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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04480749
Enrollment
100
Registered
2020-07-21
Start date
2020-10-14
Completion date
2021-12-31
Last updated
2022-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syphilis

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.

Interventions

DIAGNOSTIC_TESTAccess to Facility based Syphilis Testing

List of facilities where syphilis testing can be accessed

DIAGNOSTIC_TESTSyphilis Self-Test

Rapid Treponemal Test kit

Sponsors

Biomedical Research and Training Institute, Zimbabwe
CollaboratorOTHER
Pangaea Zimbabwe Aids Trust
CollaboratorOTHER
London School of Hygiene and Tropical Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Men who have sex with men * Able to consent

Exclusion criteria

* Unable to consent

Design outcomes

Primary

MeasureTime frameDescription
Syphilis Tests Undertaken6 monthsThe total number of participants undertaking a syphilis test

Countries

Zimbabwe

Participant flow

Participants by arm

ArmCount
Routine Testing
Among men in the control group, they will receive a list of local clinics that can provide free syphilis testing. Access to Facility based Syphilis Testing: List of facilities where syphilis testing can be accessed
50
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. Access to Facility based Syphilis Testing: List of facilities where syphilis testing can be accessed Syphilis Self-Test: Rapid Treponemal Test kit
50
Total100

Baseline characteristics

CharacteristicRoutine TestingSelf-TestingTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
50 Participants50 Participants100 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
50 Participants50 Participants100 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Region of Enrollment
Zimbabwe
50 participants50 participants100 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
50 Participants50 Participants100 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 509 / 50
other
Total, other adverse events
0 / 500 / 50
serious
Total, serious adverse events
0 / 500 / 50

Outcome results

Primary

Syphilis Tests Undertaken

The total number of participants undertaking a syphilis test

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Routine TestingSyphilis Tests Undertaken29 Participants
Self-TestingSyphilis Tests Undertaken37 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026