5150 Participants Needed

Point-of-Care Testing for Sexually Transmitted Infections

NP
Overseen ByNaomi Pressman, MS, RD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Icahn School of Medicine at Mount Sinai
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The proposed research hypothesizes that point-of-care testing (POCT) for sexually transmitted infections (STIs) gonorrhea and chlamydia will be a feasible, acceptable, and appropriate implementation strategy for improving HIV testing and Pre-exposure prophylaxis (PrEP) delivery in youth, by increasing opportunities for clinician-patient counseling, decreasing loss to follow up, and allowing for same-day HIV prevention service provision. This hypothesis will be tested in a pragmatic non-randomized trial comparing clinical (HIV testing and PrEP counseling and prescription) and implementation (feasibility, acceptability, and appropriateness) outcomes between adolescents receiving POCT compared to laboratory-based testing at three clinics within a large pediatric health system.

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 data supports the effectiveness of point-of-care testing for gonorrhea and chlamydia?

Point-of-care testing for sexually transmitted infections like gonorrhea and chlamydia is effective because it allows for rapid testing and treatment, which helps control the spread of these infections and prevents complications. This approach is especially beneficial in low-resource areas where traditional lab testing may not be feasible.12345

Is point-of-care testing for sexually transmitted infections safe for humans?

The research does not provide specific safety data for point-of-care testing for sexually transmitted infections, but these tests are generally used to improve diagnosis and treatment in various settings.26789

How is point-of-care testing for gonorrhea and chlamydia different from other treatments?

Point-of-care testing for gonorrhea and chlamydia is unique because it allows for rapid diagnosis and early treatment directly at the testing site, which helps prevent the spread of infections and reduces the need for follow-up visits. This is especially beneficial in low-resource areas where traditional lab testing may be delayed due to lack of infrastructure.2461011

Research Team

SW

Sarah Wood, MD, MSHP

Principal Investigator

Mount Sinai Adolescent Health Center

Eligibility Criteria

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

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

Treatment Details

Interventions

  • Gonorrhea/chlamydia Point-of-Care Testing
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Point-of-Care TestedExperimental Treatment1 Intervention
Participants in the intervention arm have received point-of-care testing for sexually transmitted infections.
Group II: Lab TestedActive Control1 Intervention
Participants in the control arm have received lab-based testing for sexually transmitted infections.

Find a Clinic Near You

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+

References

High prevalence of gonococcal and chlamydial infection in men who have sex with men with newly diagnosed HIV infection: an opportunity for same-day presumptive treatment. [2020]
Point-of-Care Testing for Sexually Transmitted Infections. [2023]
Mapping patient pathways and estimating resource use for point of care versus standard testing and treatment of chlamydia and gonorrhoea in genitourinary medicine clinics in the UK. [2021]
Field evaluation of the CRT and ACON chlamydia point-of-care tests in a tropical, low-resource setting. [2019]
Impact of deploying multiple point-of-care tests with a 'sample first' approach on a sexual health clinical care pathway. A service evaluation. [2021]
Potential for Point-of-Care Tests to Reduce Chlamydia-associated Burden in the United States: A Mathematical Modeling Analysis. [2021]
Direct urine polymerase chain reaction for chlamydia and gonorrhoea: a simple means of bringing high-throughput rapid testing to remote settings? [2018]
Impact of Point-of-Care Testing on the Management of Sexually Transmitted Infections in South Africa: Evidence from the HVTN702 Human Immunodeficiency Virus Vaccine Trial. [2023]
Point-of-care testing for sexually transmitted infections in low- and middle-income countries: a scoping review protocol. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Point-of-care testing for chlamydia and gonorrhoea: implications for clinical practice. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Point-of-Care Testing for Sexually Transmitted Infections: A Review of Recent Developments. [2020]