Clinical trial NCT01662336: Real-life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program
Official title: Real-Life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program: A Prospective Observational Cohort Study (KASA PMOS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus Infection
Keywords: Human Immunodeficiency Virus infection
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-08-10
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were enrolled from the offices (at clinic or hospital) of primary care physicians across Canada treating HIV-positive patients.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Adherent to Treatment at Month 6
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change From Baseline in Adherence Summative Score at Months 6 and 12
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Adherence Integration Subscale Score at Months 6 and 12
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Adherence Perseverance Subscale Score at Months 6 and 12
timeFrame: Baseline, Month 6 and Month 12
measure: Percentage of Participants Adherent to Treatment at Month 12
timeFrame: Baseline and 12 months
measure: Change From Baseline in Health-related Quality of Life General Health Perception Domain Score
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Health-related Quality of Life Physical Functioning Domain Score
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Health-related Quality of Life Role Functioning Domain Score
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Health-related Quality of Life Social Functioning Domain Score
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Health-related Quality of Life Cognitive Functioning Domain Score
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Health-related Quality of Life Pain Domain Score
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Health-related Quality of Life Mental Health Domain Score
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Health-related Quality of Life Energy/ Fatigue Domain Score
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Patient Perception of Stress
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Psychological Well-being
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Coping Self-Efficacy
timeFrame: Baseline, Month 6 and Month 12
measure: Health Resource Utilization
timeFrame: Baseline, Month 6 and Month 12
measure: Viral Load at Each Visit
timeFrame: Baseline, Month 6 and Month 12
measure: Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit
timeFrame: Baseline, Month 6 and Month 12
measure: Healthcare Provider Satisfaction
timeFrame: Month 6 and Month 12
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie Corporation
name: Christina Pelizon, MD
role: STUDY_DIRECTOR
References: