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RECRUITING
NCT07300254

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

View on ClinicalTrials.gov

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

OTHER

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