Point of Care STI Testing

NCT ID: NCT06844045

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

5150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-16

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Point of Care STI Testing

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Point-of-Care Tested

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

Group Type EXPERIMENTAL

Gonorrhea/chlamydia Point-of-Care Testing

Intervention Type BEHAVIORAL

Point-of-care testing for sexually transmitted infections.

Lab Tested

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Gonorrhea/chlamydia Point-of-Care Testing

Point-of-care testing for sexually transmitted infections.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Philadelphia

OTHER

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Sarah Wood

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah Wood, MD, MSHP

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Adolescent Health Center

Locations

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Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Central Contacts

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Naomi Pressman, MS, RD

Role: CONTACT

(212) 731-7810

Facility Contacts

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Susan Lee, MPH

Role: primary

215-590-1000

Other Identifiers

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GCO 24-1934

Identifier Type: -

Identifier Source: org_study_id

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