Peer Delivered HIV/Syphilis Self-Testing With Assisted Partner Notification Services

NCT06791928 | Enrolling By Invitation Phase 2 DMC

• 1 other identifier: Makerere University
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Background and rationale Men who engage in sexual relations with other men (MSM) are disproportionately affected by HIV and other sexually transmitted infections (STI), such as syphilis. Globally, MSM have a 28 times greater risk of HIV acquisition than adult men (15-49 years) in the general population. In Uganda, HIV prevalence in MSM is 13.2% versus 4.7% in similarly aged heterosexual males, while syphilis prevalence is 8.3% versus 5.8% in males aged 15-64 years. Syphilis and HIV transmission share common sexual risk behaviors, and syphilis increases HIV acquisition risk three-fold. Uganda guidelines recommend annual HIV/syphilis testing for MSM, but uptake of facility-based HIV testing is low (32%) of the estimated MSM population in Kampala. Assisted partner notification (services, i.e., tracing sexual partners of people with HIV and offering them testing services, is the standard of care (SOC) in Uganda. The World Health Organization recommends task shifting to MSM peers to increase access to and availability of HIV/syphilis testing services. Differentiated service delivery models, such as peer-delivered HIV/syphilis self-tests and assisted partner notification with linkage to care, could improve engagement in care by MSM. Our prior work found that peer-delivery of HIV self-tests (HIVST) was feasible and acceptable to 90% of MSM in Uganda. All those newly diagnosed with HIV received confirmatory testing, were linked to care, and started antiretroviral treatment (ART). Other work in Zimbabwe found high acceptability (89.6%) of peer-delivered syphilis self-tests among MSM. Joint delivery of peer-delivered HIV/syphilis self-tests and assisted partner notification is an empowering, innovative approach that could substantially increase testing among MSM in Uganda and help achieve global HIV 95:95:95 targets. However, no studies to our knowledge have evaluated the effectiveness of peer-delivered HIV/syphilis self-tests and assisted partner notification services for MSM in any setting. Study objectives

1. 1.To assess the feasibility and acceptability of implementation of peer-delivered self-tests for HIV and syphilis with partner services for Ugandan MSM.
2. 2.To assess the preliminary effectiveness of peer-delivered HIV/syphilis self-tests and partner services versus facility-based testing.
3. 3.To estimate the cost-effectiveness of peer-delivered HIV/syphilis self-tests and partner services compared to facility-based testing.
4. 4.Adoption (proportion reached using self-tests and assisted partner notification.
5. 5.Linkage (proportion of testers linked to services)
6. 6.Intervention acceptability (assessed using 5-point Likert scales)
7. 7.Fidelity (assessed through 20 field observations checklist of peer activities (10 per arm).

Conditions

HIV; Syphilis

Outcome Measures

Primary Outcomes (1)

• Intervention acceptability

  This will be measured as uptake of HIVST and syphilis self-testing kits between the two arms

  12 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

a) deliver HIVST/syphilis self-testing kits to MSM within their networks using SNS and target never or infrequent testers; b) actively link MSM who test positive to confirmatory testing and care; c) offer sexual partners voluntary assisted partner notification and HIV/syphilis testing while maintaining confidentiality

Behavioral: Peer distribution of self testking kits

Control arm

ACTIVE COMPARATOR

a) distribute invitation letters to social network members for fast-track HIV/syphilis testing at a health facility. All MSM will receive: i) free confirmatory HIV and syphilis testing, condoms, and treatment and ii) psychosocial peer support at the health facility.

Behavioral: Peer distribution of self testking kits

Interventions

Peer distribution of self testking kits BEHAVIORAL

Participants will be given a demonstration and instructions on how to use self-test kits (written and pictorial instructions in Luganda) and provided with ten serialized kits (five HIVST and five syphilis self-testing) to distribute to eligible social and sexual network members. Peers effective at reaching infrequent and non-testers will be asked to distribute an additional three to five test kits. Each peer will receive an IRB-approved $5 for each kit distributed and accounted for as in prior studies. (62). Respondents will be compensated for each successful recruitment, and SNS recruiting will continue until the sample size of 200 is attained. Each peer will receive a REC-approved transport facilitation of $30 per month since most MSM who have never tested are hard to trace. Control group peers will only distribute invitation letters for fast-track HIV/syphilis at the study clinic to minimize contamination (i.e., use of the intervention by control group participants).

Control arm; Intervention arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: MSM
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 years and older,
• Self-report of anal sexual intercourse at least once in the prior quarter
• self-identify as MSM,
• not tested in the past three months or never tested for HIV or syphilis before;
• willing to provide informed consent;
• willing to undergo study procedures

You may not qualify if:

• Participants who already know that they have HIV and those who are on treatment for syphilis
• Those enrolled in other HIV prevention trial
• We shall exclude participants who don't speak English and Luganda

Sponsors & Collaborators

• Makerere University: lead
• National Institutes of Health (NIH): collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

Infectious Diseases Institute, Makerere University

Wakiso, Uganda

Location

MeSH Terms

Conditions

Syphilis

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Stephen Okoboi, BSc, MPH, PhD

  Infectious Diseases Institute, Makerere University

  PRINCIPAL INVESTIGATOR

• Barbara A Castelnuovo, MD, MPH. PhD

  Infectious Diseases Institute, Makerere University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention peers will: a) deliver HIVST/syphilis self-testing kits to MSM within their networks using SNS and target never or infrequent testers; b) actively link MSM who test positive to confirmatory testing and care; c) offer sexual partners voluntary assisted partner notification and HIV/syphilis testing while maintaining confidentiality. Control arm peers will: a) distribute invitation letters to social network members for fast-track HIV/syphilis testing at a health facility. All MSM will receive: i) free confirmatory HIV and syphilis testing, condoms, and treatment and ii) psychosocial peer support at the health facility.

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 24, 2025
• Study Start: August 25, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After study completion and during the publication
• Access Criteria: During a publication, dataset shall be accompanied with an anonymized dataset

Locations

UG (1)