NCT06791928: PEER

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

ENROLLING BY INVITATION Phase 2 Last updated 24 January 2025

What this trial tests

Phase 2 trial testing Peer distribution of self testking kits in HIV in 200 participants. Enrolling by invitation.

Timeline

25 August 2024

Primary endpoint
1 December 2026

1 December 2028

Quick facts

Lead sponsor	Makerere University
Phase	Phase 2
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	200
Start date	25 August 2024
Primary completion	1 December 2026
Estimated completion	1 December 2028
Sites	1 location across Uganda

Drugs / interventions tested

• Peer distribution of self testking kits

Conditions studied

• HIV — all drugs for HIV →
• Syphilis — all drugs for Syphilis →

Sponsor

Makerere University

Who can join

Adults 18 to 65, male only, with HIV or Syphilis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. To assess the feasibility and acceptability of implementation of peer-delivered self-tests for HIV and syphilis with partner services for Ugandan MSM.
2. To assess the preliminary effectiveness of peer-delivered HIV/syphilis self-tests and partner services versus facility-based testing.
3. To estimate the cost-effectiveness of peer-delivered HIV/syphilis self-tests and partner services compared to facility-based testing.

Study design Objective 1: Cross-sectional qualitative study design (formative stage). Objective 2: Cluster randomized trial to pilot test the preliminary effectiveness of peer-delivered HIV/syphilis self-tests and partner services versus facility-based testing.

Objective 3: Cost-effectiveness analysis using payers and health sector perspectives.

Primary outcomes for objective 2:

1. Adoption (proportion reached using self-tests and assisted partner notification.
2. Linkage (proportion of testers linked to services)
3. Intervention acceptability (assessed using 5-point Likert scales)
4. Fidelity (assessed through 20 field observations checklist of peer activities (10 per arm).

Data analysis Objective 1: Investigators will use content analysis techniques. Two coders will read a random subset of interviews to identify general themes and create a preliminary codebook. A subset of transcripts will be coded together, and findings will be discussed to resolve discrepancies. An additional subset of interviews will be coded using the revised codebook, and Cohen's kappa will be calculated. Themes with kappa values of \<0.60 will be redefined.

Objective 2: Sociodemographic characteristics will be summarized using descriptive statistics. The primary outcomes shall be analyzed using intent-to-treat. All participants who receive an HIV/syphilis test will be included in the analysis. Those who receive the self-test kits but do not use them will also be included in intent-to-treat analyses to provide the most generalizable effect measure. Mixed effects/multi-level models using modified Poisson regression with robust standard errors will be used to estimate relative risks of HIV/syphilis testing (yes/no). They permit estimation of relative risks with more stability than log binomial or logistic models. The random effects from mixed effects/multi-level model appropriately adjust for correlation in outcomes within participants and between participants recruited by the same peer (i.e., clustering effect).

Objective 3: Cost-effectiveness analysis of peer-delivered HIV/syphilis self-tests and partner services compared to facility-based testing. Cost-effectiveness will be estimated as cost per additional person reached and cost per additional person linked from the healthcare sector and client perspectives.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.