At-home STI self-swab testing offered with telemedicine medication abortion
STI Self-swab Testing At the Time of Telemed Medication Abortion Provision
This project will try offering at-home self-collected vaginal swab tests for chlamydia, gonorrhea, and trichomonas to people getting medication abortion by telemedicine in Hawai'i to see if patients use and accept it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 14 Years and up |
| Sex | Female |
| Sponsor | Queen's Medical Center Academic / other |
| Locations | 1 site (Honolulu, Hawaii) |
| Trial ID | NCT06951438 on ClinicalTrials.gov |
What this trial studies
This exploratory interventional cohort compares telemedicine medication abortion patients who are offered an at-home self-collected vaginal swab for PCR testing of chlamydia, gonorrhea, and trichomonas to a contemporaneous in-clinic cohort via chart review. Telemedicine participants across the Hawaiian Islands who are eligible for STI testing or request screening are recruited at the time of their abortion televisit and receive instructions and a kit for self-collection. Primary outcomes include acceptability, feasibility, uptake, STI positivity rates, and average time from testing to treatment for positives. The study is conducted through the Queen's Medical Center Options Center in Honolulu, Hawai'i.
Who should consider this trial
Good fit: People aged 14 and older seeking medication abortion by telemedicine through Queen's Medical Center Options Center in Hawai'i who can read English and either meet CDC indications for STI testing or desire screening are eligible.
Not a fit: Individuals living outside the state of Hawai'i, those who are incarcerated, or those unwilling or unable to perform a vaginal self-swab (or who cannot access telehealth) may not receive benefit from this service.
Why it matters
Potential benefit: If successful, this approach could increase access to timely STI screening and faster treatment for people obtaining medication abortion by telemedicine in Hawai'i.
How similar studies have performed: Prior research shows self-collected vaginal swabs with PCR are accurate and acceptable for chlamydia, gonorrhea, and trichomonas, though packaging this service specifically at the time of telemedicine medication abortion is a newer application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients of the Queen Medical Center Options Center clinic seeking telemedicine medication abortion. 2. Patients for whom, according to the CDC guidelines for STI Testing11, STI testing is indicated, or patients who desire STI screening 3. Age 14 and over 4. Can speak and read English 5. Displays capacity for informed consent Exclusion Criteria: 1. Home address that is not located in the state of Hawai'i 2. Incarcerated 3. Unwilling to perform vaginal swab collection
Where this trial is running
Honolulu, Hawaii
- Queens Medical Center, 1004 Clinic POB1 — Honolulu, Hawaii, United States (Recruiting)
Study contacts
- Study coordinator: Olivia H Manayan, MD, MPH
- Email: omanayan@hawaii.edu
- Phone: 808-348-7859
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.