Development of an Economic and Relationship-Strengthening Intervention for Alcohol Drinkers Living with HIV in Malawi.
Amy A Conroy, Scott Tebbetts, Lynae A Darbes...
https://pubmed.ncbi.nlm.nih.gov/36520335Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06367348
Mlambe: A Randomized Controlled Trial of an Economic and Relationship-Strengthening Intervention to Reduce Alcohol Use in Malawi
Led by University of California, San Francisco · Updated on 2026-05-14
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating an intervention called Mlambe designed to reduce heavy alcohol use among married or cohabitating couples affected by HIV in Malawi. The study addresses how alcohol use, intimate partner violence, and economic insecurity affect health outcomes and HIV treatment adherence. This trial is the first to combine economic support and relationship skills to help couples break the cycle of poverty and reduce harmful drinking. Participants are randomly assigned to either standard HIV care with brief alcohol advice or the Mlambe intervention. Mlambe includes incentivized savings accounts, financial literacy training, and relationship skills education aimed at improving couple communication and support. The trial will compare the effectiveness and cost-effectiveness of Mlambe versus usual care over several months. During the study, researchers will assess alcohol use through questionnaires and biomarker tests at 11, 15, and 20 months. They will also monitor HIV viral suppression, medication adherence, appointment attendance, and relationship dynamics. Participants will be followed up over nearly two years to measure changes in drinking behavior, HIV outcomes, and couple support.
CONDITIONS
Brief Title
An Economic and Relationship-strengthening Intervention to Reduce Alcohol Use in Malawi
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- In a married or cohabitating union
- Have at least one partner with a positive AUDIT-C screen in prior 3 months
- Currently on antiretroviral therapy (ART) for at least 6 months
- Have disclosed HIV status to partner
You will not qualify if you...
- Severe intimate partner violence reported in the previous 3 months or fear for safety by participation
- Participation in Mlambe's pilot study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - Up to 20 months
Participants receive the Mlambe intervention, which includes incentivized savings accounts, financial literacy training, and relationship skills building to reduce problematic drinking and improve economic and HIV outcomes.
Sessions scheduled throughout the intervention period
Long-term Monitoring
Duration - Up to 20 months
Participants are followed for assessment of alcohol use, HIV outcomes, and relationship dynamics after the intervention period.
Assessments at approximately 11, 15, and 20 months
Trial Site Locations
Total: 1 location
1
Invest in Knowledge Initiative (IKI)
Zomba, Malawi
Actively Recruiting
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Research Team
J
James Mkandawire
A
Amy Conroy, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
'I told her this is your life': relationship dynamics, partner support and adherence to antiretroviral therapy among South African couples.
Amy Conroy, Anna Leddy, Mallory Johnson...
https://pubmed.ncbi.nlm.nih.gov/28398134Couple Interdependence Impacts Alcohol Use and Adherence to Antiretroviral Therapy in Malawi.
Amy A Conroy, Stacey A McKenna, Allison Ruark
https://pubmed.ncbi.nlm.nih.gov/30218319The Unaddressed Needs of Alcohol-Using Couples on Antiretroviral Therapy in Malawi: Formative Research on Multilevel Interventions.
Amy A Conroy, Allison Ruark, Stacey A McKenna...
https://pubmed.ncbi.nlm.nih.gov/31456201Results of a Couples-Based Randomized Controlled Trial Aimed to Increase Testing for HIV.
Lynae A Darbes, Nuala M McGrath, Victoria Hosegood...
https://pubmed.ncbi.nlm.nih.gov/30730356Asset ownership and health and mental health functioning among AIDS-orphaned adolescents: findings from a randomized clinical trial in rural Uganda.
Fred M Ssewamala, Chang-Keun Han, Torsten B Neilands
https://pubmed.ncbi.nlm.nih.gov/19520472Does Economic Strengthening Improve Viral Suppression Among Adolescents Living with HIV? Results From a Cluster Randomized Trial in Uganda.
Laura Gauer Bermudez, Fred M Ssewamala, Torsten B Neilands...
https://pubmed.ncbi.nlm.nih.gov/29846836Economic and relationship-strengthening intervention to reduce alcohol use in couples living with HIV in Malawi: a study protocol for a randomised controlled trial of Mlambe.
James Mkandawire, Fred M Ssewamala, Judith A Hahn...
https://pubmed.ncbi.nlm.nih.gov/39929508