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

Primary Purpose

Syphilis

Status
Completed
Phase
Phase 4
Locations
Zimbabwe
Study Type
Interventional
Intervention
Access to Facility based Syphilis Testing
Syphilis Self-Test
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Syphilis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Men who have sex with men
  • Able to consent

Exclusion Criteria:

  • Unable to consent

Sites / Locations

  • Harare City Council Health Facilities

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Routine Testing

Self-Testing

Arm Description

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

Outcomes

Primary Outcome Measures

Syphilis Tests Undertaken
The total number of participants undertaking a syphilis test

Secondary Outcome Measures

Full Information

First Posted
July 2, 2020
Last Updated
March 25, 2022
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Biomedical Research and Training Institute, Zimbabwe, Pangaea Zimbabwe Aids Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04480749
Brief Title
Syphilis Self-testing to Expand Test Uptake Among Men Who Have Sex With Men (SST)
Official Title
Syphilis Self-testing to Expand Test Uptake Among Men Who Have Sex With Men (SST)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 14, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Biomedical Research and Training Institute, Zimbabwe, Pangaea Zimbabwe Aids Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syphilis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Routine Testing
Arm Type
Other
Arm Description
Among men in the control group, they will receive a list of local clinics that can provide free syphilis testing.
Arm Title
Self-Testing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Access to Facility based Syphilis Testing
Intervention Description
List of facilities where syphilis testing can be accessed
Intervention Type
Diagnostic Test
Intervention Name(s)
Syphilis Self-Test
Intervention Description
Rapid Treponemal Test kit
Primary Outcome Measure Information:
Title
Syphilis Tests Undertaken
Description
The total number of participants undertaking a syphilis test
Time Frame
6 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Men who have sex with men
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men who have sex with men Able to consent Exclusion Criteria: Unable to consent
Facility Information:
Facility Name
Harare City Council Health Facilities
City
Harare
State/Province
NIL Return
Country
Zimbabwe

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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