Screen2Prevent (S2P): Using Digital Health to Improve HIV Screening and Prevention for Adolescents in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84,000
- 试验地点
- 6
- 主要终点
- Monthly HIV detection rates per 1,000 eligible patients
研究概览
简要总结
Screen2Prevent is a study intended to improve HIV prevention and detection through implementation and evaluation of three different broad-scale HIV screening approaches a) targeted, b) universally offered opt-in, and c) universally offered opt-out in Emergency Departments (EDs) by leveraging digital health to identify and link adolescents seeking care in the ED to HIV Pre-Exposure Prophylaxis (PrEP)/Antiretroviral treatment (ART).
详细描述
At each SC, each of the three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) will be employed, one at a time, for a period of 8 months and a total study period of 24 months.
All patients 14-24 years of age that are seeking care in participating EDs during the study period will be given the opportunity to complete the computerized sexual health survey (cSHS) on a tablet. The cSHS asks patients to decide whether they want to be tested for HIV and contains questions based on the 2021 update to the CDC PrEP eligibility guidelines that stratify risk for HIV exposure and acquisition. The patient will agree (or not) to completing the cSHS on the tablet. The cSHS is not mandatory, so a patient may decline to use the tablet, and their parent or guardian may decline as well.
Throughout study activities (for all screening strategy phases), certain cSHS results will trigger real-time EHR-integrated decision support for clinicians on whether HIV testing should be ordered and whether counseling/prescription for PrEP should be provided. It also implements a text messaging platform with the patient for basic PrEP information and enrollment into a digital health PrEP linkage platform.
Additionally, all SCs will abstract baseline (plus 3 months) EHR data for all eligible patients to be used as a comparator in the analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 14-24 years, inclusive
- •Present to the participating ED, regardless of chief complaint during the study period
排除标准
- 未提供
研究组 & 干预措施
1. Universally offered opt-in > Universally offered opt-out > Targeted
The intervention includes three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) which will each be employed, one at a time, for a period of 8 months.
干预措施: HIV screening strategies (Other)
2. Universally offered opt-out > Universally offered opt-in > Targeted
The intervention includes three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) which will each be employed, one at a time, for a period of 8 months.
干预措施: HIV screening strategies (Other)
3. Universally offered opt-in > Targeted > Universally offered opt-out
The intervention includes three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) which will each be employed, one at a time, for a period of 8 months.
干预措施: HIV screening strategies (Other)
4. Universally offered opt-out > Targeted > Universally offered opt-in
The intervention includes three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) which will each be employed, one at a time, for a period of 8 months.
干预措施: HIV screening strategies (Other)
5. Targeted > Universally offered opt-out > Universally offered opt-in
The intervention includes three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) which will each be employed, one at a time, for a period of 8 months.
干预措施: HIV screening strategies (Other)
6. Targeted > Universally offered opt-in > Universally offered opt-out
The intervention includes three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) which will each be employed, one at a time, for a period of 8 months.
干预措施: HIV screening strategies (Other)
结局指标
主要结局
Monthly HIV detection rates per 1,000 eligible patients
时间窗: 36 months
Compare the rate of HIV detection between each screening strategy (targeted, universal opt-in, universal opt-out) to baseline using the all patients analysis set.
Rapid PrEP/ART initiation (defined by prescription within 72 hours of ED discharge)
时间窗: 36 months
Compare the rates of rapid start of PrEP/ART, defined as PrEP/ART prescription within 72 hours of ED discharge, between adolescents and young adults who visit the ED prior to implementation of cSHS and those who visit after implementation of cSHS using the all patients analysis set.
次要结局
- Cost per HIV case detected(36 months)
- Rapid PrEP/ART initiation (defined by prescription within 72 hours of ED discharge)(36 months)