Point of Care STI Testing

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06844045
Status
Recruiting

Conditions

  • Point of Care STI Testing

Eligibility Criteria

Sex
ALL
Age
16 Years - 24 Years
Healthy Volunteers
Not accepted

Interventions

  • Gonorrhea/chlamydia Point-of-Care Testing — BEHAVIORAL
    Point-of-care testing for sexually transmitted infections.

Study Details

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.

Key Dates

Start date
Feb 24, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
6,460 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Susan Lee, MPH
215-590-1000
Nadia Dowshen (PRINCIPAL_INVESTIGATOR)

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