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

NCT06951438 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-06-26

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DIAGNOSTIC_TEST

Self-swab collection PCR test for chlamydia, gonorrhea, trichomonas

Self-swab collection PCR test for chlamydia, gonorrhea, trichomonas

Sponsors & Collaborators

  • University of Hawaii Foundation

    collaborator UNKNOWN

  • Queen's Medical Center

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-22
Primary Completion
2026-04-30
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06951438 on ClinicalTrials.gov