Pre-Exposure Prophylaxis (PrEP) Provision for Ugandan Fisherfolk
NCT ID: NCT05084716
Last Updated: 2024-08-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
885 participants
INTERVENTIONAL
2021-09-24
2023-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention
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.
Enhanced PrEP provision
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 Standard of Care
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.
No interventions assigned to this group
Comparison Community
The comparison community will receive standard of care for PrEP provision.
No interventions assigned to this group
Interventions
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Enhanced PrEP provision
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.
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
Yes
Sponsors
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Mildmay Uganda Limited
OTHER
Makerere University
OTHER
RAND
OTHER
Responsible Party
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Principal Investigators
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Laura M Bogart, PhD
Role: PRINCIPAL_INVESTIGATOR
RAND
Rhoda K Wanyenze, MBChB,PhD,MPH
Role: PRINCIPAL_INVESTIGATOR
Makerere University
Locations
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Makerere University School of Public Health
Kampala, , Uganda
Mildmay Uganda
Kampala, , Uganda
Countries
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References
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Bogart LM, Musoke W, Mukama CS, Allupo S, Klein DJ, Sejjemba A, Mwima S, Kadama H, Mulebeke R, Pandey R, Wagner Z, Mukasa B, Wanyenze RK. Enhanced Oral Pre-exposure Prophylaxis (PrEP) Implementation for Ugandan Fisherfolk: Pilot Intervention Outcomes. AIDS Behav. 2024 Oct;28(10):3512-3524. doi: 10.1007/s10461-024-04432-w. Epub 2024 Jul 19.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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