Pre-Exposure Prophylaxis (PrEP) Provision for Ugandan Fisherfolk

RanD

Status: Completed

Conditions: HIV

Treatments: Behavioral: Enhanced PrEP provision

Study type: Interventional

Funder types: Other

Identifiers

NCT05084716

R34MH119924

Details and patient eligibility

About

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.

Full 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.

Enrollment: 885 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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885 participants in 3 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Enhanced PrEP provision

Pre-Intervention Standard of Care

No Intervention group

Description:

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.

Comparison Community

No Intervention group

Description:

The comparison community will receive standard of care for PrEP provision.