Real-life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program

• Sponsor: AbbVie (prior sponsor, Abbott) (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01662336
• Collaborator: (none)
• Enrollment: 173
• Duration (Months): 48

Study Details

Study Description

Brief Summary

The overall purpose of the study was to describe the real-life adherence, effectiveness and safety of the Kaletra Adherence Support Assistance (KASA) Program in human immunodeficiency virus (HIV)-positive patients who were receiving treatment with lopinavir / ritonavir (LPV/r; Kaletra®) in Canada.

Condition or Disease	Intervention/Treatment	Phase
Human Immunodeficiency Virus Infection	Drug: Lopinavir / ritonavir; Behavioral: Kaletra Adherence Support Assistance Program

Detailed Description

The Kaletra Adherence Support Assistance (KASA) Program is a customized support network that has been offered to patients treated with lopinavir / ritonavir (LPV/r; Kaletra®). KASA offers individual counseling with an HIV experienced nurse who assists patients with various aspects of their therapy including life-style changes, emotional stress, and adverse events. Patients enrolled in KASA may also have access to various healthcare professionals (dietician, social worker, psychologist, etc.) or may be offered other types of support (transportation, exercise, etc.), which may help improve their quality of life as well as adherence or compliance while taking LPV/r.

This was a 12-month, multi-center, Canadian Post Marketing Observational Study utilizing a prospective single cohort design. All treatments including participation in the KASA program were according to the decision of the treating physician and the patients and were not affected in any way by their decision to participate in the study. Follow-up was for 12 months at an interval of every six months.

Study Design

• Study Type: Observational
• Actual Enrollment: 173 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Real-Life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program: A Prospective Observational Cohort Study (KASA PMOS)
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm

Intervention/Treatment

Lopinavir/Ritonavir + KASA Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.

Drug: Lopinavir / ritonavir; Prescribed according to the product monograph and physician's discretion.; Other Names: Kaletra® LPV/r ; Behavioral: Kaletra Adherence Support Assistance Program; A customized support network for patients treated with lopinavir / ritonavir that offers individual counseling with an HIV experienced nurse who assists patients with various aspects of their therapy including life-style changes, emotional stress, and adverse events, and may provide access to various healthcare professionals or may offer other types of support such as transportation, exercise, etc.; Other Names: KASA

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Adherent to Treatment at Month 6 [Baseline and 6 months]

   Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12 item tool that measures the patient's confidence to undertake treatment related activities and behaviors including medication regimen, diet and exercise. Each question is answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy. A participant was considered to have maintained adherence if the change in the ASES summative score at month 6 relative to Baseline was greater than or equal to zero. Participants who discontinued from the study or were lost to follow-up were considered non-adherent.

Secondary Outcome Measures

1. Change From Baseline in Adherence Summative Score at Months 6 and 12 [Baseline, Month 6 and Month 12]

   Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the participant's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy.

2. Change From Baseline in Adherence Integration Subscale Score at Months 6 and 12 [Baseline, Month 6 and Month 12]

   Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the patient's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). The 12 items converge to two subscales measuring adherence integration and adherence perseverance. The adherence integration subscale score ranges from 0 to 90, with higher scores indicating higher treatment self-efficacy.

3. Change From Baseline in Adherence Perseverance Subscale Score at Months 6 and 12 [Baseline, Month 6 and Month 12]

   Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the patient's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). The 12 items converge to two subscales measuring adherence integration and adherence perseverance. The adherence perseverance subscale score ranges from 0 to 30, with higher scores indicating higher treatment self-efficacy.

4. Percentage of Participants Adherent to Treatment at Month 12 [Baseline and 12 months]

   Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12 item tool that measures the patient's confidence to undertake treatment related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy. A participant was considered to have maintained adherence if the change in the ASES summative score at month 12 was greater than or equal to zero. Participants who discontinued from the study or were lost to follow-up were considered non-adherent.

5. Change From Baseline in Health-related Quality of Life General Health Perception Domain Score [Baseline, Month 6 and Month 12]

   Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.

6. Change From Baseline in Health-related Quality of Life Physical Functioning Domain Score [Baseline, Month 6 and Month 12]

   Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.

7. Change From Baseline in Health-related Quality of Life Role Functioning Domain Score [Baseline, Month 6 and Month 12]

   Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.

8. Change From Baseline in Health-related Quality of Life Social Functioning Domain Score [Baseline, Month 6 and Month 12]

   Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.

9. Change From Baseline in Health-related Quality of Life Cognitive Functioning Domain Score [Baseline, Month 6 and Month 12]

   Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.

10. Change From Baseline in Health-related Quality of Life Pain Domain Score [Baseline, Month 6 and Month 12]

    Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.

11. Change From Baseline in Health-related Quality of Life Mental Health Domain Score [Baseline, Month 6 and Month 12]

    Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.

12. Change From Baseline in Health-related Quality of Life Energy/ Fatigue Domain Score [Baseline, Month 6 and Month 12]

    Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.

13. Change From Baseline in Patient Perception of Stress [Baseline, Month 6 and Month 12]

    Change in perception of stress was measured by the Perceived Stress Scale (PSS), a 10-item questionnaire that assesses the degree to which the participant considered situations as stressful. The PSS score ranges from 0 to 40, with higher scores indicating higher levels of perceived stress.

14. Change From Baseline in Psychological Well-being [Baseline, Month 6 and Month 12]

    Change in psychological well-being was measured by the Center for Epidemiologic Studies Depression scale (CES-D), a 20-item questionnaire assessing the presence of depressive state during the previous week. The possible range of scores is 0 to 60, with higher scores indicating the presence of more symptomatology.

15. Change From Baseline in Coping Self-Efficacy [Baseline, Month 6 and Month 12]

    Change in coping self-efficacy was measured by the Coping Self-Efficacy Scale (CSE), a 26-item questionnaire that measures perceived self-efficacy in coping with daily psychological challenges. A summative score ranging from 0 to 260 was calculated, with higher scores indicating higher coping self-efficacy.

16. Health Resource Utilization [Baseline, Month 6 and Month 12]

    Health resource utilization (HRU) was measured by a self-administered questionnaire that contained a series of questions aimed at measuring the patient's utilization of healthcare resources and economic impact of the disease.

17. Viral Load at Each Visit [Baseline, Month 6 and Month 12]

18. Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit [Baseline, Month 6 and Month 12]

19. Healthcare Provider Satisfaction [Month 6 and Month 12]

    For each participant, healthcare provider (HCP) satisfaction with the KASA program was measured by three questions assessing 1) the overall satisfaction with the KASA program, 2) subjective assessment on whether the KASA program was beneficial in maintaining adherence with HIV treatments, and 3) the likelihood of recommending KASA in the future. The scores for each question ranged from 0 to 100, with higher scores indicating higher satisfaction.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Subject is HIV-positive

• On treatment with LPV/r or currently initiated on treatment with LPV/r.

• Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel.

• Willing to be enrolled in the Kaletra Adherence Support Assistance (KASA) program.

• Prescribed LPV/r as part of his/her treatment by the treating physician.

Exclusion Criteria:

• Not willing to sign an informed consent.

• In the opinion of the treating physician is unlikely to be available for the 12-month follow-up duration of the study.

• Is currently participating in a clinical trial of an investigational product.

• Not willing to participate in the KASA program.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AbbVie (prior sponsor, Abbott)

Investigators

• Study Director: Christina Pelizon, MD, AbbVie Corporation

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: AbbVie (prior sponsor, Abbott)
• ClinicalTrials.gov Identifier: NCT01662336
• Other Study ID Numbers: P13-566
• First Posted: Aug 10, 2012
• Last Update Posted: Jan 29, 2018
• Last Verified: Jun 1, 2017

• Keywords provided by AbbVie (prior sponsor, Abbott): Human Immunodeficiency Virus infection
• Additional relevant MeSH terms: Virus Diseases; Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes; Ritonavir; Lopinavir

Study Results

Participant Flow

Recruitment Details	Patients were recruited from the practices of 8 physicians in Canada between 29 June 2012 and 06 August 2015.

Arm/Group Title	Lopinavir/Ritonavir + KASA
Arm/Group Description	Patients were treated according to the standard of care provided by their respective study sites. Treatments with lopinavir / ritonavir (LPV/r; Kaletra®) and participation in the Kaletra Adherence Support Assistance (KASA) program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
Period Title: Overall Study
STARTED	173
Completed Month 6 Visit	142
Completed Month 12 Visit	109
COMPLETED	107
NOT COMPLETED	66

Baseline Characteristics

Arm/Group Title	Lopinavir/Ritonavir + KASA
Arm/Group Description	Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
Overall Participants	173
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.7 (10.0)
Sex: Female, Male (Count of Participants)
Female	24 13.9%
Male	149 86.1%
Race/Ethnicity, Customized (Count of Participants)
American Indian/ Alaska	7 4%
Asian	13 7.5%
Black	15 8.7%
Hispanic or Latino	1 0.6%
Other	5 2.9%
White	130 75.1%
Missing	2 1.2%
Adherence Self-Efficacy Scale (ASES) Scores (units on a scale) [Mean (Standard Deviation) ]
Adherence Summative Score	102.5 (17.3)
Adherence Integration Subscale Score	77.1 (13.2)
Adherence Perseverance Subscale Score	25.0 (5.0)
Health Status Assessment (HSA) (units on a scale) [Mean (Standard Deviation) ]
General Health Perception	58.2 (23.2)
Physical Functioning	67.8 (26.2)
Role Functioning	68.3 (29.5)
Social Functioning	67.8 (26.4)
Cognitive Functioning	64.0 (24.3)
Pain	64.4 (24.8)
Mental Health	61.3 (22.6)
Energy/ Fatigue	54.8 (21.6)
Patient Perception of Stress (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	16.3 (7.5)
Psychological Well-being (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	18.4 (11.6)
Coping Self-Efficacy Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	187.0 (42.6)

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Adherent to Treatment at Month 6
Description	Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12 item tool that measures the patient's confidence to undertake treatment related activities and behaviors including medication regimen, diet and exercise. Each question is answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy. A participant was considered to have maintained adherence if the change in the ASES summative score at month 6 relative to Baseline was greater than or equal to zero. Participants who discontinued from the study or were lost to follow-up were considered non-adherent.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

The intent-to treat population included all enrolled participants who received at least 1 dose of lopinavir/ritonavir; participants with missing information on the absolute change in the ASES summative score who were not discontinued from the study or lost to follow-up were excluded.

Arm/Group Title	Lopinavir/Ritonavir + KASA
Arm/Group Description	Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
Measure Participants	157
Number (95% Confidence Interval) [percentage of participants]	43.3 25%

2. Secondary Outcome

Title	Change From Baseline in Adherence Summative Score at Months 6 and 12
Description	Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the participant's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy.
Time Frame	Baseline, Month 6 and Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with non-missing data at baseline and each time point

Arm/Group Title	Lopinavir/Ritonavir + KASA
Arm/Group Description	Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
Measure Participants	164
Change from Baseline to Month 6	-1.2 (16.9)
Change from Baseline to Month 12	-5.1 (21.1)

3. Secondary Outcome

Title	Change From Baseline in Adherence Integration Subscale Score at Months 6 and 12
Description	Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the patient's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). The 12 items converge to two subscales measuring adherence integration and adherence perseverance. The adherence integration subscale score ranges from 0 to 90, with higher scores indicating higher treatment self-efficacy.
Time Frame	Baseline, Month 6 and Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with non-missing data at baseline and each time point

Arm/Group Title	Lopinavir/Ritonavir + KASA
Arm/Group Description	Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
Measure Participants	168
Change from Baseline to Month 6	-0.7 (13.1)
Change from Baseline to Month 12	-3.6 (15.8)

4. Secondary Outcome

Title	Change From Baseline in Adherence Perseverance Subscale Score at Months 6 and 12
Description	Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the patient's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). The 12 items converge to two subscales measuring adherence integration and adherence perseverance. The adherence perseverance subscale score ranges from 0 to 30, with higher scores indicating higher treatment self-efficacy.
Time Frame	Baseline, Month 6 and Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with non-missing data at baseline and each time point

Arm/Group Title	Lopinavir/Ritonavir + KASA
Arm/Group Description	Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
Measure Participants	164
Change from Baseline to Month 6	-0.1 (4.9)
Change from Baseline to Month 12	-1.0 (6.2)

5. Secondary Outcome

Title	Percentage of Participants Adherent to Treatment at Month 12
Description	Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12 item tool that measures the patient's confidence to undertake treatment related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy. A participant was considered to have maintained adherence if the change in the ASES summative score at month 12 was greater than or equal to zero. Participants who discontinued from the study or were lost to follow-up were considered non-adherent.
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

The intent-to treat population; participants with missing information on the absolute change in the ASES summative score who were not discontinued from the study or lost to follow-up were excluded.

Arm/Group Title	Lopinavir/Ritonavir + KASA
Arm/Group Description	Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
Measure Participants	159
Number (95% Confidence Interval) [percentage of participants]	30.2 17.5%

6. Secondary Outcome

Title	Change From Baseline in Health-related Quality of Life General Health Perception Domain Score
Description	Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.
Time Frame	Baseline, Month 6 and Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with non-missing data at baseline and each time point.

Arm/Group Title	Lopinavir/Ritonavir + KASA
Arm/Group Description	Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
Measure Participants	166
Change from Baseline to Month 6	-1.0 (17.6)
Change from Baseline to Month 12	1.5 (17.7)

7. Secondary Outcome

Title	Change From Baseline in Health-related Quality of Life Physical Functioning Domain Score
Description	Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.
Time Frame	Baseline, Month 6 and Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with non-missing data at baseline and each time point.

Arm/Group Title	Lopinavir/Ritonavir + KASA
Arm/Group Description	Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
Measure Participants	169
Change from Baseline to Month 6	0.0 (21.8)
Change from Baseline to Month 12	0.1 (22.2)

8. Secondary Outcome

Title	Change From Baseline in Health-related Quality of Life Role Functioning Domain Score
Description	Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.
Time Frame	Baseline, Month 6 and Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with non-missing data at baseline and each time point.

Arm/Group Title	Lopinavir/Ritonavir + KASA
Arm/Group Description	Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
Measure Participants	168
Change from Baseline to Month 6	-0.4 (26.5)
Change from Baseline to Month 12	0.8 (27.1)

9. Secondary Outcome

Title	Change From Baseline in Health-related Quality of Life Social Functioning Domain Score
Description	Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.
Time Frame	Baseline, Month 6 and Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with non-missing data at baseline and each time point.

Arm/Group Title	Lopinavir/Ritonavir + KASA
Arm/Group Description	Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
Measure Participants	165
Change from Baseline to Month 6	0.4 (20.3)
Change from Baseline to Month 12	2.9 (23.5)

10. Secondary Outcome

Title	Change From Baseline in Health-related Quality of Life Cognitive Functioning Domain Score
Description	Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.
Time Frame	Baseline, Month 6 and Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with non-missing data at baseline and each time point.

Arm/Group Title	Lopinavir/Ritonavir + KASA
Arm/Group Description	Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
Measure Participants	167
Change from Baseline to Month 6	1.2 (18.3)
Change from Baseline to Month 12	4.7 (18.3)

11. Secondary Outcome

Title	Change From Baseline in Health-related Quality of Life Pain Domain Score
Description	Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.
Time Frame	Baseline, Month 6 and Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with non-missing data at baseline and each time point.

Arm/Group Title	Lopinavir/Ritonavir + KASA
Arm/Group Description	Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
Measure Participants	167
Change from Baseline to Month 6	-0.3 (17.7)
Change from Baseline to Month 12	-1.0 (19.5)

12. Secondary Outcome

Title	Change From Baseline in Health-related Quality of Life Mental Health Domain Score
Description	Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.
Time Frame	Baseline, Month 6 and Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with non-missing data at baseline and each time point.

Arm/Group Title	Lopinavir/Ritonavir + KASA
Arm/Group Description	Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
Measure Participants	168
Change from Baseline to Month 6	-3.0 (20.5)
Change from Baseline to Month 12	-1.4 (16.5)

13. Secondary Outcome

Title	Change From Baseline in Health-related Quality of Life Energy/ Fatigue Domain Score
Description	Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.
Time Frame	Baseline, Month 6 and Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with non-missing data at baseline and each time point.

Arm/Group Title	Lopinavir/Ritonavir + KASA
Arm/Group Description	Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
Measure Participants	168
Change from Baseline to Month 6	-2.4 (21.0)
Change from Baseline to Month 12	-0.1 (16.7)

14. Secondary Outcome

Title	Change From Baseline in Patient Perception of Stress
Description	Change in perception of stress was measured by the Perceived Stress Scale (PSS), a 10-item questionnaire that assesses the degree to which the participant considered situations as stressful. The PSS score ranges from 0 to 40, with higher scores indicating higher levels of perceived stress.
Time Frame	Baseline, Month 6 and Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with non-missing data at baseline and each time point.

Arm/Group Title	Lopinavir/Ritonavir + KASA
Arm/Group Description	Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
Measure Participants	166
Change from Baseline to Month 6	-0.3 (9.3)
Change from Baseline to Month 12	-0.8 (9.1)

15. Secondary Outcome

Title	Change From Baseline in Psychological Well-being
Description	Change in psychological well-being was measured by the Center for Epidemiologic Studies Depression scale (CES-D), a 20-item questionnaire assessing the presence of depressive state during the previous week. The possible range of scores is 0 to 60, with higher scores indicating the presence of more symptomatology.
Time Frame	Baseline, Month 6 and Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with non-missing data at baseline and each time point.

Arm/Group Title	Lopinavir/Ritonavir + KASA
Arm/Group Description	Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
Measure Participants	169
Change from Baseline to Month 6	1.7 (10.6)
Change from Baseline to Month 12	1.0 (10.0)

16. Secondary Outcome

Title	Change From Baseline in Coping Self-Efficacy
Description	Change in coping self-efficacy was measured by the Coping Self-Efficacy Scale (CSE), a 26-item questionnaire that measures perceived self-efficacy in coping with daily psychological challenges. A summative score ranging from 0 to 260 was calculated, with higher scores indicating higher coping self-efficacy.
Time Frame	Baseline, Month 6 and Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with non-missing data at baseline and each time point.

Arm/Group Title	Lopinavir/Ritonavir + KASA
Arm/Group Description	Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
Measure Participants	168
Change from Baseline to Month 6	2.4 (64.4)
Change from Baseline to Month 12	8.1 (54.9)

17. Secondary Outcome

Title	Health Resource Utilization
Description	Health resource utilization (HRU) was measured by a self-administered questionnaire that contained a series of questions aimed at measuring the patient's utilization of healthcare resources and economic impact of the disease.
Time Frame	Baseline, Month 6 and Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with non-missing data at each time point.

Arm/Group Title	Baseline	Month 6	Month 12
Arm/Group Description
Measure Participants	173	142	109
Emergency Room	8.1 4.7%	8.5 NaN	5.5 NaN
Admitted to Hospital	3.5 2%	2.8 NaN	3.7 NaN
Admitted to a Long-Term Care Facility	0.0 0%	0.7 NaN	0.9 NaN
Visit to a Doctor's Office/ Clinic	55.5 32.1%	50.7 NaN	50.5 NaN
Ambulance Service	2.9 1.7%	1.4 NaN	1.8 NaN
Physiotherapist/ Rehabilitation	3.5 2%	7.7 NaN	8.3 NaN
Psychiatrist/ Psychologist/ Counselor	9.2 5.3%	12.0 NaN	12.8 NaN
Nursing Services	12.7 7.3%	14.8 NaN	11.0 NaN
Specialist	16.2 9.4%	12.7 NaN	14.7 NaN

18. Secondary Outcome

Title	Viral Load at Each Visit
Time Frame	Baseline, Month 6 and Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with non-missing data at baseline and each time point

Arm/Group Title	Lopinavir/Ritonavir + KASA
Arm/Group Description	Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
Measure Participants	172
Baseline	111.3 (10.1)
Month 6	55.7 (3.7)
Month 12	47.2 (2.5)

19. Secondary Outcome

Title	Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit
Time Frame	Baseline, Month 6 and Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with non-missing data at each time point

Arm/Group Title	Lopinavir/Ritonavir + KASA
Arm/Group Description	Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
Measure Participants	171
Baseline	547.0 (294.21)
Month 6	620.8 (294.88)
Month 12	620.2 (301.45)

20. Secondary Outcome

Title	Healthcare Provider Satisfaction
Description	For each participant, healthcare provider (HCP) satisfaction with the KASA program was measured by three questions assessing 1) the overall satisfaction with the KASA program, 2) subjective assessment on whether the KASA program was beneficial in maintaining adherence with HIV treatments, and 3) the likelihood of recommending KASA in the future. The scores for each question ranged from 0 to 100, with higher scores indicating higher satisfaction.
Time Frame	Month 6 and Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with non-missing data at each time point

Arm/Group Title	Month 6	Month 12
Arm/Group Description
Measure Participants	142	109
Overall Satisfaction with KASA Program	74.1 (22.10)	73.3 (22.16)
Benefits in Maintaining Treatment Adherence	65.6 (26.38)	62.7 (25.25)
Likelihood to Recommend KASA Program in Future	74.7 (21.99)	70.0 (23.14)

Adverse Events

Time Frame	12 months
Arm/Group Title	Lopinavir/Ritonavir + KASA
Arm/Group Description	Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
All Cause Mortality
	Lopinavir/Ritonavir + KASA
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Lopinavir/Ritonavir + KASA
	Affected / at Risk (%)	# Events
Total	3/173 (1.7%)
Cardiac disorders
Cardiac disorder	1/173 (0.6%)
General disorders
Death	1/173 (0.6%)
Psychiatric disorders
Depression	1/173 (0.6%)
Other (Not Including Serious) Adverse Events
	Lopinavir/Ritonavir + KASA
	Affected / at Risk (%)	# Events
Total	0/173 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.