PSPs that Respond in Agreement on Relevant Items on the ISQ that each Implementation Strategy is Fit for Use Based on Clinic Characteristics [Up to Month 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI Assessed by SSIs Based on SSPs Characteristics [Up to Month 13]
Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.
- Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI Assessed by ISQ Responses Based on SSPs Characteristics [Up to Month 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI Assessed by FRAME-IS Responses Based on SSPs Characteristics [Up to Month 13]
The Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) is a measure that will provide a precise understanding of modifications, the process of modifying or adapting, and the relationship between different forms of modification and subsequent health and implementation outcomes.
- Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI Assessed by IMC Based on SSPs Characteristics [Up to Month 13]
Perception of facilitators and barriers measured from themes emerged from IMC with sites using an interview guide.
- Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI Assessed by Facilitation Calls Based on SSPs Characteristics [Up to Month 13]
Perception of facilitators and barriers measured from themes emerged from facilitation calls with sites using an interview guide.
- Perceptions of Utility of Implementation Strategies Assessed by SSIs in PSPs Based on Patient Subgroups [Up to Month 13]
Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.
- Proportion of Injections Occurring within Target Window from Target Date Based on Study Arm [Up to Month 13]
The target window is - 7 days for injection dose 2 and ± 7 days of target date for subsequent injections.
- Proportion of Injections Occurring within Target Window from Target Date Based on Clinical Characteristics [Up to Month 13]
The target window is - 7 days for injection dose 2 and ± 7 days of target date for subsequent injections.
- Proportion of Injections Occurring within Target Window from Target Date Based on Patient Subgroups [Up to Month 13]
The target window is - 7 days for injection dose 2 and ± 7 days of target date for subsequent injections.
- Proportion of PSPs Completing Target Number of Injections Based on Patient Subgroups [Up to Month 13]
The target window is - 7 days for injection dose 2 and ± 7 days of target date for subsequent injections.
- Perception of Barriers and Facilitators to Fidelity to Injections Assessed by SSIs Based on Patient Subgroups in PSPs [Up to Month 13]
Perceptions of fidelity to injections measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.
- Perception of Barriers and Facilitators to Fidelity to Injections Assessed by IMC Based on Patient Subgroups in PSPs [Up to Month 13]
Perception to fidelity of injections measured from themes emerged from IMC with sites using an interview guide.
- Perception of Barriers and Facilitators to Fidelity to Injections Assessed by Facilitation Calls Based on Patient Subgroups in PSPs [Up to Month 13]
Perception to fidelity of injections measured from themes emerged from facilitation calls with sites using an interview guide.
- Perception of Barriers and Facilitators to Fidelity to Injections Assessed by ISQ Based on Patient Subgroups in PSPs [Up to Month 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Perception of Barriers and Facilitators to Fidelity to Injections Assessed by SSIs Based on Provider Subgroups in SSPs [Up to Month 13]
Perceptions of fidelity to injections measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.
- Perception of Barriers and Facilitators to Fidelity to Injections Assessed by FRAME-IS Response Based on Provider Subgroups in SSPs [Up to Month 13]
The Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) is a measure that will provide a precise understanding of modifications, the process of modifying or adapting, and the relationship between different forms of modification and subsequent health and implementation outcomes.
- Perception of Barriers and Facilitators to Fidelity to Injections Assessed by IMC Based on Provider Subgroups in SSPs [Up to Month 13]
Perception to fidelity of injections measured from themes emerged from IMC with sites using an interview guide.
- Perception of Barriers and Facilitators to Fidelity to Injections Assessed by Facilitation Calls Based on Provider Subgroups in SSPs [Up to Month 13]
Perception to fidelity of injections measured from themes emerged from facilitation calls with sites using an interview guide.
- Perception of Barriers and Facilitators to Fidelity to Injections Assessed by ISQ Based on Provider Subgroups in SSPs [Up to Month 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Proportion of Site Staff who Administer Sexual Health Assessment [Up to Month 13]
- Proportion of Eligible PSPs for Which Sexual Health Assessment are Administered [Up to Month 13]
- Proportion of MSM and TGM who take the Sexual Health Assessment Based on Clinic Characteristics [Up to Month 13]
- Proportion of MSM and TGM who take the Sexual Health Assessment Based on Patient Subgroups [Up to Month 13]
- Proportion of MSM and TGM who take the Sexual Health Assessment Based on Service Delivery Method [Up to Month 13]
- Proportion of MSM and TGM who report having had Sex in the Last 6 months through Month 13 on the Sexual Health Assessment by Service Delivery Method [Up to Month 13]
- Proportion of MSM and TGM who Expressed Interest in PrEP or Never Heard of PrEP out of those who Report Having had Sex in the last 6 Months through Month 13 by Service Delivery Method [Up to Month 13]
- Proportion of PSPs who initiate APRETUDE After Taking the Sexual Health Assessment Based on Clinic Characteristics [Up to Month 13]
- Proportion of PSPs who initiate APRETUDE After Taking the Sexual Health Assessment Based on Patient Subgroups [Up to Month 13]
- Proportion of PSPs who initiate APRETUDE After Taking the Sexual Health Assessment Based on Service Delivery Method [Up to Month 13]
- Perceptions of Sexual Health Assessment Assessed by SSIs Based on Patient Subgroups in PSPs [Up to Month 13]
Perceptions of sexual health assessment measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.
- Perceptions of Sexual Health Assessment Assessed by FRAME-IS Based on Patient Subgroups in PSPs [Up to Month 13]
The Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) is a measure that will provide a precise understanding of modifications, the process of modifying or adapting, and the relationship between different forms of modification and subsequent health and implementation outcomes.
- Perceptions of Sexual Health Assessment Assessed by IMC Based on Patient Subgroups in PSPs [Up to Month 13]
Perception to sexual health assessment measured from themes emerged from IMC with sites using an interview guide.
- Perceptions of Sexual Health Assessment Assessed by Facilitation Calls Based on Patient Subgroups in PSPs [Up to Month 13]
Perception to sexual health assessment measured from themes emerged from facilitation calls with sites using an interview guide.
- Perceptions of Sexual Health Assessment Assessed by ISQ Based on Patient Subgroups in PSPs [Up to Month 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Perceptions of Sexual Health Assessment Assessed by SSIs Based on Provider Subgroups in SSPs [Up to Month 13]
Perceptions of sexual health assessment measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.
- Perceptions of Sexual Health Assessment Assessed by FRAME-IS Based on Provider Subgroups in SSPs [Up to Month 13]
The Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) is a measure that will provide a precise understanding of modifications, the process of modifying or adapting, and the relationship between different forms of modification and subsequent health and implementation outcomes.
- Perceptions of Sexual Health Assessment Assessed by IMC Based on Provider Subgroups in SSPs [Up to Month 13]
Perception to sexual health assessment measured from themes emerged from IMC with sites using an interview guide.
- Perceptions of Sexual Health Assessment Assessed by Facilitation Calls Based on Provider Subgroups in SSPs [Up to Month 13]
Perception to sexual health assessment measured from themes emerged from facilitation calls with sites using an interview guide.
- Perceptions of Sexual Health Assessment Assessed by ISQ Based on Provider Subgroups in SSPs [Up to Month 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Components of Adaptations and Changes to Implementation Strategies Using FRAME-IS [Pre-implementation and up to Month 13]
The Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) is a measure that will provide a precise understanding of modifications, the process of modifying or adapting, and the relationship between different forms of modification and subsequent health and implementation outcomes.
- Components of Adaptations and Changes to Implementation Strategies Using SSIs in SSPs [Month 13]
Components of Adaptations and changes to implementation strategies assessed from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.
- Components of Adaptations and Changes to Implementation Strategies Using ISQ in SSPs [Month 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Components of Adaptations and Changes to Implementation Strategies Using FRAME-IS in SSPs [Month 13]
The Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) is a measure that will provide a precise understanding of modifications, the process of modifying or adapting, and the relationship between different forms of modification and subsequent health and implementation outcomes.
- Components of Adaptations and Changes to Implementation Strategies Using IMC in SSPs [Month 13]
Components of Adaptations and changes to implementation strategies measured from themes emerged from IMC with sites using an interview guide.
- Components of Adaptations and Changes to Implementation Strategies Using Facilitation Calls in SSPs [Month 13]
Components of Adaptations and changes to implementation strategies measured from themes emerged from facilitation calls with sites using an interview guide.
- Components of Adaptations and Changes to Implementation Strategies Using SSIs in PSPs [Up to Month 13]
Components of Adaptations and changes to implementation strategies assessed from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.
- Components of Adaptations and Changes to Implementation Strategies Using ISQ in PSPs [Up to Month 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Proportion of PSPs with History of PrEP Use that Complete the Sexual Health Assessment and ISQ and Start APRETUDE Based on Patient Subgroups [Up to Month 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Reasons for Choosing and Switching to APPRITUDE Assessed by SSI Based on Patient Subgroups [Up to Month 13]
Reasons for choosing and switching to APPRETUDE assessed from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.
- Reasons for Choosing and Switching to APPRITUDE Assessed by ISQ Based on Patient Subgroups [Up to Month 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Perceptions, Barriers and Facilitators Assessed by SSIs in SSPs [Up to Month 13]
Perceptions, Barriers and Facilitators assessed from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.
- Perceptions, Barriers and Facilitators Assessed by ISQ in SSPs [Up to Month 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Perceptions, Barriers and Facilitators Assessed by FRAME-IS in SSPs [Up to Month 13]
The Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) is a measure that will provide a precise understanding of modifications, the process of modifying or adapting, and the relationship between different forms of modification and subsequent health and implementation outcomes.
- Perceptions, Barriers and Facilitators Assessed by IMC in SSPs [Up to Month 13]
Perceptions, Barriers and Facilitators measured from themes emerged from IMC with sites using an interview guide.
- Perceptions, Barriers and Facilitators Assessed by Facilitation Calls in SSPs [Up to Month 13]
Perceptions, Barriers and Facilitators measured from themes emerged from facilitation calls with sites using an interview guide.
- Perceptions, Barriers and Facilitators Assessed by ISQ in PSPs [Up to Month 13]
ISQ measures a range, including acceptability, feasibility, and utility.
- Perceptions, Barriers and Facilitators Assessed by SSIs in PSPs [Up to Month 13]
Perceptions, Barriers and Facilitators assessed from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participant must be ≥ 18 years of age inclusive, at the time of signing the informed consent.
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No prior history of receiving CAB PrEP
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HIV negative test result at screening
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Capable of giving signed informed consent form
Exclusion Criteria:
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HIV indeterminate or positive test result during screening and prior to initiation of CAB PrEP
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A participant of concurrent interventional clinical or implementation science study at any time during the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Los Angeles | California | United States | 90036 |
| 2 | GSK Investigational Site | Orlando | Florida | United States | 32806 |
| 3 | GSK Investigational Site | Pensacola | Florida | United States | 32503 |
| 4 | GSK Investigational Site | Sarasota | Florida | United States | 31121 |
Sponsors and Collaborators
- ViiV Healthcare
Investigators
- Study Director: GSK Clinical Trials, ViiV Healthcare
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 217710