Dysautonomia International

Screen2Prevent (S2P)

Purpose

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).

Condition

HIV Infections

Eligibility

Eligible Ages: Between 14 Years and 24 Years
Eligible Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

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

Exclusion Criteria

None

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomizing ED departments to implement 3 screening strategies sequentially for 8 months each
Primary Purpose: Screening
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Other 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.	Other: 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-out. With opt-in screening, all patients are offered screening, which they may then agree to undergo. Opt-out screening consists of notifying patients that the test will be conducted unless they explicitly decline. Each screening strategy implements the cSHS, a text messaging platform, and Clinical Decision Support for identification of youth needing HIV treatment/prevention and linkage to services.
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.	Other: 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-out. With opt-in screening, all patients are offered screening, which they may then agree to undergo. Opt-out screening consists of notifying patients that the test will be conducted unless they explicitly decline. Each screening strategy implements the cSHS, a text messaging platform, and Clinical Decision Support for identification of youth needing HIV treatment/prevention and linkage to services.
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.	Other: 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-out. With opt-in screening, all patients are offered screening, which they may then agree to undergo. Opt-out screening consists of notifying patients that the test will be conducted unless they explicitly decline. Each screening strategy implements the cSHS, a text messaging platform, and Clinical Decision Support for identification of youth needing HIV treatment/prevention and linkage to services.
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.	Other: 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-out. With opt-in screening, all patients are offered screening, which they may then agree to undergo. Opt-out screening consists of notifying patients that the test will be conducted unless they explicitly decline. Each screening strategy implements the cSHS, a text messaging platform, and Clinical Decision Support for identification of youth needing HIV treatment/prevention and linkage to services.
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.	Other: 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-out. With opt-in screening, all patients are offered screening, which they may then agree to undergo. Opt-out screening consists of notifying patients that the test will be conducted unless they explicitly decline. Each screening strategy implements the cSHS, a text messaging platform, and Clinical Decision Support for identification of youth needing HIV treatment/prevention and linkage to services.
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.	Other: 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-out. With opt-in screening, all patients are offered screening, which they may then agree to undergo. Opt-out screening consists of notifying patients that the test will be conducted unless they explicitly decline. Each screening strategy implements the cSHS, a text messaging platform, and Clinical Decision Support for identification of youth needing HIV treatment/prevention and linkage to services.

Recruiting Locations

University of South Florida
Tampa, Florida 33612

Contact:
Elizabeth Enriquez-Bruce
813-250-2574
enriquezbruce@usf.edu

St. Jude Children's Research Hospital
Memphis, Tennessee 38015

Contact:
Jamie Russell
901-595-8300
jamie.russell@stjude.org

More Details

Status: Recruiting
Sponsor: Westat

Study Contact

Erin Ricketts
240-453-2786
erinricketts@westat.com

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.