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

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

Detailed Description
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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.

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

Conditions
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HIV/AIDS, Alcohol Abuse

Intervention / Treatment
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* Behavioral: Mlambe


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Couples will be randomized 1:1 to intervention or control arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Comparison<br>Standard of care, e.g. regular HIV care plus brief advice on alcohol use | |
| Experimental: Mlambe Intervention<br>A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes. | Behavioral: Mlambe<br>* A combined economic and relationship-strengthening intervention at the couple level to redirect funds spent on alcohol into financial investments (e.g., education, income-generating business) and to improve couple relationships and adherence to ART.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment Rate | Proportion of eligible couples who agree to participate in the study | Baseline (Time 0) | 
| Retention Rate | Proportion of enrolled couples retained at the end of the study | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of couples who are satisfied with the intervention at 10 months | Proportion of couples reporting to be satisfied or very satisfied about their overall experience with the Mlambe intervention on a five-point Likert scale at 10 months. | 10 months | 
| Proportion of couples who are satisfied with the intervention at 15 months | Proportion of couples reporting to be satisfied or very satisfied about their overall experience with the Mlambe intervention on a five-point Likert scale at 15 months. | 15 months | 
| 10 month follow up survey completion | Proportion of couples who complete follow up surveys at 10 months | 10 months | 
| 15 month follow up survey completion | Proportion of couples who complete follow up surveys at 15 months | 15 months | 
| 75% Intervention Completion | Proportion of couples who attend 75% of intervention sessions | 10 months | 
| 100% Intervention Completion | Proportion of couples who attend 100% of intervention sessions | 10 months |