Recruiting

POCT for STIs

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06844045

Conditions

Point of Care STI Testing

Eligibility Criteria

Sex: All

Age: 16 - 24

Healthy Volunteers: Not accepted

Interventions

Gonorrhea/chlamydia Point-of-Care Testing

Study Details

Brief summary:

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.

Conditions

Point of Care STI Testing

Study ID

NCT06844045

Start date

Feb 24, 2026

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 24

Healthy Volunteers: Not accepted

Inclusion Criteria:

\- Patients age 16-24 years receiving POCT or lab-based GC/CT testing

Exclusion Criteria:

\- Patients with known HIV or active PrEP prescriptions.

Study Design

Enrollment

6460 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Point-of-Care Tested

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

no intervention: Lab Tested

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

Interventions

Gonorrhea/chlamydia Point-of-Care Testing

Point-of-care testing for sexually transmitted infections.

Primary outcome measure

  • Rates of HIV Test Completion [ Time Frame: Day 1 - Measured on date of STI testing ]

Central Contacts and Locations

Central contacts

Naomi Pressman, MS, RD

(212) 731-7810naomi.pressman@mountsinai.org

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Susan Lee, MPH

215-590-1000lees8@chop.edu

Principal Investigator:

Nadia Dowshen

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • HIV Prevention
  • HIV Testing
  • HIV Pre-Exposure Prophylaxis
  • Gonorrhea
  • Chlamydia
  • Sexually Transmitted Infections

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-05-05.