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Syphilis Point of care Testing in tertiary Emergency Department setting: Implementation and Impact on care of Women (SPOTED)

Syphilis Point of care Testing in tertiary Emergency Department setting: Implementation and Impact on care of Women (SPOTED)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000355370
Acronym
SPOTED
Enrollment
800
Registered
2026-03-20
Start date
2026-05-04
Completion date
2027-11-29
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Syphilis is a sexually transmitted infection that can be present without causing any symptoms and can pass from a pregnant woman to her baby and make the baby very unwell. The number of syphilis cases in women of childbearing age and who are pregnant is increasing in Australia and the key to stopping its spread is to diagnose and treat it as quickly as possible. This study will look at whether using a rapid test for syphilis in an emergency department, that can be done from a few drops of blood at the bedside, can improve testing and treating for women who are pregnant or who are of childbearing age. The study will also try to understand the opinions of the participants as well as the doctors and nurses as to how they found the process of using the point of care tests.

Interventions

The two study cohorts are 1) all pregnant women and 2) women of reproductive age (18-45), undergoing clinical assessment that includes the need for sexually transmitted infection (STI) testing, presenting to a tertiary emergency department (ED). These two cohorts will be offered enrolment in the study. The study will involve all consenting participants having syphilis serology blood testing done as well as undergoing a single syphilis point of care test (syPOCT). The syPOCT will be the Australia

The two study cohorts are 1) all pregnant women and 2) women of reproductive age (18-45), undergoing clinical assessment that includes the need for sexually transmitted infection (STI) testing, presenting to a tertiary emergency department (ED). These two cohorts will be offered enrolment in the study. The study will involve all consenting participants having syphilis serology blood testing done as well as undergoing a single syphilis point of care test (syPOCT). The syPOCT will be the Australian TGA approved Abbott Determine Syphilis TP. The syPOCT will be performed on a finger prick blood sample by an ED nurse who is part of the SPOTED study team and has undergone training in performing and interpreting this syPOCT. Each participant will undergo one valid, interpretable syPOCT test during their current ED admission. The syPOCT result will be read 15 minutes after it has been collected and results will be documented in patient notes and communicated with treating ED medical officer. If the result is positive, the participant will be counselled on the result, the Queensland Syphilis Surveillance Register will be contacted to obtain previous testing and treatment history and in consultation with Infectious diseases consultant a decision will be made to offer treatment for syphilis in the ED. SPOTED study team will review all syphilis serology for consenting participants within 7 days from patient enrolement in the study. Regardless of syPOCT result (ie positive and negative) all participants will be reviewed in the Infectious Diseases outpatient clinic within 2 weeks from their index ED presentation during which the syPOCT was performed. During that clinic visit, syphilis serology results will be reviewed and a further offer of treatment made if appropriate and treatment will be administered if participant consents to this. All SPOTED study team members will undergo specific training in use of the syPOCT device. maintain a training log, check lot expiry dates and document their results in a data sheet which we reviewed every month by the study PI. In addition, where there is uncertainty regarding the interpretation of a syPOCT test result the SPOTED study team member will check with a second team member to ensure the result is being interpretated correctly. Adherence to the intervention is confirmed each time a completed CRF is collected by a study team member and any concerns for non-adherence will be discussed by PI with study team.

Sponsors

Metro North Hospital and Health Service
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

Presentations to ED inside the hours 0800-1600hrs on Mondays to Fridays. Adequate standard of spoken and written English to be able to understand the consent form Adult female, aged 18-45 years inclusive (ie biologically female, cis gender). Current pregnancy is confirmed at presentation as standard of care (to determine allocation to Cohort 1 Pregnant or Cohort 2 Not Pregnant). Having, or recommended to have, sexual health testing as part of their clinical care at ED, including a pregnancy test on a urine sample. Any previous syphilis serology testing had occurred more than 6 weeks prior to ED presentation. Willing to participate and signed consent. Willing to attend a 2-week follow-up appointment at RBWH. Willing to complete the Participant Survey at the same time in ED.

Exclusion criteria

Aged less than 18 years of age. syphilis serology done within the last 6 weeks highly distressed patients in ED transgender persons and transgender women

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 4, 2026