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Screen Smart: Using Digital Health to Improve HIV Screening and Prevention

NCT06003192 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63000

Last updated 2025-05-04

No results posted yet for this study

Summary

The goal of this interrupted time series quasi-experimental design study is to implement universal opt- out HIV testing and linkage to HIV preventive care in 15-21 year old adolescents visiting the pediatric emergency department (ED). The main question\[s\] it aims to answer are:

1. What is the uptake, reach and effectiveness of universally offered, opt-out HIV screening across pediatric EDs after implementing an adapted version of a tablet-based screening process?
2. What is the successful linkage to comprehensive HIV pre-exposure prophylaxis (PrEP) care using a novel, digital health platform? Participants will

1. Complete the previously developed and validated computerized sexual health screen (cSHS) containing questions regarding their personal sexual health history
2. Have the opportunity to opt-out of clinician-ordered HIV testing
3. Patients meeting CDC criteria for HIV PrEP will be given the opportunity to enroll in the digital health PrEP linkage platform and followed for 3 months after enrollment.

Conditions

  • HIV Infections

Interventions

OTHER

Universal Opt-out HIV Screening

Using a tablet device, offering universal opt-out HIV screening to adolescents seeking care in a pediatric emergency department.

Sponsors & Collaborators

  • University of Utah

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Jennifer L Reed, MD, MS · Children's Hospital Medical Center, Cincinnati

  • Monika Goyal, MD, MSCE · Children's National Research Institute

  • Nadia Dowshen, MD, MSHP · Children's Hospital of Philadelphia

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-16
Primary Completion
2027-12-15
Completion
2028-03-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06003192 on ClinicalTrials.gov