NCT05862857: OPAL-Aim 1

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

Completed NA Results posted Last updated 11 March 2026

What this trial tests

NA trial testing HIV-focused mobilization in HIV/AIDS in 9,375 participants. Completed in 28 March 2025.

Timeline

13 July 2023

Primary endpoint
3 February 2025

28 March 2025

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	9,375
Start date	13 July 2023
Primary completion	3 February 2025
Estimated completion	28 March 2025
Sites	2 locations across Kenya, Uganda

Drugs / interventions tested

• HIV-focused mobilization
• Multi-disease-focused mobilization

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →

Sponsor

University of California, San Francisco

Who can join

18 and older, any sex, with HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Biomedical HIV Prevention Uptake at 4 Weeks Primary · Measured 4 weeks after clinic screening visit

The proportion of HIV-negative adults, receiving an Aim 1 mobilization card, who initiate PrEP or PEP after mobilization. This outcome will be measured by pill dispensing records and Ministry of Health (MoH) PrEP and PEP registry records. Mean was calculated as the average percentage across the clusters (groups of nearby alcohol-serving venues).

Group	Value	95% CI
Intervention Clusters	23.7	20.0 – 27.4
Control Clusters	24.1	18.7 – 29.5

Biomedical HIV Prevention Uptake at 8 Weeks Secondary · Measured 8 weeks after clinic screening visit

The proportion of HIV-negative adults, receiving an Aim 1 mobilization card, who initiate PrEP or PEP after mobilization. This outcome will be measured by pill dispensing records and Ministry of Health (MoH) PrEP and PEP registry records. Mean was calculated as the average percentage across the clusters (groups of nearby alcohol-serving venues).

Group	Value	95% CI
Intervention Clusters	23.8	20.0 – 27.5
Control Clusters	24.1	18.6 – 29.6

Biomedical HIV Prevention Uptake at 12 Weeks Secondary · Measured 12 weeks after clinic screening visit

The proportion of HIV-negative adults, receiving an Aim 1 recruitment card, who initiate PrEP or PEP after mobilization. This outcome will be measured by pill dispensing records and Ministry of Health (MoH) PrEP and PEP registry records. Mean was calculated as the average percentage across the clusters (groups of nearby alcohol-serving venues).

Group	Value	95% CI
Intervention Clusters	23.8	20.0 – 27.6
Control Clusters	24.1	18.7 – 29.6

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Association between Levels of Alcohol Use, Perceived HIV Risk, and Untreated HIV Among Persons at Alcohol-Serving Venues in Kenya and Uganda.
   Beesiga B, Litunya J, Nakato JZ, Agola JA, et al · · 2026 · PMID 41746468 · DOI 10.1007/s10461-026-05056-y