Pre-Exposure Prophylaxis (PrEP) Provision for Ugandan Fisherfolk

HIV Clinical Trial

Official title:

PrEP Provision for Ugandan Fisherfolk

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05084716
• Other study ID #: R34MH119924
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 24, 2021
• Est. completion date: January 31, 2024

Study information

• Verified date: October 2023
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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:

1. 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.

2. 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.

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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1180
• Est. completion date: January 31, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Uganda	Makerere University School of Public Health	Kampala
Uganda	Mildmay Uganda	Kampala

Sponsors (3)

Lead Sponsor	Collaborator
RAND	Makerere University, Mildmay Uganda Limited

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of time on PrEP	Number of months (0-6) that a participant is on PrEP	Baseline to six months after
Primary	Percent of people who accept PrEP of those offered	Percent of people who accept PrEP of those offered	6 months