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Hidden syphilis: new study targets silent spread in women and straight men

NCT ID NCT07300254

Knowledge-focused Sponsor: Monash University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aims to understand how syphilis bacteria spread from people without visible symptoms, focusing on women and men who have sex with women only—groups often overlooked in past research. Researchers will collect swabs and blood samples from 480 participants with early syphilis to check if live bacteria are present in the mouth, anus, vagina, or urine. The goal is to find out if asymptomatic transmission is possible, which could help improve prevention efforts.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could clarify how syphilis spreads without symptoms, potentially improving prevention strategies for understudied groups.
What could go wrong
This is an observational study, not a treatment trial. It may not directly change clinical practice, and findings may not apply to all populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 480 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Women and Men-Who-Have-Sex-With-Women-Only with early infectious syphilis

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 1. 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. 2. Individuals who have received antibiotic treatment within 1 month prior to enrolment, with the EXCEPTION of metronidazole. 3. Diagnosis of late latent syphilis (\>1 year) or latent syphilis of unknown duration.

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Conditions

The condition(s) this trial relates to.

primary syphilis syphilis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Syphilis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Burrell Street Clinic, Guy's and St Thomas'

    RECRUITING

    London, SE10UN, United Kingdom

  • Foundation for Professional Development

    NOT_YET_RECRUITING

    Pretoria, 0184, South Africa

  • Jefferiss Clinic St Mary's Hospital, Imperial College London

    RECRUITING

    London, W21DL, United Kingdom

  • London School of Hygiene & Tropical Medicine

    ACTIVE_NOT_RECRUITING

    London, WC1E7HT, United Kingdom

  • Monash University

    ACTIVE_NOT_RECRUITING

    Melbourne, Victoria, 3004, Australia

  • Mortimer Market Centre

    RECRUITING

    London, WC1E6JB, United Kingdom

  • National Institute for Communicable Diseases

    NOT_YET_RECRUITING

    Johannesburg, 2192, South Africa

  • Shanghai Skin Disease Hospital

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200443, China

  • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200082, China

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