Point-of-Care Testing for Sexually Transmitted Infections

Overseen By Naomi Pressman, MS, RD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: PrEP

Disqualifiers: Known HIV

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether quick, on-the-spot testing for sexually transmitted infections (STIs) like gonorrhea and chlamydia can enhance HIV testing and prevention in young people. Faster results may lead to more effective counseling and quicker access to HIV prevention services. Participants will receive either point-of-care testing (quicker, done at the clinic) or traditional lab testing to determine which method is more effective. This trial suits young people aged 16-24 who need testing for these STIs but do not have HIV or a current prescription for PrEP (a medication to prevent HIV). As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in STI and HIV prevention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have an active PrEP prescription, you would not be eligible to participate.

What prior data suggests that this point-of-care testing is safe for sexually transmitted infections?

Research has shown that quick tests for sexually transmitted infections like gonorrhea and chlamydia are generally well-received. Studies have found these tests to be very accurate, matching expected results over 99% of the time. This indicates that the tests are dependable and rarely make mistakes, with reports of malfunction occurring in less than 4% of cases.

No major side effects have been reported with these tests, suggesting they are safe for most people. These quick tests provide fast results, aiding in timely treatment and advice. This not only improves health but also enhances the testing process. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about point-of-care testing for gonorrhea and chlamydia because it offers rapid results directly at the testing site, unlike traditional lab-based testing that can take days. This quicker turnaround time allows for immediate diagnosis and treatment, reducing the spread of infections and improving patient outcomes. Additionally, point-of-care testing is more accessible since it can be performed in various settings without specialized lab equipment, making it ideal for use in resource-limited areas.

What evidence suggests that point-of-care testing is effective for improving HIV testing and PrEP delivery in youth?

This trial will compare point-of-care testing (POCT) with lab-based testing for sexually transmitted infections. Studies have shown that quick tests conducted at the point of care for gonorrhea and chlamydia are highly effective. The World Health Organization reports that these tests are over 90% accurate in identifying individuals with or without these infections. Specifically, for chlamydia, these quick tests match lab test results 99% of the time. Rapid results from these tests help reduce the infectious period and expedite treatment. Overall, POCT offers a reliable and fast method to diagnose and manage these sexually transmitted infections. ^{1 3 6 7 8}

Who Is on the Research Team?

Sarah Wood, MD, MSHP

Principal Investigator

Mount Sinai Adolescent Health Center

Are You a Good Fit for This Trial?

This trial is for young people aged 16-24 who are being tested for gonorrhea and chlamydia at certain clinics. It's not open to those already known to have HIV or who are actively on PrEP (a medication regimen to prevent HIV).

Inclusion Criteria

I am between 16 and 24 years old and getting tested for GC/CT.

Exclusion Criteria

Patients with known HIV

I am currently taking medication to prevent HIV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive point-of-care or lab-based STI testing and same-day HIV prevention services

1 day

1 visit (in-person)

Follow-up

Participants are monitored for STI treatment and PrEP counseling outcomes

Up to 9 months

What Are the Treatments Tested in This Trial?

Interventions

• Gonorrhea/chlamydia Point-of-Care Testing

Trial Overview The study is testing if using point-of-care tests for STIs like gonorrhea and chlamydia can help improve HIV testing and counseling, as well as the delivery of PrEP in youth compared to standard lab-based tests.

How Is the Trial Designed?

Group I: Point-of-Care Tested Experimental Treatment 1 Intervention

Participants in the intervention arm have received point-of-care testing for sexually transmitted infections.

Group II: Lab Tested Active Control 1 Intervention

Participants in the control arm have received lab-based testing for sexually transmitted infections.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7606737/

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 ...

2. journals.lww.com journals.lww.com/stdjournal/fulltext/2021/08001/a_narrative_review_of_where_we_are_with.14.aspx

A Narrative Review of Where We Are With Point-of-Care... Three POC tests for chlamydia and gonorrhea and 2 for trichomonas have been cleared by the Food and Drug Administration and can provide rapid results during the ...

3. thelancet.com thelancet.com/journals/lanwpc/article/PIIS2666-6065(24)00104-4/fulltext

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) ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2765941

Evaluation of the Performance of a Point-of-Care Test ... For women, all 3 comparator assays were CIS positive in 92.2% (119 of 129) of chlamydial infections and 86.7% (39 of 45) of gonococcal ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4899593/

A Systematic Review of Point of Care Testing for ... Thirteen articles evaluated test performance, yielding at least one test for each infection with sensitivity and specificity ≥90%. Each infection also had ...

6. who.int who.int/news-room/fact-sheets/detail/sexually-transmitted-infections-(stis)

Sexually transmitted infections (STIs) In 2020 there were an estimated 374 million new infections in people 15–49 years with 1 of 4 curable STIs: chlamydia, gonorrhoea, syphilis and ...

7. bmcinfectdis.biomedcentral.com bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-024-09057-x

Point-of-care Testing for Sexually Transmitted Infections ... For QC testing, concordance with the expected results for CT and NG was > 99% and rates of unsuccessful tests were < 4%. For TV testing, ...

8. diagnostics.roche.com diagnostics.roche.com/global/en/article-listing/lab-leaders/article/sti-testing-improving-patient-access.html

STI 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) ...