Clinical trial NCT05862857: The Outreach and Prevention at ALcohol Venues in East Africa Study (OPAL-East Africa- Aim 1)
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: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: Drinking venues
Biomedical HIV prevention
Uganda
Kenya
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: 2023-05-17
Enrollment: 7727
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 test innovative interventions to increase uptake and use of biomedical HIV prevention options by engaging women and men at drinking venues in rural Kenya and Uganda in care, while gaining insights into the facilitators, barriers, and cost-effectiveness of these approaches.

Detailed description: \[BACKGROUND\] Alcohol use is a common risk factor for both HIV prevention uptake and retention in sub-Saharan Africa (SSA). Interventions that promote biomedical HIV prevention (PrEP and PEP) among persons with heavy alcohol use and their sexual partners are urgently needed. Alcohol-serving drinking venues play an important role as sites of HIV transmission in SSA and are ideal sites to engage women and men at increased risk of HIV in biomedical prevention services.

\[OVERVIEW\] 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. The investigators now need to determine whether multi-disease mobilization can promote uptake of HIV prevention for adults at drinking venues in the context of new biomedical prevention options.

The project will rigorously test innovative interventions in Kenya and Uganda to increase uptake of biomedical HIV prevention, and assess facilitators, barriers, and cost-effectiveness of these approaches.

Specific Aims:

* Compare the effectiveness of two mobilization strategies to increase uptake of biomedical HIV prevention among adults at drinking venues.
* Determine the cost-effectiveness of interventions that increase biomedical HIV prevention uptake 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 reach and uptake of biomedical HIV prevention and exploring associated facilitators and barriers.

Eligibility criteria: Participant Inclusion Criteria:

* adult (≥18 years)
* patron or worker at a drinking venue within the study community

Exclusion Criteria:

* age \<18 years
* previous participation in the study (may only participate once)
* inability to consent (including gross inebriation)

Primary outcomes:
measure: Biomedical HIV prevention uptake at 4 weeks
timeFrame: Measured 4 weeks after clinic screening visit
Secondary outcomes:
measure: Biomedical HIV prevention uptake at 8 weeks
timeFrame: Measured 8 weeks after clinic screening visit
measure: Biomedical HIV prevention uptake at 12 weeks
timeFrame: Measured 12 weeks after clinic screening visit
measure: HIV testing uptake
timeFrame: Measured at clinic screening visit
measure: Yield of adults with untreated HIV
timeFrame: Measured at clinic screening visit
measure: Yield of adults with heavy alcohol use
timeFrame: Measured at clinic screening visit
measure: Adults with untreated HIV who initiate ART
timeFrame: Measured within one week of presenting for clinic-based screening with a recruitment card
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: