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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест Rapid Syphilis 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 approximatel

Первичные конечные точки

• Acceptability and Feasibility of Rapid Syphilis Testing [Срок оценки: 12 months]

Вторичные конечные точки (2)

• Secondary Outcomes [Срок оценки: 12 months]
• Assess the acceptability and feasibility of a point-of-care rapid syphilis testing in a university-affiliated family planning clinic. [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 1 центр

• Queen's Medical Center, 1004 Clinic POB1 — Honolulu

Публикации

• 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. PMID 34812790
• Harvey 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. PMID 39374019
• Nuwagaba-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. PMID 38860665
• Stafford 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. PMID 39718531
• Missed 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. PMID 33369594
• Corrigendum 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. PMID 34752533
• Cao 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. PMID 37934903
• Chan 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. PMID 33793630

Идентификаторы

NCT: NCT07358949 · RA-2026-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗