Point of Care STI Testing

Not Applicable

Not yet recruiting

• Conditions: Point of Care STI Testing

• Registration Number: NCT06844045
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-19
• Last Update Submitted: 2025-02-19
• Study First Posted: 2025-02-25
• Last Update Posted: 2025-02-25
• Study Start: 2025-05-01
• Primary Completion: 2026-03-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rates of HIV Test Completion	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 Outcome Measures

Name	Time	Method
Number of participants who received PrEP counseling	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
Time to STI treatment	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

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States