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临床试验/NCT06003192
NCT06003192招募中不适用

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

Children's Hospital Medical Center, Cincinnati8 个研究点 分布在 1 个国家目标入组 63,000 人开始时间: 2024年12月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
63,000
试验地点
8
主要终点
HIV infection rates per 1000 eligible patients during each month

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
15 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All patients 15-21 years of age visiting a pediatric emergency department.

排除标准

  • Unable to understand English
  • Critically ill
  • Cognitively impaired
  • Altered mental status

结局指标

主要结局

HIV infection rates per 1000 eligible patients during each month

时间窗: 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

HIV testing rates per 1000 eligible patients during each month

时间窗: 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.

Linkage of PrEP

时间窗: 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.

次要结局

  • Demographics associated with PrEP eligibility(30 months)
  • Identification of PrEP eligible and interest in starting PrEP(30 months)
  • Demographics associated with PrEP linkage to care(30 months)
  • Demographics associated with HIV screening acceptance(30 months)
  • HIV positivity rates in different sexual risk strata(30 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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