Clinical trial NCT05084716: Pre-Exposure Prophylaxis (PrEP) Provision for Ugandan Fisherfolk
Official title: PrEP Provision for Ugandan Fisherfolk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: PrEP
Fisherfolk
Uganda
HIV/AIDS
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Mildmay Uganda Limited
name: Makerere University
First posted: 2021-10-20
Enrollment: 885
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a pilot test of enhancements to the standard of care for providing PrEP in Ugandan fishing communities. The specific aims are to conduct a mixed-methods study assessing enhancements to the standard of care for providing PrEP in fisherfolk communities in Lake Victoria, Uganda.

Detailed description: The study will take place at two landing sites at which PrEP is provided to fisherfolk through the Ugandan national PrEP program. The comparison site will receive the standard of care for PrEP provision. At the intervention site, the investigators will implement a three-pronged intervention:

1. During healthcare outreach events we will conduct PrEP workshops, in which people who want to know more about PrEP learn basic facts about PrEP and are taught skills about how to advocate for PrEP in their community.
2. Check-in Calls: To support PrEP adherence, healthcare workers will call PrEP users two weeks after initiation, and the week before refill events, to check in about any questions and to remind them of the next date and place to pick up refills. Calls after PrEP initiation will ask about side effects.
3. To support PrEP adherence, healthcare workers will encourage PrEP users to select an adherence supporter, who is a family member or friend to whom they disclose their PrEP use. The adherence supporter agrees to remind the PrEP user to adhere to PrEP and get refills. Healthcare workers will ask the PrEP user for the name and contact information for the adherence supporter, so that the adherence supporter can be contacted to remind them about refills, as well as if the PrEP user does not show up for a refill.

Eligibility criteria: Inclusion Criteria for PrEP initiation:

* Tests HIV-negative at a healthcare outreach/HIV testing event in one of the two selected fishing communities and is PrEP-eligible

Exclusion Criteria:

* Not meeting the inclusion criteria

Primary outcomes:
measure: Number of Participants With PrEP Initiation
timeFrame: Baseline. Individuals are asked if they wish to initiate PrEP after they have been tested and deemed eligible
measure: Number of Participants Who Persisted On PrEP After Initiation
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants Who Maintained PrEP Prescriptions Over 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Makerere University School of Public Health
city: Kampala
country: Uganda
facility: Mildmay Uganda
Study officials:
affiliation: RAND
name: Laura M Bogart, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Makerere University
name: Rhoda K Wanyenze, MBChB,PhD,MPH
role: PRINCIPAL_INVESTIGATOR
References: