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

Background: Little 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. Speci...

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Main Authors: Parry, C.D.H., Morojele, N.K., Myers-Franchi, Bronwyn, Kekwaletswe, C.T., Manda, S.O.M., Sorsdahl, K., Ramjee, G., Hahn, J.A., Rehm, J., Shuper, P.A.
Format: Journal Article
Language:English
Published: 2014
Subjects:
Online Access:http://hdl.handle.net/20.500.11937/84399
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author Parry, C.D.H.
Morojele, N.K.
Myers-Franchi, Bronwyn
Kekwaletswe, C.T.
Manda, S.O.M.
Sorsdahl, K.
Ramjee, G.
Hahn, J.A.
Rehm, J.
Shuper, P.A.
author_facet Parry, C.D.H.
Morojele, N.K.
Myers-Franchi, Bronwyn
Kekwaletswe, C.T.
Manda, S.O.M.
Sorsdahl, K.
Ramjee, G.
Hahn, J.A.
Rehm, J.
Shuper, P.A.
author_sort Parry, C.D.H.
building Curtin Institutional Repository
collection Online Access
description Background: Little 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/Design: A 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 registration: Pan African Clinical Trials Register Number: PACTR201405000815100.
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spelling curtin-20.500.11937-843992021-07-30T03:50:13Z Efficacy of an alcohol-focused intervention for improving adherence to antiretroviral therapy (ART) and HIV treatment outcomes - a randomised controlled trial protocol Parry, C.D.H. Morojele, N.K. Myers-Franchi, Bronwyn Kekwaletswe, C.T. Manda, S.O.M. Sorsdahl, K. Ramjee, G. Hahn, J.A. Rehm, J. Shuper, P.A. Adult Alcohol Drinking Anti-HIV Agents CD4 Lymphocyte Count Clinical Protocols Female HIV Infections Humans Male Medication Adherence South Africa Young Adult Background: Little 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/Design: A 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 registration: Pan African Clinical Trials Register Number: PACTR201405000815100. 2014 Journal Article http://hdl.handle.net/20.500.11937/84399 10.1186/1471-2334-14-500 eng http://creativecommons.org/licenses/by/4.0 fulltext
spellingShingle Adult
Alcohol Drinking
Anti-HIV Agents
CD4 Lymphocyte Count
Clinical Protocols
Female
HIV Infections
Humans
Male
Medication Adherence
South Africa
Young Adult
Parry, C.D.H.
Morojele, N.K.
Myers-Franchi, Bronwyn
Kekwaletswe, C.T.
Manda, S.O.M.
Sorsdahl, K.
Ramjee, G.
Hahn, J.A.
Rehm, J.
Shuper, P.A.
Efficacy of an alcohol-focused intervention for improving adherence to antiretroviral therapy (ART) and HIV treatment outcomes - a randomised controlled trial protocol
title Efficacy of an alcohol-focused intervention for improving adherence to antiretroviral therapy (ART) and HIV treatment outcomes - a randomised controlled trial protocol
title_full Efficacy of an alcohol-focused intervention for improving adherence to antiretroviral therapy (ART) and HIV treatment outcomes - a randomised controlled trial protocol
title_fullStr Efficacy of an alcohol-focused intervention for improving adherence to antiretroviral therapy (ART) and HIV treatment outcomes - a randomised controlled trial protocol
title_full_unstemmed Efficacy of an alcohol-focused intervention for improving adherence to antiretroviral therapy (ART) and HIV treatment outcomes - a randomised controlled trial protocol
title_short Efficacy of an alcohol-focused intervention for improving adherence to antiretroviral therapy (ART) and HIV treatment outcomes - a randomised controlled trial protocol
title_sort efficacy of an alcohol-focused intervention for improving adherence to antiretroviral therapy (art) and hiv treatment outcomes - a randomised controlled trial protocol
topic Adult
Alcohol Drinking
Anti-HIV Agents
CD4 Lymphocyte Count
Clinical Protocols
Female
HIV Infections
Humans
Male
Medication Adherence
South Africa
Young Adult
url http://hdl.handle.net/20.500.11937/84399