Reducing Hazardous Alcohol Use and Optimizing Treatment as Prevention Among Men Living With HIV in Risk Environments
Launched by SAN DIEGO STATE UNIVERSITY · Jan 9, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a program called Kisoboka, which means "It is possible." The goal of this program is to help men living with HIV who drink alcohol in risky environments, like fishing communities, to reduce their alcohol use, take their HIV medications regularly, and achieve undetectable levels of the virus in their bodies. The trial will compare the Kisoboka program with other brief counseling and referrals to see which approach is more effective in helping participants improve their health.
To be eligible for this trial, participants must be men aged 18 or older, living with HIV, and residing in a fishing community. They should also show signs of potentially dangerous drinking and have been on HIV treatment for at least six months. Participants will attend counseling sessions that can be individual or in a group, ranging from one to six sessions over a period of 1 to 16 weeks. It's important to note that the trial is not yet recruiting participants, but if you or someone you know fits these criteria, it could be a valuable opportunity to receive support and improve health outcomes.
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- • 1. living with HIV;
- • 2. residing in a fishing community (on most days/nights);
- • 3. AUDIT-C positive (≥4) indicating potential hazardous drinking;
- • 4. \>6 months since initial antiretroviral treatment (ART) initiation;
- • 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.
- 7. 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;
- Exclusion Criteria:
- • 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
About San Diego State University
San Diego State University (SDSU) is a leading academic institution recognized for its commitment to research and innovation in various fields, including health sciences. With a robust infrastructure for clinical trials, SDSU engages in cutting-edge research aimed at advancing medical knowledge and improving patient care. The university fosters collaboration among interdisciplinary teams of researchers, clinicians, and students, enabling the development of novel therapeutic interventions and evidence-based practices. SDSU's dedication to ethical standards and rigorous scientific methodologies ensures that its clinical trials contribute valuable insights to the medical community and enhance public health outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Kampala, , Uganda
Patients applied
Trial Officials
Susan M Kiene, PhD, MPH
Principal Investigator
San Diego State University
Joseph KB Matovu, PhD, MHS
Principal Investigator
Makerere University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported