- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01662336
Real-life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program
Real-Life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program: A Prospective Observational Cohort Study (KASA PMOS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Kaletra Adherence Support Assistance (KASA) Program is a customized support network that has been offered to patients treated with lopinavir / ritonavir (LPV/r; Kaletra®). KASA offers individual counseling with an HIV experienced nurse who assists patients with various aspects of their therapy including life-style changes, emotional stress, and adverse events. Patients enrolled in KASA may also have access to various healthcare professionals (dietician, social worker, psychologist, etc.) or may be offered other types of support (transportation, exercise, etc.), which may help improve their quality of life as well as adherence or compliance while taking LPV/r.
This was a 12-month, multi-center, Canadian Post Marketing Observational Study utilizing a prospective single cohort design. All treatments including participation in the KASA program were according to the decision of the treating physician and the patients and were not affected in any way by their decision to participate in the study. Follow-up was for 12 months at an interval of every six months.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Lopinavir/Ritonavir + KASA
Patients were treated according to the standard of care provided by their respective study sites.
Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
|
Prescribed according to the product monograph and physician's discretion.
Other Names:
A customized support network for patients treated with lopinavir / ritonavir that offers individual counseling with an HIV experienced nurse who assists patients with various aspects of their therapy including life-style changes, emotional stress, and adverse events, and may provide access to various healthcare professionals or may offer other types of support such as transportation, exercise, etc.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Adherent to Treatment at Month 6
Time Frame: 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.
|
Baseline and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Adherence Summative Score at Months 6 and 12
Time Frame: 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.
|
Baseline, Month 6 and Month 12
|
Change From Baseline in Adherence Integration Subscale Score at Months 6 and 12
Time Frame: 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. |
Baseline, Month 6 and Month 12
|
Change From Baseline in Adherence Perseverance Subscale Score at Months 6 and 12
Time Frame: 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.
|
Baseline, Month 6 and Month 12
|
Percentage of Participants Adherent to Treatment at Month 12
Time Frame: 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.
|
Baseline and 12 months
|
Change From Baseline in Health-related Quality of Life General Health Perception Domain Score
Time Frame: 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.
|
Baseline, Month 6 and Month 12
|
Change From Baseline in Health-related Quality of Life Physical Functioning Domain Score
Time Frame: 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.
|
Baseline, Month 6 and Month 12
|
Change From Baseline in Health-related Quality of Life Role Functioning Domain Score
Time Frame: 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.
|
Baseline, Month 6 and Month 12
|
Change From Baseline in Health-related Quality of Life Social Functioning Domain Score
Time Frame: 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.
|
Baseline, Month 6 and Month 12
|
Change From Baseline in Health-related Quality of Life Cognitive Functioning Domain Score
Time Frame: 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.
|
Baseline, Month 6 and Month 12
|
Change From Baseline in Health-related Quality of Life Pain Domain Score
Time Frame: 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.
|
Baseline, Month 6 and Month 12
|
Change From Baseline in Health-related Quality of Life Mental Health Domain Score
Time Frame: 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.
|
Baseline, Month 6 and Month 12
|
Change From Baseline in Health-related Quality of Life Energy/ Fatigue Domain Score
Time Frame: 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.
|
Baseline, Month 6 and Month 12
|
Change From Baseline in Patient Perception of Stress
Time Frame: 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.
|
Baseline, Month 6 and Month 12
|
Change From Baseline in Psychological Well-being
Time Frame: 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.
|
Baseline, Month 6 and Month 12
|
Change From Baseline in Coping Self-Efficacy
Time Frame: 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.
|
Baseline, Month 6 and Month 12
|
Health Resource Utilization
Time Frame: 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.
|
Baseline, Month 6 and Month 12
|
Viral Load at Each Visit
Time Frame: Baseline, Month 6 and Month 12
|
Baseline, Month 6 and Month 12
|
|
Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit
Time Frame: Baseline, Month 6 and Month 12
|
Baseline, Month 6 and Month 12
|
|
Healthcare Provider Satisfaction
Time Frame: 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.
|
Month 6 and Month 12
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Virus Diseases
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Ritonavir
- Lopinavir
Other Study ID Numbers
- P13-566
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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