Syphilis InfectionNCT07358949
Feasibility and Acceptability of Point of Care Rapid Syphilis Testing Among Patients Seeking Family Planning Services in Hawai'i
An observational study of Syphilis Infection, run by Queen's Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Syphilis Infection
- What is being tested?
- Rapid Syphilis Test
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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%.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mary Tschann, PhD, MPH contact
United States1 site, 1 recruiting
- Recruiting
Queen's Medical Center, 1004 Clinic POB1
Honolulu, Hawaii, 96813
Elaine Chan, MD, 415-596-1812, echan99@hawaii.edu
About this study
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.
Read more
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
- 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.
Read the 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.
- Conditions
- Syphilis Infection
- Being tested
- Rapid Syphilis Test
- Keywords
- feasibility, rapid syphilis testing, family planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Syphilis TestDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
Secondary Outcomes
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.
Measured: 12 months
Assess the acceptability and feasibility of a point-of-care rapid syphilis testing in a university-affiliated family planning clinic.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start20 Jul 2026
- Primary completion1 Aug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Syphilis InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elaine Chan, Queen's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358949
- Sponsor's protocol ID
- RA-2026-001
- Status last verified
- Sep 2026
- First submitted
- 31 Dec 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34812790Harvey 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.
PubMed 39374019Nuwagaba-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.
PubMed 38860665Stafford 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.
PubMed 39718531Missed 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.
PubMed 33369594Corrigendum 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.
PubMed 34752533Cao 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.
PubMed 37934903Chan 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.
PubMed 33793630Plotzker 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.
PubMed 35340101McNicholas 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.
PubMed 25286295Adimora 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.
PubMed 15627221Johnson 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.
PubMed 35631068Gan 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.
PubMed 40829011
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Point of Care Rapid Syphilis Testing Among Patients Seeking Family Planning Services in Hawai'i
- ClinicalTrials.gov ID
- NCT07358949
- Acronym / sponsor ID
- RA-2026-001
- Conditions
- Syphilis Infection
- Keywords
- feasibility, rapid syphilis testing, family planning
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Queen's Medical CenterUniversity, hospital or other
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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%.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Confirmed history (by patient report or medical records) of syphilis
- Home address outside Hawai'i
- Currently incarcerated
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid Syphilis TestThis 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. | Diagnostic test | – |
Primary outcome
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.
2 secondary outcomes
Secondary Outcomes
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Results publication: PubMed 34812790Teresi 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.
- Results publication: PubMed 39374019Harvey 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.
- Results publication: PubMed 38860665Nuwagaba-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.
- Results publication: PubMed 39718531Stafford 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.
- Results publication: PubMed 33369594Missed 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.
- Results publication: PubMed 34752533Corrigendum 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.
- Results publication: PubMed 37934903Cao 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.
- Results publication: PubMed 33793630Chan 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.
- Results publication: PubMed 35340101Plotzker 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.
- Results publication: PubMed 25286295McNicholas 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.
- Results publication: PubMed 15627221Adimora 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.
- Results publication: PubMed 35631068Johnson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary Tschann, PhD, MPH contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syphilis Infection, run by Queen's Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elaine Chan, MD (415-596-1812, echan99@hawaii.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability and Feasibility of Rapid Syphilis Testing (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07358949, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.