Clinical trial NCT01781949: The HIV Testing Using Enhanced Screening Techniques in Emergency Departments Trial
Official title: Effectiveness of Rapid HIV Screening Methods in Urban Emergency Departments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rapid HIV Screening
Keywords: HIV infection
Targeted screening
Nontargeted screening
Emergency department
Urgent care
Effectiveness
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: Alameda County Medical Center
name: Johns Hopkins University
name: University of Cincinnati
First posted: 2013-02-01
Enrollment: 76235
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate the effectiveness of 3 modern rapid HIV screening methods, including a novel targeted strategy, in urban emergency department settings in the United States.

Detailed description: Early identification of undiagnosed HIV infection remains a critical public health priority. In the United States, approximately 250,000 HIV-infected individuals remain undiagnosed and 50,000 new infections occur annually, despite several substantial HIV-related public health initiatives. Although HIV testing is an important intervention, controversy still exists as to how it should be implemented.

In 2006, the Centers for Disease Control and Prevention (CDC) recommended nontargeted opt-out HIV screening in clinical settings where the undiagnosed prevalence was ≥0.1%. Emergency departments (EDs) have been a major focus of these recommendations, prompted by the fact that over 120 million ED visits occur annually in the United States, they serve large proportions of underserved patients, and are the most common site of missed diagnostic opportunities for HIV infection. In contrast, in 2007 the United States Preventive Services Task Force recommended targeted HIV screening (i.e., testing high-risk subpopulations) as the principal approach to HIV testing because insufficient evidence existed to support the CDC recommendations.

Led by Jason Haukoos, MD, MSc, the research team has pioneered investigations in this area since 2004, recently publishing the largest clinical trial to date, concluding that nontargeted opt-out rapid HIV screening in the ED was associated with a small increase in number of newly-identified HIV-infected patients when compared to diagnostic testing (i.e., testing based on clinical signs or symptoms) by physicians. The investigators also recently developed the Denver HIV Risk Score (DHRS), the first multivariable tool to estimate risk of HIV infection. The DHRS combines 3 demographic and 5 behavioral characteristics, and classifies patients into distinct strata with increasing HIV prevalence.

To build on this work, the investigators propose the following specific aims: (1) to evaluate and compare the effectiveness of 3 rapid HIV screening strategies when fully-integrated into ED care; (2) to measure and compare programmatic costs of each HIV screening strategy; and (3) to measure and compare ED operational processes of each HIV screening strategy. In doing so, the investigators will perform a multi-center prospective randomized control trial to test the following hypotheses: (1) targeted rapid HIV screening using the DHRS to identify high-risk patients is significantly associated with new HIV diagnoses when compared to traditional targeted rapid HIV screening and nontargeted rapid HIV screening; (2) enhanced and traditional targeted rapid HIV screening is more cost effective per newly-identified patient than nontargeted rapid HIV screening; and (3) enhanced targeted rapid HIV screening is associated with non-inferior ED process metrics and crowding when compared to traditional targeted screening or nontargeted screening.

To accomplish these aims, the investigative team will conduct: (1) a prospective randomized controlled "pragmatic" clinical effectiveness trial in the EDs at Denver Health Medical Center (Denver, CO), Alameda County Medical Center (Oakland, CA), Johns Hopkins Hospital (Baltimore, MD), and the University of Cincinnati Medical Center (Cincinnati, OH); and (2) nested observational studies to evaluate programmatic costs and operational metrics between the 3 rapid HIV screening strategies and using newly-diagnosed HIV infection as the primary outcome.

Eligibility criteria: Inclusion Criteria:

* Greater than or equal to 16 years of age
* Clinically stable
* Capable of providing consent for medical care

Exclusion Criteria:

* \< 16 years old
* Unable to consent for medical care
* Prisoners or detainees
* Self-identified as infected with HIV
* Occupational exposure
* Sexual assault
* Fast-track patients

Primary outcomes:
measure: Confirmed Newly-Diagnosed HIV Infection
timeFrame: Day 1
Secondary outcomes:
measure: CD4 Count
timeFrame: Day 1
measure: HIV Viral Load
timeFrame: Day 1
measure: Linkage-to-Care
timeFrame: Expected average of 1 week, but may be up to 1 month
measure: Development of AIDS
timeFrame: 1 year after diagnosis
measure: Initiation of Antiretroviral Therapy
timeFrame: 1 year after diagnosis
measure: Treatment for Opportunistic Infections
timeFrame: 1 year after diagnosis
measure: Hospitalization
timeFrame: 1 year after diagnosis
measure: Scheduled Medical Care Visits
timeFrame: 1 year after diagnosis
measure: Unscheduled Medical Care Visits
timeFrame: 1 year after diagnosis
measure: Mortality
timeFrame: 1 year after diagnosis
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Alameda County Medical Center
state: California
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
Study officials:
affiliation: Denver Health and Hospital Authority
name: Jason S Haukoos, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haukoos JS, Lyons MS, Rothman RE, White DAE, Hopkins E, Bucossi M, Ruffner AH, Ancona RM, Hsieh YH, Peterson SC, Signer D, Toerper MF, Saheed M, Pfeil SK, Todorovic T, Al-Tayyib AA, Bradley-Springer L, Campbell JD, Gardner EM, Rowan SE, Sabel AL, Thrun MW; HIV TESTED Trial Investigators. Comparison of HIV Screening Strategies in the Emergency Department: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2117763. doi: 10.1001/jamanetworkopen.2021.17763.
citation: Mohareb AM, Patel AV, Laeyendecker OB, Toerper MF, Signer D, Clarke WA, Kelen GD, Quinn TC, Haukoos JS, Rothman RE, Hsieh YH. The HIV Screening Cascade: Current Emergency Department-Based Screening Strategies Leave Many Patients With HIV Undiagnosed. J Acquir Immune Defic Syndr. 2021 May 1;87(1):e167-e169. doi: 10.1097/QAI.0000000000002609. No abstract available.