Trial Outcomes & Findings for Pre-Exposure Prophylaxis (PrEP) Provision for Ugandan Fisherfolk (NCT NCT05084716)

Results Overview

Individuals who are eligible for PrEP (tested HIV-negative, aged 18 and older, in fisherfolk community) are asked by a healthcare provider whether they want to start taking PrEP

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

885 participants

Primary outcome timeframe

Baseline. Individuals are asked if they wish to initiate PrEP after they have been tested and deemed eligible

Results posted on

2024-08-13

Participant Flow

This study was conducted at two mainland fisherfolk landing sites in Wakiso District, Uganda. We collected healthcare facility data on HIV testing and PrEP eligibility 6-months before and during the intervention (4-9/21 \& 9/21-2/22, respectively) in the intervention community, and during the intervention in the comparison community; and medical records for de-identified client-level PrEP initiation and refill dates for all PrEP users who initiated before and during the intervention (4/21-8/22).

Unit of analysis: Community

Participant milestones

Participant milestones
Measure	Intervention Period, Intervention Site At the intervention site during healthcare facility outreach events, all community members were offered the opportunity to attend intervention workshops where they learned basic facts about PrEP and were taught skills about how to advocate for PrEP in their community. Check-in reminder calls were conducted systematically with PrEP users. Healthcare facility staff encouraged PrEP initiators to select an adherence supporter.	Pre-intervention Period, Intervention Site Prior to the intervention period in the intervention community, healthcare facility staff provided PrEP through outreach events and in local healthcare facilities according to the standard of care.	Intervention Period, Comparison Site During the intervention period in the comparison community, healthcare facility staff provided PrEP through outreach events and in local healthcare facilities according to the standard of care.
Overall Study STARTED	199 1	142 1	544 1
Overall Study COMPLETED	199 1	142 1	544 1
Overall Study NOT COMPLETED	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

We only had IRB approval to collect demographic data for those who initiated PrEP

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Period, Intervention Site n=199 Participants At the intervention site during healthcare facility outreach events, PrEP initiators will be offered guidance on selecting an adherence supporter during PrEP initiation. All outreach event attendees at the events will be offered the opportunity to attend the intervention workshops. Check-in reminder calls will be conducted systematically with PrEP users. Enhanced PrEP provision: The intervention will train health care providers to facilitate workshops at outreach events where attendees can learn basic facts about PrEP and be taught skills about how to advocate for PrEP in their community. Healthcare facility staff will encourage PrEP initiators to select an adherence supporter. Check-in reminder calls will be conducted systematically with PrEP users.	Pre-intervention Period, Intervention Site n=142 Participants Prior to the intervention period in the intervention community, healthcare facility staff will provide PrEP through outreach events and in local healthcare facilities according to the standard of care.	Intervention Period, Comparison Site n=544 Participants At the control site, healthcare facility staff will continue to provide PrEP according to the standard of care.	Total n=885 Participants Total of all reporting groups
Age, Continuous	31.2 years STANDARD_DEVIATION 9.5 • n=192 Participants • We only had IRB approval to collect demographic data for those who initiated PrEP	29.1 years STANDARD_DEVIATION 7.9 • n=120 Participants • We only had IRB approval to collect demographic data for those who initiated PrEP	27.3 years STANDARD_DEVIATION 5.3 • n=426 Participants • We only had IRB approval to collect demographic data for those who initiated PrEP	28.6 years STANDARD_DEVIATION 7.2 • n=738 Participants • We only had IRB approval to collect demographic data for those who initiated PrEP
Sex: Female, Male Female	105 Participants n=192 Participants • We only had IRB approval to collect demographic data for those who initiated PrEP	49 Participants n=120 Participants • We only had IRB approval to collect demographic data for those who initiated PrEP	160 Participants n=426 Participants • We only had IRB approval to collect demographic data for those who initiated PrEP	314 Participants n=738 Participants • We only had IRB approval to collect demographic data for those who initiated PrEP
Sex: Female, Male Male	87 Participants n=192 Participants • We only had IRB approval to collect demographic data for those who initiated PrEP	71 Participants n=120 Participants • We only had IRB approval to collect demographic data for those who initiated PrEP	266 Participants n=426 Participants • We only had IRB approval to collect demographic data for those who initiated PrEP	424 Participants n=738 Participants • We only had IRB approval to collect demographic data for those who initiated PrEP
Race/Ethnicity, Customized Black African	199 Participants n=199 Participants	142 Participants n=142 Participants	544 Participants n=544 Participants	885 Participants n=885 Participants

PRIMARY outcome

Timeframe: Baseline. Individuals are asked if they wish to initiate PrEP after they have been tested and deemed eligible

Population: All individuals eligible for PrEP are given the option of initiating (1) or declining (0).

Individuals who are eligible for PrEP (tested HIV-negative, aged 18 and older, in fisherfolk community) are asked by a healthcare provider whether they want to start taking PrEP

Outcome measures

Outcome measures
Measure	Intervention Period, Intervention Site n=199 Participants At the intervention site during healthcare facility outreach events, all community members will be offered the opportunity to attend intervention workshops where they can learn basic facts about PrEP and be taught skills about how to advocate for PrEP in their community. Check-in reminder calls will be conducted systematically with PrEP users. Healthcare facility staff will encourage PrEP initiators to select an adherence supporter.	Pre-Intervention Period, Intervention Site n=142 Participants Prior to the intervention period in the same community, healthcare facility staff will provide PrEP through outreach events and in local healthcare facilities according to the standard of care.	Intervention Period, Comparison Site n=544 Participants During the intervention period in the control community, healthcare facility staff will provide PrEP through outreach events and in local healthcare facilities according to the standard of care.
Number of Participants With PrEP Initiation	192 Participants	120 Participants	426 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Analysis of PrEP persistence is restricted to those who initiated PrEP

Percentage of PrEP users who are still on PrEP at 6 months post-initiation

Outcome measures

Outcome measures
Measure	Intervention Period, Intervention Site n=192 Participants At the intervention site during healthcare facility outreach events, all community members will be offered the opportunity to attend intervention workshops where they can learn basic facts about PrEP and be taught skills about how to advocate for PrEP in their community. Check-in reminder calls will be conducted systematically with PrEP users. Healthcare facility staff will encourage PrEP initiators to select an adherence supporter.	Pre-Intervention Period, Intervention Site n=120 Participants Prior to the intervention period in the same community, healthcare facility staff will provide PrEP through outreach events and in local healthcare facilities according to the standard of care.	Intervention Period, Comparison Site n=426 Participants During the intervention period in the control community, healthcare facility staff will provide PrEP through outreach events and in local healthcare facilities according to the standard of care.
Number of Participants Who Persisted On PrEP After Initiation	92 Participants	8 Participants	145 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Analysis of PrEP coverage is restricted to those who initiated PrEP

Percentage of PrEP users with a PrEP medication possession ratio of at least 80% coverage by PrEP prescriptions over 6 months. (i.e., 144 of 180 days)

Outcome measures

Outcome measures
Measure	Intervention Period, Intervention Site n=192 Participants At the intervention site during healthcare facility outreach events, all community members will be offered the opportunity to attend intervention workshops where they can learn basic facts about PrEP and be taught skills about how to advocate for PrEP in their community. Check-in reminder calls will be conducted systematically with PrEP users. Healthcare facility staff will encourage PrEP initiators to select an adherence supporter.	Pre-Intervention Period, Intervention Site n=120 Participants Prior to the intervention period in the same community, healthcare facility staff will provide PrEP through outreach events and in local healthcare facilities according to the standard of care.	Intervention Period, Comparison Site n=426 Participants During the intervention period in the control community, healthcare facility staff will provide PrEP through outreach events and in local healthcare facilities according to the standard of care.
Number of Participants Who Maintained PrEP Prescriptions Over 6 Months	69 Participants	0 Participants	300 Participants

Adverse Events

Intervention Period, Intervention Site

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pre-Intervention Period, Intervention Site

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention Period, Comparison Site

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Laura Bogart

RAND

Phone: 3103930411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place