The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Linkage-to-Care Trial: rationale and design of an emergency department-based randomized clinical trial of linkage-to-care strategies for hepatitis C.

BACKGROUND: Hepatitis C (HCV) poses a major public health problem in the USA. While early identification is a critical priority, subsequent linkage to a treatment specialist is a crucial step that bridges diagnosed patients to treatment, cure, and prevention of ongoing transmission. Emergency departments (EDs) serve as an important clinical setting for HCV screening, although optimal methods of linkage-to-care for HCV-diagnosed individuals remain unknown. In this article, we describe the rationale and design of The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Linkage-to-Care Trial. METHODS: The DETECT Hep C Linkage-to-Care Trial will be a single-center prospective comparative effectiveness randomized two-arm parallel-group superiority trial to test the effectiveness of linkage navigation and clinician referral among ED patients identified with untreated HCV with a primary hypothesis that linkage navigation plus clinician referral is superior to clinician referral alone when using treatment initiation as the primary outcome. Participants will be enrolled in the ED at Denver Health Medical Center (Denver, CO), an urban, safety-net hospital with approximately 75,000 annual adult ED visits. This trial was designed to enroll a maximum of 280 HCV RNA-positive participants with one planned interim analysis based on methods by O'Brien and Fleming. This trial will further inform the evaluation of cost effectiveness, disparities, and social determinants of health in linkage-to-care, treatment, and disease progression. DISCUSSION: When complete, the DETECT Hep C Linkage-to-Care Trial will significantly inform how best to perform linkage-to-care among ED patients identified with HCV. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04026867 Original date: July 1, 2019 URL: https://clinicaltrials.gov/ct2/show/NCT04026867.

Development of a 2-step algorithm to identify emergency department patients for HIV pre-exposure prophylaxis.

BACKGROUND: Expanded access to HIV PrEP is a central pillar of the "Ending the HIV Epidemic" initiative. Identification of PrEP eligible individuals in EDs remains understudied. Our goal was to estimate the accuracy of the Denver HIV Risk Score (DHRS), a quantitative HIV risk tool, for determining PrEP eligibility, and to incorporate it into a novel screening algorithm to optimize sensitivity and specificity. METHODS: We performed a prospective cross-sectional study in two urban EDs. Patients were eligible if ≥18 years of age and without HIV. Research staff collected individual HIV risk, components of the DHRS, and PrEP eligibility per 2017 CDC guidelines. Accuracy estimates were calculated for the DHRS alone and the DHRS plus additional PrEP-specific questions. RESULTS: 1002 patients were enrolled with a median age of 39 years; 54.8% were male, 29.5% Black/non-Hispanic, and 22.5% Hispanic. Overall, 119 (11.9%, 95% CI: 9.9%-14.0%) were PrEP eligible; 5% endorsed history of sex with a partner at higher risk for HIV or condomless sex with multiple partners, 4% an STI, and 2% sharing IDU equipment. A DHRS ≥25 had a sensitivity of 92.4% (95% CI: 86.1%-96.5%) and a specificity of 17.2% (95% CI: 14.8%-19.9%) for PrEP eligibility. A 2-step algorithm, "DHRS-PrEP", beginning with a DHRS ≥25, followed by a step with questions specific to IDU, STI, and sexual partners improved the specificity to 100% (95% CI: 99.6%-100%). CONCLUSIONS: Among a heterogeneous ED sample, a substantial proportion was identified as PrEP eligible, and a 2-step algorithm had high sensitivity and specificity for identifying PrEP-eligible patients.

HIV Risk and Pre-Exposure Prophylaxis Eligibility Among Emergency Department Patients.

Our objective was to estimate the prevalence of pre-exposure prophylaxis (PrEP) eligibility, characterize self-perceived and quantified human immunodeficiency virus (HIV) risk, and assess PrEP knowledge and receptiveness of initiating PrEP among emergency department (ED) patients. We performed an IRB-approved cross-sectional study from two urban EDs. Patients were eligible if ≥18 years of age and not known to have HIV. Research staff obtained verbal consent and used a structured 29-item instrument to assess HIV risk, PrEP eligibility based on 2017 Centers for Disease Control and Prevention (CDC) guidelines, and general PrEP knowledge among unselected and enriched patient samples, the latter informed by the Denver HIV Risk Score (DHRS). We enrolled 1002 patients with a median age of 39 years; 54.8% were male, 30.9% White/non-Hispanic, 29.5% Black/non-Hispanic, and 22.5% Hispanic. In the full cohort, 119 [11.9%, 95% confidence interval (CI): 9.9-14.0%] were PrEP eligible, and among the unselected cohort, 36 (7.1%, 95% CI: 5.1-9.8%) were PrEP eligible. Using the DHRS, 100 patients were considered "high risk" with 32 (32.0%) reporting zero perceived risk. Correlation between the DHRS and self-perceived HIV risk was low (r = 0.13). Of the full cohort, 203 (20.3%) had heard of PrEP, and of these, 33 (16.3%) were PrEP eligible with 25 (75.8%) willing to start PrEP immediately. Yet, of the 119 patients who were PrEP eligible, only 34 (28.6%) had heard of PrEP. In summary, among a heterogeneous ED population, there was discordance in self-perceived and quantified HIV risk. HIV PrEP eligibility was ∼7% with the highest eligibility among those identified as DHRS "high risk." A significant opportunity exists to identify and initiate PrEP among ED patients.