Point-of-care Testing for Sexually Transmitted Infections
(MATCH-POINT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if quick, on-the-spot tests for sexually transmitted infections (STIs) enable faster treatment for pregnant women compared to standard lab tests. It focuses on infections such as syphilis, chlamydia, gonorrhea, and trichomonas. The study will also evaluate the ease and cost-effectiveness of using these tests in a busy hospital setting. Pregnant women needing STI testing and having certain risk factors, such as multiple sex partners or a new partner, may be suitable candidates for this trial. Participants will either receive immediate results from point-of-care STI tests or follow the standard procedure, and their treatment outcomes will be compared. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance STI testing and treatment for pregnant women.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What prior data suggests that point-of-care STI tests are safe for pregnant women?
Research has shown that point-of-care tests (POCTs) for sexually transmitted infections (STIs) are safe for humans. These tests quickly detect infections like chlamydia, gonorrhea, syphilis, and trichomonas at the point of care. Studies have found that the results are highly accurate, with chlamydia test results matching standard lab tests 99% of the time, indicating reliability and safety.
POCTs involve simple steps, such as a fingerstick blood test or a vaginal swab, which most people find easy to handle. The World Health Organization (WHO) has set high standards for these tests, ensuring they accurately identify those with and without infections.
Overall, POCTs are safe, effective, and help reduce the time individuals remain infectious, which is crucial for controlling STIs.12345Why are researchers excited about this trial?
Researchers are excited about point-of-care (POC) testing for sexually transmitted infections (STIs) because it offers rapid results and immediate treatment options. Unlike traditional STI testing, which often involves waiting for lab results, POC testing allows for same-day counseling and treatment, reducing the time between diagnosis and care. This approach not only improves patient outcomes by ensuring timely treatment but also helps minimize the spread of infections by addressing them promptly. Moreover, POC testing can alleviate the stress and uncertainty patients often experience while waiting for their test results, making the process more patient-friendly and efficient.
What evidence suggests that point-of-care STI tests are effective for improving timely treatment of STIs in pregnant women?
Research has shown that quick tests for sexually transmitted infections (STIs), provided to participants in the intervention arm of this trial, can be highly effective. One study found that these tests for chlamydia, gonorrhea, and trichomonas significantly reduced the number of untreated days by thousands. Tests for chlamydia demonstrated 99% accuracy. Another study indicated that these quick tests led to faster and more appropriate treatment for infections like gonorrhea and chlamydia. Overall, these tests can ensure quicker diagnosis and timely treatment, which is especially important for pregnant women. Participants in the control arm will receive standard STI testing.12678
Who Is on the Research Team?
Kristin Wall, PhD
Principal Investigator
Emory University
Are You a Good Fit for This Trial?
This trial is for pregnant women who may have sexually transmitted infections (STIs) like syphilis, chlamydia, gonorrhea, or trichomonas. It's being conducted in a large safety-net hospital to improve maternal and child health.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete a baseline survey and receive either POCTs or standard laboratory STI testing
Treatment
Participants receive STI treatment based on test results, with same-day counseling and treatment for POCTs
Follow-up
Participants complete a follow-up survey approximately one month after diagnosis if diagnosed with an STI
Pregnancy Monitoring
Participants are monitored for pregnancy outcomes and repeat STI testing up to pregnancy completion
What Are the Treatments Tested in This Trial?
Interventions
- Point-of-care STI tests
- Standard of care STI testing
Trial Overview
The study compares point-of-care STI tests that give quick results with standard lab-based testing to see if they can speed up treatment for STIs in pregnant women. It also examines the practicality and cost-effectiveness of these rapid tests.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
If participants wait for POCT results: * Positive results will prompt same-day counseling and treatment. * Treatment will be directly observed for gonorrhea and syphilis, or provided as a same-day prescription for trichomonas. * Chlamydia treatment may be directly observed or prescribed, depending on the clinical setting, consistent with the standard of care. If participants do not wait for POCT results: * Positive results will be communicated via phone and/or Patient Portal. * Treatment will proceed as in the standard-of-care control arm.
Participants will undergo routine clinical care at Grady Memorial Hospital (GMH), consistent with CDC STI Treatment Guidelines. * Positive results will be communicated via phone and/or Patient Portal. * For trichomoniasis or chlamydia, treatment will involve sending a prescription to the patient's preferred pharmacy. For syphilis or gonorrhea, patients will be asked to return to the clinic for an antibiotic infection.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Citations
Point-of-Care Testing for Sexually Transmitted Infections A ...
The WHO's TPPs include test sensitivity and specificity for the following infections: gonorrhea, 90%/90%; chlamydia, higher than 90%/98%; syphilis treponemal ...
Clinical effectiveness and analytical quality of a national ...
POC testing for chlamydia, gonorrhoea and trichomonas averted 4930, 5620 and 7075 infectious days, respectively. Results concordance was high [99.0% (chlamydia) ...
Impact of point-of-care gonorrhea and chlamydia testing in ...
This study demonstrated implementing POC STI testing is associated with significantly improved appropriateness of CT/NG treatment. The quicker turnaround time ...
STI point-of care tests: a call for quality-assured evaluation ...
Overall, the ProSPeRo Project data presented here confirm that STI POCTs do not perform as well when evaluated in clinics and other field ...
5.
bmcinfectdis.biomedcentral.com
bmcinfectdis.biomedcentral.com/articles/supplements/volume-24-supplement-1Point-of-care Testing for Sexually Transmitted Infections
Independent clinic-based evaluation of dual POCTs for screening for HIV and syphilis in men who have sex with men in Italy, Malta, Peru, and the United Kingdom
6.
diagnostics.roche.com
diagnostics.roche.com/global/en/article-listing/lab-leaders/article/sti-testing-improving-patient-access.htmlSTI testing: Improving access and patient outcomes
Effective and integrated point-of-care testing and treatment are essential to curb transmission rates for sexually transmitted infections (STIs) ...
Point-of-Care Testing for Sexually Transmitted Infections ...
This toolkit can support decision-making on the use of POCTs for sexually transmitted infections (STIs), including human immunodeficiency virus (HIV), by local ...
Potential for Point-of-Care Tests to Reduce Chlamydia ...
POCT with 99% sensitivity could avert up to 12 700 (95% CrI 5000–22 200) PID cases per year, if 100% were treated immediately (baseline LTFU 20% ...
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