S2P: Screen to Prevent: Using Digital Health to Improve HIV Screening and Prevention

• Sponsor: Children's Hospital Medical Center, Cincinnati (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06003192
• Collaborator: University of Utah (Other)
• Enrollment: 63,000
• Locations: 4
• Anticipated Duration (Months): 17
• Patients Per Site: 15750
• Patients Per Site Per Month: 925.5

Study Details

Study Description

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

3. Complete the previously developed and validated computerized sexual health screen (cSHS) containing questions regarding their personal sexual health history

4. Have the opportunity to opt-out of clinician-ordered HIV testing

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	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 Design

• Study Type: Observational
• Anticipated Enrollment: 63000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Screen to Prevent: Using Digital Health to Improve HIV Screening and Prevention for Adolescents in the Emergency Department
• Anticipated Study Start Date: Jul 1, 2024
• Anticipated Primary Completion Date: Sep 1, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. HIV testing rates per 1000 eligible patients during each month [30 months]

   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.

2. HIV infection rates per 1000 eligible patients during each month [30 months]

   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

3. Linkage of PrEP [30 months]

   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.

Secondary Outcome Measures

1. Identification of PrEP eligible and interest in starting PrEP [30 months]

   The proportion of patients who are identified as PrEP eligible and who endorse interest in starting PrEP

2. Demographics associated with PrEP eligibility [30 months]

   Sociodemographic and visit characteristics associated with PrEP eligibility.

3. Demographics associated with PrEP linkage to care [30 months]

   Sociodemographic and visit characteristics associated with completion of PrEP care visit within 1 month of study enrollment.

4. Demographics associated with HIV screening acceptance [30 months]

   Sociodemographic and visit characteristics associated with patient HIV screening acceptance

5. HIV positivity rates in different sexual risk strata [30 months]

   Comparison of HIV positivity rates between patients in the different sexual risk strata (determined by patient entered cSHS)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nationwide Children's Hospital	Columbus	Ohio	United States	43205
2	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
3	University of Utah	Salt Lake City	Utah	United States	84112
4	Children's Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• Children's Hospital Medical Center, Cincinnati
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Hospital Medical Center, Cincinnati
• ClinicalTrials.gov Identifier: NCT06003192
• Other Study ID Numbers: 1R01HD110321-01A1
• First Posted: Aug 21, 2023
• Last Update Posted: Aug 23, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Children's Hospital Medical Center, Cincinnati: HIV; adolescents; emergency department; mHealth; preventive care
• Additional relevant MeSH terms: HIV Infections

Study Results

No Results Posted as of Aug 23, 2023