A cluster randomised controlled trial protocol of an adapted intervention for alcohol use disorders in people living with HIV and AIDS : impact on alcohol use, general functional ability, quality of life and adherence to HAART
Date
2017-01-28
Journal Title
Journal ISSN
Volume Title
Publisher
BioMed Central
Abstract
ENGLISH SUMMARY : Background: Interventions for alcohol use disorders (AUDs) in HIV infected individuals have been primarily
targeted at HIV risk reduction and improved antiretroviral treatment adherence. However, reduction in alcohol use
is an important goal. Alcohol use affects other key factors that may influence treatment course and outcome. In this
study the authors aim to administer an adapted intervention for AUDs to reduce alcohol use in people living with
HIV/AIDS (PLWHA).
Methods: This study is a cluster randomised controlled trial at 16 HIV care clinics. A motivational interviewing and
cognitive behavioural therapy based intervention for AUDs, developed through adaptation and piloted in Zimbabwe, will
be administered to PLWHA with AUDs recruited at HIV clinics. The intervention will be administered over 16 sessions at 8
HIV clinics. This intervention will be compared with an equal attention control in the form of the World Health
Organization Mental Health Gap Action Programme (WHO mhGAP) guide, adapted for the Zimbabwean context. General
function, quality of life, and adherence to highly active antiretroviral treatment (HAART) will be secondary outcomes.
Booster sessions will be administered to both groups at 3 and 6 months respectively.
The primary outcome measure will be the Alcohol Use Disorder Identification Test (AUDIT) score. The World Health
Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0), World Health Organisation Quality of Life (WHOQoL) HIV,
viral load, and CD4 counts will be secondary outcome measures. Outcome assessments will be administered at baseline,
3, 6, and 12 months. Moderating factors such as perceived social support, how people cope with difficult situations and
post-traumatic exposure and experience will be assessed at baseline. Trained research assistants will recruit participants.
The outcome assessors who will be trained in administering the outcome and moderating tools will be blinded to the
treatment arms allocated to the participants. However, the principal investigator, participants and intervention staff will be
unblinded. Data will be analysed using STATA Version 14. Primary and secondary outcomes will be measured at four time points that
is; at baseline, 3, 6, and 12 months respectively. All participants will be included in the analysis of primary and secondary
outcome measures. The mean AUDIT scores will be compared between groups using student t-tests. Multilevel logistic
regression analysis will be performed for binominal variables and multilevel linear regression for continuous variables.
Descriptive statistics will be computed for baseline and follow-up assessments.
Discussion: The study will be the first to address problematic alcohol use in PLWHA in Zimbabwe. It seeks to use local
resources in delivering a modified, brief, evidence-based, and culturally contextualised intervention. The study results will
determine the effectiveness of adapting psychological interventions for AUDs in HIV infected adults using a task-sharing
framework.
Description
CITATION: Madhombiro, M., et al. 2017. A cluster randomised controlled trial protocol of an adapted intervention for alcohol use disorders in people living with HIV and AIDS: impact on alcohol use, general functional ability, quality of life and adherence to HAART. BMC Psychiatry, 17:44, doi:10.1186/s12888-017-1208-3.
The original publication is available at http://bmcpsychiatry.biomedcentral.com
The original publication is available at http://bmcpsychiatry.biomedcentral.com
Keywords
HIV-positive persons -- Alcohol use, Drug-alcohol interactions, Alcoholism -- Treatment, Operant behavior
Citation
Madhombiro, M., et al. 2017. A cluster randomised controlled trial protocol of an adapted intervention for alcohol use disorders in people living with HIV and AIDS: impact on alcohol use, general functional ability, quality of life and adherence to HAART. BMC Psychiatry, 17:44, doi:10.1186/s12888-017-1208-3.