Pre-Exposure Prophylaxis (PrEP) Provision for Ugandan Fisherfolk

Study Overview
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Brief Summary
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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
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The study will take place at two landing sites at which PrEP is provided to fisherfolk through the national PrEP program. The control site will administer the standard of care for PrEP provision through the national program. At the intervention site, the investigators will implement a three-pronged intervention: During healthcare outreach events we will conduct PrEP workshops, in which people who want to know more about PrEP can learn basic facts about PrEP and also can be taught skills about how to advocate for PrEP in their community. Check-in Calls: To support PrEP adherence, healthcare workers will call PrEP users regularly (e.g., 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. 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 them 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.

Official Title
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PrEP Provision for Ugandan Fisherfolk

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Enhanced PrEP provision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Behavioral: Enhanced PrEP provision<br>* 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.<br>|
| No Intervention: Control<br>At the control site, healthcare facility staff will continue to provide PrEP according to the standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of time on PrEP | Number of months (0-6) that a participant is on PrEP | Baseline to six months after | 
| Percent of people who accept PrEP of those offered | Percent of people who accept PrEP of those offered | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PrEP, Fisherfolk, Uganda, HIV/AIDS