Point of Care STI Testing

NCT06844045 | Recruiting

• 1 other identifier: GCO 24-1934
• Study Type: interventional
• Target: 6,460
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of participants who received PrEP counseling

  Day 1 - Same day as STI testing encounter

• Time to STI treatment

  Time from STI diagnosis to treatment, up to 9 months

Study Arms (2)

Point-of-Care Tested

EXPERIMENTAL

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

Behavioral: Gonorrhea/chlamydia Point-of-Care Testing

Lab Tested

NO INTERVENTION

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

Interventions

Gonorrhea/chlamydia Point-of-Care Testing BEHAVIORAL

Point-of-care testing for sexually transmitted infections.

Point-of-Care Tested

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \- Patients with known HIV or active PrEP prescriptions.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Children's Hospital of Philadelphia: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Gonorrhea; Chlamydia Infections; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Communicable Diseases; Genital Diseases; Urogenital Diseases; Chlamydiaceae Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah Wood, MD, MSHP

  Mount Sinai Adolescent Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naomi Pressman, MS, RD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 25, 2025
• Study Start: February 24, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Specify Other Time Frame After the end of the award period. No end date.
• 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.

Locations

US (1)