Performance of the Abbott RealTime CT/NG for detection of Chlamydia trachomatis and Neisseria gonorrhoeae.
C A Gaydos, C P Cartwright, P Colaninno...
https://pubmed.ncbi.nlm.nih.gov/20668135Actively Recruiting
Led by Queen's Medical Center · Updated on 2025-06-26
75
Participants Needed
1
Research Sites
8 weeks
Total Duration
Q
Queen's Medical Center
Lead Sponsor
U
University of Hawaii Foundation
Collaborating Sponsor
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
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
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)
Total: 1 location
1
Queens Medical Center, 1004 Clinic POB1
Honolulu, Hawaii, United States, 96813
Actively Recruiting
O
Olivia H Manayan, MD, MPH
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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