Screen2Prevent (S2P)

Официальное название

Screen2Prevent (S2P): Using Digital Health to Improve HIV Screening and Prevention for Adolescents in the Emergency Department

Обзор

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).

Подробное описание

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.

Вмешательства

• Другое HIV screening strategies
  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. A targeted screening approach is defined as screening those who are at increased likelihood for acquiring HIV. Alternatively, a universally offered screening approach is defined as screening all, regardless of behavior informing risk. There are two types of universally offered screening, opt-in and opt-

Первичные конечные точки

• Monthly HIV detection rates per 1,000 eligible patients [Срок оценки: 36 months]
• Rapid PrEP/ART initiation (defined by prescription within 72 hours of ED discharge) [Срок оценки: 36 months]

Вторичные конечные точки (2)

• Cost per HIV case detected [Срок оценки: 36 months]
• Rapid PrEP/ART initiation (defined by prescription within 72 hours of ED discharge) [Срок оценки: 36 months]

Критерии участия

Критерии включения

• Age 14-24 years, inclusive
• Present to the participating ED, regardless of chief complaint during the study period

Критерии исключения

• None

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

США · 5 центров

• University of South Florida — Tampa
• Emory Atlanta Adolescent Consortium — Atlanta
• Johns Hopkins University — Baltimore
• St. Jude Children's Research Hospital — Memphis
• Baylor College of Medicine — Houston

Идентификаторы

NCT: NCT07728123 · ATN164 (S2P)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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