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NCT06036238 | RECRUITING | HIV/AIDS


The Outreach and Prevention at ALcohol Venues in East Africa Study (OPAL-East Africa- Aim 2) (OPAL-Aim 2)
Sponsor:

University of California, San Francisco

Brief Summary:

This study will evaluate the effect of a brief alcohol counseling intervention on PrEP and PEP adherence among adults with heavy alcohol use at high risk for HIV, while gaining insights into the facilitators, barriers, and cost-effectiveness of this approach.

Condition or disease

HIV/AIDS

Intervention/treatment

Healthy Living Intervention (HLI)

Standard of Care

Phase

NA

Detailed Description:

The investigators have developed a mobilization strategy of integrating HIV testing within multi-disease screening to recruit \>2,000 people from drinking venues in Kenya and Uganda and invite them to begin biomedical HIV prevention if eligible (OPAL Aim 1; NCT05862857) 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 400 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Innovative Strategies to Promote Biomedical HIV Prevention Uptake and Retention Among High-risk Adults at Drinking Venues in Kenya and Uganda
Actual Study Start Date : 2024-05-17
Estimated Primary Completion Date : 2026-06
Estimated Study Completion Date : 2027-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * Adult (≥18 years)
  • * 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
  • * Ineligible for PrEP based on MoH guidelines
  • * Intention to move away from the study community in the coming year
  • * Gross inebriation or inability to provide informed consent

The Outreach and Prevention at ALcohol Venues in East Africa Study (OPAL-East Africa- Aim 2) (OPAL-Aim 2)

Location Details

NCT06036238


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Locations


RECRUITING

Kenya,

Kenya Medical Research Institute (KEMRI)

Mbita, Kenya,

RECRUITING

Uganda,

Infectious Diseases Research Collaboration (IDRC)

Mbarara, Uganda,

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