Pilot of an Intervention to Reduce Alcohol Use and Improve ART Adherence Among Men Living with HIV with Pregnant Partners in Uganda.

Launched by SAN DIEGO STATE UNIVERSITY · Mar 21, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new program aimed at helping men living with HIV reduce their alcohol use and stick to their HIV treatment, known as antiretroviral therapy (ART). The study focuses on men who drink alcohol in hazardous amounts and have pregnant partners. It’s important to address alcohol use because it can make it harder for men to follow their treatment, which increases the risk of passing HIV to their partners, especially when they are pregnant. The researchers will compare two groups: one group will receive the new program aimed at reducing alcohol use and improving treatment adherence, while the other group will receive standard care.

To participate, men need to be living with HIV, show signs of hazardous drinking, and have been on ART for at least six months. They also need a detectable viral load or have missed doses of their medication recently. Women must be pregnant, HIV negative, and at least 18 years old. Couples living together for more than six months are preferred. Participants will take part in assessments at the beginning of the study, and again at three and six months, to see how the program is working and to provide feedback on their experience. This study will be crucial in understanding how to support men with HIV in managing their health and protecting their partners.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • FOR MEN
• • 1. living with HIV;
• • 2. AUDIT-C positive (≥4) indicating potential hazardous drinking;
• • 3. \>6 months since initial antiretroviral treatment (ART) initiation;
• • 4. 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
• • 5. not planning to move from the area within the next 6 months;
• • 6. have their own mobile phone and can be reached via phone.
• • FOR WOMEN
• • 1. 18+ years of age (or emancipated minor)
• • 2. Pregnant
• • 3. HIV negative
• • FOR COUPLES (IF INDIVIDUAL ELIGIBILITY CRITERIA ABOVE ARE MET)
• • 1. married/living together \>6 months;
• • 2. planning to stay together \>6 months
• • 3. lived in the area for \>3 months and
• • 4. not planning to move within \<6 months.
• • 5. 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 Criteria:
• • FOR MEN
• • 1. visibly intoxicated at enrollment (eligible to enroll when not intoxicated);
• • 2. does not speak Luganda or English;
• • 3. currently receiving a majority of work payments via mobile money/digital payments;
• • 4. participated in the Kisoboka pilot RCT;
• • 5. 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.