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

Official title

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

Overview

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.

Interventions

• Other No Intervention: Observational Cohort
  No intervention: Observational study

Primary outcome measures

• Number of Biological Samples Testing Positive for Treponema pallidum DNA by PCR [Time frame: Samples are taken at time of consent - single visit study]

Secondary outcome measures (2)

• Load of Treponema pallidum DNA in Positive Biological Samples by In-house Quantitative PCR (qPCR) assay [Time frame: Samples are taken at time of consent - single visit study]
• Number of Treponema pallidum-Positive Samples Demonstrating Viable Organisms via Novel In-house Viability Assay [Time frame: Samples are collected at time of consent - single study visit]

Eligibility criteria

Inclusion criteria

\- 1. Any cis-woman, cis-MSW, or nonbinary individuals with a penis who have sex with women only, (who meet all other study criteria) 2. Aged ≥18 years of age, 3. At least one sexual partner in the last 12 months 4. One of either:

a. Untreated clinically suspected primary or secondary syphilis. i. Must have rash or lesion(s) clinically suggestive of early infectious syphilis infection.

ii. May have positive PCR result, positive Dark-ground Microscopy result, positive syphilis serology or positive point-of-care syphilis test, but these are not necessary at the time of enrolment.

b. Untreated early latent (no clinical signs indicative of primary or secondary syphilis) syphilis with positive syphilis serology or positive point-of-care test, and one or more of the following(11): i. A documented syphilis seroconversion within the prior 12 months. ii. A sustained (longer than 2 weeks) fourfold or greater increase in the titre in the prior 12 months in a person previously treated for syphilis.

iii. Unequivocal symptoms of primary or secondary syphilis within the prior 12 months.

iv. Contact in the prior 12 months with a sex partner who had untreated primary, secondary, or early latent syphilis.

v. Documented reactive nontreponemal and treponemal tests, and the only possible exposure occurred during the previous 12 months vi. RPR/VDRL titre >= 1:64 5. Be willing and able to complete study procedures, including physical examination 6. Receiving syphilis treatment on the day of recruitment 7. Have sufficient language proficiency to understand the requirements of the study 8. Provide informed consent as per individual site's local ethics requirements

Exclusion criteria

• Men, transwomen, or other people, with a penis, who have had any sexual contact, including kissing, oral sex or anal sex, with men (or any other individual with a penis) in the previous one year.
• Individuals who have received antibiotic treatment within 1 month prior to enrolment, with the EXCEPTION of metronidazole.
• Diagnosis of late latent syphilis (>1 year) or latent syphilis of unknown duration.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

United Kingdom · 4 centers

• Burrell Street Clinic, Guy's and St Thomas' — London
• Jefferiss Clinic St Mary's Hospital, Imperial College London — London
• Mortimer Market Centre — London
• London School of Hygiene & Tropical Medicine — London

China · 2 centers

• Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Shanghai
• Shanghai Skin Disease Hospital — Shanghai

South Africa · 2 centers

• National Institute for Communicable Diseases — Johannesburg
• Foundation for Professional Development — Pretoria

Australia · 1 center

• Monash University — Melbourne

Identifiers

NCT: NCT07300254 · MUCTC-24018

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗