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

• Sponsor: London School of Hygiene and Tropical Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT04480749
• Collaborator: Biomedical Research and Training Institute, Zimbabwe (Other), Pangaea Zimbabwe Aids Trust (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.6
• Patients Per Site Per Month: 6.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Syphilis	Diagnostic Test: Access to Facility based Syphilis Testing; Diagnostic Test: Syphilis Self-Test	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Syphilis Self-testing to Expand Test Uptake Among Men Who Have Sex With Men (SST)
• Actual Study Start Date: Oct 14, 2020
• Actual Primary Completion Date: Jul 1, 2021
• Actual Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Routine Testing Among men in the control group, they will receive a list of local clinics that can provide free syphilis testing.	Diagnostic Test: Access to Facility based Syphilis Testing; List of facilities where syphilis testing can be accessed
Experimental: 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.	Diagnostic Test: Access to Facility based Syphilis Testing; List of facilities where syphilis testing can be accessed; Diagnostic Test: Syphilis Self-Test; Rapid Treponemal Test kit

Outcome Measures

Primary Outcome Measures

1. Syphilis Tests Undertaken [6 months]

   The total number of participants undertaking a syphilis test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Men who have sex with men

• Able to consent

Exclusion Criteria:

• Unable to consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harare City Council Health Facilities	Harare	NIL Return	Zimbabwe

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 26, 2019

More Information

Publications

None provided.

• Responsible Party: London School of Hygiene and Tropical Medicine
• ClinicalTrials.gov Identifier: NCT04480749
• Other Study ID Numbers: 17848
• First Posted: Jul 21, 2020
• Last Update Posted: Jul 25, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Syphilis

Study Results

Participant Flow

Arm/Group Title	Routine Testing	Self-Testing
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	50	50
COMPLETED	50	50
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Routine Testing	Self-Testing	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	50	50	100
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	50 100%	50 100%	100 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	50 100%	50 100%	100 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	50 100%	50 100%	100 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Zimbabwe	50 100%	50 100%	100 100%

Outcome Measures

1. Primary Outcome

Title	Syphilis Tests Undertaken
Description	The total number of participants undertaking a syphilis test
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Routine Testing	Self-Testing
Arm/Group Description	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	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
Measure Participants	50	50
Count of Participants [Participants]	29 58%	37 74%

Adverse Events

Time Frame	6 months
Arm/Group Title	Routine Testing		Self-Testing
Arm/Group Description	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		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
All Cause Mortality
	Routine Testing		Self-Testing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		9/50 (18%)
Serious Adverse Events
	Routine Testing		Self-Testing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Routine Testing		Self-Testing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.