Screen2Prevent (S2P)
ConditionHIV Infections
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-24
SponsorWestat
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 14-24 years, inclusive
Present to the participating ED, regardless of chief complaint during the study period
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
HIV screening strategies
Other interventionThe 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.
Treatment groups
84,000 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: 1. Universally offered opt-in > Universally offered opt-out > TargetedOther 1 intervention
Group B: 2. Universally offered opt-out > Universally offered opt-in > TargetedOther 1 intervention
Group C: 3. Universally offered opt-in > Targeted > Universally offered opt-outOther 1 intervention
Group D: 4. Universally offered opt-out > Targeted > Universally offered opt-inOther 1 intervention
Group E: 5. Targeted > Universally offered opt-out > Universally offered opt-inOther 1 intervention
Group F: 6. Targeted > Universally offered opt-in > Universally offered opt-outOther 1 intervention
Trial outcomes
Primary outcomes
1
Monthly HIV detection rates per 1,000 eligible patients
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.
Time frame
36 months2
Rapid PrEP/ART initiation (defined by prescription within 72 hours of ED discharge)
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.
Time frame
36 monthsSecondary outcomes
1
Cost per HIV case detected
Compare the cost per HIV case detected between each of the screening strategies and baseline using the all patients analysis set.
Time frame
36 months2
Rapid PrEP/ART initiation (defined by prescription within 72 hours of ED discharge)
Compare the proportions of rapid start of PrEP/ART, defined as PrEP/ART prescription within 72 hours of ED discharge, among those who visit the ED during implementation of cSHS between those who engage in ScreenWell versus those who do not using the cSHS Analysis Set.
Time frame
36 months Source ClinicalTrials.gov