Assessing Acceptability and Feasibiity of STI Self-swab Testing, to be Offered at the Time of Telemed Medication Abortion Provision

Part of paid clinical trials in Honolulu, Hawaii.

Sponsor
Queen's Medical Center
Study ID
NCT06951438
Status
Recruiting
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Conditions

  • Chlamydia
  • Gonorrhea
  • Sexually Transmitted Disease (STD)
  • Trichomonas Infection

Eligibility Criteria

Sex
FEMALE
Age
14 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Self-swab collection PCR test for chlamydia, gonorrhea, trichomonas — DIAGNOSTIC_TEST
    Self-swab collection PCR test for chlamydia, gonorrhea, trichomonas

Study Details

The goal of this interventional study is to provide more access to STI testing for patients who seek abortion care through telemedicine, particularly for those whose access to STI testing is otherwise limited. The main questions it aims to answer are: What is the acceptability, feasibility, and utilization of self-collected STI screening at the time of telemedicine medication abortion provision? How does the uptake of such a service among patients receiving telemedicine abortion care compare to the population of patients who seek in-person medication abortion care? What are the positivity rates for STIs in among patients receiving telemedicine medication abortion care compared to the positivity rates for a contemporaneous, in-clinic population? What is the average time to between testing and treatment for patients who test positive for an STI using the self-collection service? Researchers will compare the intervention group to a contemporaneous, in-clinic population on uptake of STI screening, as well as on positivity rates for the STIs tested. Participants will be asked to perform self-swab collection for STI testing for gonorrhea, chlamydia, and trichomonas. They will be instructed to send their specimens to a lab using prepaid postage. Upon completion of sample collection and shipping, they will be asked to complete a survey assessing basic demographic information, as well as acceptability and feasibility of the intervention. Patients who test positive for an STI will be promptly provided/referred to treatment.

Key Dates

Start date
May 22, 2025
Status verified
Jun 2025
Primary completion
Apr 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
75 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Self-swab Arm
    These patients will be recruited to the study actively. Upon signing an informed consent, they will be instructed to collect an at-home, self-swab test for STI testing. The kit for collection will be provided for them, as well as the shipping materials for the specimen.
  • No Intervention: in-clinic STI testing arm
    This population will not be actively recruited. Demographic data will be collected for comparison to the intervention arm via retrospective chart review of a contemporaneous, in-clinic population seeking abortion care.

Primary Outcome Measure

Utilization of self-collected STI screening at the time of telemedicine medication abortion provision [ Time Frame: 1) up to one year 2) up to one year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Queens Medical Center, 1004 Clinic POB1HonoluluHawaii96813
Olivia H Manayan, MD, MPH
808-348-7859
Olivia H Manayan, MD MPH (PRINCIPAL_INVESTIGATOR)

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By research site
Queens Medical Center, 1004 Clinic POB1· Honolulu, HI

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