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

NCT06003192 | Recruiting DMC

• 1 other identifier: 1R01HD110321-01A1
• Study Type: interventional
• Target: 63,000
• Locations: 1 country
• Sites: 4

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. 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. 2.What is the successful linkage to comprehensive HIV pre-exposure prophylaxis (PrEP) care using a novel, digital health platform? Participants will
3. 3.Complete the previously developed and validated computerized sexual health screen (cSHS) containing questions regarding their personal sexual health history
4. 4.Have the opportunity to opt-out of clinician-ordered HIV testing
5. 5.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

Keywords

HIV; adolescents; emergency department; mHealth; preventive care

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Identification of PrEP eligible and interest in starting PrEP

  30 months

• Demographics associated with PrEP eligibility

  30 months

• Demographics associated with PrEP linkage to care

  30 months

• Demographics associated with HIV screening acceptance

  30 months

• HIV positivity rates in different sexual risk strata

  30 months

Study Arms (1)

Universal Opt-out HIV Screening

OTHER

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

Interventions

Universal Opt-out HIV Screening OTHER

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

Universal Opt-out HIV Screening

Eligibility Criteria

• Age: 15 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• University of Utah: collaborator

Study Sites (4)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

NOT YET RECRUITING

Children's Wisconsin

Milwaukee, Wisconsin, 53226, United States

NOT YET RECRUITING

MeSH Terms

Conditions

HIV Infections; Emergencies

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tricia Cobb, MS

CONTACT

513-636-7966; patricia.cobb@cchmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interrupted Times Series Model

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 21, 2023
• Study Start: December 16, 2024
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): March 15, 2028
• Last Updated: May 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)