Clinical trial NCT06951438: Assessing Acceptability and Feasibiity of STI Self-swab Testing, to be Offered at the Time of Telemed Medication Abortion Provision
Official title: STI Self-swab Testing At the Time of Telemed Medication Abortion Provision
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sexually Transmitted Disease (STD)
Gonorrhea
Chlamydia
Trichomonas Infection
Keywords: STI testing
telemedicine
medication abortion
self-swab collection
vaginal swab
Lead sponsor: Queen's Medical Center
Sponsor class: OTHER
Collaborators: name: University of Hawaii Foundation
First posted: 2025-04-30
Enrollment: 75
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Study Design:

This is an explorative cohort study that will assess the accessibility, feasibility, and utilization of a new intervention: at-home, self-collected STI testing at the time of medication abortion received through telemedicine services.

The study will take place within the Complex Family Planning clinic, the Options Center in Honolulu, Hawaii.

The intervention group will be recruited from the telemedicine medication abortion patients.

This group will be compared to the control group with data pulled from a chart review of a comparison cohort of patients seen for in-clinic medication abortion during a contemporaneous period.

Patients in the telehealth group may be physically based on any of the Hawaiian Islands but must have internet access for telehealth services. During the initial telemedicine consultation for medication abortion, the patient will be screened for eligibility using the eligibility criteria described as detailed below. If a patient is eligible for the study, they will be asked if they would like to be enrolled in the study in order to perform STI testing via self-collection. If they do not wish to participate in the study, resources for alternative ways to get STI testing will be provided to them.

If the patient expresses interest in the study, at the conclusion of their telemedicine visit for abortion care, they will redirected to a separate telemedicine visit with the research coordinator. The research coordinator will describe the study in further detail and obtain informed consent if the patient still wishes to proceed. Patients will sign consent forms via Adobe e-sign, a secure digital platform.

Once informed consent has been obtained, the research associate will do a short teaching session that reviews the following points with participants:

1. Contents of the specimen collection kit, which will include written instructions for specimen collection
2. How to collect the specimen (this may be done with illustrative models or drawings) and how to handle the specimen once it has been collected. This will include instructions on how to place the swab in the collection tube containing buffer solution, and how to send the swab to the lab. Patients will be instructed to collect their specimens for STI testing prior to taking their medications for medication abortion, in order to improve the ease of collection.
3. Verifying that patients are willing to receive a survey following specimen receipt via text message, and that they have a working mobile phone number.
4. Verifying that they accept receiving positive test results by phone.
5. Asking if, and how, patients would like to be notified of negative test results.

Patient information will be de-identified and connected to a unique Study ID. This study ID will label all specimens that patients send in the mail. All identifiable information, including signed consent forms, will be stored in a password protected and encrypted computer in the PI's research office on site.

The specimen collection kit will be included within the medication abortion kits, which are mailed to patients using a USPS bubble mailer. The patients will be able to locate their package by using a USPS tracking number once the kits have been mailed to them. Within the mailer, collection instructions and a prepaid envelope to send the specimens for processing will also be included. No PHI will be included in the specimen collection kit; all study materials sent to the laboratory for processing will be labeled only with the patient's study ID number.

Once the medication abortion kit and swab collection kit have been received, patients will perform self-swab collection before they initiate their medication abortion and send their specimen to the processing lab using the prepaid envelope provided for them. All specimens will be processed at the Emory Clinical Labs in Atlanta, GA. Once the lab has confirmed specimen receipt, the participant will receive a link via text message or email from the study team at QMC to a survey that assesses the acceptability and feasibility of the self-swab. This is a modified version of a validated survey that is used assess acceptability feasibility of telehealth-based interventions.18 The survey will also collect limited and non-identifiable demographic information. There will be a free-text portion at the end for patients to input any additional feedback regarding the intervention.

Once STI tests have been processed, the results will be emailed back to the research team using secure QMC email. All results sent through email will be deidentified, using only the patient's study ID number to identify the results. The lab staff will notify the PI if a submitted specimen is deemed inadequate for processing. If the swab is deemed inadequate, the research team will offer the patient the opportunity to swab again and provide them with a new test kit. Once the research team has received the results, they will be reported to the patient and scanned into the patient's electronic medical record.

If the lab staff does not receive a specimen from the patient prior to the patient's scheduled medication abortion follow-up appointment (typically scheduled 1-2 weeks after the initial consultation), the participant will be asked during the follow-up visit if they still desire or intend to send in a specimen, and reminded of the self-swab instructions if they express an intention to still complete the testing. If the patient does not attend her scheduled follow-up visit, one attempt will be made to contact her regarding specimen collection on the day of the scheduled appointment via phone call. If the study team is unsuccessful in contacting the patient at this time, no further attempts at contact will be made.

All patients who have a positive test result will be notified and provided options for treatment as soon as the research team is notified of the result. Patients may opt to receive negative test results via phone call (with option to approve leaving a detailed message on voicemail or not), Epic MyChart or text message, or opt out of receiving updates about negative test results.

Study population:

The study population will be patients living in Hawai'i who seek abortion care via telemedicine. The investigator team currently sees patients through telemedicine on six of the Hawaiian Islands (O'ahu, Maui, Hawai'i island, Kaua'i, Moloka'i, and Lāna'i). For many patients, specifically those located on Kaua'i, Lāna'i, and Moloka'i, medication abortion is the only option available for termination without having to fly to see an abortion provider. While Kaua'i has several in-person providers who provide medication abortion, on Lāna'i and Moloka'i, there are no providers on island who provide medication abortions in clinic, so telemedicine medication abortion is their only option.

Number of subjects

The investigator team will enroll a total of 75 subjects for this study. The guidance for determining sample sizes in pilot studies assessing feasibility recommends 70-100 subjects, which will allow analysis for correlation between variables without sacrificing significant confidence intervals. Additionally, in a very similar feasibility study assessing a telehealth STI intervention for same-sex male couples,15 the sample comprised of 50 couples, with samples collected from 100 study subjects.

For the contemporaneous, in-clinic population that will serve as the control group, all charts for patients who receive medication abortion in the same time frame that recruitment for the study took place will be reviewed.

Eligibility criteria: 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

Primary outcomes:
measure: Utilization of self-collected STI screening at the time of telemedicine medication abortion provision
timeFrame: 1) up to one year 2) up to one year
measure: Acceptability of self-collected STI screening at the time of telemedicine medication abortion provision
timeFrame: Up to two weeks after completion of the intervention
measure: Feasibility of self-collected STI screening at the time of telemedicine medication abortion provision
timeFrame: 1) Up to two weeks after completion of the intervention
Secondary outcomes:
measure: Comparison of uptake and STI positivity rates between the telehealth and in-clinic population
timeFrame: up to one year
measure: Time elapsed between test result and prescription for treatment for patients who have a positive test for STI
timeFrame: one week
Other outcomes:
Locations:
Study officials:
References:
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