Rapid syphilis testing at family planning visits in Hawai‘i

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This nonrandomized feasibility study tests the Syphilis Health Check rapid, point-of-care test at a university-affiliated Hawaii family planning clinic. Clinicians will perform the fingerstick test during abortion or contraception visits, with positive results confirmed by laboratory testing. The study aims to see whether offering rapid testing is feasible for staff and acceptable to patients, and to estimate how many participants are needed for future work. Enrollment targets 50–75 sexually active adults ages 14 and older who seek contraception or abortion services in Hawai‘i.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 14 years or older
* Seeking contraception or abortion services
* Sexually active (engages in any form of sexual activity with another person)
* Denies history of syphilis infection
* Can speak and read English
* Displays capacity for informed consent

Exclusion Criteria:

* Confirmed history (by patient report or medical records) of syphilis
* Home address outside Hawai'i
* Currently incarcerated

Number of Subjects:

Recommendations for sample size in pilot studies range from 70 to 100 patients.28 Given this is a nonrandomized feasibility study with no comparator (i.e., to a control or to serological testing), we aim to enroll 50 to 75 participants to support analysis for correlation between variables while being able to achieve relatively small confidence intervals. This number takes into account the practical considerations of study personnel resources and in-person patient volume in our clinic. All patients eligible for the rapid syphilis testing will be approached for study participation.

Where it's running

• Queen's Medical Center, 1004 Clinic POB1
  Honolulu, Hawaii, United States Recruiting

Study contacts

• Study coordinator: Elaine Chan, MD
• Email: echan99@hawaii.edu
• Phone: 415-596-1812

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.