Kisoboka: Reducing Hazardous Alcohol Use and Optimizing Treatment as Prevention Among Men Living With HIV in Risk Environments

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
Uganda
Makerere University Walter Reed Program
RECRUITING
Kampala
Contact Information
Primary
Joseph Matovu, PhD, MHS
jmatovu@musph.ac.ug
+256 414 543872
Time Frame
Start Date: 2025-06-16
Estimated Completion Date: 2029-02
Participants
Target number of participants: 716
Treatments
Experimental: Kisoboka (BE + MI and synergy)
Experimental: Behavioral Economics (BE)
Experimental: Motivational Interviewing (MI)
Active_comparator: Screening and Referral (S&R)
Related Therapeutic Areas
Sponsors
Collaborators: Makerere University, National Institute on Alcohol Abuse and Alcoholism (NIAAA), Makerere University Walter Reed Program
Leads: San Diego State University

This content was sourced from clinicaltrials.gov