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Testing a systematically braided alcohol reduction and HIV status neutral intervention among people receiving STI care in Malawi: study protocol for a pilot hybrid type 1 effectiveness-implementation randomized controlled trial.

作者信息

Lancaster Kathryn E, Bula Agatha K, Matoga Mitch M, Hosseinipour Mina C, Hoffman Irving F, Grullon Jaslyn A, Umar Eric, Msolola Jimmy, Magidson Jessica F, Bonumwezi Jessica L, Hahn Judith A, Parcesepe Angela M

机构信息

Department of Implementation Science, Wake Forest University School of Medicine, Winston-Salem, NC, United States.

UNC Project, Malawi, Tidziwe Centre, Lilongwe, Malawi.

出版信息

Front Public Health. 2025 Apr 30;13:1572288. doi: 10.3389/fpubh.2025.1572288. eCollection 2025.


DOI:10.3389/fpubh.2025.1572288
PMID:40371302
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12075419/
Abstract

BACKGROUND: Heavy alcohol use is common in Malawi among people receiving sexually transmitted infections (STI) care and is a critical barrier to the success of HIV prevention and treatment efforts. METHODS: This protocol presents a pilot hybrid type 1 effectiveness-implementation trial evaluating the short-term effectiveness and implementation of a scalable evidence-based intervention (EBI) to reduce alcohol use and provide HIV prevention and treatment counseling for people with heavy drinking receiving STI care in Malawi. We developed a 3-session intervention, Treat4All, that uses motivational interviewing, problem-solving skills, psychoeducation, alcohol refusal, HIV prevention and treatment skills building, and goal setting to reduce alcohol and facilitate engagement in HIV prevention and treatment. We have also integrated HIV prevention content to focus on persistent PrEP use and HIV treatment adherence to improve antiretroviral therapy (ART) adherence and viral suppression. We will conduct a two-arm pilot randomized controlled trial (RCT) in an STI care setting in urban Malawi to compare the preliminary effectiveness and implementation of Treat4All to usual care for decreasing the proportion of heavy drinking days, corroborated with phosphatidylethanol, an alcohol biomarker, and improving HIV outcomes (viral suppression among PWH; PrEP use among those at risk). We will randomly assign 160 people receiving STI care in Lilongwe who report heavy drinking ( = 80 people with HIV; PWH;  = 80 people at high risk of HIV acquisition) to Treat4All or usual care. DISCUSSION: Our study will produce a systematically braided, scalable HIV status-neutral EBI for alcohol reduction and optimization of HIV prevention and treatment behaviors to evaluate in a larger effectiveness-implementation trial. Our study will directly expand alcohol reduction and HIV status-neutral programs for alcohol-impacted populations throughout sub-Saharan Africa and other regions where alcohol contributes to the ongoing HIV epidemic. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT06668363.

摘要

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本文引用的文献

[1]
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SSM Popul Health. 2025-2-25

[2]
Availability of substance use screening and treatment within HIV clinical sites across seven geographic regions within the IeDEA consortium.

Int J Drug Policy. 2024-2

[3]
Advancing the science of integrating multiple interventions by blending and bundling.

JNCI Cancer Spectr. 2023-8-31

[4]
Assessing the adoption, acceptability and fidelity of the alcohol use disorders test for alcohol use disorders screening in HIV clinics in Malawi.

Alcohol. 2025-5

[5]
Depression, Alcohol Use, and Sexual Behaviors by HIV Infection Stage and Diagnosis Timing Among STI Clinic Patients in Lilongwe, Malawi.

AIDS Behav. 2023-11

[6]
Costs of a Brief Alcohol Consumption Reduction Intervention for Persons Living with HIV in Southwestern Uganda: Comparisons of Live Versus Automated Cell Phone-Based Booster Components.

AIDS Behav. 2023-9

[7]
Consensus for the use of the alcohol biomarker phosphatidylethanol (PEth) for the assessment of abstinence and alcohol consumption in clinical and forensic practice (2022 Consensus of Basel).

Drug Test Anal. 2022-10

[8]
Alcohol-Related Behavioral Research and Its Integration into Primary and Secondary HIV Preventive Interventions: A Summing Up.

AIDS Behav. 2021-12

[9]
HIV Prevention and Treatment Behavior Change and the Situated Information Motivation Behavioral Skills (sIMB) Model: A Qualitative Evaluation of a Community Health Worker Intervention in Rakai, Uganda.

AIDS Behav. 2022-2

[10]
Project Khanya: results from a pilot randomized type 1 hybrid effectiveness-implementation trial of a peer-delivered behavioural intervention for ART adherence and substance use in HIV care in South Africa.

J Int AIDS Soc. 2021-6

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