Status:
NOT_YET_RECRUITING
Pilot of an Intervention to Reduce Alcohol Use and Improve ART Adherence Among Men Living With HIV With Pregnant Partners in Uganda.
Lead Sponsor:
San Diego State University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Makerere University
Conditions:
HIV Antiretroviral Therapy (ART) Adherence
Alcohol Consumption
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 associat...
Detailed Description
Men in Uganda who drink heavily face serious health and social challenges, including difficulty staying on HIV treatment, which increases the risk of passing HIV to their partners. Pregnant women in s...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
February 1 2027
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06900634
Start Date
February 1 2027
End Date
February 1 2028
Last Update
June 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Makerere University Walter Reed Program
Kampala, Uganda