Human Immunodeficiency Virus Infection
Conditions
Keywords
Human Immunodeficiency Virus infection
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.
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.
Interventions
Prescribed according to the product monograph and physician's discretion.
BEHAVIORALKaletra 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.
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Viral Load at Each Visit | Baseline, Month 6 and Month 12 | — |
| Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit | Baseline, Month 6 and Month 12 | — |
| 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. |
| 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. |
Participant flow
Recruitment details
Patients were recruited from the practices of 8 physicians in Canada between 29 June 2012 and 06 August 2015.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 173 |
| Total | 173 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 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
| Characteristic | Lopinavir/Ritonavir + KASA |
|---|---|
| Adherence Self-Efficacy Scale (ASES) Scores Adherence Integration Subscale Score | 77.1 units on a scale STANDARD_DEVIATION 13.2 |
| Adherence Self-Efficacy Scale (ASES) Scores Adherence Perseverance Subscale Score | 25.0 units on a scale STANDARD_DEVIATION 5 |
| Adherence Self-Efficacy Scale (ASES) Scores Adherence Summative Score | 102.5 units on a scale STANDARD_DEVIATION 17.3 |
| Age, Continuous | 50.7 years STANDARD_DEVIATION 10 |
| Coping Self-Efficacy Scale | 187.0 units on a scale STANDARD_DEVIATION 42.6 |
| Health Status Assessment (HSA) Cognitive Functioning | 64.0 units on a scale STANDARD_DEVIATION 24.3 |
| Health Status Assessment (HSA) Energy/ Fatigue | 54.8 units on a scale STANDARD_DEVIATION 21.6 |
| Health Status Assessment (HSA) General Health Perception | 58.2 units on a scale STANDARD_DEVIATION 23.2 |
| Health Status Assessment (HSA) Mental Health | 61.3 units on a scale STANDARD_DEVIATION 22.6 |
| Health Status Assessment (HSA) Pain | 64.4 units on a scale STANDARD_DEVIATION 24.8 |
| Health Status Assessment (HSA) Physical Functioning | 67.8 units on a scale STANDARD_DEVIATION 26.2 |
| Health Status Assessment (HSA) Role Functioning | 68.3 units on a scale STANDARD_DEVIATION 29.5 |
| Health Status Assessment (HSA) Social Functioning | 67.8 units on a scale STANDARD_DEVIATION 26.4 |
| Patient Perception of Stress | 16.3 units on a scale STANDARD_DEVIATION 7.5 |
| Psychological Well-being | 18.4 units on a scale STANDARD_DEVIATION 11.6 |
| Race/Ethnicity, Customized American Indian/ Alaska | 7 Participants |
| Race/Ethnicity, Customized Asian | 13 Participants |
| Race/Ethnicity, Customized Black | 15 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants |
| Race/Ethnicity, Customized Missing | 2 Participants |
| Race/Ethnicity, Customized Other | 5 Participants |
| Race/Ethnicity, Customized White | 130 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 149 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 173 |
| serious Total, serious adverse events | 3 / 173 |
Outcome results
Primary
Percentage of Participants Adherent to Treatment at Month 6
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lopinavir/Ritonavir + KASA | Percentage of Participants Adherent to Treatment at Month 6 | 43.3 percentage of participants |
Secondary
Change From Baseline in Adherence Integration Subscale Score at Months 6 and 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.
Time frame: Baseline, Month 6 and Month 12
Population: Intent-to-treat population with non-missing data at baseline and each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lopinavir/Ritonavir + KASA | 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 |
| Lopinavir/Ritonavir + KASA | 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
Change From Baseline in Adherence Perseverance Subscale Score at Months 6 and 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.
Time frame: Baseline, Month 6 and Month 12
Population: Intent-to-treat population with non-missing data at baseline and each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lopinavir/Ritonavir + KASA | 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 |
| Lopinavir/Ritonavir + KASA | 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
Change From Baseline in Adherence Summative Score at Months 6 and 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.
Time frame: Baseline, Month 6 and Month 12
Population: Intent-to-treat population with non-missing data at baseline and each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lopinavir/Ritonavir + KASA | 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 |
| Lopinavir/Ritonavir + KASA | 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
Change From Baseline in Coping Self-Efficacy
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
Population: Intent-to-treat population with non-missing data at baseline and each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lopinavir/Ritonavir + KASA | Change From Baseline in Coping Self-Efficacy | Change from Baseline to Month 6 | 2.4 units on a scale | Standard Deviation 64.4 |
| Lopinavir/Ritonavir + KASA | Change From Baseline in Coping Self-Efficacy | Change from Baseline to Month 12 | 8.1 units on a scale | Standard Deviation 54.9 |
Secondary
Change From Baseline in Health-related Quality of Life Cognitive Functioning Domain Score
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
Population: Intent-to-treat population with non-missing data at baseline and each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lopinavir/Ritonavir + KASA | 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 |
| Lopinavir/Ritonavir + KASA | 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
Change From Baseline in Health-related Quality of Life Energy/ Fatigue Domain Score
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
Population: Intent-to-treat population with non-missing data at baseline and each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lopinavir/Ritonavir + KASA | 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 |
| Lopinavir/Ritonavir + KASA | 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
Change From Baseline in Health-related Quality of Life General Health Perception Domain Score
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
Population: Intent-to-treat population with non-missing data at baseline and each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lopinavir/Ritonavir + KASA | 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 |
| Lopinavir/Ritonavir + KASA | 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
Change From Baseline in Health-related Quality of Life Mental Health Domain Score
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
Population: Intent-to-treat population with non-missing data at baseline and each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lopinavir/Ritonavir + KASA | 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 |
| Lopinavir/Ritonavir + KASA | 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
Change From Baseline in Health-related Quality of Life Pain Domain Score
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
Population: Intent-to-treat population with non-missing data at baseline and each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lopinavir/Ritonavir + KASA | 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 |
| Lopinavir/Ritonavir + KASA | 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
Change From Baseline in Health-related Quality of Life Physical Functioning Domain Score
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
Population: Intent-to-treat population with non-missing data at baseline and each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lopinavir/Ritonavir + KASA | 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 |
| Lopinavir/Ritonavir + KASA | 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
Change From Baseline in Health-related Quality of Life Role Functioning Domain Score
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
Population: Intent-to-treat population with non-missing data at baseline and each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lopinavir/Ritonavir + KASA | 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 |
| Lopinavir/Ritonavir + KASA | 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
Change From Baseline in Health-related Quality of Life Social Functioning Domain Score
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
Population: Intent-to-treat population with non-missing data at baseline and each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lopinavir/Ritonavir + KASA | 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 |
| Lopinavir/Ritonavir + KASA | 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
Change From Baseline in Patient Perception of Stress
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
Population: Intent-to-treat population with non-missing data at baseline and each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lopinavir/Ritonavir + KASA | Change From Baseline in Patient Perception of Stress | Change from Baseline to Month 6 | -0.3 units on a scale | Standard Deviation 9.3 |
| Lopinavir/Ritonavir + KASA | 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
Change From Baseline in Psychological Well-being
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
Population: Intent-to-treat population with non-missing data at baseline and each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lopinavir/Ritonavir + KASA | Change From Baseline in Psychological Well-being | Change from Baseline to Month 6 | 1.7 units on a scale | Standard Deviation 10.6 |
| Lopinavir/Ritonavir + KASA | Change From Baseline in Psychological Well-being | Change from Baseline to Month 12 | 1.0 units on a scale | Standard Deviation 10 |
Secondary
Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit
Time frame: Baseline, Month 6 and Month 12
Population: Intent-to-treat population with non-missing data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lopinavir/Ritonavir + KASA | Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit | Baseline | 547.0 cells/mm³ | Standard Deviation 294.21 |
| Lopinavir/Ritonavir + KASA | Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit | Month 6 | 620.8 cells/mm³ | Standard Deviation 294.88 |
| Lopinavir/Ritonavir + KASA | Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit | Month 12 | 620.2 cells/mm³ | Standard Deviation 301.45 |
Secondary
Healthcare Provider Satisfaction
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
Population: Intent-to-treat population with non-missing data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lopinavir/Ritonavir + KASA | Healthcare Provider Satisfaction | Overall Satisfaction with KASA Program | 74.1 units on a scale | Standard Deviation 22.1 |
| Lopinavir/Ritonavir + KASA | Healthcare Provider Satisfaction | Benefits in Maintaining Treatment Adherence | 65.6 units on a scale | Standard Deviation 26.38 |
| Lopinavir/Ritonavir + KASA | Healthcare Provider Satisfaction | Likelihood to Recommend KASA Program in Future | 74.7 units on a scale | Standard Deviation 21.99 |
| Month 6 | Healthcare Provider Satisfaction | Overall Satisfaction with KASA Program | 73.3 units on a scale | Standard Deviation 22.16 |
| Month 6 | Healthcare Provider Satisfaction | Benefits in Maintaining Treatment Adherence | 62.7 units on a scale | Standard Deviation 25.25 |
| Month 6 | Healthcare Provider Satisfaction | Likelihood to Recommend KASA Program in Future | 70.0 units on a scale | Standard Deviation 23.14 |
Secondary
Health Resource Utilization
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
Population: Intent-to-treat population with non-missing data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir + KASA | Health Resource Utilization | Visit to a Doctor's Office/ Clinic | 55.5 percentage of participants |
| Lopinavir/Ritonavir + KASA | Health Resource Utilization | Specialist | 16.2 percentage of participants |
| Lopinavir/Ritonavir + KASA | Health Resource Utilization | Physiotherapist/ Rehabilitation | 3.5 percentage of participants |
| Lopinavir/Ritonavir + KASA | Health Resource Utilization | Ambulance Service | 2.9 percentage of participants |
| Lopinavir/Ritonavir + KASA | Health Resource Utilization | Emergency Room | 8.1 percentage of participants |
| Lopinavir/Ritonavir + KASA | Health Resource Utilization | Nursing Services | 12.7 percentage of participants |
| Lopinavir/Ritonavir + KASA | Health Resource Utilization | Admitted to a Long-Term Care Facility | 0.0 percentage of participants |
| Lopinavir/Ritonavir + KASA | Health Resource Utilization | Admitted to Hospital | 3.5 percentage of participants |
| Lopinavir/Ritonavir + KASA | Health Resource Utilization | Psychiatrist/ Psychologist/ Counselor | 9.2 percentage of participants |
| Month 6 | Health Resource Utilization | Ambulance Service | 1.4 percentage of participants |
| Month 6 | Health Resource Utilization | Emergency Room | 8.5 percentage of participants |
| Month 6 | Health Resource Utilization | Admitted to Hospital | 2.8 percentage of participants |
| Month 6 | Health Resource Utilization | Admitted to a Long-Term Care Facility | 0.7 percentage of participants |
| Month 6 | Health Resource Utilization | Visit to a Doctor's Office/ Clinic | 50.7 percentage of participants |
| Month 6 | Health Resource Utilization | Physiotherapist/ Rehabilitation | 7.7 percentage of participants |
| Month 6 | Health Resource Utilization | Psychiatrist/ Psychologist/ Counselor | 12.0 percentage of participants |
| Month 6 | Health Resource Utilization | Nursing Services | 14.8 percentage of participants |
| Month 6 | Health Resource Utilization | Specialist | 12.7 percentage of participants |
| Month 12 | Health Resource Utilization | Admitted to a Long-Term Care Facility | 0.9 percentage of participants |
| Month 12 | Health Resource Utilization | Emergency Room | 5.5 percentage of participants |
| Month 12 | Health Resource Utilization | Psychiatrist/ Psychologist/ Counselor | 12.8 percentage of participants |
| Month 12 | Health Resource Utilization | Admitted to Hospital | 3.7 percentage of participants |
| Month 12 | Health Resource Utilization | Specialist | 14.7 percentage of participants |
| Month 12 | Health Resource Utilization | Ambulance Service | 1.8 percentage of participants |
| Month 12 | Health Resource Utilization | Visit to a Doctor's Office/ Clinic | 50.5 percentage of participants |
| Month 12 | Health Resource Utilization | Nursing Services | 11.0 percentage of participants |
| Month 12 | Health Resource Utilization | Physiotherapist/ Rehabilitation | 8.3 percentage of participants |
Secondary
Percentage of Participants Adherent to Treatment at 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). 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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lopinavir/Ritonavir + KASA | Percentage of Participants Adherent to Treatment at Month 12 | 30.2 percentage of participants |
Secondary
Viral Load at Each Visit
Time frame: Baseline, Month 6 and Month 12
Population: Intent-to-treat population with non-missing data at baseline and each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lopinavir/Ritonavir + KASA | Viral Load at Each Visit | Baseline | 111.3 copies/mL | Standard Deviation 10.1 |
| Lopinavir/Ritonavir + KASA | Viral Load at Each Visit | Month 6 | 55.7 copies/mL | Standard Deviation 3.7 |
| Lopinavir/Ritonavir + KASA | Viral Load at Each Visit | Month 12 | 47.2 copies/mL | Standard Deviation 2.5 |