Real-life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program
The study will assess the effectiveness of KASA (Kaletra Patient Support Program) on improving or maintaining treatment adherence in HIV positive patients that have been initiated on treatment with Kaletra®. This will be a purely observational study conducted on patients that will be on treatment with Kaletra®. All treatments will be as per routine care including the use of KASA which will be determined exclusively by the physician and the patient without consideration of the study.
The efficacy of disease management programs as assessed in randomized clinical trials is not representative of real - life effectiveness observed under routine clinical practice. In real - life settings the utilization of and compliance with disease management programs by physicians and patients is not uniform. Therefore assessment of their true effectiveness is ideally conducted under a pure observational setting without any interference from the investigators with respect to making the programs available to patients and enforcing their adherence to them.
Human Immunodeficiency Virus Infection
|Study Design:||Observational Model: Case-Only|
|Official Title:||Real Life Effectiveness of KASA: A Prospective Observational Cohort Study|
- Adherence will be measured by the Adherence Self - Efficacy Scale (ASES) .The primary outcome measure of the current study will be adherence with KALETRA treatment at 6 months after enrollment in the KASA program. [ Time Frame: 6 months ] [ Designated as safety issue: No ]The ASES is a 12 item tool that measures the patient's confidence to undertake treatment related activities and behaviors including medication regimen but also diet and exercise.
- Change in patient Quality of Life as measured by the QOL 601-2 (Health Status Assessment Questionnaire) [ Time Frame: From Month 0 to Month 12 ] [ Designated as safety issue: No ]The QOL 601-2 ("Health Status Assessment" ) survey is a brief, comprehensive measure of health-related quality of life used extensively in Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS).
- Change in patient perception of stress as measured by the Perceived Stress Scale [ Time Frame: From 0 months to 12 months ] [ Designated as safety issue: No ]The Perceived Stress Sale is a 10-item questionnaire that assesses the degree to which the patient considers situations as stressful.
- Change in psychological well-being as measured by the Center for Epidemiologic studies depression scale (CES-D) [ Time Frame: From 0 months to 12 months ] [ Designated as safety issue: No ]The CES-D is a 20-item questionnaire assessing the presence of depressive state during the previous week.
- Change in Coping Self-Efficacy will be measured the change in the Coping Self - Efficacy Scale (CSE) [ Time Frame: From 0 months to 12 months ] [ Designated as safety issue: No ]CSE is a 13 item questionnaire that measures perceived self-efficacy in coping with daily psychological challenges.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
HIV (Human Immunodeficiency Virus) positive subjects
Subjects participating in this purely observational study will be HIV-infected adults, who are currently being treated with Kaletra® or those who are initiated on treatment with Kaletra® and willing to be enrolled in the KASA program.
All treatments will be as per routine care which will be determined exclusively by the physician and the patient without consideration of the study
This is a 12-month, multi-center, Canadian Post Marketing Observational Study utilizing a prospective single cohort design. Patients that are treated with Kaletra® including those that are initiated on treatment with Kaletra® will be eligible to participate. All treatments including participation in the KASA (Kaletra Adherence Support Assistance) program will be according to the decision of the treating physician and the patients and will not be affected in any way by their decision to participate in the study. Follow-up will be for 12 months with visits conducted according to the physician judgment. However, assessments every six months will be recommended.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01662336
|Site Reference ID/Investigator# 75442|
|Montreal, Canada, H3H 1V1|
|Site Reference ID/Investigator# 75444|
|Montreal, Canada, H2L 4P9|
|Site Reference ID/Investigator# 77613|
|Ottawa, Canada, K1N 6N5|
|Site Reference ID/Investigator# 126514|
|Prince George, Canada, V2L 2P6|
|Site Reference ID/Investigator# 79793|
|Toronto, Canada, M5G 1N8|
|Site Reference ID/Investigator# 75438|
|Vancouver, Canada, V6Z 2C7|
|Site Reference ID/Investigator# 75439|
|Vancouver, Canada, V6Z 2T1|
|Site Reference ID/Investigator# 75440|
|Victoria, Canada, V8W 1M8|
|Study Director:||Linda Assouline||AbbVie Corporation|