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

NCT06951438 | Recruiting FDA Device

• 1 other identifier: RA-2025-009
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Utilization of self-collected STI screening at the time of telemedicine medication abortion provision

  Utilization rates will be reported as a percentage. Both enrollment in the study, as well as utilization of the actual STI testing services, will be reported as measures of utilization. The former (1) will be reported as the percentage of eligible patients who chose to enroll in the study, while the latter (2) will be reported as the percentage of enrolled patients who submitted samples for STI testing.

  1) up to one year 2) up to one year

• Acceptability of self-collected STI screening at the time of telemedicine medication abortion provision

  Acceptability will be measured using a modified version of the Digital Health Acceptability Questionnaire (DHAQ) which is a validated survey that is used to assess acceptability and feasibility of telehealth-based interventions. The first five questions (1-5) are validated to assess attitude toward the service as a means to address healthcare needs, while the second five questions (6-10) address individual capacity and effort to use the telehealth intervention. A copy of this survey can be found in Table A. This is a 10 question survey of Likert scales from 1 to 5, with 1 being "Strongly Disagree" and 5 being "Strongly Agree". We will calculate median and IQR across the domains of the DHAQ to determine a median acceptability score, which will be calculated using the scores from questions 1-5.

  Up to two weeks after completion of the intervention

• Feasibility of self-collected STI screening at the time of telemedicine medication abortion provision

  Feasibility will be measured using a modified version of the Digital Health Acceptability Questionnaire (DHAQ) which is a validated survey that is used to assess acceptability and feasibility of telehealth-based interventions. The first five questions (1-5) are validated to assess attitude toward the service as a means to address healthcare needs, while the second five questions (6-10) address individual capacity and effort to use the telehealth intervention. A copy of this survey can be found in Table A. This is a 10 question survey of Likert scales from 1 to 5, with 1 being "Strongly Disagree" and 5 being "Strongly Agree". We will calculate median and IQR across the domains of the DHAQ to determine a median acceptability score, which will be calculated using the scores from questions 6-10.

  1) Up to two weeks after completion of the intervention

Secondary Outcomes (2)

• Comparison of uptake and STI positivity rates between the telehealth and in-clinic population

  up to one year

• Time elapsed between test result and prescription for treatment for patients who have a positive test for STI

  one week

Study Arms (2)

Self-swab Arm

EXPERIMENTAL

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.

Diagnostic Test: Self-swab collection PCR test for chlamydia, gonorrhea, trichomonas

in-clinic STI testing arm

NO INTERVENTION

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 DIAGNOSTIC_TEST

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

Self-swab Arm

Eligibility Criteria

• Age: 14 Years+
• Gender Eligibility Details: Participants must be pregnant in order to participate
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of the Queen Medical Center Options Center clinic seeking telemedicine medication abortion.
• Patients for whom, according to the CDC guidelines for STI Testing11, STI testing is indicated, or patients who desire STI screening
• Age 14 and over
• Can speak and read English
• Displays capacity for informed consent

You may not qualify if:

• Home address that is not located in the state of Hawai'i
• Incarcerated
• Unwilling to perform vaginal swab collection

Sponsors & Collaborators

• Queen's Medical Center: lead
• University of Hawaii Foundation: collaborator

Study Sites (1)

Queens Medical Center, 1004 Clinic POB1

Honolulu, Hawaii, 96813, United States

RECRUITING

Related Publications (19)

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Sexually Transmitted Diseases; Gonorrhea; Chlamydia Infections; Trichomonas Infections

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Chlamydiaceae Infections; Protozoan Infections; Parasitic Diseases

Central Study Contacts

Olivia H Manayan, MD, MPH

CONTACT

808-348-7859; omanayan@hawaii.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 30, 2025
• Study Start: May 22, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)