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

NCT ID: NCT06003192

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 63000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-16
• Study Completion Date: 2028-03-15

Brief 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.

Detailed Description

Using a previously developed tablet-based, broad scale gonorrhea and chlamydia screening process, the investigators will adapt, refine, and test this process with the aim of increasing universally offered, opt-out HIV screening in the pediatric ED through electronic integration of patient reported data for provision of clinical decision support for HIV screening and identification of PrEP candidacy. The investigators will then use mHealth to link patients to PrEP services. The goal of this study is to (1) adapt, refine, and test this previously implemented multi-center, ED-based, screening study with a goal of increasing universally offered, opt-out HIV screening among adolescents in the pediatric ED and (2) link at-risk adolescents to PrEP services and preventive care. This will be accomplished through a network of children's hospital EDs (Pediatric Emergency Care Applied Research Network or PECARN). This research will contribute to the evidence base for creating clinically effective and sustainable HIV screening programs that can be successfully implemented into the clinical workflow of the ED. It will also improve identification and linkage to PrEP care for at risk adolescents using mHealth strategies by first identifying adolescents and young adults (AYA) who are PrEP candidates based on their responses to a computerized sexual health screen (cSHS) and subsequently (1) providing clinical decision support to providers via the electronic health record and (2) direct text messaging from the cSHS to PrEP candidates providing educational content and connecting youth to a PrEP navigator. This intervention will rely on an innovative approach that electronically integrates patient-reported data to guide clinical decision support.

Conditions

HIV Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Universal Opt-out HIV Screening

The intervention is offering universal opt-out HIV screening to all adolescents 15 to 21 years of age that are seeking care in the emergency department.

Group Type: OTHER

Universal Opt-out HIV Screening

Intervention Type: OTHER

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

Interventions

Universal Opt-out HIV Screening

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All patients 15-21 years of age visiting a pediatric emergency department.

Exclusion Criteria

• Unable to understand English
• Critically ill
• Cognitively impaired
• Altered mental status

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Utah

OTHER

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer L Reed, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Monika Goyal, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Nadia Dowshen, MD, MSHP

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status: RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status: NOT_YET_RECRUITING

University of Utah

Salt Lake City, Utah, United States

Site Status: NOT_YET_RECRUITING

Children's Wisconsin

Milwaukee, Wisconsin, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Tricia Cobb, MS

Role: CONTACT

patricia.cobb@cchmc.org

513-636-7966

Facility Contacts

Kristin Stukus, MD

Role: primary

Kristin.Stukus@nationwidechildrens.org

614-722-4385

Annie Truelove

Role: backup

annie.truelove@nationwidechildrens.org

614-355-5791

Cynthia Mollen, MD, MSCE

Role: primary

MOLLENC@chop.edu

215-590-4410

Joe Zorc, MD, MSCE

Role: backup

ZORC@chop.edu

215-590-4410

Charlie Casper, PhD

Role: primary

Charlie.Casper@hsc.utah.edu

8015816410

Melissa Laws, BSN

Role: backup

Melissa.Laws@hsc.utah.edu

8015816410

Michelle Pickett, MD, MS

Role: primary

mpickett@mcw.edu

414-460-0276

Danny Thomas, MD

Role: backup

dthomas@mcw.edu

414-266-2625

Other Identifiers

1R01HD110321-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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