75 Participants Needed

Self-swab Testing for STDs

(STAMP Trial)

OH
Overseen ByOlivia H Manayan, MD, MPH
Age: Any Age
Sex: Female
Trial Phase: Academic
Sponsor: Queen's Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how individuals perceive and use self-swab tests for sexually transmitted infections (STIs) such as gonorrhea, chlamydia, and trichomonas, particularly in the context of telemedicine abortion care. The researchers aim to determine if self-swab tests are a viable option for those with limited access to STI testing. Participants will collect their own swab samples at home, send them to a lab, and complete a survey about their experience. This trial may suit those seeking telemedicine abortion care at Queen Medical Center in Hawaii who require STI testing. As an unphased trial, it provides a unique opportunity to contribute to research that could enhance access to STI testing for many.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on self-swab testing for STIs, so it's unlikely that your current medications would need to be stopped, but you should confirm with the trial organizers.

What prior data suggests that self-swab collection for STI testing is safe?

Research shows that self-swab testing for sexually transmitted infections (STIs) is generally easy for individuals to perform. Studies have found that self-swab methods for detecting infections like chlamydia, gonorrhea, and trichomonas are safe for home use.

Tests such as the Xpert® CT/NG and the binx io are designed for simplicity and have received FDA approval, indicating they meet U.S. safety standards. These tests allow individuals to collect their own samples safely and easily. A swab is used to take a sample, which is then sent to a lab for testing.

While some may find self-swabbing slightly uncomfortable, serious issues are rare. Overall, self-swab testing provides a safe way to check for STIs without visiting a clinic.12345

Why are researchers excited about this trial?

Researchers are excited about the self-swab testing for STDs because it offers a convenient, private alternative to traditional in-clinic testing. Unlike standard STD tests that require a visit to a healthcare facility, this method allows individuals to collect samples at home. This can significantly increase accessibility, encourage more people to get tested, and potentially lead to earlier detection and treatment of infections like chlamydia, gonorrhea, and trichomonas. By reducing barriers to testing, this approach could play a crucial role in public health efforts to control the spread of these infections.

What evidence suggests that self-swab testing is effective for STI screening?

This trial will compare self-swab testing with in-clinic STI testing. Studies have shown that self-swab tests for sexually transmitted infections (STIs) are effective. In one study, 28.7% of participants had at least one treatable STI, such as chlamydia, gonorrhea, or trichomonas, using this method. Research indicates that self-swab tests reliably detect these infections. Participants in the self-swab arm of this trial will collect samples at home and send them to a lab for analysis. This approach simplifies testing and encourages more people to get tested, especially through telemedicine services. Overall, self-swab testing is a practical option for STI screening.678910

Are You a Good Fit for This Trial?

This trial is for patients over age 14 at the Queen Medical Center Options Clinic seeking a medication abortion via telemedicine, who either meet CDC guidelines for STI testing or want screening. Participants must speak and read English and be able to give informed consent.

Inclusion Criteria

I am 14 years old or older.
I can speak and read English.
I am a patient at the Queen Medical Center Options Center seeking a telemedicine medication abortion.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (virtual)

Intervention

Participants perform self-swab collection for STI testing and send specimens to the lab

Up to 1 week
1 visit (virtual)

Follow-up

Participants are monitored for test results and provided treatment if STI positive

1-2 weeks
1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Self-swab collection PCR test for chlamydia, gonorrhea, trichomonas
Trial Overview The study tests the acceptability and feasibility of self-swab STI testing (for chlamydia, gonorrhea, trichomonas) offered alongside telemedication abortion services. It compares this group's uptake and positivity rates with those receiving in-person care.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Self-swab ArmExperimental Treatment1 Intervention
Group II: in-clinic STI testing armActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Queen's Medical Center

Lead Sponsor

Trials
24
Recruited
4,900+

University of Hawaii Foundation

Collaborator

Trials
2
Recruited
60+

Citations

At-home specimen self-collection as an additional testing ...Recent studies suggest that STI screening in MSM reduces chlamydia incidence by 15%, and increased screening for MSM taking PrEP would result in a 17% decrease ...
Self-obtained Vaginal Swabs for Diagnosis of Treatable ...Of the 512 participants examined at their initial study visit, 28.7% were found to be infected with 1 or more treatable STDs (5.3% with N gonorrhoeae, 17.8% ...
At-Home Specimen Self-Collection and Self-Testing for ...These events highlighted previously known benefits of at-home STI self-testing or specimen self-collection and accelerated testing demand via telemedicine. We ...
Validation of Rapid Point-of-Care Diagnostic Tests for ...We used self-collected vaginal swabs to validate the selected test kits for self-test use due to our desire to identify a test that could be ...
Advances in STI Testing at Home and in Non-Clinical ...A commentary on recent successes and challenges for home STI specimen collection, for point-of- care test usage close to the home, and ...
Xpert® CT/NGDetection of Chlamydia trachomatis and Neisseria gonorrhoeae infections in around 90 minutes.
Sexually Transmitted Infections (STI) Profile, With CT/NG/ ...This test is used to screen for and diagnose sexually transmitted infections and blood borne pathogens including syphilis, hepatitis B virus (HBV), hepatitis C ...
8.mybinxhealth.commybinxhealth.com/binx-io/
binx ioTest, enable diagnosis, and treat in a single visit with the first FDA-cleared, CLIA-waived, point-of-care platform for CT/NG testing for males and females.
At-Home Specimen Self-Collection and Self-Testing for ...COVID-19 has accelerated the evaluation and development of STI self-tests and specimen self-collection. The remaining obstacles are high price, regulatory ...
Alinity m STI AssayAlinity m STI assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the direct, qualitative detection and differentiation.
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