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

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Notable Recruitment opened Show 6 more changesShow less
    • Lead sponsor: Queen's Medical Center to Queen's Medical Center
    • Start date changed from estimate of Jul 1, 2026 to Jul 20, 2026
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised
    • Publications: details revised at 13 of 13 entries
  2. Notable Start date: Mar 30, 2026 to Jul 1, 2026v4
  3. Notable Start date: Jan 15, 2026 to Mar 30, 2026v3
  4. Notable Primary endpoints: 2 to 1
    • Secondary endpoints: 1 to 2
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07358949
Lead Sponsor Queen's Medical Center
Conditions
(from sponsor)
Syphilis Infection
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov