Actively Recruiting

Age: 18Years +
All Genders
NCT07300254

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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

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Treponemal Shedding, Load, and Viability, in Women and Men-who-have-sex-with-women-only With Early Infectious Syphilis: Implications for Transmission | DecenTrialz