Recommendations for Providing Quality Sexually Transmitted Diseases Clinical Services, 2020.
Roxanne Y Barrow, Faruque Ahmed, Gail A Bolan...
https://pubmed.ncbi.nlm.nih.gov/31899459/Actively Recruiting
Led by Queen's Medical Center · Updated on 2025-06-26
75
Participants Needed
1
Research Sites
8 weeks
Total Duration
Researchers are evaluating the use of at-home, self-collected STI testing during telemedicine medication abortion care. The study aims to understand how acceptable, feasible, and utilized this self-swab testing is compared to traditional in-clinic STI testing among patients seeking medication abortion. It also seeks to compare STI positivity rates between telemedicine and in-clinic patients and assess the time between testing and treatment for positive cases. The study involves patients receiving telemedicine medication abortion care who will be offered a self-collection kit for testing gonorrhea, chlamydia, and trichomonas. Participants will collect specimens before starting their medication abortion and send them to a lab using prepaid postage. They will complete a survey on demographics, acceptability, and feasibility after specimen submission. The self-swab kit is included in the mailed abortion medication package, and results are securely communicated to patients and their medical records. A control group includes patients receiving in-clinic medication abortion, with data collected retrospectively. Participants will engage in telemedicine visits for consent and instruction, self-collect and mail specimens, and complete follow-up surveys. Testing is processed at a central lab, with support provided if specimens are inadequate. Positive results prompt timely treatment referrals. The study monitors utilization, acceptability, feasibility, STI positivity rates, and treatment timelines. The study is expected to last up to one year, with surveys completed within two weeks after specimen collection.
CONDITIONS
Assessing Acceptability and Feasibiity of STI Self-swab Testing, to be Offered at the Time of Telemed Medication Abortion Provision
O
Olivia H Manayan, MD, MPH
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Queen's Medical Center
Lead Sponsor
University of Hawaii Foundation
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Self-Collected STI Swab (Home) | In-Clinic STI Swab (Clinician-Collected) |
|---|---|---|
| What it is | A self-collected swab test for chlamydia, gonorrhea, and trichomonas, performed by the patient at home using a mail-in kit provided at the telemedicine medication abortion consultation. | A clinician-collected vaginal swab test for chlamydia, gonorrhea, and trichomonas, obtained at an in-person visit in the clinic. |
| Role in the trial | Investigational approach under evaluation for feasibility and acceptability during telemedicine abortion care. | Standard reference for comparison, representing in-clinic clinician-collected STI screening. |
| Primary use | Detecting chlamydia, gonorrhea, and trichomonas infections in patients seeking telemedicine medication abortion using a swab they collect themselves and send for laboratory PCR/NAAT analysis. | Screening for chlamydia, gonorrhea, and trichomonas by provider-collection of swab specimens in the clinic, followed by standard laboratory PCR/NAAT testing. |
| How it is given or performed | Participants receive a collection kit at or after their telemedicine visit. They collect a vaginal swab sample themselves at home and mail it to the laboratory for PCR testing. | A trained clinician collects the vaginal swab sample during an in-person clinic visit; the sample is then submitted for laboratory PCR testing. |
| Evidence status / maturity | Multiple studies and meta-analyses confirm that self-collected vaginal swabs for chlamydia and gonorrhea tested by NAAT are highly accurate, with sensitivity and specificity comparable to clinician-collected samples, and are generally acceptable to patients. | Considered the established reference method for STI screening; considered highly accurate based on extensive evidence and clinical use. |
| Important limitations | Some users may experience challenges with mail-in kit use or sample collection. Delays may occur if mailing or self-collection steps are not completed promptly. Acceptability and return rates may vary across populations. | Requires an in-person clinic visit, which may be a barrier for those unable to travel or access reproductive healthcare services in person. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (telemedicine)
Duration - Up to 2 weeks
Participants who enroll will receive a self-swab collection kit included with their medication abortion kit. They will collect their specimens at home before starting the medication abortion and send the samples to the lab using prepaid mailers.
No in-person visits; specimen collection and mailing done at home
Duration - Up to 2 weeks after specimen receipt
After the lab receives the specimen, participants will complete a survey assessing acceptability and feasibility of the self-swab. Participants will receive their test results via phone, text, or email and be offered treatment if positive.
1 follow-up telemedicine contact (survey and results notification)
Duration - 1 to 2 weeks after initial consultation
Participants typically attend a follow-up visit 1 to 2 weeks after the initial consultation to discuss medication abortion progress and may be reminded about specimen submission if not already sent.
1 scheduled follow-up visit (in-person or telemedicine)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/33789080/Queen's Medical Center
Lead Sponsor
University of Hawaii Foundation
Collaborating Sponsor