Actively Recruiting
Treponemal Shedding, Load, and Viability, in Women and Men-who-have-sex-with-women-only With Early Infectious Syphilis: Implications for Transmission
Led by Monash University · Updated on 2026-04-03
480
Participants Needed
9
Research Sites
160 weeks
Total Duration
On this page
Sponsors
M
Monash University
Lead Sponsor
M
Melbourne Sexual Health Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
How syphilis is transmitted between sexual partners is unclear. Asymptomatic detection i.e. detection of syphilis bacteria (Tp) from anatomical sites without lesions, in patients with syphilis infection, suggests that asymptomatic transmission from these sites may play a role. However, no existing studies have established whether the syphilis bacteria (Tp) detected was viable. This means it is not known if the bacteria at this anatomical site is alive and therefore able to transmit the infection. Further, studies have focused mostly on men who have sex with men, resulting in a lack of evidence regarding anal shedding in men-who-have-sex-with-women only and women (regardless of sexual behaviour), and no data on asymptomatic vaginal shedding in women. This study will explore: 1. Patterns of Tp detection in women and men-who-have-sex-with-women only. 2. Whether detected Tp from each asymptomatic anatomical sites is viable 3. Duration of Tp detection and viability (alive and transmissible bacteria). Patients presenting to a participating sexual health service (overseas only) for management of suspected/confirmed early infectious syphilis will be eligible. During the routine clinical examination, participants will have additional oral and anal swabs, urine, vaginal swab (where relevant), penile skin swab (where relevant) and blood sample collected, in addition to the routine samples taken from the same sites and routine serology collected when syphilis is diagnosed.
CONDITIONS
Official Title
Treponemal Shedding, Load, and Viability, in Women and Men-who-have-sex-with-women-only With Early Infectious Syphilis: Implications for Transmission
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any cis-woman, cis-man who has sex with women only, or nonbinary individual with a penis who has sex with women only
- 18 years of age or older
- Had at least one sexual partner in the last 12 months
- Untreated suspected or confirmed early infectious syphilis with rash or lesions suggestive of syphilis, or untreated early latent syphilis with positive syphilis tests and criteria indicating infection within the last 12 months
- Willing and able to complete study procedures including physical examination
- Receiving syphilis treatment on the day of recruitment
- Sufficient language skills to understand study requirements
- Able to provide informed consent according to local ethics requirements
You will not qualify if you...
- Men, transwomen, or others with a penis who have had any sexual contact with men in the past year
- Received antibiotic treatment in the month before enrolment, except metronidazole
- Diagnosed with late latent syphilis (more than 1 year) or latent syphilis of unknown duration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Monash University
Melbourne, Victoria, Australia, 3004
Active, Not Recruiting
2
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200082
Not Yet Recruiting
3
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China, 200443
Not Yet Recruiting
4
National Institute for Communicable Diseases
Johannesburg, South Africa, 2192
Not Yet Recruiting
5
Foundation for Professional Development
Pretoria, South Africa, 0184
Not Yet Recruiting
6
Burrell Street Clinic, Guy's and St Thomas'
London, United Kingdom, SE10UN
Actively Recruiting
7
Jefferiss Clinic St Mary's Hospital, Imperial College London
London, United Kingdom, W21DL
Actively Recruiting
8
Mortimer Market Centre
London, United Kingdom, WC1E6JB
Actively Recruiting
9
London School of Hygiene & Tropical Medicine
London, United Kingdom, WC1E7HT
Active, Not Recruiting
Research Team
B
Brigid M Scally
CONTACT
J
Janet Towns
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here