NCT06900634Not yet recruiting
Pilot of an Intervention to Reduce Alcohol Use and Improve ART Adherence Among Men Living With HIV With Pregnant Partners in Uganda.
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
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 21 Mar 2025
- Start date
- 1 Feb 2027
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- San Diego State University
- Diseases
- HIV
- NCT number
- NCT06900634
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Feb 2027 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- currently receiving a majority of work payments via mobile money/digital payments;
Other
- 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.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Makerere University Walter Reed Program Coordinator of this site? Confirm its status | Kampala | Uganda | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.