Point of Care STI Testing

Mount Sinai Health System

Status: Not yet enrolling

Conditions: Point of Care STI Testing

Treatments: Behavioral: Gonorrhea/chlamydia Point-of-Care Testing

Study type: Interventional

Funder types: Other

Identifiers

NCT06844045

GCO 24-1934

Details and patient eligibility

About

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.

Enrollment: 5,150 estimated patients

Sex: All

Ages: 16 to 24 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5,150 participants in 2 patient groups

Point-of-Care Tested

Experimental group

Description:

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

Treatment:

Behavioral: Gonorrhea/chlamydia Point-of-Care Testing

Lab Tested

No Intervention group

Description:

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