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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06844045
Enrollment
6460
Registered
2025-02-25
Start date
2026-02-24
Completion date
2026-12-31
Last updated
2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Point of Care STI Testing

Keywords

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

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.

Interventions

BEHAVIORALGonorrhea/chlamydia Point-of-Care Testing

Point-of-care testing for sexually transmitted infections.

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER
Children's Hospital of Philadelphia
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 24 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Rates of HIV Test CompletionDay 1 - Measured on date of STI testingRates 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

MeasureTime frameDescription
Number of participants who received PrEP counselingDay 1 - Same day as STI testing encounterPrEP counseling will be measured using visit note data from the date of the STI testing encounter
Time to STI treatmentTime from STI diagnosis to treatment, up to 9 monthsDays between STI test order and delivery of antibiotics for STI treatment, measured using EHR data

Countries

United States

Contacts

CONTACTNaomi Pressman, MS, RD
naomi.pressman@mountsinai.org(212) 731-7810
PRINCIPAL_INVESTIGATORSarah Wood, MD, MSHP

Mount Sinai Adolescent Health Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026