Actively Recruiting
Kisoboka: Reducing Hazardous Alcohol Use and Optimizing Treatment as Prevention Among Men Living With HIV in Risk Environments
Led by San Diego State University · Updated on 2026-05-12
716
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
S
San Diego State University
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the Kisoboka intervention to help men living with HIV in fishing communities reduce hazardous alcohol use, improve adherence to HIV medications, and achieve undetectable HIV viral loads. These communities face unique social and structural challenges, including prevalent drinking norms, stressful work, and economic factors that contribute to high alcohol misuse and poor HIV outcomes. The study compares Kisoboka to other behavioral approaches to optimize treatment as prevention among men who drink at hazardous levels. The study includes several intervention groups: Kisoboka, Behavioral Economics, Motivational Interviewing, and Screening and Referral. Kisoboka combines financial goal setting, text reminders, substance-free activities, mobile money use, social support, and motivational counseling to reduce alcohol use and improve medication adherence. Participants attend 1 to 6 counseling sessions over 1 to 16 weeks, which can be individual or group sessions, depending on their assigned study arm. Participants will be monitored through assessments at baseline, 6, and 12 months to measure changes in alcohol use via Phosphatidylethanol levels, hazardous drinking status, ART adherence, and HIV viral loads. Secondary measures include depressive symptoms, physical health, self-reported adherence, and food security. The study uses random assignment and double masking to compare outcomes. Participants must have access to a mobile phone and remain in the community during the study period, with follow-up visits to track progress and safety.
CONDITIONS
Brief Title
Reducing Hazardous Alcohol Use and Optimizing Treatment as Prevention Among Men Living With HIV in Risk Environments
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Living with HIV
- Residing in a fishing community most days or nights
- Positive AUDIT-C score (4 or higher) indicating potential hazardous drinking
- Started antiretroviral treatment more than 6 months ago
- Not planning to move from the area within the next 6 months
- Own a mobile phone and can be reached by phone
- Meet one of the following indicating potential suboptimal treatment as prevention: (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 or more ART doses in the past 2 weeks, or (iii) no viral load test results for the prior 13 months and reports missing 2 or more ART doses in the past 2 weeks
You will not qualify if you...
- Visibly intoxicated at enrollment (may enroll when not intoxicated)
- Does not speak Luganda or English
- Currently receiving most work payments via mobile money or digital payments
- Participated in the Kisoboka pilot randomized controlled trial
- Unable to read basic Luganda or English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive behavioral interventions including financial goal setting, motivational interviewing focused on alcohol reduction and ART adherence, and support activities such as text reminders and social support to reduce hazardous alcohol use and optimize treatment as prevention.
Regular visits with intervention activities over 12 months
Duration - Up to 12 months after treatment start
Participants are followed up to assess changes in alcohol use, ART adherence, HIV viral load, depressive symptoms, physical health, and food security at 6 and 12 months after starting treatment.
Visits at 6 and 12 months for assessments
Trial Site Locations
Total: 1 location
1
Makerere University Walter Reed Program affiliated sites in Buikwe, Nakasongola, Mukono, and Kayunga Districts
Kampala, Uganda
Actively Recruiting
Research Team
J
Joseph Matovu, PhD, MHS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
4
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