Peer-led HIV Self-testing Among Men in Two Ugandan Fishing Communities

NCT05685498 | Completed

• 1 other identifier: BusitemaU
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this behavioral interventional study is to assess the feasibility and acceptability of a peer-led HIV self-testing intervention among men in two fishing communities along the shores of Lake Victoria in Uganda. The main objectives of the study are: a) to assess the feasibility of implementing a peer-led HIV self-testing intervention among men in a fishing community context; b) determine the uptake of HIV self-testing among men in the fishing communities, and c) determine linkage to and retention in HIV care among newly diagnosed HIV-positive men following peer-led HIV self-testing. Participants will:

• Be administered a baseline questionnaire to assess prior HIV testing behaviors and willingness to self-test for HIV
• Receive two HIV self-test kits, one for them and one for someone else that they prefer to give the kit, to determine HIV testing behaviors among men and their significant others
• Be administered follow-up questionnaires at one (1), six (6) and 12 months post-baseline to determine linkage to and retention in HIV care among those testing HIV-positive, as well as linkage to appropriate HIV prevention services among those testing HIV-negative.

Conditions

HIV Testing

Keywords

HIV self-testing; Men; Fishing communities; Uganda

Outcome Measures

Primary Outcomes (3)

• Percentage of men who have self-tested for HIV

  Men will receive HIV self-test kits and be trained in how to use them as well as read and interpret results by trained peer-leaders. Uptake of HIV self-testing will be defined as the percentage of those that received HIV self-test kits from their peer-leaders who actually used them to self-test for HIV.

  One month from the time of receiving the kits.

• Percentage of men with confirmed HIV-positive results who have been linked to HIV care

  As per the manufacturer's instructions, all men with HIV-positive self-test results will be required to seek confirmatory HIV testing at the nearest health facility or at an outreach event, as case may be. For this outcome, we will aim to assess the percentage of men with confirmed HIV-positive results who have been linked to HIV care services (i.e. the percentage of men with confirmed HIV-positive results who have been started on antiretroviral therapy as per Uganda's national test and treat policy).

  One to six months after a HIV-positive self-test result

• Percentage of linked HIV-positive men who have been retained in HIV care

  Investigators will aim to assess the percentage of linked HIV-positive results who have been retained in HIV care (i.e. percentage of linked HIV-positive men who will still be receiving their antiretroviral therapy over the study duration).

  Six to 12 months after linkage to HIV care

Secondary Outcomes (2)

• Percentage of men with confirmed HIV-positive results who have disclosed their HIV-positive status to their peer-leaders

  Six to 12 months after HIV self-testing

• Percentage of men with confirmed HIV-positive results who have been linked to HIV care at community-based mobile outreaches.

  Six to 12 months after HIV self-testing

Study Arms (1)

Peer-led HIV self-testing among male fisherfolk in Uganda

OTHER

Men aged 15 years or older, who self-report a HIV-negative or unknown HIV status at enrolment and last tested for HIV three or more months are enrolled into the study. Enrolled men receive two HIV self-test kits from a trained community-based distributor (or peer-leader). Peer-leaders are selected from existing social networks and are trained in HIV self-testing procedures prior to distributing HIV self-test kits. The goal of the study is to assess if distribution of HIV self-test kits to men through trained local peer-leaders is feasible and acceptable in a fishing community context, and whether this approach can help to improve access to HIV testing services and, by implication, improve HIV testing uptake and subsequent linkage to appropriate HIV prevention, care and treatment services. Men are interviewed at baseline will be followed up at 1, 6 and 12 months post-baseline to determine HIV testing uptake, linkage to and retention in HIV care.

Behavioral: Peer-led HIV self-testing among male fisherfolk in Uganda

Interventions

Peer-led HIV self-testing among male fisherfolk in Uganda BEHAVIORAL

This behavioral intervention is centered on the distribution of HIV self-test kits to men through their respective peer-leaders. The investigators have identified up to 18 social network groups; each group is represented by 1-2 peer-leaders who were selected during community engagement meetings. Peer-leaders have received a 3-day training in the HIV self-testing processes, communication skills, existing referral mechanisms, and basic counseling skills. After the training, each peer-leader nominated up to 20 male members (15+ years) from within their social networks who were screened for study eligibility. Eligible male social network members were administered a baseline interview and requested to go to their peer-leaders to obtain their HIV self-test kits.

Peer-led HIV self-testing among male fisherfolk in Uganda

Eligibility Criteria

• Age: 15 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 15 years or older
• Residence in the targeted fishing community (and intended to stay for 12 or more months)
• Self-reported HIV-negative or unknown HIV status at enrolment
• Last HIV test was done three or more months from the time of enrolment

You may not qualify if:

• Men reporting a history of intimate partner violence in the past year preceding the survey
• Men who did not belong to pre-identified social networks in the community
• Men who were mentally incapacitated to understand the informed consent process
• Unemancipated minors aged 15-17 years

Sponsors & Collaborators

• Joseph KB Matovu: lead
• Makerere University: collaborator
• RAND: collaborator

Study Sites (2)

Buvuma district

Buikwe, Uganda

Location

Kalangala District

Kalangala, Uganda

Location

Related Publications (1)

• Matovu JK, Namwama AT, Kemigisha L, Taasi G, Nakabugo J, Wandabwa J, Bogart LM, Fakier N, Wanyenze RK, Olupot-Olupot P, Musinguzi J, Serwadda D. Feasibility, acceptability and preliminary effects of a social network-based, peer-led HIV self-testing intervention among men in two Ugandan fishing communities, 2022. Arch Public Health. 2025 Jan 24;83(1):23. doi: 10.1186/s13690-025-01511-9.

  PMID: 39849572 DERIVED

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Officials

• Joseph KB Matovu, PhD

  Busitema University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 17, 2023
• Study Start: July 18, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 24 months after the end of the last follow-up visit.
• Access Criteria: Individual data users will be required to submit a request to the study PI by email indicating the primary question that they intend to answer and the type of data that they need. After a careful review of the request received, de-identified individual data will be availed to the person requesting the data. While data will be generally available to researchers with or without Busitema University Faculty of Health Sciences, only students enrolled at Busitema University Faculty of Health Sciences or Makerere University School of Public Health will have access to the data.

Locations

UG (2)