NCT06771843Recruiting
Reducing Hazardous Alcohol Use and Optimizing Treatment as Prevention Among Men Living With HIV in Risk Environments
Kisoboka: Reducing Hazardous Alcohol Use and Optimizing Treatment as Prevention Among Men Living With HIV in Risk Environments
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
The investigators developed the Kisoboka ("It is possible") Intervention to address limitations of existing evidence-based interventions to optimize treatment as prevention among men living with HIV who drink alcohol at hazardous levels in "risk environments" such as fishing communities through reductions in hazardous alcohol use, improved adherence to HIV medications and achieving undetectable HIV viral loads. Social and structural determinants unique to fishing communities interact to create a risk environment where hazardous drinking impedes adherence to HIV medications among men living with HIV, including prevalent social norms of drinking, drinking as a way of experiencing "reward" and connecting with others (e.g. in the context of transactional sex), stressful work conditions, a "live for today" outlook, and a cash-based economy with no traditional savings infrastructure leading to ease of daily expenditure on drinking and sex work. These social and environmental conditions result in high levels of alcohol misuse and HIV risk, poor HIV outcomes, and exacerbation of HIV-associated wellness comorbidities such as poor mental and subjective physical health and food insecurity. The goal of this study is to learn if the intervention called Kisoboka works to help men in fishing communities reduce hazardous alcohol use, be better able to take the participants HIV medication as prescribed, and have undetectable HIV viral loads. The investigators will compare the Kisoboka intervention to a brief alcohol screening, adherence counseling, and referrals, and to components of the Kisoboka intervention. Participants will attend intervention counseling sessions according to the study arm to which the participants are randomly assigned. The number of sessions ranges from 1 to 6 over 1 to 16 weeks and are individual only or both individual and group sessions.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 716 (estimated)
- First submitted
- 9 Jan 2025
- Start date
- 16 Jun 2025
- Primary completion date
- Oct 2028
- Lead sponsor
- San Diego State University
- Diseases
- HIV
- NCT number
- NCT06771843
What you commit to
- Study type: Interventional
- Planned participants: 716
- From 16 Jun 2025 to the primary completion date, Oct 2028
- 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
- 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
Who the study is looking for
- living with HIV;
- residing in a fishing community (on most days/nights);
- AUDIT-C positive (≥4) indicating potential hazardous drinking;
- \>6 months since initial antiretroviral treatment (ART) initiation;
- not planning to move from the area within the next 6 months;
- have their own mobile phone and can be reached via phone.
- 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;
Age in the registry: 18 years to - · Sex: Male · 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 affiliated sites in Buikwe, Nakasongola, Mukono, and Kayunga Districts Coordinator of this site? Confirm its status | Kampala | Uganda | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.