Sexually Transmitted Disease (STD)STAMPNCT06951438
Assessing Acceptability and Feasibiity of STI Self-swab Testing, to be Offered at the Time of Telemed Medication Abortion Provision
A study testing Self-swab collection PCR test for chlamydia, gonorrhea, trichomonas in people with Sexually Transmitted Disease (STD) and Gonorrhea, run by Queen's Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Disease (STD), Gonorrhea, Chlamydia
- What is being tested?
- Self-swab collection PCR test for chlamydia, gonorrhea, trichomonas
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Home address that is not located in the state of Hawai'i
- Incarcerated
- Unwilling to perform vaginal swab collection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Queens Medical Center, 1004 Clinic POB1
Honolulu, Hawaii, 96813
Olivia H Manayan, MD, MPH, 808-348-7859
Olivia H Manayan, MD MPH
About this study
Official title: STI Self-swab Testing At the Time of Telemed Medication Abortion Provision
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?
Read more
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.
Read the 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:
- Contents of the specimen collection kit, which will include written instructions for specimen collection
- 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.
- Verifying that patients are willing to receive a survey following specimen receipt via text message, and that they have a working mobile phone number.
- Verifying that they accept receiving positive test results by phone.
- 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.
- Being tested
- Self-swab collection PCR test for chlamydia, gonorrhea, trichomonas
- Keywords
- STI testing, telemedicine, medication abortion, self-swab collection, vaginal swab
- Medical subject headings
- Sexually Transmitted Diseases, Gonorrhea, Chlamydia Infections, Trichomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-swab collection PCR test for chlamydia, gonorrhea, trichomonasDiagnostic test
Self-swab collection PCR test for chlamydia, gonorrhea, trichomonas
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: up to one year
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.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start22 May 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted Disease (STD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hawaii Foundation
- Responsible party
- Principal investigator, Olivia Manayan, MD MPH, Queen's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951438
- Sponsor's protocol ID
- RA-2025-009
- Acronym
- STAMP
- Status last verified
- Jun 2025
- First submitted
- 18 Mar 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: individual participant data will be anonymized.
Publications
Gaydos CA, Cartwright CP, Colaninno P, Welsch J, Holden J, Ho SY, Webb EM, Anderson C, Bertuzis R, Zhang L, Miller T, Leckie G, Abravaya K, Robinson J. Performance of the Abbott RealTime CT/NG for detection of Chlamydia trachomatis and Neisseria gonorrhoeae. J Clin Microbiol. 2010 Sep;48(9):3236-43. doi: 10.1128/JCM.01019-10. Epub 2010 Jul 28.
PubMed 20668135US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for HIV, STD and TB Prevention (NCHSTP), Division of STD/HIV Prevention, Sexually Transmitted Disease Morbidity for selected STDs by age, race/ethnicity and gender 1996-2014, CDC WONDER Online Database. Accessed 2025 Jan 7. http://wonder.cdc.gov/std-race-age.html.
The Guttmacher Institute. State laws and policies: An overview of consent to reproductive health services by young people. Published 2023 Aug 30. Accessed 2024 Dec 26. https://www.guttmacher.org/state-policy/explore/overview-minors-consent-law
Committee Opinion No. 665: Guidelines for Adolescent Health Research. Obstet Gynecol. 2016 Jun;127(6):e183-e186. doi: 10.1097/AOG.0000000000001486.
PubMed 27214193Haydon HM, Major T, Kelly JT, Catapan SC, Caffery LJ, Smith AC, Gallegos-Rejas V, Thomas EE, Banbury A, Snoswell CL. Development and validation of the Digital Health Acceptability Questionnaire. J Telemed Telecare. 2023 Dec;29(10_suppl):8S-15S. doi: 10.1177/1357633X231202279.
PubMed 38007698Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.
PubMed 34812790Spielberg F, Levy V, Lensing S, Chattopadhyay I, Venkatasubramanian L, Acevedo N, Wolff P, Callabresi D, Philip S, Lopez TP, Padian N, Blake DR, Gaydos CA. Fully integrated e-services for prevention, diagnosis, and treatment of sexually transmitted infections: results of a 4-county study in California. Am J Public Health. 2014 Dec;104(12):2313-20. doi: 10.2105/AJPH.2014.302302. Epub 2014 Oct 16.
PubMed 25320878Sullivan SP, Sullivan PS, Stephenson R. Acceptability and Feasibility of a Telehealth Intervention for STI Testing Among Male Couples. AIDS Behav. 2021 Dec;25(12):4029-4043. doi: 10.1007/s10461-021-03173-4. Epub 2021 Jan 28.
PubMed 33507455Lunny C, Taylor D, Hoang L, Wong T, Gilbert M, Lester R, Krajden M, Ogilvie G. Self-Collected versus Clinician-Collected Sampling for Chlamydia and Gonorrhea Screening: A Systemic Review and Meta-Analysis. PLoS One. 2015 Jul 13;10(7):e0132776. doi: 10.1371/journal.pone.0132776. eCollection 2015.
PubMed 26168051Center for Disease Control. Screening recommendations and considerations referenced in treatment guidelines and original sources. Published 2024 Mar 22. Accessed 2024 Oct 1. https://www.cdc.gov/std/treatment-guidelines/screening-recommendations.htm
Norris A, Upadhyay U, O'Donnell J, et al. #WeCount report: April 2022 to June 2024. Society of Family Planning. Published 2024 Oct 22. doi:10.46621/728122kflzwf
Kerestes C, Murayama S, Tyson J, Natavio M, Seamon E, Raidoo S, Lacar L, Bowen E, Soon R, Platais I, Kaneshiro B, Stowers P. Provision of medication abortion in Hawai'i during COVID-19: Practical experience with multiple care delivery models. Contraception. 2021 Jul;104(1):49-53. doi: 10.1016/j.contraception.2021.03.025. Epub 2021 Mar 28.
PubMed 33789080Barrow RY, Ahmed F, Bolan GA, Workowski KA. Recommendations for Providing Quality Sexually Transmitted Diseases Clinical Services, 2020. MMWR Recomm Rep. 2020 Jan 3;68(5):1-20. doi: 10.15585/mmwr.rr6805a1.
PubMed 31899459McNicholas C, Madden T, Secura G, Peipert JF. The contraceptive CHOICE project round up: what we did and what we learned. Clin Obstet Gynecol. 2014 Dec;57(4):635-43. doi: 10.1097/GRF.0000000000000070.
PubMed 25286295Frost JJ, Gold RB, Bucek A. Specialized family planning clinics in the United States: why women choose them and their role in meeting women's health care needs. Womens Health Issues. 2012 Nov-Dec;22(6):e519-25. doi: 10.1016/j.whi.2012.09.002.
PubMed 23122212
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STI Self-swab Testing At the Time of Telemed Medication Abortion Provision
- ClinicalTrials.gov ID
- NCT06951438
- Acronym / sponsor ID
- STAMP / RA-2025-009
- Keywords
- STI testing, telemedicine, medication abortion, self-swab collection, vaginal swab
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Queen's Medical CenterUniversity, hospital or other
- Collaborators
- University of Hawaii Foundation
- Study start
- 22 May 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Contents of the specimen collection kit, which will include written instructions for specimen collection
- 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.
- Verifying that patients are willing to receive a survey following specimen receipt via text message, and that they have a working mobile phone number.
- Verifying that they accept receiving positive test results by phone.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-swab Arm | Experimental | Diagnostic Test: Self-swab collection PCR test for chlamydia, gonorrhea, trichomonasThese 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. |
| 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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Home address that is not located in the state of Hawai'i
- Incarcerated
- Unwilling to perform vaginal swab collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-swab collection PCR test for chlamydia, gonorrhea, trichomonasSelf-swab collection PCR test for chlamydia, gonorrhea, trichomonas | Diagnostic test | Self-swab Arm |
Primary outcome
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.
2 secondary outcomes
Comparison of uptake and STI positivity rates between the telehealth and in-clinic population
Time frame: up to one year
Time elapsed between test result and prescription for treatment for patients who have a positive test for STI
Time frame: one week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Background: PubMed 20668135Gaydos CA, Cartwright CP, Colaninno P, Welsch J, Holden J, Ho SY, Webb EM, Anderson C, Bertuzis R, Zhang L, Miller T, Leckie G, Abravaya K, Robinson J. Performance of the Abbott RealTime CT/NG for detection of Chlamydia trachomatis and Neisseria gonorrhoeae. J Clin Microbiol. 2010 Sep;48(9):3236-43. doi: 10.1128/JCM.01019-10. Epub 2010 Jul 28.
- BackgroundUS Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for HIV, STD and TB Prevention (NCHSTP), Division of STD/HIV Prevention, Sexually Transmitted Disease Morbidity for selected STDs by age, race/ethnicity and gender 1996-2014, CDC WONDER Online Database. Accessed 2025 Jan 7. http://wonder.cdc.gov/std-race-age.html.
- BackgroundThe Guttmacher Institute. State laws and policies: An overview of consent to reproductive health services by young people. Published 2023 Aug 30. Accessed 2024 Dec 26. https://www.guttmacher.org/state-policy/explore/overview-minors-consent-law
- Background: PubMed 27214193Committee Opinion No. 665: Guidelines for Adolescent Health Research. Obstet Gynecol. 2016 Jun;127(6):e183-e186. doi: 10.1097/AOG.0000000000001486.
- Background: PubMed 38007698Haydon HM, Major T, Kelly JT, Catapan SC, Caffery LJ, Smith AC, Gallegos-Rejas V, Thomas EE, Banbury A, Snoswell CL. Development and validation of the Digital Health Acceptability Questionnaire. J Telemed Telecare. 2023 Dec;29(10_suppl):8S-15S. doi: 10.1177/1357633X231202279.
- Background: PubMed 34812790Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.
- Background: PubMed 25320878Spielberg F, Levy V, Lensing S, Chattopadhyay I, Venkatasubramanian L, Acevedo N, Wolff P, Callabresi D, Philip S, Lopez TP, Padian N, Blake DR, Gaydos CA. Fully integrated e-services for prevention, diagnosis, and treatment of sexually transmitted infections: results of a 4-county study in California. Am J Public Health. 2014 Dec;104(12):2313-20. doi: 10.2105/AJPH.2014.302302. Epub 2014 Oct 16.
- Background: PubMed 33507455Sullivan SP, Sullivan PS, Stephenson R. Acceptability and Feasibility of a Telehealth Intervention for STI Testing Among Male Couples. AIDS Behav. 2021 Dec;25(12):4029-4043. doi: 10.1007/s10461-021-03173-4. Epub 2021 Jan 28.
- Background: PubMed 26168051Lunny C, Taylor D, Hoang L, Wong T, Gilbert M, Lester R, Krajden M, Ogilvie G. Self-Collected versus Clinician-Collected Sampling for Chlamydia and Gonorrhea Screening: A Systemic Review and Meta-Analysis. PLoS One. 2015 Jul 13;10(7):e0132776. doi: 10.1371/journal.pone.0132776. eCollection 2015.
- BackgroundCenter for Disease Control. Screening recommendations and considerations referenced in treatment guidelines and original sources. Published 2024 Mar 22. Accessed 2024 Oct 1. https://www.cdc.gov/std/treatment-guidelines/screening-recommendations.htm
- BackgroundNorris A, Upadhyay U, O'Donnell J, et al. #WeCount report: April 2022 to June 2024. Society of Family Planning. Published 2024 Oct 22. doi:10.46621/728122kflzwf
- Background: PubMed 33789080Kerestes C, Murayama S, Tyson J, Natavio M, Seamon E, Raidoo S, Lacar L, Bowen E, Soon R, Platais I, Kaneshiro B, Stowers P. Provision of medication abortion in Hawai'i during COVID-19: Practical experience with multiple care delivery models. Contraception. 2021 Jul;104(1):49-53. doi: 10.1016/j.contraception.2021.03.025. Epub 2021 Mar 28.
- Individual participant dataSharing planned: No. individual participant data will be anonymized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-swab collection PCR test for chlamydia, gonorrhea, trichomonas in people with Sexually Transmitted Disease (STD) and Gonorrhea, run by Queen's Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivia H Manayan, MD, MPH (808-348-7859, omanayan@hawaii.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06951438, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.