Alcohol and HIV medicine program for men with pregnant partners
Tests Kisoboka Amaka to cut drinking in men with HIV.
Plain-language title generated from the registry record
Registry title: Pilot of an Intervention to Reduce Alcohol Use and Improve ART Adherence Among Men Living With HIV With Pregnant Partners in Uganda.
Key facts
- Where
- Kampala, UgandaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for couples in Uganda: a man living with HIV who drinks hazardous amounts of alcohol and may not be taking his HIV medicine well, and his pregnant, HIV-negative partner.
- Age
- 18 years or older (women: 18+ or an emancipated minor).
- Sex
- Men living with HIV and their pregnant female partners.
- Disease stage
- Men: living with HIV, on HIV treatment (ART) for more than 6 months, with a detectable viral load or missed doses. Women: pregnant.
- Earlier treatment
- Men must have started ART more than 6 months ago.
- Biomarker or test result
- Men: AUDIT-C score of 4 or more (possible hazardous drinking). Last HIV viral load test detectable (>20), or missing viral load results for 13 months with ≥2 missed ART doses in the past 2 weeks. Women: HIV negative.
Main reasons for not taking part
- Man visibly drunk at enrollment (can enroll when not drunk)
- Does not speak Luganda or English, or cannot read basic Luganda or English
- Man gets most of his work pay by mobile money or digital payments
- Man took part in the Kisoboka pilot trial
- Woman who does not feel she can safely take part
Read by machine on 12 November 2026.
Where in Uganda
- Makerere University Walter Reed ProgramKampala, UgandaContact: Fred Magala, Program DirectorNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- San Diego State University
- Trial code
- NCT06900634
- Record updated
- 22 June 2026
- Original description
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.Read full original descriptionShow less
Utilizing Implementation Research Methodologies to Adapt an Intervention to Reduce Alcohol Use and Improve HIV Care Outcomes Among Men Living With HIV Who Have Serodiscordant Pregnant Partners
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.
Inclusion: 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).
Exclusion: currently receiving a majority of work payments via mobile money/digital payments; FOR MEN; visibly intoxicated at enrollment (eligible to enroll when not intoxicated); does not speak Luganda or English; 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.