Promoting Adherence to Anti-HIV Drug Regimens

Not Applicable

Completed

• Conditions: HIV Infections

• Registration Number: NCT00051805
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

One of the main causes of treatment failure in HIV infected individuals is lack of adherence to complicated drug regimens. The purpose of this study is to evaluate the effectiveness of a behavioral intervention program designed to improve adherence to anti-HIV drug regimens. Participants in this study will be recruited from the University of Alabama at Birmingham (UAB) Outpatient HIV Clinic.

Detailed Description

Poor adherence to complicated antiretroviral (ARV) drug regimens is one of the most pressing behavioral problems in the clinical management of HIV infected persons. Recent medical advances have made it possible to maintain tighter control of viral replication, allowing people with HIV to live longer, healthier lives. However, the complexity of ARV drug regimens and drug side effects make medication adherence problematic. Deviations from the prescribed regimen may allow the virus to resume rapid replication and develop drug resistant mutations that could render the prescribed drugs useless. This study will evaluate the efficacy of a 6-month, theory-based behavioral intervention to enhance adherence to antiretroviral treatment regimens. HIV-related attitudes, depressive symptoms, coping strategies, and social support will also be assessed to examine theoretical assumptions regarding the causal relationship between psychosocial constructs and medication adherence.

Participants in this study will be recruited from UAB Outpatient HIV Clinic patients who are taking ARV medication. Participants will be randomized to a Standard Adherence Promotion Group or an Enhanced Adherence Promotion Group. The Enhanced Adherence Promotion will systematically address specific psychosocial issues associated with medication adherence. Participants will be followed for 6 months, and adherence will be evaluated at monthly study visits. Pill counts, viral loads, self-reported adherence to ARV medication, CD4 count, and genotypic viral resistance will be assessed.

Study Timeline

• Study Start: 2002-08
• Study First Submitted: 2003-01-16
• Study First Submitted QC: 2003-01-16
• Study First Posted: 2003-01-17
• Study Completion: 2006-07
• Status Verified: 2007-08
• Last Update Submitted: 2007-09-17
• Last Update Posted: 2007-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pill counts for ARV medications

Secondary Outcome Measures

Name	Time	Method
Viral load
disease progression measures (CD4 count, viral resistance)
self-reported adherence
self-reported psychosocial measures

Trial Locations

Locations (1)

University of Alabama at Birmingham Outpatient HIV Clinic; 🇺🇸 Birmingham, Alabama, United States