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

NCT ID: NCT05862857

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7727 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-13
• Study Completion Date: 2025-03-28

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.

Conditions

HIV/AIDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Aim 1: HIV-focused mobilization

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

Group Type: ACTIVE_COMPARATOR

HIV-focused mobilization

Intervention Type: BEHAVIORAL

Patrons and employees of drinking venues that are randomized to HIV-focused recruitment will receive a recruitment card offering free HIV testing at the local clinic

Aim 1: Multi-disease-focused mobilization

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.

Group Type: EXPERIMENTAL

Multi-disease-focused mobilization

Intervention Type: BEHAVIORAL

Patrons and employees of drinking venues that are randomized to HIV-focused recruitment will receive a recruitment card offering free health screenings that may include hypertension, diabetes, HIV, malaria (if febrile), and TB (if symptomatic), and pregnancy at the local clinic

Interventions

HIV-focused mobilization

Patrons and employees of drinking venues that are randomized to HIV-focused recruitment will receive a recruitment card offering free HIV testing at the local clinic

Intervention Type: BEHAVIORAL

Multi-disease-focused mobilization

Patrons and employees of drinking venues that are randomized to HIV-focused recruitment will receive a recruitment card offering free health screenings that may include hypertension, diabetes, HIV, malaria (if febrile), and TB (if symptomatic), and pregnancy at the local clinic

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Berkeley

OTHER

Sponsor Role: collaborator

Makerere University

OTHER

Sponsor Role: collaborator

Infectious Diseases Research Collaboration, Uganda

OTHER

Sponsor Role: collaborator

Kenya Medical Research Institute

OTHER

Sponsor Role: collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabriel Chamie, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Kenya Medical Research Institute (KEMRI)

Mbita, , Kenya

Infectious Diseases Research Collaboration (IDRC)

Mbarara, , Uganda

Countries

Kenya; Uganda

Other Identifiers

1R01AA030464-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-37054

Identifier Type: -

Identifier Source: org_study_id