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

March 16, 2026 updated by: Elaine Chan, Queen's Medical Center

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a nonrandomized feasibility study of a clinician-administered point of care rapid syphilis test. The study will take place within the Queen's Medical Center Options Clinic, where the University of Hawai'i Complex Family Planning program is based. The Options Center is a primary referral site for abortion throughout Hawai'i. 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. Rapid syphilis testing will be offered to sexually active adults seeking abortion or contraception services. Positive results will be followed by laboratory-based syphilis testing. The investigators hypothesize that rapid syphilis testing at the family planning clinic will be feasible and acceptable to both patients and staff.

If the patient expresses interest in syphilis testing, a research associate will describe the study in further detail and obtain informed consent via a paper-based informed consent document.

All study personnel will undergo the SHC training, which includes an online module and quiz available on the SHC website. Study personnel who are certified to collect the SHC will collect the specimen via fingerstick using a sterile lancet. They will collect the blood using the pipette provided in each kit, then add the blood to the sample well of the SHC cassette. They will then add four drops of diluent to the sample well. The study personnel can read the result at the 10-minute mark, and no later than 15 minutes. Any line in the 'T' zone, even if faint, accompanied by a line in the 'C' zone, will be interpreted as a positive result. The study personnel, if not a family planning provider, will inform the physician of all test results. All participants with a positive SHC test will be recommended to get confirmatory serological testing. All participants will receive their results before the end of their family planning visit.

Traditional serological testing requires external laboratory equipment and facilities. The SHC is read in the clinic without additional equipment or laboratory technicians, thus expediting time from specimen collection to diagnosis. Participants with positive SHC results will require more thorough evaluation to stage and determine appropriate treatment. The physician will conduct a detailed health history and physical exam. The SHC is a qualitative treponemal test; therefore, after their counseling and discussion with the physician, the participant will be asked to go to the laboratory to draw blood for an RPR, for which there is no rapid test. The RPR acts as a confirmatory test while also providing quantitative information to monitor treatment effectiveness.

If the participant is pregnant and desires to continue with pregnancy, then the patient will be referred to a pharmacy or clinic that can administer Bicillin. These may include Queen's pharmacy, other pharmacy, Healthy Mothers Healthy Babies, PATH Clinic, Diamond Head STI Clinic. Additional appointments as needed will be made to complete the treatment (up to 3 total doses of Bicillin). If there is still an ongoing shortage and/or recall of Bicillin at the time of study initiation, the physician will call 808-833-9281 to request an appointment with the Hawai'i Department of Public Health STI/HIV Clinic for assistance with where to refer the patient for Bicillin treatment options. At the time of writing, Bicillin is prioritized for pregnant individuals only. For participants with positive SHC who are terminating pregnancy or who are not pregnant, the alternative treatment is doxycycline per CDC guidelines. The physician will prescribe 2 to 4 weeks of doxycycline 100mg BID based on the staging of infection in accordance with CDC guidelines. Patients will be counseled on increased sun sensitivity with longer durations of doxycycline use, and recommend sun protection.

Positive SHC results that have been confirmed with positive serum RPR will be reported to the State of Hawai'i Department of Health using the Sexually Transmitted Infection Confidential Case Report within three business days per state guidelines, either through mail, fax, or phone .

For partner notification, the study physician will provide resources for patients to share with their partner(s) for testing options. Options will include: 1) the patient informs their sexual partner(s) directly or anonymously through a text-based service; 2) the physician informs their sexual partner(s) via a text-based service; 3) deferring to the public health department to inform their sexual partner(s) through their intervention specialist team.

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Queen's Medical Center, 1004 Clinic POB1
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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%.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability and Feasibility of Rapid Syphilis Testing
Time Frame: 12 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Outcomes
Time Frame: 12 months

Secondary outcomes:

  • Number of family planning patients who had syphilis testing in the past year.
  • Number of family planning patients who test positive for syphilis.
  • Time (in days) to prescribe treatment after positive syphilis test.
12 months
Assess the acceptability and feasibility of a point-of-care rapid syphilis testing in a university-affiliated family planning clinic.
Time Frame: 12 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 31, 2025

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RA-2026-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Syphilis Infection

Clinical Trials on Rapid Syphilis Test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe