STI Self-swab Testing At the Time of Telemed Medication Abortion Provision
Phase: NA
Conditions: Sexually Transmitted Disease (STD), Gonorrhea, Chlamydia, Trichomonas Infection
Sponsor: Queen's Medical Center

 
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Title: STAMP (STI self-swab Testing At the time of telemed Medication abortion Provision)  
 
Version 3.0 – April 9, 2025 
 
Principal Investigator: Olivia Manayan, MD MPH 
Co-Investigator(s): Mary Tschann, PhD, MPH, Bliss Kaneshiro, MD MPH, Reni Soon, MD MPH, 
Melissa Natavio, MD MPH, Shandhini Raidoo, MD MPH, Catherine Rault, MD MPH,  
Research Associates: Natalia Fornal, Jacob Erban, Thaneswari Ganesan 
 
Research Site(s): The Queen’s Medical Center: Options Center, POB1 Suite 1004 
 
Abbreviations: 
• 
STI: sexually transmitted infection 
• 
GC: Gonorrhea 
• 
CT: Chlamydia 
 
Section I: Purpose and Background 
 
1. Specific aims and objectives 
 
This project aims to improve access to primary care by assessing the utilization, acceptance, and 
feasibility of a self-collected STI screening service at the time of telemedicine medication abortion 
provision.  
 
Primary Outcomes 
• 
Assess the acceptability, feasibility, and utilization of self-collected STI screening at the time of 
telemedicine medication abortion provision 
 
Secondary Outcomes 
• 
Assess the positivity rate of GC and CT infections in our participants compared to the positivity 
rates of GC/CT in patients seeking in-clinic abortion care 
• 
Assess the rate of uptake of self-swab collection for STI testing compared to that of the in-clinic 
population of patients seeking abortion care 
• 
Measure the time elapsed between test result and prescription for treatment for patients who have 
a positive test for STI.  
 
2. Background, significance, and rationale 
 
Abortions are an essential and commonly utilized aspect of reproductive healthcare; it is estimated that 
one in every four (24.7%) pregnant-capable individuals will have an abortion by the time they reach 45 
years of age.1 The Supreme Court’s Dobbs v. Jackson Women’s Health Organization decision, which 
overturned the federal protections for abortion previously established through the Roe vs. Wade decision, 
has led to drastic changes in the scope and accessibility of abortion care across the United States,2 
particularly in states with restrictive laws on abortion. Restricting abortion access has also been associated 
with other adverse health outcomes, such as an increase in the prevalence of STI rates.3 
 
As many reproductive-aged females report sexual and reproductive health (SRH) clinics as their primary 
site for accessing healthcare services in general,4,5 offering a mix of health screening services, such as STI 
testing and cervical cancer screening at the time of abortion care may help to increase accessibility and 
usage of these services. Additionally, as it has been previously shown that patients who seek abortion care 

 
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have higher rates of STIs compared to the general population,6 routinely offering STI screening to 
patients receiving abortion care may help to improve diagnosis and treatment in this at-risk population by 
diagnosing and treating asymptomatic patients in a timely manner.7 
 
For abortion care in Hawaiʻi, telemedicine services are well-established, and have been vital in providing 
access to areas with a paucity of abortion providers. Previously, patients were required to fly to Oʻahu, 
Maui, or Hawai`i island to access abortion services.8 Currently, approximately one-third of abortion 
services provided in Hawaiʻi are provided through telemedicine services.9 The Options Center, located at 
the Queens Medical Center on O`ahu, is the one of the largest providers and referral centers for abortions 
in the state,10 providing both medication abortions (via telehealth and in-person visits) and outpatient 
aspiration procedures for abortion. During in-person visits, STI screening, either through self-collected or 
physician-collected specimen, is routinely offered according to the CDC guidelines for STI screening.11 
However, due to the inability to perform a physical exam during telemedicine visits, our clinic does not 
currently offer STI testing during telemedicine abortion consultation.  
 
Self-collected STI testing (including testing for gonorrhea, chlamydia, and trichomonas) has been shown 
to have comparable rates of sensitivity and specificity to physician-collected swabs.12 Previous studies 
have also demonstrated that patients find self-swabbing for STI testing acceptable and favorable.13 In one 
prospective study, patients who opted for home-based, self-collected STI testing were more likely to 
complete STI testing than a clinic-based cohort.14 By offering patients the option to self-collect swabs for 
STI testing at the time of telemedicine abortion, we can help to improve accessibility of these services for 
these patients.  
 
 
3. Preliminary studies 
 
Previous studies assessing the acceptability and feasibility of STI testing and treatment delivered through 
telemedicine consultation have shown promising results. In one study conducted by Sullivan et al,15 
participants expressed high levels of acceptability of at-home, self-collection for STI testing compared to 
previous methods used. Additionally, there was a high rate (96%) of returned specimens, with 99.4% of 
returned specimens found to be adequate for processing. In a separate study that looked at electronic 
delivery of STI education, testing, and treatment, although return rates of swab collection kits were lower 
(67%), participants expressed acceptability of telemedicine STI services, with 80% reporting preference 
for telemedicine services over in-clinic services for future STI services.16 
 
Currently, there have been no studies done in the United States examining STI testing at the time of 
telemedicine medication abortion provision. Additionally, none of the major providers of telemedicine 
abortion in Hawai`i currently offer self-swab STI testing as a concurrent service, which creates a gap in 
care for telemedicine abortion patients.  
 
Section II: Criteria for Subject Selection 
 
1. Number of subjects 
 
We will enroll a total of 75 subjects for this study. The guidance for determining sample sizes in pilot 
studies assessing feasibility17 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.  
 

 
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For the contemporaneous, in-clinic population that will serve as the control group, all charts for patients 
who receive medication abortion from 4/30/25 (or whenever the intervention group begins enrollment) -
4/30/26 (or whenever the intervention group concludes enrollment) will be reviewed.  
 
2. Demographics of subjects 
 
Intervention group: Patients who undergo screening and are found to meet inclusion criteria will be 
invited to participate in this study.  
 
Inclusion Criteria 
 
1. Patients of the Queen’s Medical Center POB1 1004 clinic seeking telemedicine medication 
abortion. 
2. Patients for whom, according to the CDC guidelines for STI Testing11, STI testing is indicated 
(Appendix A), or patients who desire STI screening 
3. Age 14 and over 
4. Can speak and read English 
5. Have an individual, personal email account and mobile phone with text message and internet 
capabilities for receiving survey links 
6. 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 
 
Retrospective chart review group (control): 
 
The inclusion and exclusion criteria for the control group will be the same as above, with the exception 
that patients will be seeking medication abortion in-person, and will not need to perform vaginal swab 
collection at home. A home address is not required as they will receive their medications and testing in 
clinic at the time of visit. Additionally, they will be seeking in-person rather than telemedicine medication 
abortion.  
 
For the secondary outcome of comparing STI positivity rates, since we are looking to see overall 
positivity rates of our in-clinic vs telehealth population, we will compare all methods of STI testing 
(clinician swab, self-swab, urine) for our in-clinic population to our self-swab telehealth group. As 
displayed in previous validation studies, sensitivity and specificity between self-collected swabs and 
physician-collected swabs for STI testing are not significantly different.14 Similarly, since we are looking 
to see the uptake of STI-testing as a service (with self-swab being the only feasible option for telehealth 
patients), we will look at all methods of STI testing when comparing uptake of testing between the two 
groups.  
 
Vulnerable Subjects 
 
Minors 
Minors ought to be able to consent for their own participation in research studies if they are able to 
consent to the corresponding medical care being provided, so long as the participant does not encounter 
more than minimal risk that individuals may assume on their own.19 As minors in the state of Hawai`i are 
able to consent independently for all STI services beginning at the age of 14,20 they too should be allowed 

 
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to consent independently for a study which provides them access to STI testing. When separated by age 
group, adolescents aged 15 to 19 years old have the second highest rates of gonorrhea and chlamydia in 
the state of Hawai`i.21 Precluding this population from our study would potentially lead to missed 
screening opportunities for members of an at-risk population.  
 
As self-collected swabs are widely available for STI testing both in clinics and online and have shown to 
yield reliable results,12 STI testing through participation in this study does not differ from the standard of 
care or incur more than minimal risk for participants.  
 
Pregnant patients 
Although we will be recruiting patients who are pregnant at the time of initial visit, as they are seeking 
abortion care, they are choosing to end their pregnancy and thus can make informed choices without 
being subject to undue influence. Additionally, the services being provided as part of this study are 
completely optional and in addition to abortion care services, and will not affect the patient’s ability to 
receive abortion care. 
 
Section III: Methods and Procedures 
 
1. Study design and methods: 
 
This is an explorative pilot 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 Queen’s POB 1 1004 clinic, with the study population consisting of 
patients who utilize telemedicine services for medication abortion consultations and a chart review of 
comparison group 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 above. 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 telephone visit, to take place between the patient and the research 
associate. The research associate will describe the study in further detail and obtain informed consent if 
the patient still wishes to proceed. Patients may sign consent forms via Adobe e-sign, a secure digital 
platform. Adobe e-sign will be accessed via a computer on the Queens Medical Campus. The password 
protected consent form will be sent via Adobe e-sign to the patient’s email where they will sign it. The 
signed consent form is unable to download via email. The only way to access the password-protected, 
signed consent form is via an account for Adobe e-sign that is only accessible to the researcher who sent 
the consent form to the patient for signature. Only one device will have the electronic consent form for 
patients to read and sign. E-consent forms will be deleted in their electronic format and printed from a 
Queens Medical Center printer and stored in a locked cabinet in a locked office in a locked building on 
Queens Medical Center. The patients will receive an emailed copy of their informed consent form once it 
has been electronically signed. 
 
 

 
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Once informed consent has been obtained, the patient will fill out Part I of the intervention survey via text 
message link (Appendix E). The research associate will then do a short teaching session that reviews the 
following points with participants: 
1. Contents of the specimen collection kit (Appendix B), which will include written instructions 
for specimen collection (Appendix C) 
2. How to collect the specimen (this may be done with illustrative models) 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 at QMC. Only the PI 
and Dr. Tschann will have access to the identifiable information. Jessica Ingersoll, who will be oversee 
analysis at the Emory Labs using specimens prelabeled with the study ID, will not have access to 
participant PHI.   
 
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 can perform self-
swab collection 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. Please see Appendix D 
for a copy of the reporting forms that will be used for specimen processing. 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 service (Appendix E). 
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.   
 
It will be reported by the lab staff to the PI if a submitted specimen is deemed inadequate for processing. 
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. Once the research team has received the results, they will be reported to the patient 
and scanned into the patient’s electronic medical record. Patients will be able to access this through the 
“Document Center” section of their MyChart app. Based on previous experiences from the Queen’s IT 
and Medical Records departments, this section of MyChart is not visible to parents with proxy access and 
thus should not be visible to parents unless shown by the patient themselves. In order to add an extra layer 
of security, adolescent patients will have the option to get their test results sent to them via encrypted 
email. All positive test results will still be reported to the Department of Health.  
 

 
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If the lab staff does not receive a specimen from the patient prior to the patient’s scheduled follow-up 
appointment after medication abortion (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 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 patient does not respond when 
attempting to contact her, 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 result is made available to the research team. Patients may opt to receive negative test results via 
phone call (with option to approve leaving a detailed message on voicemail or not), myChart or text 
message, or opt out of receiving updates about negative test results.  
 
2. Data analysis and monitoring: 
 
Data analysis will be performed for each outcome being measured as follows: 
 
Primary Outcomes 
 
• 
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”.  
o We will calculate median and IQR across the domains of the DHAQ to determine a 
median acceptability score  
o Three total scores will be calculated: 
▪ 
The acceptability score, which will be calculated using the scores from questions 
1-5 
▪ 
The feasibility score, which will be calculated using scores from questions 6-10 
▪ 
The composite score, which will combine the first two scores to calculate overall 
acceptability and feasibility of the intervention15 
• 
Feasibility will be measured using multiple factors, in accordance with guidelines put forth by 
Teresi et al16 for feasibility pilot studies: 
o Participants’ answers from the modified DHAQ relating to the ease of service (6-10, as 
above) 
o The percentage of returned specimens that are adequate for processing will be reported as 
a measure of feasibility 
• 
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 a measure of utilization. The 
former will be reported as the percentage of eligible patients who chose to enroll in the study, 
while the latter will be reported as the percentage of enrolled patients who submitted samples for 
STI testing.  
 
Secondary Outcomes  
 
• 
Comparison of uptake and STI positivity rates between the telehealth and in-clinic population 

 
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o 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. We will abstract information about patient demographics (age, race/ethnicity, 
and island of residence), gestational age, pregnancy history, STI testing, and STI 
infection (see Appendix E). In order to do this, a HIPAA waiver is requested to perform a 
retrospective chart review on all patients who received in-clinic abortion care in the same 
timeframe as the study.  
• 
Time to treatment 
o 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.  
 
 
 
3. Data storage, security, and confidentiality:    
  
Patient information will be de-identified and connected to a unique Study ID. A codebook linking the 
patient’s MRN and unique Study ID will be stored in a password protected and encrypted computer in the 
PI’s research office at QMC. This study ID will be the only identifier used on all study-related material 
that is sent to the patient or the lab for processing.   
 
The signed consent forms will also be stored in a locked cabinet in the PI’s research office at QMC, in a 
folder located in a locked office. Only the research team will have access to identifiable information on an 
as-needed basis. Emory Labs will not have access to participant PHI.   
 
  
4. Transition from research participation (if applicable):  
 
Not applicable  
 
5. Study timeline:   
  
Data collection will begin as soon as the first subject is enrolled and will continue until after the last 
subject’s STI testing has resulted. We hope for the total timeline to be approximately 1 year, which allows 
for time for data analysis, retrospective chart review of the comparison group, and write-up of the 
intervention results.   
 
Projected timeline is as follows: 
• 
February 2025: IRB Approval received 
• 
April 2025 – April 2026: Participant Recruitment and Data Collection 
• 
April 2026: Data Analysis  
• 
April 2026 - May 2025: Report Writing 
• 
May 2026: Thesis Presentation, submission of findings for presentation at national meetings 
 
  
Section IV:  Risk/Benefit Assessment  
 

 
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1. Risk category (Minimal or Greater than Minimal):  
 
This study poses minimal risk to the patient.   
  
2. Potential risk(s):   
 
a. There is minimal risk that the privacy of the patient’s medical information could be breached.  
b. There is minimal risk that the patient could injure themselves during swab collection. In a study 
performed to assess the sensitivity and specificity of the Abbott RealTime CT/NG assay using 
self-collected and clinician-collected specimens, patients preferred self-swab over clinician-
collected swabs, with self-collected swabs and clinician-collected swabs yielding comparable 
rates of sensitivity and specificity. No adverse events, including injury, were reported as a result 
of self-collection.22 
 
3. Protection against risk(s):   
  
Please see Section III, #3 above regarding protection of patient’s medical information. In addition, if the 
patient is a minor and their package containing testing materials is opened by a parent, this may result in a 
breach of privacy for the patient. To minimize this risk, the packaging containing both medication 
abortion medications and testing materials is a discreet, USPS Priority Mail package. The patient is 
provided with tracking information so they know when to expect this package and can anticipate its 
arrival accordingly. Alternatively, if the patient is worried that their parents will open their mail, they can 
elect to have the package sent to a different address.    
 
In previous studies performed assessing at-home, self-swab collection for STI testing, there was no 
mention of injury among adverse outcomes. Additionally, in a survey delivered through a multi-site 
clinical trial for self-collected STI testing, the majority (96.2%) of participants found self-swabbing to be 
“very easy” (89.6%) or “somewhat easy” (6.6%), while only 0.5% of participants found self-swabbing to 
be “somewhat or very difficult”.12 If a participant is injured in an attempt to self-swab, they may be seen 
in our 1004 to assess and/or repair the injury. If the patient is located on a neighbor island, they may seek 
care with their OB/GYN or at an urgent care facility. This visit will be billed through their insurance 
provider.  
  
4. Potential benefit(s) to the subject (direct medical benefit(s)):   
  
The direct benefit to the subject includes increased access to STI testing and treatment services.  
  
5. Alternative to participation:   
  
Declining participation will not affect patients’ medical care, as patients will still be provided abortion 
care through telemedicine, which was the intended purpose of their visit. Additionally, if patients would 
prefer to get in-person STI testing, they will be provided with locations near them that offer STI testing.  
  
Section V:  Subject Identification, and Consent/Assent  
  
1. Method of subject identification and recruitment:    
  
Patients of the 1004 clinic who utilize the telemedicine service for medication abortion consultation. 
Patients will not be pre-screened before their visit for eligibility; eligibility will be assessed by the 
physician during the telemedicine abortion visit.   
  

 
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2. Process of consent:   
  
Any patient who fulfills the inclusion criteria at the time of their visit will be asked if they are interested 
in participating in the study. If they are interested, at the completion of their medication abortion 
consultation, they will be immediately directed to a new telehealth visit with a member of the research 
team. At this visit, the study will be reviewed with the patient and informed consent will be collected if 
the patient wishes to participate. A standard, IRB-approved consent form will be used. The consent form 
will be sent to the patient for review via Adobe e-sign during this research visit. Once the patient has 
received the consent form, it will be reviewed by the research associate with the patient verbally, 
explaining the nature and purpose of the study, intervention and tasks associated with participating, as 
well as all risks and benefits associated with participation. Research associates can answer questions 
about the study and complete informed consent. If questions are outside of research associates’ scope, 
then physicians will be available to answer these questions.  Patients will be able to complete their 
consent via the Adobe e-sign platform. If enrolled, patients will be provided a signed copy of the consent 
form sent to their email.    
  
3. Subject capacity assessment procedures:  
 
Not applicable.  
  
4. Subject/Representative comprehension:   
  
Patient must be able to understand and communicate effectively in English. As part of obtaining informed 
consent, patients must be able to demonstrate comprehension of the risks and benefits of study to the 
researcher. If they are unable to do so using basic English, they will not be deemed appropriate for 
participation in this study.  
  
5. Debriefing procedures for non-disclosed information (if applicable):  
 
Not applicable. 
  
6. Documentation of consent/assent:   
  
An IRB-approved consent form will be used to document consent. Subjects will be provided with a copy 
of the signed consent form. A copy of the signed consent form will be scanned into the subject’s medical 
record and a physical copy will be stored with their study materials in the PI’s secure office. 
  
7. Costs to the subject 
 
No monetary cost will be incurred by the subject as a result of participation in this study, as all testing 
costs will be covered completely by the research study. As chlamydia is the most common STI in 
Hawaiʻi,23 this is the test we anticipate will most likely resulting as positive. If a patient tests positive for 
chlamydia, the research team will cover the costs of antibiotic (doxycycline) treatment, which will be 
mailed to the patient. If a patient tests positive for gonorrhea or trichomonas and requires treatment, the 
treatment will be ordered for the patient and will be the responsibility of the patient or her insurance. 
  
8. Payment for participation:  
 
Participants will be compensated a total of $25. They will receive a Long’s gift card in the mail with the 
medication abortion and swab collection kits.  
  

 
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9. Study costs:  
 
The study costs will be covered by Thu, who have provided an $9,375 grant to cover costs for participant 
remuneration, the distribution, shipping, and processing of STI self-collection kits, and treatment for 
participants who test positive for Chlamydia infection.  
  
 
Works Cited 
 
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2. Baden K, Dreweke J, Gibson C. Clear and growing evidence that Dobbs is harming reproductive 
health and freedom. Published 2024 Aug 22. Accessed 2024 Oct 1. 
https://www.guttmacher.org/2024/05/clear-and-growing-evidence-dobbs-harming-reproductive-
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3. Srinivas M, Wong NS, Wallace R, et al. Sexually transmitted infection rates and closure of family 
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-—-1-.pdf.  
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Transmitted Diseases. 2005; 32 (12): 729-733. doi: 10.1097/01.olq.0000190057.61633.8d. 

 
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doi:10.1097/AOG.0b013e3181d4450d. 
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doi:10.1007/s10461-021-03173-4.  
16. Spielberg F, Levy V, Lensing S, et al. 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;104(12):2313-2320. doi:10.2105/AJPH.2014.302302 
17. Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility 
Pilot Studies. Med Care. 2022;60(1):95-103. doi:10.1097/MLR.0000000000001664. 
18. Haydon HM, Major T, Kelly JT, et al. Development and validation of the Digital Health 
Acceptability Questionnaire. J Telemed Telecare. 2023;29(10_suppl):8S-15S. 
doi:10.1177/1357633X231202279  
19. American College of Obstetricians and Gynecologists. Guidelines for adolescent health research. 
Committee Opinion No. 665. Obstet Gynecol 2016;127:e183–6.  
20. 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.  
21. US 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. 
22. Gaydos CA, Cartwright CP, Colaninno P, et al. Performance of the Abbott RealTime CT/NG for 
detection of Chlamydia trachomatis and Neisseria gonorrhoeae, Journal of Clinical 
Microbiology. 2010;48(9):3236-3243. doi:10.1128/jcm.01019-10 
23. US Center for Disease Control and Prevention. Spotlight on sexually transmitted infections & 
prevention: Hawaii. 2023. CDC-135809-DS1. Accessed 2024 December 16.  
24. North Carolina Department of Health and Human Services. Self-collected vaginal swabs for 
gonorrhea and chlamydia. Published 2011 Apr. Accessed 2024 Dec 26. 
https://epi.dph.ncdhhs.gov/cd/lhds/manuals/std/labtesting/selfcollectedswabs.pdf 
 
 
APPENDICES 
 
Appendix A: CDC guidelines for STI testing for female patients11 
 
Women 
Chlamydia 
  
• 
Sexually active women under 25 years of age 
• 
Sexually active women 25 years of age and older if at increased risk 
• 
Retest approximately 3 months after treatment 
• 
Rectal chlamydial testing can be considered in females based on reported sexual 
behaviors and exposure, through shared clinical decision between the patient and the 
provider 

 
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Gonorrhea 
• 
Sexually active women under 25 years of age 
• 
Sexually active women 25 years of age and older if at increased risk 
• 
Retest 3 months after treatment2 
• 
Pharyngeal and rectal gonorrhea screening can be considered in females based on 
reported sexual behaviors and exposure, through shared clinical decision between the 
patient and the provider 
Syphilis 
• 
Screen asymptomatic adults at increased risk (history of incarceration or transactional 
sex work, geography, race/ethnicity) for syphilis infection 
Herpes† 
• 
Type-specific HSV serologic testing can be considered for women presenting for an 
STI evaluation (especially for women with multiple sex partners) 
Trichomonas 
• 
Consider screening for women receiving care in high-prevalence settings (e.g., STI 
clinics and correctional facilities) and for asymptomatic women at increased risk for 
infection (e.g., women with multiple sex partners, transactional sex, drug misuse, or a 
history of STI or incarceration) 
HIV 
• 
All women aged 13-64 years (opt-out) 
• 
All women who seek evaluation and treatment for STIs 
HPV, Cervical 
Cancer 
• 
Women 21-29 years of age every 3 years with cytology 
• 
Women 30-65 years of age every 3 years with cytology, or every 5 years with a 
combination of cytology and HPV testing 
Hepatitis B 
Screening 
• 
Women at increased risk (having had more than one sex partner in the previous 6 
months, evaluation or treatment for an STI, past or current injection-drug use, and an 
HBsAg-positive sex partner) 
Hepatitis C 
Screening 
• 
All adults over age 18 years should be screened for hepatitis C except in settings where 
the hepatitis C infection (HCV) positivity is < 0.1% 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix B: Contents of specimen collection kit 
 
1. Abbott Multi-Collect Specimen kit: this kit is comprised of a sterile collection swab and a 
collection tube with buffer solution.  
2. Tape to secure the collection tube 
3. Instructions for collection (Appendix C) 
4. Watertight, sealable biohazard bag to place specimen in after collection 
5. Small absorbent pad, to be wrapped around the specimen collection tube and secured 
with a rubber band 
6. Padded envelope to protect collected samples 
7. FedEx Clinical Pack to place padded envelope with enclosed sample in 
8. Prepaid shipping label to Emory Clinical Labs 

 
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9. Shipment log requisition form (Appendix D), to be sent with sample  
 
 
Appendix C: Written Instructions for self-swab collection24 
 
NOTE: Please wear gloves whenever handling specimen collection kit materials, particularly the buffer 
solution. Wash your hands prior to putting gloves on.  
NOTE: In order to avoid injury to your genital tract, avoid inserting the swab higher than instructed. Swab 
collection should not be painful. If it is, stop collection and contact your doctor.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Appendix D: Patient specimen collection log (to be sent with completed sample) 
 
 
 
 
Appendix E: Intervention survey, link to be texted to patients 
 
Part I: Demographics (to be completed at the time of enrollment) 
 
1. Please enter your study ID number: 
2. Which island do you live on?  
a. Hawai`i (Big Island) 
b. Kaua`i 
c. Lana`i 
d. Maui 
e. Moloka`i 
f. O`ahu 
 
3. What is your ethnicity (please check all that apply): 
a. American Indian/Alaska Native/Eskimo/Inuit 
b. Asian Indian 
c. Black 
d. Caucasian/White 
e. Chinese 
f. Fijian 
g. Filipino 
h. Guamanian/Chamorro 
i. 
Japanese 

 
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j. 
Korean 
k. Mexican 
l. 
Micronesian 
m. Native Hawaiian 
n. Puerto Rican 
o. Samoan 
p. Vietnamese 
q. Other Asian 
r. Other Pacific Islander 
s. Other Hispanic/Latinx 
t. 
Other (write in) 
 
Part II: Digital Health Acceptability Questionnaire – to be completed post-collection  
Post-collection survey 
 
Thank you for submitting your specimen! We appreciate your time and effort. Please take some time to 
fill out the following survey to the best of your ability. The entire survey should take approximately five 
to ten minutes.  
 
 
Thinking about all of the telehealth [phone/video] appointments that you have had related to this study, 
please choose the response [Strongly disagree through to Strongly agree] below that best fits your 
opinion. 
1. 
STI testing through telehealth fits with my idea of what good healthcare should be. 
2. 
Having video appointments for STI testing is in line with my healthcare goals. 
3. 
It took very little effort to have STI testing appointments via video. 
4. 
Having healthcare appointments via video for STI testing was not a burden. 

 
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5. 
I believe video appointments for STI testing meet my healthcare needs. 
6. 
Having video appointments for STI testing saved me time. 
7. 
Telehealth video STI testing was easy for me to use. 
8. 
I have no doubt in my ability to set up and have my healthcare appointments via video. 
9. 
I really enjoy having my healthcare appointments for STI testing via video. 
10. I liked having my healthcare appointments for STI testing via video. 

 
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