An Economic and Relationship-strengthening Intervention for HIV-affected Couples Who Drink Alcohol in Malawi

University of California San Francisco (UCSF)

Status: Completed

Conditions: Alcohol Abuse; HIV/AIDS

Treatments: Behavioral: Mlambe

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04906616

R34AA027983-01 (U.S. NIH Grant/Contract)

P0535590

Details and patient eligibility

About

A couples-based alcohol-reduction and economic and relationship-strengthening intervention for HIV-affected couples in Malawi.

Full description

This project aims to develop and pilot test a combined economic and relationship-strengthening intervention to redirect funds spent on alcohol into financial investments (e.g., education, income-generating business) and to improve couple relationships and adherence to ART. The study hypothesizes that engaging couples to work together on alcohol use and financial goals-equipped with financial, communication, and problem-solving skills-will decrease alcohol use, and improve relationship dynamics and adherence to ART. Specifically, the project aims: (1) to adapt and integrate two proven interventions, Suubi and Uthando Lwethu, using the ADAPT-ITT method, into a combined intervention for HIV-affected couples with a heavy alcohol user (to be called Mlambe); (2) to develop and pilot test the study procedures to evaluate Mlambe; and (3) to assess the feasibility and acceptability of Mlambe through a pilot study. In the formative phase, the study will develop a draft of the intervention manual and conduct five focus group discussions with couples and key stakeholders to obtain input on the intervention. In the pilot phase, 80 HIV-affected couples with a heavy alcohol user will be enrolled and randomized to either Mlambe or the comparison arm (regular HIV care plus brief advice on alcohol use). The study will conduct qualitative interviews with a subset of 20 couples to contextualize feasibility and acceptability data, and then will analyze the mixed- methods feasibility and acceptability data to refine intervention and procedures for a future trial.

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• in a married or cohabitating union
• have at least one partner with a positive AUDIT-C screen in prior 3 months who is also currently on ART for at least 6 months who has disclosed their HIV status to their partner

Exclusion criteria

• severe intimate partner violence reported in previous 3 months and/or fear that safety would be at risk by participation in the study (reported at screening)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

Control Comparison

No Intervention group

Description:

Standard of care, e.g. regular HIV care plus brief advice on alcohol use

Mlambe Intervention

Experimental group

Description:

A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes.

Treatment:

Behavioral: Mlambe