Trial Outcomes & Findings for The Outreach and Prevention at ALcohol Venues in East Africa Study (OPAL-East Africa- Aim 1) (NCT NCT05862857)
NCT ID: NCT05862857
Last Updated: 2026-03-11
Results Overview
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).
COMPLETED
NA
9375 participants
Measured 4 weeks after clinic screening visit
2026-03-11
Participant Flow
Unit of analysis: Drinking Venue Clusters
Participant milestones
| Measure |
Intervention Clusters
Patrons and workers at drinking venues were given a mobilization card for free multi-disease testing at the local clinic, including: diabetes, hypertension, HIV, malaria, TB, pregnancy.
|
Control Clusters
Patrons and workers at drinking venues were given a mobilization card for free HIV testing at the local clinic.
|
|---|---|---|
|
Overall Study
STARTED
|
4927 32
|
4448 32
|
|
Overall Study
COMPLETED
|
4927 32
|
4448 32
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Variable was added after study launch; therefore Data are missing from 705 participants - 415 in intervention group, 290 in control group
Baseline characteristics by cohort
| Measure |
Intervention Clusters
n=4916 Participants
Patrons and workers at drinking venues were given a mobilization card for free multi-disease testing at the local clinic, including: diabetes, hypertension, HIV, malaria, TB, pregnancy.
|
Control Clusters
n=4432 Participants
Patrons and workers at drinking venues were given a mobilization card for free HIV testing at the local clinic.
|
Total
n=9348 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 years
n=4916 Participants
|
32 years
n=4432 Participants
|
32 years
n=9348 Participants
|
|
Sex: Female, Male
Female
|
1621 Participants
n=4916 Participants
|
1714 Participants
n=4432 Participants
|
3335 Participants
n=9348 Participants
|
|
Sex: Female, Male
Male
|
3295 Participants
n=4916 Participants
|
2718 Participants
n=4432 Participants
|
6013 Participants
n=9348 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4916 Participants
|
0 Participants
n=4432 Participants
|
0 Participants
n=9348 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4916 Participants
|
0 Participants
n=4432 Participants
|
0 Participants
n=9348 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4916 Participants
|
0 Participants
n=4432 Participants
|
0 Participants
n=9348 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4916 Participants
n=4916 Participants
|
4432 Participants
n=4432 Participants
|
9348 Participants
n=9348 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=4916 Participants
|
0 Participants
n=4432 Participants
|
0 Participants
n=9348 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4916 Participants
|
0 Participants
n=4432 Participants
|
0 Participants
n=9348 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4916 Participants
|
0 Participants
n=4432 Participants
|
0 Participants
n=9348 Participants
|
|
Region of Enrollment
Kenya
|
2355 Participants
n=4916 Participants
|
2241 Participants
n=4432 Participants
|
4596 Participants
n=9348 Participants
|
|
Region of Enrollment
Uganda
|
2561 Participants
n=4916 Participants
|
2191 Participants
n=4432 Participants
|
4752 Participants
n=9348 Participants
|
|
Patron or worker
Patron
|
4028 Participants
n=4501 Participants • Variable was added after study launch; therefore Data are missing from 705 participants - 415 in intervention group, 290 in control group
|
3753 Participants
n=4142 Participants • Variable was added after study launch; therefore Data are missing from 705 participants - 415 in intervention group, 290 in control group
|
7781 Participants
n=8643 Participants • Variable was added after study launch; therefore Data are missing from 705 participants - 415 in intervention group, 290 in control group
|
|
Patron or worker
Worker
|
473 Participants
n=4501 Participants • Variable was added after study launch; therefore Data are missing from 705 participants - 415 in intervention group, 290 in control group
|
389 Participants
n=4142 Participants • Variable was added after study launch; therefore Data are missing from 705 participants - 415 in intervention group, 290 in control group
|
862 Participants
n=8643 Participants • Variable was added after study launch; therefore Data are missing from 705 participants - 415 in intervention group, 290 in control group
|
PRIMARY outcome
Timeframe: Measured 4 weeks after clinic screening visitPopulation: Population includes persons who received a mobilization card and contributed to the pre-specified, primary analysis, which excluded two clusters where \<18 cards were distributed
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).
Outcome measures
| Measure |
Intervention Clusters
n=31 Venue Clusters
Patrons and workers at drinking venues were given a mobilization card for free multi-disease testing at the local clinic, including: diabetes, hypertension, HIV, malaria, TB, pregnancy.
|
Control Clusters
n=31 Venue Clusters
Patrons and workers at drinking venues were given a mobilization card for free HIV testing at the local clinic.
|
|---|---|---|
|
Biomedical HIV Prevention Uptake at 4 Weeks
|
23.7 % of participants
Interval 20.0 to 27.4
|
24.1 % of participants
Interval 18.7 to 29.5
|
SECONDARY outcome
Timeframe: Measured 8 weeks after clinic screening visitPopulation: Population includes persons who received a mobilization card and contributed to the pre-specified, primary analysis, which excluded two clusters where \<18 cards were distributed
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).
Outcome measures
| Measure |
Intervention Clusters
n=31 Venue Clusters
Patrons and workers at drinking venues were given a mobilization card for free multi-disease testing at the local clinic, including: diabetes, hypertension, HIV, malaria, TB, pregnancy.
|
Control Clusters
n=31 Venue Clusters
Patrons and workers at drinking venues were given a mobilization card for free HIV testing at the local clinic.
|
|---|---|---|
|
Biomedical HIV Prevention Uptake at 8 Weeks
|
23.8 % of participants
Interval 20.0 to 27.5
|
24.1 % of participants
Interval 18.6 to 29.6
|
SECONDARY outcome
Timeframe: Measured 12 weeks after clinic screening visitPopulation: Population includes persons who received a mobilization card and contributed to the pre-specified, primary analysis, which excluded two clusters where \<18 cards were distributed
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).
Outcome measures
| Measure |
Intervention Clusters
n=31 Venue Clusters
Patrons and workers at drinking venues were given a mobilization card for free multi-disease testing at the local clinic, including: diabetes, hypertension, HIV, malaria, TB, pregnancy.
|
Control Clusters
n=31 Venue Clusters
Patrons and workers at drinking venues were given a mobilization card for free HIV testing at the local clinic.
|
|---|---|---|
|
Biomedical HIV Prevention Uptake at 12 Weeks
|
23.8 % of participants
Interval 20.0 to 27.6
|
24.1 % of participants
Interval 18.7 to 29.6
|
SECONDARY outcome
Timeframe: Measured at clinic screening visitThe proportion of HIV-unknown adults, receiving an Aim 1 recruitment card, who accept clinic-based HIV testing at the clinic screening visit. HIV testing will be done in accordance with Kenyan and Ugandan national testing algorithms. Uptake will be recorded on study CRFs.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at clinic screening visitThe proportion of persons accepting HIV screening who are identified with newly diagnosed HIV or those who are self-reported to have known HIV infection but out of care and off of ART. HIV testing will be done in accordance with Kenyan and Ugandan national testing algorithms. Uptake, test results, HIV status, and current ART use will be recorded on study CRFs.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at clinic screening visitHeavy alcohol use is defined as self-reported AUDIT-C score (a standardized, three question survey) of greater than or equal to 4 for men and greater than or equal to 3 for women. These outcomes will be recorded on study CRFs.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured within one week of presenting for clinic-based screening with a recruitment cardThe proportion of adults with untreated HIV that initiate ART. Current and prior ART use will be self-reported and recoded on study CRFs. New ART prescriptions will be measured through pill dispensing data and MoH registries.
Outcome measures
Outcome data not reported
Adverse Events
Intervention Clusters
Control Clusters
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place