Point of Care STI Testing

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

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.

Study Overview

• Status: Recruiting
• Conditions: Point of Care STI Testing
• Intervention / Treatment: Behavioral: Gonorrhea/chlamydia Point-of-Care Testing

• Study Type: Interventional
• Enrollment (Estimated): 6460
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Naomi Pressman, MS, RD; Phone Number: (212) 731-7810; Email: naomi.pressman@mountsinai.org

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Children's Hospital of Philadelphia
      • Contact: Susan Lee, MPH; Phone Number: 215-590-1000; Email: lees8@chop.edu
      • Principal Investigator: Nadia Dowshen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Point-of-Care Tested; Participants in the intervention arm have received point-of-care testing for sexually transmitted infections.	Behavioral: Gonorrhea/chlamydia Point-of-Care Testing; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of HIV Test Completion	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.	Day 1 - Measured on date of STI testing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who received PrEP counseling	PrEP counseling will be measured using visit note data from the date of the STI testing encounter	Day 1 - Same day as STI testing encounter
Time to STI treatment	Days between STI test order and delivery of antibiotics for STI treatment, measured using EHR data	Time from STI diagnosis to treatment, up to 9 months

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Sarah Wood, MD, MSHP, Mount Sinai Adolescent Health Center

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): February 25, 2025

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Chlamydia; Gonorrhea; HIV Prevention; HIV Testing; Sexually Transmitted Infections; HIV Pre-Exposure Prophylaxis
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Chlamydiaceae Infections; Sexually Transmitted Diseases, Bacterial; Neisseriaceae Infections; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases; Chlamydia Infections; Gonorrhea
• Other Study ID Numbers: GCO 24-1934

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Specify Other Time Frame After the end of the award period. No end date.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal. Any purpose. Data will be findable for the research community through the NIHM Data Archive Collection.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No