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

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: HIV/AIDS

Treatments: Behavioral: Healthy Living Intervention (HLI); Behavioral: Standard of Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06036238

22-37054-2

1R01AA030464-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

400 participants in 2 patient groups

Standard of Care (Control)

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard of Care

Healthy Living Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Healthy Living Intervention (HLI)