Effects of a behavioral intervention on antiretroviral medication adherence among people living with HIV - The healthy living project randomized controlled study

Objective: To examine the effect of a 15-session individually delivered cognitive behavioral intervention on anfiretroviral (ART) medication adherence. Design: A multisite, 2-group, randomized controlled trial. Participants: Two hundred four HIV-infected participants with selfreported ART adherence < 85% from a total of 3818 participants screened were randomized into the trial. Potential participants were recruited for the main trial based on sexual risk criteria in Los Angeles, Milwaukee, New York, and San Francisco. Intervention: The primary outcome of the intervention was a reduction in HIV transmission risk behaviors. Fifteen 90-minute individually delivered sessions were divided into 3 modules: Stress, Coping, and Adjustment; Safer Behaviors; and Health Behaviors, including an emphasis on ART adherence. Controls received no intervention until trial completion. Both groups completed follow-up assessments at 5, 10, 15, 20, and 25 months after randomization. Main Outcome Measure: Self-reported ART adherence as measured by 3-day computerized assessment. Results: A significance difference in rates of reported adherence was observed between intervention and control participants at months 5 and 15, corresponding to the assessments after the Stress, Coping, and Adjustment module (5-month time point) and after the Health Behaviors module (15-month time point). The relative improvements among the intervention group compared with the control group dissipated at follow-up. Conclusions: Cognitive behavioral intervention programs may effectively improve ART adherence, but the effects of intervention may be short-lived.