The Outreach and Prevention at ALcohol Venues in East Africa Study (OPAL-East Africa- Aim 1) (OPAL-Aim 1)

University of California San Francisco (UCSF)

Status: Completed

Conditions: HIV/AIDS

Treatments: Behavioral: HIV-focused mobilization; Behavioral: Multi-disease-focused mobilization

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05862857

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

22-37054

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7,727 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7,727 participants in 2 patient groups

Aim 1: HIV-focused mobilization

Active Comparator group

Description:

Patrons and workers at drinking venues will be given a recruitment card for free HIV testing at the local clinic.

Treatment:

Behavioral: HIV-focused mobilization

Aim 1: Multi-disease-focused mobilization

Experimental group

Description:

Patrons and workers at drinking venues will be given a recruitment card for free multi-disease testing at the local clinic, including: diabetes, hypertension, HIV, malaria, TB, pregnancy.

Treatment:

Behavioral: Multi-disease-focused mobilization