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

Recruitingn/aAges 14 Years - anyFemaleQueen's Medical Center
NCT07358949 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 fingersti

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📋 Eligibility rules (as published)
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.
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What it tests

  • Rapid Syphilis Test
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Where

1 site
Queen's Medical Center, 1004 Clinic POB1
Honolulu, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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