Pilot of an Intervention to Reduce Alcohol Use and Improve ART Adherence Among Men Living With HIV With Pregnant Partners in Uganda.
Starting soon · Not applicable
Conditions studied: HIV Antiretroviral Therapy (ART) Adherence, Alcohol Consumption
In brief
Hazardous alcohol use, which is common among men in Uganda, is a primary driver of both HIV risk and intimate partner violence (IPV) in this setting. Among men living with HIV, alcohol use is associated with non-adherence to antiretroviral therapy (ART) and a detectable viral load, increasing the risk of onward HIV transmission to partners. This risk is further heightened when the partner is pregnant, due to the potential for vertical transmission. Therefore, addressing factors that interfere with optimal HIV care outcomes among men living with HIV is critical to HIV prevention in pregnant women. The goal of this randomized controlled trial (RCT) is to pilot test an intervention that combines alcohol reduction and economic strengthening to improve ART adherence. The study will assess implementation outcomes and preliminary efficacy among men living with HIV who engage in hazardous alcohol use and their pregnant partners (n=30 couples). The main questions it aims to answer are: 1. What are the implementation outcomes (acceptability, appropriateness, feasibility, fidelity, and safety) at the individual, implementer, and organizational levels, and what bridging factors may impede success (e.g., community-academic partnership)? 2. Does the intervention reduce hazardous alcohol use and improve ART adherence among men living with HIV? Researchers will compare the intervention group (n=15 couples) to the standard of care group (n=15 couples) to determine if the intervention leads to behavior change in alcohol use and ART adherence among men living with HIV. Participants will: 1. Men in the intervention group will receive the Amaka intervention, designed to reduce alcohol use and improve ART adherence. 2. Complete assessments on hazardous alcohol use, ART adherence, and implementation outcomes at multiple time points (baseline, 3 and 6 months). 3. Engage with implementers to provide post-implementation feedback on feasibility and acceptability.
Key facts
- Study ID
- NCT06900634
- Run by
- San Diego State University
- People needed
- 60
- Starts
- 2027-02-01
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2026-06-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- FOR MEN
- living with HIV;
- AUDIT-C positive (≥4) indicating potential hazardous drinking;
- >6 months since initial antiretroviral treatment (ART) initiation;
- an indicator of potential suboptimal treatment as prevention (TasP) either: (i) last HIV viral load test (within 6 months) was detectable (>20) or (ii) last viral load test between 6 and 13 months ago was detectable (>20) and reports missing ≥2 ART doses in the past 2 weeks or (iii) a lack of viral load test results for the prior 13 months in clinic records and reports missing ≥2 ART doses in the past 2 weeks
- not planning to move from the area within the next 6 months;
- have their own mobile phone and can be reached via phone.
- FOR WOMEN
- 18+ years of age (or emancipated minor)
- Pregnant
- HIV negative
- FOR COUPLES (IF INDIVIDUAL ELIGIBILITY CRITERIA ABOVE ARE MET)
- married/living together >6 months;
- planning to stay together >6 months
- lived in the area for >3 months and
- not planning to move within <6 months.
- similar responses on Couple Verification Screening (CVS) form, an instrument to determine if couples are legitimate (e.g., asking each person what they ate the last time they shared a meal with their partner).
You may not qualify if…
- FOR MEN
- visibly intoxicated at enrollment (eligible to enroll when not intoxicated);
- does not speak Luganda or English;
- currently receiving a majority of work payments via mobile money/digital payments;
- participated in the Kisoboka pilot RCT;
- unable to read basic Luganda or English
- FOR WOMEN For safety purposes, we will not enroll women who do not feel they can safely participate in the study.
Where it is running
- Makerere University Walter Reed Program — Kampala, Uganda
Full record on ClinicalTrials.gov
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