Clinical trial NCT06003192: Screen Smart: Using Digital Health to Improve HIV Screening and Prevention
Official title: Screen Smart: Using Digital Health to Improve HIV Screening and Prevention for Adolescents in the Emergency Department
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Keywords: HIV
adolescents
emergency department
mHealth
preventive care
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: University of Utah
First posted: 2023-08-21
Enrollment: 63000
Sex: ALL
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interrupted Times Series Model
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: HIV testing rates per 1000 eligible patients during each month
timeFrame: 30 months
measure: HIV infection rates per 1000 eligible patients during each month
timeFrame: 30 months
measure: Linkage of PrEP
timeFrame: 30 months
Secondary outcomes:
measure: Identification of PrEP eligible and interest in starting PrEP
timeFrame: 30 months
measure: Demographics associated with PrEP eligibility
timeFrame: 30 months
measure: Demographics associated with PrEP linkage to care
timeFrame: 30 months
measure: Demographics associated with HIV screening acceptance
timeFrame: 30 months
measure: HIV positivity rates in different sexual risk strata
timeFrame: 30 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Milwaukee
country: United States
facility: Children's Wisconsin
state: Wisconsin
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jennifer L Reed, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's National Research Institute
name: Monika Goyal, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Nadia Dowshen, MD, MSHP
role: PRINCIPAL_INVESTIGATOR
References: