Recruiting

STI Testing

Sponsor:

Queen's Medical Center

Code:

NCT06951438

Conditions

Sexually Transmitted Disease (STD)

Gonorrhea

Chlamydia

Trichomonas Infection

Eligibility Criteria

Sex: Female

Age: 14+

Healthy Volunteers: Accepted

Interventions

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

Study Details

Brief 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

Study ID

NCT06951438

Start date

May 22, 2025

Status verified date

Jun, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 14+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

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

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

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 ]
  • Acceptability of self-collected STI screening at the time of telemedicine medication abortion provision [ Time Frame: Up to two weeks after completion of the intervention ]
  • Feasibility of self-collected STI screening at the time of telemedicine medication abortion provision [ Time Frame: 1) Up to two weeks after completion of the intervention ]

Central Contacts and Locations

Central contacts

Olivia H Manayan, MD, MPH

808-348-7859omanayan@hawaii.edu

Locations

Queens Medical Center, 1004 Clinic POB1

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Olivia H Manayan, MD, MPH

808-348-7859

Principal Investigator:

Olivia H Manayan, MD MPH

More Information

Sponsor

Queen's Medical Center

Last update posted

Jun 26, 2025

Last verified

Jun, 2025

Keywords

  • STI testing
  • telemedicine
  • medication abortion
  • self-swab collection
  • vaginal swab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Queen's Medical Center on 2025-06-26.