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.

A retrospective, descriptive study of hepatitis C testing, prevalence, and care continuum among adults on probation.

BACKGROUND: Despite constituting the largest segment of the correctional population, individuals on court-ordered probation remain largely unstudied with respect to hepatitis C virus (HCV) testing and linkage-to-care. We conducted a retrospective, descriptive analysis to estimate prevalence of diagnosed HCV and the subsequent HCV care cascade among a cohort of individuals enrolled in an adult probation program over a 25-month period in Denver, Colorado. METHODS: We utilized probabilistic matching with first and last name, sex, and birthdate to identify individuals enrolled in probation between July 1, 2016 and July 30, 2018 who had a medical record at the participating safety-net healthcare institution as of December 31, 2019. Electronic medical record data were queried for evidence of HCV testing and care through June 30, 2021. The state HCV registry was also queried for prevalence of reported HCV cases among the cohort. RESULTS: This cohort included 8,903 individuals; 6,920 (78%) individuals had a medical record at the participating institution, and of these, 1,037 (15%) had ever been tested for HCV (Ab or RNA) and 308 (4% of those with a medical record, 30% of those tested) had detectable HCV RNA. Of these, 105 (34%) initiated HCV treatment, 89 (29%) had a subsequent undetectable HCV viral load, and 65 (21%) had documentation of HCV cure. Eleven percent of the total cohort had records of positive HCV Ab or RNA tests in the state HCV registry. CONCLUSIONS: This study demonstrates the importance of HCV screening and linkage-to-care for individuals enrolled in probation programs. A focus on this population could enhance progress towards HCV elimination goals.

The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Screening Trial: rationale and design of a multi-center pragmatic randomized clinical trial of hepatitis C screening in emergency departments.

BACKGROUND: Early identification of HCV is a critical health priority, especially now that treatment options are available to limit further transmission and provide cure before long-term sequelae develop. Emergency departments (EDs) are important clinical settings for HCV screening given that EDs serve many at-risk patients who do not access other forms of healthcare. 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) Screening Trial. METHODS: The DETECT Hep C Screening Trial is a multi-center prospective pragmatic randomized two-arm parallel-group superiority trial to test the comparative effectiveness of nontargeted and targeted HCV screening in the ED with a primary hypothesis that nontargeted screening is superior to targeted screening when identifying newly diagnosed HCV. This trial will be performed in the EDs at Denver Health Medical Center (Denver, CO), Johns Hopkins Hospital (Baltimore, MD), and the University of Mississippi Medical Center (Jackson, MS), sites representing approximately 225,000 annual adult visits, and designed using the PRECIS-2 framework for pragmatic trials. When complete, we will have enrolled a minimum of 125,000 randomized patient visits and have performed 13,965 HCV tests. In Denver, the Screening Trial will serve as a conduit for a distinct randomized comparative effectiveness trial to evaluate linkage-to-HCV care strategies. All sites will further contribute to embedded observational studies to assess cost effectiveness, disparities, and social determinants of health in screening, linkage-to-care, and treatment for HCV. DISCUSSION: When complete, The DETECT Hep C Screening Trial will represent the largest ED-based pragmatic clinical trial to date and all studies, in aggregate, will significantly inform how to best perform ED-based HCV screening. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04003454 . Registered on 1 July 2019.

Hepatitis C Testing and Linkage to Care Among Adults on Probation in a Large US City.

BACKGROUND: Despite constituting the largest segment of the correctional population, individuals on probation remain largely unstudied with respect to hepatitis C virus (HCV) testing and linkage to care. We implemented an HCV testing and patient navigation program at an adult probation department. METHODS: Adults were tested at a local probation department with a rapid point-of-care HCV antibody (Ab) assay followed by a laboratory-based HCV ribonucleic acid (RNA) assay if anti-HCV positive. All individuals received counseling rooted in harm reduction principles. Individuals testing positive for HCV Ab were immediately linked to a patient navigator in person or via telephone. The patient navigator assisted patients through cure unless the patient was lost to follow-up. Study participation involved an optional survey and optional point-of-care human immunodeficiency virus test. RESULTS: Of 417 individuals tested, 13% were HCV Ab positive and 65% of those tested for HCV RNA (34 of 52) had detectable HCV RNA. Of the 14 individuals who linked to an HCV treatment provider, 4 completed treatment, as measured by pharmacy fill documentation in the electronic medical record, and 1 obtained sustained virologic response. One hundred ninety-three individuals tested for HIV; none tested positive. CONCLUSIONS: The study cohort had a higher HCV seroprevalence than the general population (13% vs 2%), but linkage to care, completion of HCV treatment, and successful test-of-cure rates were all low. This study indicates that HCV disproportionately impacts adults on probation and prioritizing support for testing and linkage to care could improve health in this population. Colocalization of HCV treatment within probation programs would reduce the barrier of attending a new institution and could be highly impactful.

HIV and COVID-19: review of clinical course and outcomes.

Background:Understanding the relationship between HIV and SARS-CoV-2 has important public health implications.Objective:To summarize current research on COVID-19 among people with HIV (PWH) as published through 15 July 2021.Methods: We conducted a search of PubMed, Scopus, preprint databases (medRxiv, bioRxiv), and the references of publications found using key terms relevant to COVID-19 ('COVID-19' OR 'SARS-CoV-2' OR 'coronavirus') AND to HIV ('HIV' OR 'Human Immunodeficiency Virus' OR 'AIDS' OR 'Acquired Immunodeficiency Syndrome'). We summarized all articles that reported data or opinions on SARS-CoV-2 and HIV coinfection.Conclusions: Although many initial case series and cohort studies found no increased risk for SARS-CoV-2 infection or severe COVID-19 outcomes among PWH, recent studies have signaled an increased risk for severe COVID-19 disease progression even in the setting of well-controlled HIV. Whether this is due to the increased prevalence of comorbidities in PWH and other social determinants of health is unknown. These conflicting findings highlight the continued need for COVID-19 related research among PWH that addresses COVID-19 disease course as well as exacerbation of existing comorbidities already disproportionately represented among PWH.

Viral Hepatitis and Human Immunodeficiency Virus Testing and Linkage to Care for Individuals Enrolled in an Opioid Treatment Program.

BACKGROUND: In the United States, many opioid treatment programs (OTPs) do not offer viral hepatitis (VH) or human immunodeficiency virus (HIV) testing despite high prevalence among OTP clients. We initiated an opt-out VH and HIV testing and linkage-to-care program within our OTP. METHODS: All OTP intakes are screened for VH and HIV and evaluated for rescreening annually. A patient navigator reviews laboratory results and provides counseling in the OTP clinic. The medical record is queried to identify individuals with previously diagnosed, untreated VH or HIV. Navigation support is provided for linkage or relinkage to VH or HIV care. RESULTS: Between March 2018 and Februrary 2019, 532 individuals were screened for hepatitis C virus (HCV), 180 tested HCV antibody positive (34%), and 108 were HCV-ribonucleic acid (RNA) positive (20%). Sixty individuals were identified with previously diagnosed, untreated HCV. Of all HCV RNA+, 49% reported current injection drug use (82 of 168). Ninety-five individuals were seen by an HCV specialist (57% of HCV RNA+), 72 started treatment (43%), and 69 (41%) completed treatment. Individuals with primary care providers were most likely to start treatment. Four individuals were diagnosed with hepatitis B; 0 were diagnosed with HIV. CONCLUSIONS: The implementation of an OTP-based screening and navigation protocol has enabled significant gains in the identification and treatment of VH in this high prevalence setting.

Same-Day HIV Pre-Exposure Prophylaxis (PrEP) Initiation During Drop-in Sexually Transmitted Diseases Clinic Appointments Is a Highly Acceptable, Feasible, and Safe Model that Engages Individuals at Risk for HIV into PrEP Care.

OBJECTIVE: Strategies to increase pre-exposure prophylaxis (PrEP) uptake are needed. We hypothesized that same-day PrEP initiation in a sexually transmitted diseases (STD) clinic would be acceptable, feasible, and safe, and that individuals would engage in ongoing PrEP care. METHOD: Individuals aged ≥ 18 years were evaluated for PrEP. Exclusion criteria were HIV, history of renal dysfunction or chronic hepatitis B infection, pregnancy, indications for HIV post-exposure prophylaxis, or positive screen for acute HIV symptoms. One hundred individuals received a free 30-day PrEP starter pack and met with a patient navigator to establish ongoing care. Bivariate analysis and multivariable logistic regression were used to compare individuals who did and did not attend at least 1 PrEP follow-up appointment within 180 days of enrollment. Client satisfaction surveys were given 3 months after enrollment. RESULTS: The majority (78%) of participants completed at least 1 PrEP follow-up appointment, and 57% attended at least 2 follow-up appointments. After adjusting for race and ethnicity, age, health insurance status, and annual income, only income was associated with follow-up appointment attendance. Each additional $10,000 increase in income was associated with a 1.7-fold increase in the odds of attending a PrEP follow-up appointment (95% confidence interval, 1.07-2.66, P = .02). The majority (54%) of individuals completed the satisfaction survey and all respondents liked the option of same-day PrEP initiation. CONCLUSIONS: Our study suggests STD clinic-based, same-day PrEP initiation is acceptable, feasible, safe, and links a high proportion of individuals into ongoing PrEP care. Additional resources may be needed to support low-income individuals' retention in care.