Trial Outcomes & Findings for Real-life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program (NCT NCT01662336)

NCT ID: NCT01662336

Last Updated: 2018-01-29

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 173 participants
• Primary outcome timeframe: Baseline and 6 months
• Results posted on: 2018-01-29

Participant Flow

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

Participant milestones

Measure	Lopinavir/Ritonavir + KASA 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.
Overall Study STARTED	173
Overall Study Completed Month 6 Visit	142
Overall Study Completed Month 12 Visit	109
Overall Study COMPLETED	107
Overall Study NOT COMPLETED	66

Reasons for withdrawal

Measure	Lopinavir/Ritonavir + KASA 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.
Overall Study Adverse Event	1
Overall Study No longer on LPV/r	30
Overall Study Other	29
Overall Study Withdrawal by Subject	6

Baseline Characteristics

Intent-to-treat population included all enrolled participants who received at least 1 dose of lopinavir/ritonavir; data are reported for participants with non-missing data at baseline.

Baseline characteristics by cohort

Measure	Lopinavir/Ritonavir + KASA n=173 Participants 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.
Age, Continuous	50.7 years STANDARD_DEVIATION 10.0 • n=173 Participants
Sex: Female, Male Female	24 Participants n=173 Participants
Sex: Female, Male Male	149 Participants n=173 Participants
Race/Ethnicity, Customized American Indian/ Alaska	7 Participants n=173 Participants
Race/Ethnicity, Customized Asian	13 Participants n=173 Participants
Race/Ethnicity, Customized Black	15 Participants n=173 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=173 Participants
Race/Ethnicity, Customized Other	5 Participants n=173 Participants
Race/Ethnicity, Customized White	130 Participants n=173 Participants
Race/Ethnicity, Customized Missing	2 Participants n=173 Participants
Adherence Self-Efficacy Scale (ASES) Scores Adherence Summative Score	102.5 units on a scale STANDARD_DEVIATION 17.3 • n=164 Participants • Intent-to-treat population included all enrolled participants who received at least 1 dose of lopinavir/ritonavir; data are reported for participants with non-missing data at baseline.
Adherence Self-Efficacy Scale (ASES) Scores Adherence Integration Subscale Score	77.1 units on a scale STANDARD_DEVIATION 13.2 • n=168 Participants • Intent-to-treat population included all enrolled participants who received at least 1 dose of lopinavir/ritonavir; data are reported for participants with non-missing data at baseline.
Adherence Self-Efficacy Scale (ASES) Scores Adherence Perseverance Subscale Score	25.0 units on a scale STANDARD_DEVIATION 5.0 • n=164 Participants • Intent-to-treat population included all enrolled participants who received at least 1 dose of lopinavir/ritonavir; data are reported for participants with non-missing data at baseline.
Health Status Assessment (HSA) General Health Perception	58.2 units on a scale STANDARD_DEVIATION 23.2 • n=166 Participants • Intent-to-treat population with non-missing data at baseline
Health Status Assessment (HSA) Physical Functioning	67.8 units on a scale STANDARD_DEVIATION 26.2 • n=169 Participants • Intent-to-treat population with non-missing data at baseline
Health Status Assessment (HSA) Role Functioning	68.3 units on a scale STANDARD_DEVIATION 29.5 • n=168 Participants • Intent-to-treat population with non-missing data at baseline
Health Status Assessment (HSA) Social Functioning	67.8 units on a scale STANDARD_DEVIATION 26.4 • n=165 Participants • Intent-to-treat population with non-missing data at baseline
Health Status Assessment (HSA) Cognitive Functioning	64.0 units on a scale STANDARD_DEVIATION 24.3 • n=167 Participants • Intent-to-treat population with non-missing data at baseline
Health Status Assessment (HSA) Pain	64.4 units on a scale STANDARD_DEVIATION 24.8 • n=167 Participants • Intent-to-treat population with non-missing data at baseline
Health Status Assessment (HSA) Mental Health	61.3 units on a scale STANDARD_DEVIATION 22.6 • n=168 Participants • Intent-to-treat population with non-missing data at baseline
Health Status Assessment (HSA) Energy/ Fatigue	54.8 units on a scale STANDARD_DEVIATION 21.6 • n=168 Participants • Intent-to-treat population with non-missing data at baseline
Patient Perception of Stress	16.3 units on a scale STANDARD_DEVIATION 7.5 • n=166 Participants • Intent-to-treat population with non-missing data at baseline
Psychological Well-being	18.4 units on a scale STANDARD_DEVIATION 11.6 • n=169 Participants • Intent-to-treat population with non-missing data at baseline
Coping Self-Efficacy Scale	187.0 units on a scale STANDARD_DEVIATION 42.6 • n=168 Participants • Intent-to-treat population with non-missing data at baseline

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: 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.

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.

Outcome measures

Measure	Lopinavir/Ritonavir + KASA n=157 Participants 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.	Month 6	Month 12
Percentage of Participants Adherent to Treatment at Month 6	43.3 percentage of participants Interval 35.9 to 50.7	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

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

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.

Outcome measures

Measure	Lopinavir/Ritonavir + KASA n=164 Participants 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.	Month 6	Month 12
Change From Baseline in Adherence Summative Score at Months 6 and 12 Change from Baseline to Month 6	-1.2 units on a scale Standard Deviation 16.9	—	—
Change From Baseline in Adherence Summative Score at Months 6 and 12 Change from Baseline to Month 12	-5.1 units on a scale Standard Deviation 21.1	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

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

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.

Outcome measures

Measure	Lopinavir/Ritonavir + KASA n=168 Participants 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.	Month 6	Month 12
Change From Baseline in Adherence Integration Subscale Score at Months 6 and 12 Change from Baseline to Month 6	-0.7 units on a scale Standard Deviation 13.1	—	—
Change From Baseline in Adherence Integration Subscale Score at Months 6 and 12 Change from Baseline to Month 12	-3.6 units on a scale Standard Deviation 15.8	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

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

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.

Outcome measures

Measure	Lopinavir/Ritonavir + KASA n=164 Participants 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.	Month 6	Month 12
Change From Baseline in Adherence Perseverance Subscale Score at Months 6 and 12 Change from Baseline to Month 6	-0.1 units on a scale Standard Deviation 4.9	—	—
Change From Baseline in Adherence Perseverance Subscale Score at Months 6 and 12 Change from Baseline to Month 12	-1.0 units on a scale Standard Deviation 6.2	—	—

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: 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.

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.

Outcome measures

Measure	Lopinavir/Ritonavir + KASA n=159 Participants 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.	Month 6	Month 12
Percentage of Participants Adherent to Treatment at Month 12	30.2 percentage of participants Interval 23.3 to 37.0	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

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

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.

Outcome measures

Measure	Lopinavir/Ritonavir + KASA n=166 Participants 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.	Month 6	Month 12
Change From Baseline in Health-related Quality of Life General Health Perception Domain Score Change from Baseline to Month 6	-1.0 units on a scale Standard Deviation 17.6	—	—
Change From Baseline in Health-related Quality of Life General Health Perception Domain Score Change from Baseline to Month 12	1.5 units on a scale Standard Deviation 17.7	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

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

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.

Outcome measures

Measure	Lopinavir/Ritonavir + KASA n=169 Participants 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.	Month 6	Month 12
Change From Baseline in Health-related Quality of Life Physical Functioning Domain Score Change from Baseline to Month 6	0.0 units on a scale Standard Deviation 21.8	—	—
Change From Baseline in Health-related Quality of Life Physical Functioning Domain Score Change from Baseline to Month 12	0.1 units on a scale Standard Deviation 22.2	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

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

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.

Outcome measures

Measure	Lopinavir/Ritonavir + KASA n=168 Participants 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.	Month 6	Month 12
Change From Baseline in Health-related Quality of Life Role Functioning Domain Score Change from Baseline to Month 6	-0.4 units on a scale Standard Deviation 26.5	—	—
Change From Baseline in Health-related Quality of Life Role Functioning Domain Score Change from Baseline to Month 12	0.8 units on a scale Standard Deviation 27.1	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

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

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.

Outcome measures

Measure	Lopinavir/Ritonavir + KASA n=165 Participants 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.	Month 6	Month 12
Change From Baseline in Health-related Quality of Life Social Functioning Domain Score Change from Baseline to Month 6	0.4 units on a scale Standard Deviation 20.3	—	—
Change From Baseline in Health-related Quality of Life Social Functioning Domain Score Change from Baseline to Month 12	2.9 units on a scale Standard Deviation 23.5	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

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

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.

Outcome measures

Measure	Lopinavir/Ritonavir + KASA n=167 Participants 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.	Month 6	Month 12
Change From Baseline in Health-related Quality of Life Cognitive Functioning Domain Score Change from Baseline to Month 6	1.2 units on a scale Standard Deviation 18.3	—	—
Change From Baseline in Health-related Quality of Life Cognitive Functioning Domain Score Change from Baseline to Month 12	4.7 units on a scale Standard Deviation 18.3	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

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

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.

Outcome measures

Measure	Lopinavir/Ritonavir + KASA n=167 Participants 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.	Month 6	Month 12
Change From Baseline in Health-related Quality of Life Pain Domain Score Change from Baseline to Month 6	-0.3 units on a scale Standard Deviation 17.7	—	—
Change From Baseline in Health-related Quality of Life Pain Domain Score Change from Baseline to Month 12	-1.0 units on a scale Standard Deviation 19.5	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

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

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.

Outcome measures

Measure	Lopinavir/Ritonavir + KASA n=168 Participants 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.	Month 6	Month 12
Change From Baseline in Health-related Quality of Life Mental Health Domain Score Change from Baseline to Month 6	-3.0 units on a scale Standard Deviation 20.5	—	—
Change From Baseline in Health-related Quality of Life Mental Health Domain Score Change from Baseline to Month 12	-1.4 units on a scale Standard Deviation 16.5	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

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

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.

Outcome measures

Measure	Lopinavir/Ritonavir + KASA n=168 Participants 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.	Month 6	Month 12
Change From Baseline in Health-related Quality of Life Energy/ Fatigue Domain Score Change from Baseline to Month 6	-2.4 units on a scale Standard Deviation 21.0	—	—
Change From Baseline in Health-related Quality of Life Energy/ Fatigue Domain Score Change from Baseline to Month 12	-0.1 units on a scale Standard Deviation 16.7	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

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

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.

Outcome measures

Measure	Lopinavir/Ritonavir + KASA n=166 Participants 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.	Month 6	Month 12
Change From Baseline in Patient Perception of Stress Change from Baseline to Month 6	-0.3 units on a scale Standard Deviation 9.3	—	—
Change From Baseline in Patient Perception of Stress Change from Baseline to Month 12	-0.8 units on a scale Standard Deviation 9.1	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

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

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.

Outcome measures

Measure	Lopinavir/Ritonavir + KASA n=169 Participants 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.	Month 6	Month 12
Change From Baseline in Psychological Well-being Change from Baseline to Month 6	1.7 units on a scale Standard Deviation 10.6	—	—
Change From Baseline in Psychological Well-being Change from Baseline to Month 12	1.0 units on a scale Standard Deviation 10.0	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

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

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.

Outcome measures

Measure	Lopinavir/Ritonavir + KASA n=168 Participants 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.	Month 6	Month 12
Change From Baseline in Coping Self-Efficacy Change from Baseline to Month 6	2.4 units on a scale Standard Deviation 64.4	—	—
Change From Baseline in Coping Self-Efficacy Change from Baseline to Month 12	8.1 units on a scale Standard Deviation 54.9	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

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

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.

Outcome measures

Measure	Lopinavir/Ritonavir + KASA n=173 Participants 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.	Month 6 n=142 Participants	Month 12 n=109 Participants
Health Resource Utilization Emergency Room	8.1 percentage of participants	8.5 percentage of participants	5.5 percentage of participants
Health Resource Utilization Admitted to Hospital	3.5 percentage of participants	2.8 percentage of participants	3.7 percentage of participants
Health Resource Utilization Admitted to a Long-Term Care Facility	0.0 percentage of participants	0.7 percentage of participants	0.9 percentage of participants
Health Resource Utilization Visit to a Doctor's Office/ Clinic	55.5 percentage of participants	50.7 percentage of participants	50.5 percentage of participants
Health Resource Utilization Ambulance Service	2.9 percentage of participants	1.4 percentage of participants	1.8 percentage of participants
Health Resource Utilization Physiotherapist/ Rehabilitation	3.5 percentage of participants	7.7 percentage of participants	8.3 percentage of participants
Health Resource Utilization Psychiatrist/ Psychologist/ Counselor	9.2 percentage of participants	12.0 percentage of participants	12.8 percentage of participants
Health Resource Utilization Nursing Services	12.7 percentage of participants	14.8 percentage of participants	11.0 percentage of participants
Health Resource Utilization Specialist	16.2 percentage of participants	12.7 percentage of participants	14.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

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

Outcome measures

Measure	Lopinavir/Ritonavir + KASA n=172 Participants 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.	Month 6	Month 12
Viral Load at Each Visit Baseline	111.3 copies/mL Standard Deviation 10.1	—	—
Viral Load at Each Visit Month 6	55.7 copies/mL Standard Deviation 3.7	—	—
Viral Load at Each Visit Month 12	47.2 copies/mL Standard Deviation 2.5	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

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

Outcome measures

Measure	Lopinavir/Ritonavir + KASA n=171 Participants 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.	Month 6	Month 12
Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit Baseline	547.0 cells/mm³ Standard Deviation 294.21	—	—
Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit Month 6	620.8 cells/mm³ Standard Deviation 294.88	—	—
Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit Month 12	620.2 cells/mm³ Standard Deviation 301.45	—	—

SECONDARY outcome

Timeframe: Month 6 and Month 12

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

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.

Outcome measures

Measure	Lopinavir/Ritonavir + KASA n=142 Participants 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.	Month 6 n=109 Participants	Month 12
Healthcare Provider Satisfaction Overall Satisfaction with KASA Program	74.1 units on a scale Standard Deviation 22.10	73.3 units on a scale Standard Deviation 22.16	—
Healthcare Provider Satisfaction Benefits in Maintaining Treatment Adherence	65.6 units on a scale Standard Deviation 26.38	62.7 units on a scale Standard Deviation 25.25	—
Healthcare Provider Satisfaction Likelihood to Recommend KASA Program in Future	74.7 units on a scale Standard Deviation 21.99	70.0 units on a scale Standard Deviation 23.14	—

Adverse Events

Lopinavir/Ritonavir + KASA

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lopinavir/Ritonavir + KASA n=173 participants at risk 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.
Cardiac disorders Cardiac disorder	0.58% 1/173 • 12 months
General disorders Death	0.58% 1/173 • 12 months
Psychiatric disorders Depression	0.58% 1/173 • 12 months

Other adverse events

Adverse event data not reported

Additional Information

Global Medical Services

AbbVie (prior Sponsor Abbott)

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER