Trial Outcomes & Findings for Syphilis Self-testing to Expand Test Uptake Among Men Who Have Sex With Men (SST) (NCT NCT04480749)

NCT ID: NCT04480749

Last Updated: 2022-07-25

Results Overview

The total number of participants undertaking a syphilis test

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 100 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2022-07-25

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Routine Testing n=50 Participants 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	Self-Testing n=50 Participants 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	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Zimbabwe	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

The total number of participants undertaking a syphilis test

Outcome measures

Measure	Routine Testing n=50 Participants 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	Self-Testing n=50 Participants 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
Syphilis Tests Undertaken	29 Participants	37 Participants

Adverse Events

Routine Testing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Self-Testing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 9 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Marks

LSHTM

Phone: 020 7636 8636

Email: michael.marks@lshtm.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place