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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age14+
SponsorQueen's Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Home address that is not located in the state of Hawai'i

Incarcerated

Unwilling to perform vaginal swab collection

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Diagnostic test

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

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: Self-swab ArmExperimental treatment 1 intervention
Group B: in-clinic STI testing armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
1) up to one year 2) up to one year
2

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.

Time frame
Up to two weeks after completion of the intervention
3

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.

Time frame
1) Up to two weeks after completion of the intervention

Secondary outcomes

1

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

Once enrollment is complete for the telemedicine patient-recruitment, we will conduct a chart review of contemporaneous patients seen in-clinic for medication abortion, assessing for the percentage of patients who were offered and accepted STI testing, as well as for the positivity rates of chlamydia, gonorrhea, and trichomonas in this population.

Time frame
up to one year
2

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

For every patient who tests positive for an STI, we will measure the amount of time it takes from the time the patient is notified of their positive test result until the time the patient is sent treatment in the mail (chlamydia), or until a prescription for treatment is sent to the patient's pharmacy of choice (gonorrhea or trichomonas). The times will be reported as a range, as well as analyzed using measures of central tendency.

Time frame
one week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Queen's Medical Center

Lead sponsor

University of Hawaii Foundation

Collaborator