The Outreach and Prevention at ALcohol Venues in East Africa Study (OPAL-East Africa- Aim 2) (OPAL-Aim 2)
NCT ID: NCT06036238
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2024-05-17
2027-06-30
Brief Summary
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Detailed Description
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Following uptake of biomedical HIV prevention, persons with heavy alcohol use face challenges with retention in care and adherence to PrEP/PEP. The investigators have adapted a brief alcohol counseling intervention (Health Living Intervention) to reduce alcohol use and promote antiretroviral therapy (ART) adherence and HIV viral suppression among persons with HIV in Kenya and Uganda. The investigators now need to determine whether this intervention can promote retention in biomedical prevention and PrEP/PEP adherence among adults with heavy alcohol use.
Specific Aims:
* Determine the efficacy of the Healthy Living Intervention (HLI) to reduce heavy alcohol use vs. standard care (control) on retention in biomedical HIV prevention in a randomized trial among adults with heavy alcohol use.
* Determine the cost-effectiveness of interventions that increase biomedical HIV prevention retention among adults at high-risk for HIV who attend drinking venues.
The proposed research will address the critical intersection of alcohol use and HIV risk in SSA, by promoting retention of biomedical HIV prevention and exploring associated facilitators and barriers.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Standard of Care (Control)
Standard of care; alcohol counseling per Ministry of Health (MoH) guidelines
Standard of Care
Participants who are randomized to the control arm will receive basic alcohol counseling through the Ministry of Health if it is provided as standard of care.
Healthy Living Intervention
Healthy Living Intervention in-person alcohol counseling with booster phone calls
Healthy Living Intervention (HLI)
The Healthy Living Intervention (HLI) is a brief alcohol counseling intervention developed using the Information, Motivation, and Behavioral skills (IMB) model, a framework in which information, motivation, and behavioral skills are key determinants of health behavior. Participants initiating PrEP will be randomized to either HLI or standard of care alcohol counseling.
Interventions
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Healthy Living Intervention (HLI)
The Healthy Living Intervention (HLI) is a brief alcohol counseling intervention developed using the Information, Motivation, and Behavioral skills (IMB) model, a framework in which information, motivation, and behavioral skills are key determinants of health behavior. Participants initiating PrEP will be randomized to either HLI or standard of care alcohol counseling.
Standard of Care
Participants who are randomized to the control arm will receive basic alcohol counseling through the Ministry of Health if it is provided as standard of care.
Eligibility Criteria
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Inclusion Criteria
* HIV-uninfected (by rapid HIV antibody test)
* AUDIT-C score of \>=4 for men and \>=3 for women
* Attending a clinical visit for initiation of biomedical HIV prevention with oral or injectable PrEP or oral PEP (or the dapivirine vaginal ring, if available)
* Has access to a mobile phone
Exclusion Criteria
* Intention to move away from the study community in the coming year
* Gross inebriation or inability to provide informed consent
18 Years
ALL
Yes
Sponsors
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University of California, Berkeley
OTHER
Makerere University
OTHER
Infectious Diseases Research Collaboration, Uganda
OTHER
Kenya Medical Research Institute
OTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Gabriel Chamie, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Kenya Medical Research Institute (KEMRI)
Mbita, , Kenya
Infectious Diseases Research Collaboration (IDRC)
Mbarara, , Uganda
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22-37054-2
Identifier Type: -
Identifier Source: org_study_id
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