NCT07358949 Feasibility and Acceptability of Point of Care Rapid Syphilis Testing Among Patients Seeking Family Planning Services in Hawai'i
| NCT ID | NCT07358949 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Queen's Medical Center |
| Condition | Syphilis Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2026-07-20 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2026-07-20 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07358949 clinical trial?
This trial is open to female participants only, aged 14 Years or older, studying Syphilis Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07358949 currently recruiting?
Yes, NCT07358949 is actively recruiting participants. Contact the research team at echan99@hawaii.edu for enrollment information.
Where is the NCT07358949 trial being conducted?
This trial is being conducted at Honolulu, United States.
Who is sponsoring the NCT07358949 clinical trial?
NCT07358949 is sponsored by Queen's Medical Center. The trial plans to enroll 70 participants.