Syphilis Self-testing to Expand Test Uptake Among Men Who Have Sex With Men (SST)

NCT04480749 | Completed Phase 4 Results

• 1 other identifier: 17848
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Syphilis infection is a major global health problem, leading to substantial morbidity among key populations in low- and middle-income countries (LMICs). Men who have sex with men (MSM) are disproportionately affected by syphilis worldwide. Rates of syphilis diagnoses have been increasing amongst MSM in many countries in the last decade. A growing evidence base supporting HIV self-testing shows that self-testing kits based on the same proposed clinical pathways are feasible and reliable. The proposed study will leverage this body of evidence and apply it to syphilis self-testing. This is a pilot study conducted in Zimbabwe. It aims to collect initial data on the feasability of implementing syphilis self-testing to establish if a large scale-RCT of this approach would be appropriate and, if so, to inform the design of this trial. The investigators will recruit 100 MSM in Harare to join the pilot program. Participants will be recruited through two methods: in-person at MSM community-based organizations that currently operate HIV self-testing programs and online through banner advertisements that advertise HIV self-testing. Study Arms: Arm 1: One arm of the pilot will receive a free syphilis self-test kit (Intervention Arm) Arm 2: One arm will receive standard free facility-based syphilis testing (Control Arm). Intervention: In the intervention arm the investigators will provide a treponemal rapid syphilis test kit to all participants in the intervention arm of the pilot, delivered through MSM community facilitators. This is similar to existing rapid treponemal test kits that are available at many clinical facilities. Kits will be accompanied by simplified pictorial instructions on finger prick blood sample collection. Among participants in the control group, they will receive a list of local clinics that can provide free syphilis testing. Data Collection: For individuals in the intervention am the investigators will aim to obtain confirmation of test uptake. This will be done using either photographic confirmation sent via encrypted message on a smartphone, SMS message of a unique code or sending a unique five-digit code along with their test result to the study coordinator. The investigators will conduct cross-sectional surveys at baseline and six months later to assess sexual risk behaviours, HIV and syphilis testing experiences, and self-testing experiences. In addition to the survey data tool the investigators will conduct in-depth interviews with a small number of participants to gain additional data about their experience of syphilis self-testing. The investigators will obtain information on linkage to care from routine clinic administrative records and by providing study participants with a unique code to be provided when attending at the facility. Analysis: The investigators will used mixed-methods to evaluate our pilot intervention including The investigators will examine the proportion of individuals who undertake a syphilis test in the interventional and control arms; among those who receive a test, the proportion of individuals who receive appropriate post-testing services. The investigators will also collect qualitative data on attitudes to syphilis self-testing and quantitative data on syphilis prevalence to inform a subsequent clinical trial.

Conditions

Syphilis

Outcome Measures

Primary Outcomes (1)

• Syphilis Tests Undertaken

  The total number of participants undertaking a syphilis test

  6 months

Study Arms (2)

Routine Testing

OTHER

Among men in the control group, they will receive a list of local clinics that can provide free syphilis testing.

Diagnostic Test: Access to Facility based Syphilis Testing

Self-Testing

EXPERIMENTAL

In the intervention arm we will provide a treponemal rapid syphilis test kit to all individuals in the intervention arm of the pilot, delivered through MSM community facilitators. This is similar to existing rapid treponemal test kits that are available at many clinical facilities. Kits will be accompanied by simplified pictorial instructions on finger prick blood sample collection.

Diagnostic Test: Access to Facility based Syphilis Testing; Diagnostic Test: Syphilis Self-Test

Interventions

Access to Facility based Syphilis Testing DIAGNOSTIC_TEST

List of facilities where syphilis testing can be accessed

Routine Testing; Self-Testing

Syphilis Self-Test DIAGNOSTIC_TEST

Rapid Treponemal Test kit

Self-Testing

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Men who have sex with men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men who have sex with men
• Able to consent

You may not qualify if:

• Unable to consent

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Biomedical Research and Training Institute, Zimbabwe: collaborator
• Pangaea Zimbabwe Aids Trust: collaborator

Study Sites (1)

Harare City Council Health Facilities

Harare, NIL Return, Zimbabwe

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

Results Point of Contact

• Title: Michael Marks
• Organization: LSHTM

michael.marks@lshtm.ac.uk

020 7636 8636

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 21, 2020
• Study Start: October 14, 2020
• Primary Completion: July 1, 2021
• Study Completion: December 31, 2021
• Last Updated: July 25, 2022
• Results First Posted: July 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

ZI (1)