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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
Sponsor: Monash University
Summary
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.
Official title: Treponemal Shedding, Load, and Viability, in Women and Men-who-have-sex-with-women Only With Early Infectious Syphilis: Implications for Transmission
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
480
Start Date
2025-12-02
Completion Date
2028-12-31
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
No Intervention: Observational Cohort
No intervention: Observational study
Locations (9)
Monash University
Melbourne, Victoria, Australia
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China
National Institute for Communicable Diseases
Johannesburg, South Africa
Foundation for Professional Development
Pretoria, South Africa
Burrell Street Clinic, Guy's and St Thomas'
London, United Kingdom
Jefferiss Clinic St Mary's Hospital, Imperial College London
London, United Kingdom
Mortimer Market Centre
London, United Kingdom
London School of Hygiene & Tropical Medicine
London, United Kingdom