Clinical trial NCT06036238: The Outreach and Prevention at ALcohol Venues in East Africa Study (OPAL-East Africa- Aim 2) (OPAL-Aim 2)
Official title: Innovative Strategies to Promote Biomedical HIV Prevention Uptake and Retention Among High-risk Adults at Drinking Venues in Kenya and Uganda
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV/AIDS
Keywords: Alcohol use
Biomedical HIV prevention
Uganda
Kenya
Counseling intervention
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of California, Berkeley
name: Makerere University
name: Infectious Diseases Research Collaboration, Uganda
name: Kenya Medical Research Institute
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2023-09-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Proportion of follow up time on biomedical prevention with PrEP or PEP
timeFrame: Measured 48 weeks after PrEP or PEP initiation
Secondary outcomes:
measure: 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
timeFrame: Measured 48 weeks after PrEP or PEP initiation
measure: Proportion of participants with HIV seroconversion by week 48
timeFrame: Measured 48 weeks after PrEP or PEP initiation
Other outcomes:
Locations:
city: Mbita
country: Kenya
facility: Kenya Medical Research Institute (KEMRI)
city: Mbarara
country: Uganda
facility: Infectious Diseases Research Collaboration (IDRC)
Study officials:
affiliation: University of California, San Francisco
name: Gabriel Chamie, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: