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

NCT07358949 | Not Yet Recruiting

• 1 other identifier: RA-2026-001
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

feasibility; rapid syphilis testing; family planning

Outcome Measures

Primary Outcomes (1)

• Acceptability and Feasibility of Rapid Syphilis Testing

  We will assess feasibility with a combination of quantitative and qualitative methods, in accordance with guidelines put forth by Teresi et al for feasibility pilot studies. Outcomes: * Number of eligible participants * Number of participants who completed SHC testing * Number of participants who agreed to SHC testing * Number of participants able to obtain SHC result * To calculate feasibility, the proportion of all eligible patients who completed testing will be determined. * To calculate completion rate of the SHC tests using the number of participants who were able to obtain an SHC result divided by the number of participants who agreed to rapid syphilis testing. Descriptive statistics will be used to assess acceptibility.

  12 months

Secondary Outcomes (2)

• Secondary Outcomes

  12 months

• Assess the acceptability and feasibility of a point-of-care rapid syphilis testing in a university-affiliated family planning clinic.

  12 months

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.

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The Queens Options Center serves as a referral center for family planning services for patients throughout the state. From prior literature, the patients most impacted by persistent or continued syphilis infections are those who are structurally vulnerable, including those who are under- or uninsured, experiencing poverty, unhoused, or actively using substances. By screening universally, we may decrease the stigmatization associated with individual behavior-based screening. We acknowledge that there is a risk of increased false positives by screening universally . To mitigate this, we recommend that a participant with a positive rapid test also obtain serological testing with RPR, which is already required for treatment monitoring. As stated above, prior studies have established that the sensitivity and specificity of the SHC are greater than 95%.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's Medical Center: lead

Study Sites (1)

Queen's Medical Center, 1004 Clinic POB1

Honolulu, Hawaii, 96813, United States

Location

Related Publications (13)

• Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.

  PMID: 34812790 RESULT

• Harvey L, Jacka B, Bazerman L, Thomas A, Moody M, Irvin R, Beckwith CG. Feasibility and Performance of a Point-of-Care Hepatitis C RNA Assay in a Community Supervision Cohort. JAMA Netw Open. 2024 Oct 1;7(10):e2438222. doi: 10.1001/jamanetworkopen.2024.38222.

  PMID: 39374019 RESULT

• Nuwagaba-Biribonwoha H, Simelane S, Sithole T, Dlamini S, Mavimbela M, Dube N, Mamba S, Mamba M, Sahabo R, El Sadr WM, Abrams EJ, Justman J. Feasibility and Acceptability of Point-of-Care Testing for Sexually Transmitted Infections in Outpatient Clinics Offering Integrated Services in Eswatini. Sex Transm Dis. 2024 Nov 1;51(11):743-749. doi: 10.1097/OLQ.0000000000001997. Epub 2024 Jun 11.

  PMID: 38860665 RESULT

• Stafford I, Bakunas C, Haydamous J, Mosqueda A, Klausner JD, Mena L, Blackwell SC. Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department. Sex Transm Dis. 2025 Jun 1;52(6):352-355. doi: 10.1097/OLQ.0000000000002131. Epub 2024 Dec 24.

  PMID: 39718531 RESULT

• Missed Opportunities for Prevention of Congenital Syphilis -United States, 2018. Pediatr Infect Dis J. 2020 Nov 1;39(11):1062. doi: 10.1097/INF.0000000000002833. No abstract available.

  PMID: 33369594 RESULT

• Corrigendum to "Syphilis Screening: A Review of the Syphilis Health Check Rapid Immunochromatographic Test". J Pharm Technol. 2020 Apr;36(2):91. doi: 10.1177/8755122520904797. Epub 2020 Jan 29.

  PMID: 34752533 RESULT

• Cao W, Thorpe PG, O'Callaghan K, Kersh EN. Advantages and limitations of current diagnostic laboratory approaches in syphilis and congenital syphilis. Expert Rev Anti Infect Ther. 2023 Jul-Dec;21(12):1339-1354. doi: 10.1080/14787210.2023.2280214. Epub 2023 Nov 24.

  PMID: 37934903 RESULT

• Chan EYL, Smullin C, Clavijo S, Papp-Green M, Park E, Nelson M, Giarratano G, Wagman JA. A qualitative assessment of structural barriers to prenatal care and congenital syphilis prevention in Kern County, California. PLoS One. 2021 Apr 1;16(4):e0249419. doi: 10.1371/journal.pone.0249419. eCollection 2021.

  PMID: 33793630 RESULT

• Plotzker RE, Burghardt NO, Murphy RD, McLean R, Jacobson K, Tang EC, Seidman D. Congenital syphilis prevention in the context of methamphetamine use and homelessness. Am J Addict. 2022 May;31(3):210-218. doi: 10.1111/ajad.13265. Epub 2022 Mar 27.

  PMID: 35340101 RESULT

• McNicholas C, Madden T, Secura G, Peipert JF. The contraceptive CHOICE project round up: what we did and what we learned. Clin Obstet Gynecol. 2014 Dec;57(4):635-43. doi: 10.1097/GRF.0000000000000070.

  PMID: 25286295 RESULT

• Adimora AA, Schoenbach VJ. Social context, sexual networks, and racial disparities in rates of sexually transmitted infections. J Infect Dis. 2005 Feb 1;191 Suppl 1:S115-22. doi: 10.1086/425280.

  PMID: 15627221 RESULT

• Johnson KA, Snyder RE, Tang EC, de Guzman NS, Plotzker RE, Murphy R, Jacobson K. Geospatial Social Determinants of Health Correlate with Disparities in Syphilis and Congenital Syphilis Cases in California. Pathogens. 2022 May 6;11(5):547. doi: 10.3390/pathogens11050547.

  PMID: 35631068 RESULT

• Gan A, Shintaku KM, Begue RE. Gaps in the Care of Maternal and Congenital Syphilis in Hawai'i, 2022-2023. Pediatr Infect Dis J. 2025 Dec 1;44(12):e440-e445. doi: 10.1097/INF.0000000000004931. Epub 2025 Aug 6.

  PMID: 40829011 RESULT

Central Study Contacts

Elaine Chan, MD

CONTACT

415-596-1812; echan99@hawaii.edu

Mary Tschann, PhD, MPH

CONTACT

mtschann@hawaii.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Complex Family Planning Fellow

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 22, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)