Point of Care STI Testing

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-24
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gonorrhea/chlamydia Point-of-Care Testing

    Behavioral

    Point-of-care testing for sexually transmitted infections.

Treatment groups

6,460 Participants
are divided into 2 treatment groups
Group A: Point-of-Care TestedExperimental treatment 1 intervention
Group B: Lab TestedNo intervention 0 interventions

Trial outcomes

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.

Time frame
Day 1 - Measured on date of STI testing

Secondary outcomes

1

Number of participants who received PrEP counseling

PrEP counseling will be measured using visit note data from the date of the STI testing encounter

Time frame
Day 1 - Same day as STI testing encounter
2

Time to STI treatment

Days between STI test order and delivery of antibiotics for STI treatment, measured using EHR data

Time frame
Time from STI diagnosis to treatment, up to 9 months

Other outcomes

Sponsors and contacts

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Icahn School of Medicine at Mount Sinai

Lead sponsor

Children's Hospital of Philadelphia

Collaborator