Recruiting

Rapid Syphilis Testing

Sponsor:

Queen's Medical Center

Code:

NCT07358949

Conditions

Syphilis Infection

Eligibility Criteria

Sex: Female

Age: 14+

Healthy Volunteers: Accepted

Interventions

Rapid Syphilis Test

Study Details

Brief summary:

The purpose of the study is to see if rapid syphilis testing at the time of a family planning (contraception or abortion) visit is acceptable and practical for patients.

This study involves a fingerstick blood sample for syphilis testing during a family planning visit. Results will be ready in 10-15 minutes.

Potential Benefits

  • Participants can find out whether they are syphilis positive or negative within the visit, as soon as 10-15 minutes of the finger stick. Typically, syphilis testing results take several days.
  • If positive, there is the option of starting treatment within the same day.

Potential Risks

  • The study team will do everything possible to protect participants' privacy, including removing names and other identifiable information from study materials, however this is still a small chance there may be a breach of privacy during the study.
  • Physical risks of fingerstick are exceptionally rare when sterile technique is used. The study team will be using all best practices to reduce risk of infection or injury.
  • There is a risk of discomfort or pain with fingerstick collection. The risk of scarring is usually only associated with repeat draws, for example in patients with diabetes who have to do fingerstick draws multiple times per day.
  • There is a very small chance that the positive result is incorrect (also known as a "false positive"), meaning the participant does not actually have syphilis. To confirm the result, the investigators recommend that any positive rapid syphilis result be followed up with a blood test at the lab.

Cost for Participation

o There is no direct cost to participate in this study. After consent is signed, the participant received renumeration of $50 in form of gift card. If the participant tests positive for a syphilis infection, the participant or their health insurance will be responsible cover the costs of this medical treatment. If they do not have access to health insurance, the study team will connect the participant with agencies that have assisted patients with treatment at a reduced cost or free of cost.

Conditions

Syphilis Infection

Study ID

NCT07358949

Start date

Jul 20, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 14+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Interventions

Rapid Syphilis Test

This study aims to evaluate whether the Syphilis Health Check (SHC), an FDA-approved rapid, point-of-care syphilis test, is feasible and acceptable to patients and providers at a university-associated family planning clinic in Hawai'i.

SHC is specific for detecting Treponema pallidum antibodies in serum, plasma, or whole blood via a rapid immunochromatographic test. It has a sensitivity of 95-99% and a specificity of 94-97%, and has been studied in pregnant patients. The test costs approximately $10, takes 10-15 minutes to yield results, has a shelf life of 30 months, and remains stable at room temperature. The assay can be used as an initial screening test or in conjunction with a non-treponemal laboratory test. Treatment with antibiotics can be started immediately with a positive SHC test.

Primary outcome measure

  • Acceptability and Feasibility of Rapid Syphilis Testing [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Elaine Chan, MD

415-596-1812echan99@hawaii.edu

Mary Tschann, PhD, MPH

mtschann@hawaii.edu

Locations

Queen's Medical Center, 1004 Clinic POB1

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Elaine Chan, MD

415-596-1812echan99@hawaii.edu

More Information

Sponsor

Queen's Medical Center

Last update posted

Sep 16, 2026

Last verified

Sep, 2026

Keywords

  • feasibility
  • rapid syphilis testing
  • family planning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-02. This information was provided to ClinicalTrials.gov by Queen's Medical Center on 2026-09-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.