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

September 2, 2025 updated by: University of California, San Francisco

Innovative Strategies to Promote Biomedical HIV Prevention Uptake and Retention Among High-risk Adults at Drinking Venues in Kenya and Uganda

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Kenya
      • Mbita, Kenya
        • Recruiting
        • Kenya Medical Research Institute (KEMRI)
        • Contact:
        • Principal Investigator:
          • James Ayieko, MBChB, MPH, PhD
  • Uganda
      • Mbarara, Uganda
        • Recruiting
        • Infectious Diseases Research Collaboration (IDRC)
        • Contact:
        • Principal Investigator:
          • Moses R Kamya, MBChB, MMed, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care (Control)
Standard of care; alcohol counseling per Ministry of Health (MoH) guidelines
Behavioral: 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.
Experimental: Healthy Living Intervention
Healthy Living Intervention in-person alcohol counseling with booster phone calls
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of follow up time on biomedical prevention with PrEP or PEP
Time Frame: Measured 24 weeks after PrEP or PEP initiation
The proportion of time during the 24 weeks after PrEP/PEP initiation that a person is protected from HIV with PrEP/PEP, assessed by prescription refill data. Prescription refill data will be collected from MoH medical and pharmacy records, augmented by OPAL case report forms.
Measured 24 weeks after PrEP or PEP initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with unhealthy alcohol use (defined by AUDIT-C ≥3 for women, ≥4 for men, and phosphatidylethanol (PEth) ≥50 ng/mL) at week 48
Time Frame: Measured 48 weeks after PrEP or PEP initiation
Study staff will assess AUDIT-C scores (modified to refer to the prior 3 months, with a minimum of 0, indicating no alcohol use, and a maximum of 12) with a standard drink guide adapted to local context at baseline and every 12-weeks post-baseline. Blood will also be collected, and dried blood spots prepared for phosphatidylethanol (PEth) testing (measured in ng/mL with higher levels associated with greater alcohol use) at baseline and 48-weeks for confirmation of self-reported alcohol use.
Measured 48 weeks after PrEP or PEP initiation
Proportion of participants with HIV seroconversion by week 48
Time Frame: Measured 48 weeks after PrEP or PEP initiation
HIV seroconversion will be measured as documented rapid HIV antibody test positivity with Geenius confirmation or documented detectable HIV viral load, with rapid HIV testing. HIV testing will occur at PrEP refill and injection visits, or completion of a course of PEP.
Measured 48 weeks after PrEP or PEP initiation
Proportion of follow up time on biomedical prevention with PrEP or PEP- 48 weeks
Time Frame: Measured over 48 weeks after PrEP or PEP initiation
Secondary analysis of the primary outcome will measure the proportion of time that a person is protected from HIV with PrEP/PEP over 48 weeks, with integrated drug levels measured in hair samples collected at 48 weeks.
Measured over 48 weeks after PrEP or PEP initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of California, Berkeley
Makerere University
Kenya Medical Research Institute
Infectious Diseases Research Collaboration, Uganda

Investigators

  • Principal Investigator: Gabriel Chamie, MD, MPH, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

September 6, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Estimated)

September 10, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-37054-2
  • 1R01AA030464-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Per the approved Data Sharing agreement with the NIAAA Data Archive, the investigators will share de-identified IPD from our baseline questionnaire, which includes questions about subject demographics, HIV risk, and alcohol use.

IPD Sharing Time Frame

Data requests can be submitted starting 3 months after article publication and the data will be made accessible for up to 36 months. Extensions will be considered on a case-by-case basis.

IPD Sharing Access Criteria

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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