Efficacy of an alcohol-focused intervention for improving adherence to antiretroviral therapy (ART) and HIV treatment outcomes - a randomised controlled trial protocol.

backgroundLittle research has examined whether alcohol reduction interventions improve antiretroviral therapy (ART) adherence and HIV treatment outcomes. This study assesses the efficacy of an intervention for reducing alcohol use among HIV patients on ART who are hazardous/harmful drinkers. Specific aims include adapting a blended Motivational Interviewing (MI) and Problem Solving Therapy (PST) intervention for use with HIV patients; evaluating the efficacy of the intervention for reducing alcohol consumption; and assessing counsellors' and participants' perceptions of the intervention. METHODS/

designA randomised controlled trial will evaluate the intervention among ART patients in public hospital-based HIV clinics in Tshwane, South Africa. We will recruit patients who are HIV-positive, on ART for at least 3 months, and classified as harmful/hazardous drinkers using the AUDIT-3. Eligible patients will be randomly assigned to one of three conditions. Patients in the experimental group will receive the MI-PST intervention to reduce harmful/hazardous alcohol use. Patients in the equal-attention wellness intervention group will receive an intervention focused on addressing health risk behaviours. Patients in the control condition will receive treatment as usual. Participants will complete an interviewer-administered questionnaire at baseline and 3, 6 and 12 months post-randomisation to assess alcohol consumption, ART adherence, physical and mental health. We will also collect biological specimens to test for recent alcohol consumption, CD4 counts and HIV RNA viral loads. The primary outcome will be reduction in the volume of alcohol consumed. Secondary outcomes include reduction in harmful/hazardous use of alcohol, reduction in biological markers of drinking, increase in adherence rates, reductions in viral loads, and increases in CD4 T-cell counts. A process evaluation will ascertain counsellors' and participants' perceptions of the acceptability and effectiveness of the interventions. DISCUSSION: We have obtained ethical approval and approval from the study sites and regional and provincial health departments. The study has implications for clinicians, researchers and policy makers as it will provide efficacy data on how to reduce harmful/hazardous alcohol consumption among HIV patients and will shed light on whether reducing alcohol consumption impacts on HIV treatment adherence and other outcomes.

trial registrationPan African Clinical Trials Register Number: PACTR201405000815100.