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

HIV Infections Clinical Trial

— S2P  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06003192
• Other study ID #: 1R01HD110321-01A1
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: July 1, 2027

Study information

• Verified date: June 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Tricia Cobb, MS
• Phone: 513-636-7966
• Email: patricia.cobb[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 63000
• Est. completion date: July 1, 2027
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Children's Wisconsin	Milwaukee	Wisconsin
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Demographics associated with PrEP eligibility	Sociodemographic and visit characteristics associated with PrEP eligibility.	30 months
Secondary	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
Secondary	Demographics associated with HIV screening acceptance	Sociodemographic and visit characteristics associated with patient HIV screening acceptance	30 months
Secondary	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