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.
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
Confirmed history (by patient report or medical records) of syphilis
Home address outside Hawai'i
Currently incarcerated
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%.
Other
Prospective
Rapid Syphilis Test
Diagnostic 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.
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.
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.
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.
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