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

Study acronym: Kisoboka
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Study site revisedv6
  2. Minor Start date changed from estimate of Jun 2025 to Jun 16, 2025v5
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Apr 2025 to Jun 2025
    • Site details revised
    • Eligibility criteria shortened, about 2 words
    v4
  4. Notable Start date: Feb 2025 to Apr 2025v3
  5. Minor Secondary endpoints revised (4)v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06771843
Lead Sponsor San Diego State University
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA), Makerere University Walter Reed Program, Makerere University
Conditions
(from sponsor)
HIV Antiretroviral Therapy (ART) Adherence, Alcohol Abuse, HIV Infection, Alcohol Use Disorder, HIV Infections
Related terms Alcoholism, HIV Infections
Enrollment 716 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov