Feasibility and Acceptability of Point of Care Rapid Syphilis Testing Among Patients Seeking Family Planning Services in Hawai'i

Conditions

• Syphilis Infection

Eligibility Criteria

Sex

FEMALE

Age

14 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Rapid Syphilis Test — DIAGNOSTIC_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.

Study Details

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.

Key Dates

Start date

Mar 30, 2026

Status verified

Mar 2026

Primary completion

Aug 1, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

70 participants (estimated)

Primary Outcome Measure

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

Central Contacts

• Elaine Chan, MD
  415-596-1812
  [email protected]
• Mary Tschann, PhD, MPH
  [email protected]

Locations (1)

Find similar trials in Honolulu, HI

Related Studies

• LIMIT Trial - Lidocaine With Intramuscular Injection of Benzathine Penicillin G for Treponema Pallidum Treatment
  PHASE3 · Recruiting · Washington University School of Medicine · St Louis, Missouri
• This Study Evaluates the ALPCO Syphilis-T and Syphilis-NT CLIA Kits for Detecting Syphilis Antibodies in Serum and Plasma. Samples From At-risk, HIV-positive, Pregnant, and Healthy Individuals Will Assess Assay Performance Versus Established Comparator Tests.
  Recruiting · American Laboratory Products Company · Lancaster, California
• Implementation of an Opt-Out Testing and Rapid Diagnostic Strategy for Syphilis and HIV in Pregnant Patients Presenting to the Emergency Department
  Not Yet Recruiting · The University of Texas Health Science Center, Houston · Houston, Texas