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

NCT ID: NCT04480749

Last Updated: 2022-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-14
• Study Completion Date: 2021-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Routine Testing

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

Group Type: OTHER

Access to Facility based Syphilis Testing

Intervention Type: DIAGNOSTIC_TEST

List of facilities where syphilis testing can be accessed

Self-Testing

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.

Group Type: EXPERIMENTAL

Access to Facility based Syphilis Testing

Intervention Type: DIAGNOSTIC_TEST

List of facilities where syphilis testing can be accessed

Syphilis Self-Test

Intervention Type: DIAGNOSTIC_TEST

Rapid Treponemal Test kit

Interventions

Access to Facility based Syphilis Testing

List of facilities where syphilis testing can be accessed

Intervention Type: DIAGNOSTIC_TEST

Syphilis Self-Test

Rapid Treponemal Test kit

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Men who have sex with men
• Able to consent

Exclusion Criteria

• Unable to consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Biomedical Research and Training Institute, Zimbabwe

OTHER

Sponsor Role: collaborator

Pangaea Zimbabwe Aids Trust

OTHER

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Harare City Council Health Facilities

Harare, NIL Return, Zimbabwe

Countries

Zimbabwe

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17848

Identifier Type: -

Identifier Source: org_study_id