NCT06951438 · Queen's Medical Center
Assessing Acceptability and Feasibiity of STI Self-swab Testing, to be Offered at the Time of Telemed Medication Abortion Provision
(STAMP)
What this study is about
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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
Self-swab collection PCR test for chlamydia, gonorrhea, trichomonas
Self-swab collection PCR test for chlamydia, gonorrhea, trichomonas
Primary outcome measures
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
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.
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
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.
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Home address that is not located in the state of Hawai'i
- Incarcerated
- Unwilling to perform vaginal swab collection
Where
- Honolulu, Hawaii
Collaborators
University of Hawaii Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2025 · Source of record for eligibility and locations