NOT_YET_RECRUITING
Screen to Prevent: Using Digital Health to Improve HIV Screening and Prevention
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.
Conditions:
🦠 HIV Infections
🗓️ Study Start (Actual) 1 September 2024
🗓️ Primary Completion (Estimated) 1 April 2027
✅ Study Completion (Estimated) 1 July 2027
👥 Enrollment (Estimated) 63000
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Columbus, Ohio, United States
📍 Philadelphia, Pennsylvania, United States
📍 Salt Lake City, Utah, United States
📍 Milwaukee, Wisconsin, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 15 Years to 21 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 3 August 2023
  • First Submitted that Met QC Criteria 16 August 2023
  • First Posted 21 August 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 June 2024
  • Last Update Posted 18 June 2024
  • Last Verified June 2024