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

NCT06036238 | Recruiting

• 2 other identifiers: 22-37054-21R01AA030464-01
• Study Type: interventional
• Target: 400
• Locations: 2 countries
• Sites: 2

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.

Conditions

HIV/AIDS

Keywords

Alcohol use; Biomedical HIV prevention; Uganda; Kenya; Counseling intervention

Outcome Measures

Primary Outcomes (1)

• Proportion of follow up time on biomedical prevention with PrEP or PEP

  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 Outcomes (3)

• Proportion of follow up time on biomedical prevention with PrEP or PEP- 48 weeks

  Measured over 48 weeks after PrEP or PEP initiation

• 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

  Measured 48 weeks after PrEP or PEP initiation

• Proportion of participants with HIV seroconversion by week 48

  Measured 48 weeks after PrEP or PEP initiation

Study Arms (2)

Standard of Care (Control)

ACTIVE COMPARATOR

Standard of care; alcohol counseling per Ministry of Health (MoH) guidelines

Behavioral: Standard of Care

Healthy Living Intervention

EXPERIMENTAL

Healthy Living Intervention in-person alcohol counseling with booster phone calls

Behavioral: Healthy Living Intervention (HLI)

Interventions

Healthy Living Intervention (HLI) BEHAVIORAL

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.

Healthy Living Intervention

Standard of Care BEHAVIORAL

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.

Standard of Care (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of California, Berkeley: collaborator
• Makerere University: collaborator
• Infectious Diseases Research Collaboration, Uganda: collaborator
• Kenya Medical Research Institute: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

Kenya Medical Research Institute (KEMRI)

Mbita, Kenya

RECRUITING

Infectious Diseases Research Collaboration (IDRC)

Mbarara, Uganda

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Alcohol Drinking

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Gabriel Chamie, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kara Marson, MPH

CONTACT

650-346-5774; kara.marson@ucsf.edu

Gabriel Chamie, MD, MPH

CONTACT

gabriel.chamie@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 13, 2023
• Study Start: May 17, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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).

Locations

UG (1); KE (1)