Abstract

Background: Limited data exist on the effectiveness of interventions for alcohol use disorders (AUD) in people living with HIV which can be delivered in general health care settings in low- and middle- income countries (LMIC). Methods: Sixteen public health facilities (clusters) were selected nationally through stratified randomisation and then randomised 1: 1 to Motivational Interviewing blended with brief Cognitive Behavioural Therapy (MI-CBT) or to Enhanced Usual Care (EUC). Inclusion criteria for individuals were adults aged 18 years-plus living with HIV who met criteria for AUD defined by Alcohol Use Disorders Identification Test (AUDIT) score of 6 for women and 7 for men. Nurses working in these health facilities were trained to deliver the treatments. Participants in the MI-CBT clusters received 10 sessions. Participants in EUC clusters received 3 sessions of psychoeducation based on the WHO Mental Health Gap Intervention Guide. The primary outcome was change in the AUDIT score at 6 months post-randomization. Secondary outcomes were viral load and functioning, measured by the WHODAS 2.0. A random-effects analysis-of-covariance model was used accounting for the cluster design. Findings: 234 participants were enrolled across 16 clinics, with a mean age of 43.3 years (9.1). 78.6% of the participants were male. 175 (74.8%) were followed up at 6 months. At 6 months follow-up AUDIT score fell by 6.15 (95% CI -6.3; -6.0) points in the MI-CBT arm and by 3.09 (95% CI -3.2; -2.9) points in the EUC arm. The drop in the AUDIT score was significantly greater in the MI-CBT arm compared to EUC: mean difference -2.26 (95% CI -4.53 to -0.01) (p=0.05). The viral load fell and general function improved in both arms with no statistically significant difference between arms. Interpretations: Nurses in government primary care and hospital facilities in low-income countries can be trained to deliver low-cost interventions that can reduce AUDs among PLWH. For people living with HIV, studies with long-term follow-up are needed to show whether longer interventions using Motivational Interviewing-CBT techniques are cost-effective compared to short interventions based on psychoeducation and feedback about alcohol use. Trial Registration: Pan African Clinical Trial Registry, PACTR201509001211149. Funding Statement: Research reported in this publication was supported by the Fogarty International Center (Office of The Director, National Institutes Of Health (OD), National Institute of Nursing Research (NINR), National Institute of Mental Health (NIMH), National Institute of Dental & Craniofacial Research (NIDCR), National Institute of Neurological Disorders and Stroke (NINDS), National Heart, Lung, and Blood Institute (NHLBI), Fogarty International Center (FIC)) of the National Institutes of Health, award D43 TW010137, the DELTAS Africa Initiative [DEL-15-01]. The DELTAS Africa Initiative is an independent funding scheme of the African Academy of Sciences (AAS)’s Alliance for Accelerating Excellence in Science in Africa (AESA) and supported by the New Partnership for Africa’s Development Planning and Coordinating Agency (NEPAD Agency) with funding from the Wellcome Trust [DEL-15-01] and the UK government, Grant Number D43TW010313-02S3 from the National Institutes of Health, Fogarty International Center and the National Research Founding through Funding to Professor Soraya Seedat SARChi Research Chairs. The study also received support from King’s College London Partnership Fund for viral load testing. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Fogarty International Center or the National Institutes of Health, the DELTAS Africa Initiative, King’s College London and the National Research Foundation SARChi Research Chairs. As an FIC scholar, MM also received research training from the Clinical and Translational Science Institute (award UL1TR001412). Declaration of Interests: All authors declare no conflict of interest. Ethics Approval Statement: Stellenbosch Health Research Ethics Committee (HREC) (SI/10/14/222) and the Medical Research Council of Zimbabwe (MRCZ) (A/1936) provided ethics approval.

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