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| Name | Class |
|---|---|
| Melbourne Sexual Health Centre | UNKNOWN |
| The Alfred | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cis-women with suspected or confirmed primary syphilis infection | Cis-women with suspected or confirmed primary syphilis infection |
| |
| Cis-women with suspected or confirmed secondary syphilis infection | Cis-women with suspected or confirmed secondary syphilis infection |
| |
| Cis-women with confirmed early-latent syphilis infection | Cis-women with confirmed early-latent syphilis infection |
| |
| Men-who-have-sex-with-women-only with suspected or confirmed primary syphilis infection | Men-who-have-sex-with-women-only with suspected or confirmed primary syphilis infection |
| |
| Men-who-have-sex-with-women-only with suspected or confirmed secondary syphilis infection | Men-who-have-sex-with-women-only with suspected or confirmed secondary syphilis infection |
| |
| Men-who-have-sex-with-women-only with confirmed early-latent syphilis infection |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention: Observational Cohort | Other | No intervention: Observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Biological Samples Testing Positive for Treponema pallidum DNA by PCR | This outcome measures the presence of Treponema pallidum (Tp) DNA in collected biological samples-including lesion swabs, blood, urine, saliva, and oral/anal/genital swabs-using a validated T. pallidum polymerase chain reaction (Tp PCR) assay. Data will be reported as the number and proportion of samples that test positive, stratified by:
| Samples are taken at time of consent - single visit study |
| Measure | Description | Time Frame |
|---|---|---|
| Load of Treponema pallidum DNA in Positive Biological Samples by In-house Quantitative PCR (qPCR) assay | This outcome measures the load (copies/mL) of Treponema pallidum (Tp) DNA in collected biological samples-including lesion swabs, blood, urine, saliva, and oral/anal/genital swabs-using an in-house validated quantitative T. pallidum polymerase chain reaction (Tp qPCR) assay. Data will be reported as a comparison in load between anatomical sites and by clinical stage of syphilis. |
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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:
Unfortunately we are unable to accept people who identify as transgender
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Women and Men-Who-Have-Sex-With-Women-Only with early infectious syphilis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brigid M Scally | Contact | +61399039300 | brigid.scally@monash.edu | |
| Janet Towns | Contact | janet.towns@monash.edu |
| Name | Affiliation | Role |
|---|---|---|
| Janet Towns | Monash University | Principal Investigator |
| Marcus Chen | Monash University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monash University | Active, not recruiting | Melbourne | Victoria | 3004 | Australia | |
Request for data sharing will be considered on a case by case basis
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genital swabs, urine sample, blood sample, anal swab, oral swab
Men-who-have-sex-with-women-only with confirmed early-latent syphilis infection |
|
| 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 | This outcome measures the viability of detected Treponema pallidum in PCR-positive biological samples. Viability is assessed using a novel in-house viability assay. Results will be summarised as the number and proportion of Tp PCR-positive samples that contain viable organisms, stratified by sample type and clinical/epidemiological variables specified in the SOS Global protocol. This outcome focuses on confirming whether Tp organisms in collected specimens are capable of establishing infection, rather than merely detecting genetic material. The viability assessment does not result in a continuous scale; it is a binary laboratory outcome (viable / non-viable). | Samples are collected at time of consent - single study visit |
| Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine |
| Not yet recruiting |
| Shanghai |
| Shanghai Municipality |
| 200082 |
| China |
| Shanghai Skin Disease Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200443 | China |
| National Institute for Communicable Diseases | Not yet recruiting | Johannesburg | 2192 | South Africa |
| Foundation for Professional Development | Not yet recruiting | Pretoria | 0184 | South Africa |
| Burrell Street Clinic, Guy's and St Thomas' | Recruiting | London | SE10UN | United Kingdom |
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| Jefferiss Clinic St Mary's Hospital, Imperial College London | Recruiting | London | W21DL | United Kingdom |
|
| Mortimer Market Centre | Recruiting | London | WC1E6JB | United Kingdom |
|
| London School of Hygiene & Tropical Medicine | Active, not recruiting | London | WC1E7HT | United Kingdom |
| ID | Term |
|---|---|
| D013587 | Syphilis |
| ID | Term |
|---|---|
| D014211 | Treponemal Infections |
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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