Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06036238

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

Led by University of California, San Francisco · Updated on 2025-09-10

400

Participants Needed

2

Research Sites

158 weeks

Total Duration

On this page

Sponsors

U

University of California, San Francisco

Lead Sponsor

U

University of California, Berkeley

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • HIV-negative based on rapid antibody test
  • AUDIT-C score of 4 or higher for men and 3 or higher for women indicating heavy alcohol use
  • Attending a clinical visit to start biomedical HIV prevention with oral or injectable PrEP, oral PEP, or dapivirine vaginal ring if available
  • Access to a mobile phone
Not Eligible

You will not qualify if you...

  • Not eligible for PrEP based on Ministry of Health guidelines
  • Planning to move away from the study area within the next year
  • Severely intoxicated or unable to provide informed consent

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Kenya Medical Research Institute (KEMRI)

Mbita, Kenya

Actively Recruiting

2

Infectious Diseases Research Collaboration (IDRC)

Mbarara, Uganda

Actively Recruiting

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Research Team

K

Kara Marson, MPH

CONTACT

G

Gabriel Chamie, MD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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