Pre-Exposure Prophylaxis (PrEP) Provision for Ugandan Fisherfolk

NCT05084716 | Completed Results

• 1 other identifier: R34MH119924
• Study Type: interventional
• Target: 885
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV

Keywords

PrEP; Fisherfolk; Uganda; HIV/AIDS

Outcome Measures

Primary Outcomes (2)

• Number of Participants With PrEP Initiation

  Individuals who are eligible for PrEP (tested HIV-negative, aged 18 and older, in fisherfolk community) are asked by a healthcare provider whether they want to start taking PrEP

  Baseline. Individuals are asked if they wish to initiate PrEP after they have been tested and deemed eligible

• Number of Participants Who Persisted On PrEP After Initiation

  Percentage of PrEP users who are still on PrEP at 6 months post-initiation

  6 months

Secondary Outcomes (1)

• Number of Participants Who Maintained PrEP Prescriptions Over 6 Months

  6 months

Study Arms (3)

Intervention

EXPERIMENTAL

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.

Behavioral: Enhanced PrEP provision

Pre-Intervention Standard of Care

NO INTERVENTION

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

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

Interventions

Enhanced PrEP provision BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• RAND: lead
• Mildmay Uganda Limited: collaborator
• Makerere University: collaborator

Study Sites (2)

Makerere University School of Public Health

Kampala, Uganda

Location

Mildmay Uganda

Kampala, Uganda

Location

Related Publications (1)

• 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.

  PMID: 39028385 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

The intervention and comparison communities were mismatched: the comparison community had a less mobile population and a healthcare center (and the intervention community did not), making refill access easier. In addition, pre-intervention PrEP refill data were not available for the comparison site. Thus, we present results for the pre vs. during intervention period comparison in the intervention community, and for the intervention vs. comparison communities during the intervention period.

Results Point of Contact

• Title: Laura Bogart
• Organization: RAND

lbogart@rand.org

3103930411

Study Officials

• Laura M Bogart, PhD

  RAND

  PRINCIPAL INVESTIGATOR

• Rhoda K Wanyenze, MBChB,PhD,MPH

  Makerere University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 20, 2021
• Study Start: September 24, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 13, 2024
• Results First Posted: August 13, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

UG (2)