Screen Smart: Using Digital Health to Improve HIV Screening and Prevention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Universal Opt-out HIV Screening.
- Who it may be relevant to
- Registry conditions: HIV Infections. Basic parameters: 15 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Screen Smart: Using Digital Health to Improve HIV Screening and Prevention for Adolescents in the Emergency Department
Overview
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.
Interventions
- 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.
Primary outcome measures
- HIV testing rates per 1000 eligible patients during each month [Time frame: 30 months]
- HIV infection rates per 1000 eligible patients during each month [Time frame: 30 months]
- Linkage of PrEP [Time frame: 30 months]
Secondary outcome measures (5)
- Identification of PrEP eligible and interest in starting PrEP [Time frame: 30 months]
- Demographics associated with PrEP eligibility [Time frame: 30 months]
- Demographics associated with PrEP linkage to care [Time frame: 30 months]
- Demographics associated with HIV screening acceptance [Time frame: 30 months]
- HIV positivity rates in different sexual risk strata [Time frame: 30 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 4 centers
- Nationwide Children's Hospital — Columbus
- Children's Hospital of Philadelphia — Philadelphia
- University of Utah — Salt Lake City
- Children's Wisconsin — Milwaukee
Identifiers
NCT: NCT06003192 · 1R01HD110321-01A1