HIV Infections
Conditions
Keywords
HIV, adolescents, emergency department, preventive care, mHealth, PrEP
Brief summary
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).
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.
Interventions
OTHERHIV 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.
Sponsors
Westat
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Randomizing ED departments to implement 3 screening strategies sequentially for 8 months each
Eligibility
Sex/Gender
ALL
Age
14 Years to 24 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monthly HIV detection rates per 1,000 eligible patients | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost per HIV case detected | 36 months | Compare the cost per HIV case detected between each of the screening strategies and baseline using the all patients analysis set. |
| Rapid PrEP/ART initiation (defined by prescription within 72 hours of ED discharge) | 36 months | 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. |
Countries
United States
Contacts
CONTACTErin Ricketts
CONTACTNancy Liu
Outcome results
None listed