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Recruiting NCT06844045

Point of Care STI Testing

No phase Interventional Point of Care STI Testing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gonorrhea/chlamydia Point-of-Care Testing.
Who it may be relevant to
Registry conditions: Point of Care STI Testing. Basic parameters: 16 years — 24 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Behavioral Gonorrhea/chlamydia Point-of-Care Testing
    Point-of-care testing for sexually transmitted infections.

Primary outcome measures

  • Rates of HIV Test Completion [Time frame: Day 1 - Measured on date of STI testing]
Secondary outcome measures (2)
  • Number of participants who received PrEP counseling [Time frame: Day 1 - Same day as STI testing encounter]
  • Time to STI treatment [Time frame: Time from STI diagnosis to treatment, up to 9 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Children's Hospital of Philadelphia — Philadelphia

Identifiers

NCT: NCT06844045 · GCO 24-1934

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗