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Recruiting

NCT Number: NCT06844045

Point of Care STI Testing

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.

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Key information

Conditions

Point of Care STI Testing Bacterial Infections Bacterial Infections and Mycoses Chlamydia Infections Chlamydiaceae Infections Communicable Diseases Disease Attributes Genital Diseases Gonorrhea Gram-Negative Bacterial Infections Infections Neisseriaceae Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Urogenital Diseases

Age range

16 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Nadia Dowshen

PRINCIPAL_INVESTIGATOR

Susan Lee, MPH

CONTACT

[email protected]

215-590-1000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gonorrhea/chlamydia Point-of-Care Testing

Behavioral

Point-of-care testing for sexually transmitted infections.

Primary outcomes

  1. Rates of HIV Test Completion

    Time frame: Day 1 - Measured on date of STI testing

    Rates of HIV test completion on the day of gonorrhea/chlamydia testing will be compared between those who receive point-of-care vs. lab-based STI testing.

Secondary outcomes

  1. Number of participants who received PrEP counseling

    Time frame: Day 1 - Same day as STI testing encounter

    PrEP counseling will be measured using visit note data from the date of the STI testing encounter

  2. Time to STI treatment

    Time frame: Time from STI diagnosis to treatment, up to 9 months

    Days between STI test order and delivery of antibiotics for STI treatment, measured using EHR data

Study contacts

Contact information is provided by the study sponsor or research team.

Naomi Pressman, MS, RD

CONTACT

[email protected]

(212) 731-7810

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Children's Hospital of Philadelphia

Registry information

Official study title

Clinical and Implementation Outcomes of a Point of Care Sexually Transmitted Infection Testing Strategy to Improve HIV Prevention Service Delivery in Adolescents

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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