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

Screen Smart: Using Digital Health to Improve HIV Screening and Prevention for Adolescents in the Emergency Department

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.

Study Overview

• Status: Recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Other: Universal Opt-out HIV Screening

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.

• Study Type: Interventional
• Enrollment (Estimated): 63000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tricia Cobb, MS; Phone Number: 513-636-7966; Email: patricia.cobb@cchmc.org

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Recruiting
      • Nationwide Children's Hospital
      • Contact: Kristin Stukus, MD; Phone Number: 614-722-4385; Email: Kristin.Stukus@nationwidechildrens.org
      • Contact: Annie Truelove; Phone Number: 614-355-5791; Email: annie.truelove@nationwidechildrens.org
      • Principal Investigator: Kristin Stukus, MD
      • Sub-Investigator: Megan Brundrett, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Not yet recruiting
      • Children's Hospital of Philadelphia
      • Contact: Cynthia Mollen, MD, MSCE; Phone Number: 215-590-4410; Email: MOLLENC@chop.edu
      • Contact: Joe Zorc, MD, MSCE; Phone Number: 215-590-4410; Email: ZORC@chop.edu
      • Principal Investigator: Cynthia Mollen, MD, MSCE
      • Sub-Investigator: Marne Castillo, MEd, PhD
      • Sub-Investigator: Sarah Wood, MD, MSCE
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Not yet recruiting
      • University of Utah
      • Contact: Melissa Laws, BSN; Phone Number: 8015816410; Email: Melissa.Laws@hsc.utah.edu
      • Contact: Charlie Casper, PhD; Phone Number: 8015816410; Email: Charlie.Casper@hsc.utah.edu
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Not yet recruiting
      • Children's Wisconsin
      • Contact: Danny Thomas, MD; Phone Number: 414-266-2625; Email: dthomas@mcw.edu
      • Contact: Michelle Pickett, MD, MS; Phone Number: 414-460-0276; Email: mpickett@mcw.edu
      • Principal Investigator: Michelle Pickett, MD, MS
      • Sub-Investigator: Claudia Vicetti, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Study Population

15 to 21 year old adolescents who are visiting the emergency department.

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV testing rates per 1000 eligible patients during each month	We will employ interrupted time series analyses to compare these rates between baseline (usual care) and upon implementation of universally offered, opt-out HIV screening strategy.	30 months
HIV infection rates per 1000 eligible patients during each month	We will employ interrupted time series analyses to compare these rates between baseline (usual care) and upon implementation of universally offered, opt-out HIV screening strategy	30 months
Linkage of PrEP	The number of PrEP eligible youth who are enrolled in the mHealth platform and complete a followup appointment in their comprehensive PrEP care medical home within 1 month of the ED visit.	30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of PrEP eligible and interest in starting PrEP	The proportion of patients who are identified as PrEP eligible and who endorse interest in starting PrEP	30 months
Demographics associated with PrEP eligibility	Sociodemographic and visit characteristics associated with PrEP eligibility.	30 months
Demographics associated with PrEP linkage to care	Sociodemographic and visit characteristics associated with completion of PrEP care visit within 1 month of study enrollment.	30 months
Demographics associated with HIV screening acceptance	Sociodemographic and visit characteristics associated with patient HIV screening acceptance	30 months
HIV positivity rates in different sexual risk strata	Comparison of HIV positivity rates between patients in the different sexual risk strata (determined by patient entered cSHS)	30 months

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: University of Utah
• Investigators: Principal Investigator: Jennifer L Reed, MD, MS, Children's Hospital Medical Center, Cincinnati; Principal Investigator: Monika Goyal, MD, MSCE, Children's National Research Institute; Principal Investigator: Nadia Dowshen, MD, MSHP, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2024
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): March 15, 2028

Study Registration Dates

• First Submitted: August 3, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: HIV; mHealth; adolescents; emergency department; preventive care
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: 1R01HD110321-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No