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

Not Applicable

Completed

• Conditions: HIV/AIDS; Alcohol Abuse
• Interventions: Behavioral: Mlambe

• Registration Number: NCT04906616
• Lead Sponsor: University of California, San Francisco

Brief Summary

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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-27
• Study First Posted: 2021-05-28
• Study Start: 2021-05-31
• Primary Completion: 2023-07-13
• Study Completion: 2023-07-13
• Results First Submitted: 2023-12-13
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-24
• Last Update Submitted: 2024-01-24
• Results First Posted: 2024-02-20
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mlambe Intervention	Mlambe	A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes.

Primary Outcome Measures

Name	Time	Method
Enrollment Rate	Baseline (Time 0)	Percentage of eligible couples enrolled in the study.
Retention Rate	15 months	Percentage of enrolled and randomized participants retained at the end of the study

Secondary Outcome Measures

Name	Time	Method
100% Intervention Completion	10 months	Percentage of couples who attend 100% of intervention sessions
75% Intervention Completion	10 months	Percentage of couples who attend 75% of intervention sessions
Percentage of Couples Who Are "Satisfied" or "Very Satisfied" With the Intervention at 10 Months	10 months	Percentage of couples reporting to be "satisfied" or "very satisfied" about their overall experience with the Mlambe intervention on a five-point scale (the Mlambe Satisfaction Survey) at 10 months. Response options included: (1) very satisfied; (2) satisfied; (3) neutral; (4) unsatisfied; (5) very unsatisfied.
Percentage of Couples Who Are Satisfied With the Intervention at 15 Months	15 months	Percentage of couples reporting to be "satisfied" or "very satisfied" about their overall experience with the Mlambe intervention on a five-point scale (the Mlambe Satisfaction Survey) at 15 months. Response options included: (1) very satisfied; (2) satisfied; (3) neutral; (4) unsatisfied; (5) very unsatisfied.
10 Month Follow up Survey Completion	10 months	Percentage of couples who complete follow up surveys at 10 months
15 Month Follow up Survey Completion	15 months	Percentage of couples who complete follow up surveys at 15 months

Trial Locations

Locations (1)

Invest in Knowledge Initiative (IKI); 🇲🇼 Zomba, Malawi