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Completed

NCT Number: NCT05084716

Pre-Exposure Prophylaxis (PrEP) Provision for Ugandan Fisherfolk

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Makerere University School of Public Health, Kampala, Uganda

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About this study

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:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of Participants With PrEP Initiation

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

    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

  2. Number of Participants Who Persisted On PrEP After Initiation

    Time frame: 6 months

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

Secondary outcomes

  1. Number of Participants Who Maintained PrEP Prescriptions Over 6 Months

    Time frame: 6 months

    Percentage of PrEP users with a PrEP medication possession ratio of at least 80% coverage by PrEP prescriptions over 6 months. (i.e., 144 of 180 days)

Sponsors and collaborators

Lead sponsor

RAND

Other

Collaborators

  • Makerere University
  • Mildmay Uganda Limited

Registry information

Official study title

PrEP Provision for Ugandan Fisherfolk

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 20, 2021
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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