Syphilis Self-testing to Expand Test Uptake Among Men Who Have Sex With Men (SST)
Condition: Syphilis
MeSH terms: Syphilis
Intervention: Access to Facility based Syphilis Testing; Syphilis Self-Test
Intervention description: List of facilities where syphilis testing can be accessed; Rapid Treponemal Test kit
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men who have sex with men

          -  Able to consent

        Exclusion Criteria:

          -  Unable to consent