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

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ClinicalTrials.gov Identifier: NCT01662336
Recruitment Status : Completed
First Posted : August 10, 2012
Results First Posted : January 29, 2018
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Human Immunodeficiency Virus Infection
Interventions Drug: Lopinavir / ritonavir
Behavioral: Kaletra Adherence Support Assistance Program
Enrollment 173

Recruitment Details Patients were recruited from the practices of 8 physicians in Canada between 29 June 2012 and 06 August 2015.
Pre-assignment Details  
Arm/Group Title Lopinavir/Ritonavir + KASA
Hide 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
Reason Not Completed
Adverse Event             1
No longer on LPV/r             30
Other             29
Withdrawal by Subject             6
Arm/Group Title Lopinavir/Ritonavir + KASA
Hide 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 Number of Baseline Participants 173
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 173 participants
50.7  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 173 participants
Female
24
  13.9%
Male
149
  86.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 173 participants
American Indian/ Alaska
7
   4.0%
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   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Adherence Summative Score Number Analyzed 164 participants
102.5  (17.3)
Adherence Integration Subscale Score Number Analyzed 168 participants
77.1  (13.2)
Adherence Perseverance Subscale Score Number Analyzed 164 participants
25.0  (5.0)
[1]
Measure Description: The ASES is a 12 item tool that measures 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 ranges from 0 to 120, with higher scores indicating higher treatment self-efficacy. The 12 items converge to two subscales measuring adherence integration and adherence perseverance. The adherence integration subscale score ranges from 0 to 90 and the adherence perseverance subscale score ranges from 0 to 30.
[2]
Measure Analysis Population Description: 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)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
General Health Perception Number Analyzed 166 participants
58.2  (23.2)
Physical Functioning Number Analyzed 169 participants
67.8  (26.2)
Role Functioning Number Analyzed 168 participants
68.3  (29.5)
Social Functioning Number Analyzed 165 participants
67.8  (26.4)
Cognitive Functioning Number Analyzed 167 participants
64.0  (24.3)
Pain Number Analyzed 167 participants
64.4  (24.8)
Mental Health Number Analyzed 168 participants
61.3  (22.6)
Energy/ Fatigue Number Analyzed 168 participants
54.8  (21.6)
[1]
Measure Description: Quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA), a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The survey includes 21 items assessing 8 domains of health-related QoL 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.
[2]
Measure Analysis Population Description: Intent-to-treat population with non-missing data at baseline
Patient Perception of Stress   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 166 participants
16.3  (7.5)
[1]
Measure Description: 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.
[2]
Measure Analysis Population Description: Intent-to-treat population with non-missing data at baseline
Psychological Well-being   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 169 participants
18.4  (11.6)
[1]
Measure Description: 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.
[2]
Measure Analysis Population Description: Intent-to-treat population with non-missing data at baseline
Coping Self-Efficacy Scale   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 168 participants
187.0  (42.6)
[1]
Measure Description: 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.
[2]
Measure Analysis Population Description: Intent-to-treat population with non-missing data at baseline
1.Primary Outcome
Title Percentage of Participants Adherent to Treatment at Month 6
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 157
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
43.3
(35.9 to 50.7)
2.Secondary Outcome
Title Change From Baseline in Adherence Summative Score at Months 6 and 12
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with non-missing data at baseline and each time point
Arm/Group Title Lopinavir/Ritonavir + KASA
Hide 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 Number of Participants Analyzed 164
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from Baseline to Month 6 Number Analyzed 126 participants
-1.2  (16.9)
Change from Baseline to Month 12 Number Analyzed 93 participants
-5.1  (21.1)
3.Secondary Outcome
Title Change From Baseline in Adherence Integration Subscale Score at Months 6 and 12
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with non-missing data at baseline and each time point
Arm/Group Title Lopinavir/Ritonavir + KASA
Hide 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 Number of Participants Analyzed 168
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from Baseline to Month 6 Number Analyzed 130 participants
-0.7  (13.1)
Change from Baseline to Month 12 Number Analyzed 97 participants
-3.6  (15.8)
4.Secondary Outcome
Title Change From Baseline in Adherence Perseverance Subscale Score at Months 6 and 12
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with non-missing data at baseline and each time point
Arm/Group Title Lopinavir/Ritonavir + KASA
Hide 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 Number of Participants Analyzed 164
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from Baseline to Month 6 Number Analyzed 126 participants
-0.1  (4.9)
Change from Baseline to Month 12 Number Analyzed 94 participants
-1.0  (6.2)
5.Secondary Outcome
Title Percentage of Participants Adherent to Treatment at Month 12
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 159
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30.2
(23.3 to 37.0)
6.Secondary Outcome
Title Change From Baseline in Health-related Quality of Life General Health Perception Domain Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with non-missing data at baseline and each time point.
Arm/Group Title Lopinavir/Ritonavir + KASA
Hide 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 Number of Participants Analyzed 166
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from Baseline to Month 6 Number Analyzed 128 participants
-1.0  (17.6)
Change from Baseline to Month 12 Number Analyzed 97 participants
1.5  (17.7)
7.Secondary Outcome
Title Change From Baseline in Health-related Quality of Life Physical Functioning Domain Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with non-missing data at baseline and each time point.
Arm/Group Title Lopinavir/Ritonavir + KASA
Hide 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 Number of Participants Analyzed 169
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from Baseline to Month 6 Number Analyzed 132 participants
0.0  (21.8)
Change from Baseline to Month 12 Number Analyzed 99 participants
0.1  (22.2)
8.Secondary Outcome
Title Change From Baseline in Health-related Quality of Life Role Functioning Domain Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with non-missing data at baseline and each time point.
Arm/Group Title Lopinavir/Ritonavir + KASA
Hide 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 Number of Participants Analyzed 168
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from Baseline to Month 6 Number Analyzed 131 participants
-0.4  (26.5)
Change from Baseline to Month 12 Number Analyzed 99 participants
0.8  (27.1)
9.Secondary Outcome
Title Change From Baseline in Health-related Quality of Life Social Functioning Domain Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with non-missing data at baseline and each time point.
Arm/Group Title Lopinavir/Ritonavir + KASA
Hide 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 Number of Participants Analyzed 165
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from Baseline to Month 6 Number Analyzed 129 participants
0.4  (20.3)
Change from Baseline to Month 12 Number Analyzed 96 participants
2.9  (23.5)
10.Secondary Outcome
Title Change From Baseline in Health-related Quality of Life Cognitive Functioning Domain Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with non-missing data at baseline and each time point.
Arm/Group Title Lopinavir/Ritonavir + KASA
Hide 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 Number of Participants Analyzed 167
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from Baseline to Month 6 Number Analyzed 130 participants
1.2  (18.3)
Change from Baseline to Month 12 Number Analyzed 98 participants
4.7  (18.3)
11.Secondary Outcome
Title Change From Baseline in Health-related Quality of Life Pain Domain Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with non-missing data at baseline and each time point.
Arm/Group Title Lopinavir/Ritonavir + KASA
Hide 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 Number of Participants Analyzed 167
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from Baseline to Month 6 Number Analyzed 130 participants
-0.3  (17.7)
Change from Baseline to Month 12 Number Analyzed 98 participants
-1.0  (19.5)
12.Secondary Outcome
Title Change From Baseline in Health-related Quality of Life Mental Health Domain Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with non-missing data at baseline and each time point.
Arm/Group Title Lopinavir/Ritonavir + KASA
Hide 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 Number of Participants Analyzed 168
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from Baseline to Month 6 Number Analyzed 131 participants
-3.0  (20.5)
Change from Baseline to Month 12 Number Analyzed 98 participants
-1.4  (16.5)
13.Secondary Outcome
Title Change From Baseline in Health-related Quality of Life Energy/ Fatigue Domain Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with non-missing data at baseline and each time point.
Arm/Group Title Lopinavir/Ritonavir + KASA
Hide 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 Number of Participants Analyzed 168
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from Baseline to Month 6 Number Analyzed 131 participants
-2.4  (21.0)
Change from Baseline to Month 12 Number Analyzed 98 participants
-0.1  (16.7)
14.Secondary Outcome
Title Change From Baseline in Patient Perception of Stress
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with non-missing data at baseline and each time point.
Arm/Group Title Lopinavir/Ritonavir + KASA
Hide 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 Number of Participants Analyzed 166
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from Baseline to Month 6 Number Analyzed 130 participants
-0.3  (9.3)
Change from Baseline to Month 12 Number Analyzed 95 participants
-0.8  (9.1)
15.Secondary Outcome
Title Change From Baseline in Psychological Well-being
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with non-missing data at baseline and each time point.
Arm/Group Title Lopinavir/Ritonavir + KASA
Hide 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 Number of Participants Analyzed 169
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from Baseline to Month 6 Number Analyzed 132 participants
1.7  (10.6)
Change from Baseline to Month 12 Number Analyzed 98 participants
1.0  (10.0)
16.Secondary Outcome
Title Change From Baseline in Coping Self-Efficacy
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with non-missing data at baseline and each time point.
Arm/Group Title Lopinavir/Ritonavir + KASA
Hide 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 Number of Participants Analyzed 168
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from Baseline to Month 6 Number Analyzed 129 participants
2.4  (64.4)
Change from Baseline to Month 12 Number Analyzed 98 participants
8.1  (54.9)
17.Secondary Outcome
Title Health Resource Utilization
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with non-missing data at each time point.
Arm/Group Title Baseline Month 6 Month 12
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 173 142 109
Measure Type: Number
Unit of Measure: percentage of participants
Emergency Room 8.1 8.5 5.5
Admitted to Hospital 3.5 2.8 3.7
Admitted to a Long-Term Care Facility 0.0 0.7 0.9
Visit to a Doctor’s Office/ Clinic 55.5 50.7 50.5
Ambulance Service 2.9 1.4 1.8
Physiotherapist/ Rehabilitation 3.5 7.7 8.3
Psychiatrist/ Psychologist/ Counselor 9.2 12.0 12.8
Nursing Services 12.7 14.8 11.0
Specialist 16.2 12.7 14.7
18.Secondary Outcome
Title Viral Load at Each Visit
Hide Description [Not Specified]
Time Frame Baseline, Month 6 and Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with non-missing data at baseline and each time point
Arm/Group Title Lopinavir/Ritonavir + KASA
Hide 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 Number of Participants Analyzed 172
Mean (Standard Deviation)
Unit of Measure: copies/mL
Baseline Number Analyzed 172 participants
111.3  (10.1)
Month 6 Number Analyzed 136 participants
55.7  (3.7)
Month 12 Number Analyzed 101 participants
47.2  (2.5)
19.Secondary Outcome
Title Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit
Hide Description [Not Specified]
Time Frame Baseline, Month 6 and Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with non-missing data at each time point
Arm/Group Title Lopinavir/Ritonavir + KASA
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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 Number of Participants Analyzed 171
Mean (Standard Deviation)
Unit of Measure: cells/mm³
Baseline Number Analyzed 171 participants
547.0  (294.21)
Month 6 Number Analyzed 135 participants
620.8  (294.88)
Month 12 Number Analyzed 100 participants
620.2  (301.45)
20.Secondary Outcome
Title Healthcare Provider Satisfaction
Hide 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
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Hide Analysis Population Description
Intent-to-treat population with non-missing data at each time point
Arm/Group Title Month 6 Month 12
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[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 142 109
Mean (Standard Deviation)
Unit of Measure: units on a scale
Overall Satisfaction with KASA Program Number Analyzed 142 participants 107 participants
74.1  (22.10) 73.3  (22.16)
Benefits in Maintaining Treatment Adherence Number Analyzed 137 participants 107 participants
65.6  (26.38) 62.7  (25.25)
Likelihood to Recommend KASA Program in Future Number Analyzed 136 participants 109 participants
74.7  (21.99) 70.0  (23.14)
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lopinavir/Ritonavir + KASA
Hide 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 (%)
Total   --/-- 
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Lopinavir/Ritonavir + KASA
Affected / at Risk (%)
Total   3/173 (1.73%) 
Cardiac disorders   
Cardiac disorder  1  1/173 (0.58%) 
General disorders   
Death  1  1/173 (0.58%) 
Psychiatric disorders   
Depression  1  1/173 (0.58%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lopinavir/Ritonavir + KASA
Affected / at Risk (%)
Total   0/173 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Global Medical Services
Organization: AbbVie (prior Sponsor Abbott)
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01662336     History of Changes
Other Study ID Numbers: P13-566
First Submitted: August 8, 2012
First Posted: August 10, 2012
Results First Submitted: June 19, 2017
Results First Posted: January 29, 2018
Last Update Posted: January 29, 2018