Challenges in coverage of future hepatitis C vaccines: Review and potential solutions.

Background: Motivated by the high mortality burden of hepatitis C virus (HCV) and the unprecedented rapid development of the COVID-19 and respiratory syncytial virus (RSV) vaccines, we note that a prompt HCV vaccine rollout may streamline the World Health Organization's goal to eliminate HCV before 2030. While progress in the development of HCV vaccine candidates has rapidly flourished, vaccine hesitancy and HCV incidence are both particularly prevalent in people who inject drugs (PWID). The aim of this paper is to document several potential challenges in HCV vaccine uptake and provide a set of preliminary recommendations for public and community health professionals to improve acceptance.

Getting to full disclosure: HCV testing and status disclosure behaviors among PWID and their injecting partners.

Background: People who inject drugs (PWID) face a substantial risk of hepatitis C virus (HCV) infection, often in the context of multiple injecting partnerships. The disclosure of HCV status to injecting partners holds significant implications for prevention and care among PWID.

Methods: We used cross-sectional dyadic survey data (collected from both members of injecting partnerships) to estimate the prevalence of HCV-status disclosure between PWID and their injecting partners, overall and by partnership HCV infection status.

Retreatment of Hepatitis C Virus Among People Who Inject Drugs.

Background: Hepatitis C virus (HCV) is a leading cause of infectious disease death in the United States. Although highly effective direct-acting antiviral (DAA) regimens are well established, retreatment among people who inject drugs (PWID) has not been sufficiently studied. This study assessed DAA retreatment outcomes and associated factors.

Hospital Addiction Consultation Service and Opioid Use Disorder Treatment: The START Randomized Clinical Trial.

Importance: Medications for opioid use disorder (MOUD) are effective, but hospitalized people with opioid use disorder (OUD) seldom receive MOUD while in the hospital or link with treatment after.

Objective: To test whether an addiction-focused consultation service, the Substance Use Treatment and Recovery Team (START), increases MOUD initiation during hospitalization and linkage to follow-up care after discharge.

Design, Setting, And Participants: This 1:1 randomized clinical trial grouped participants into the START intervention or usual care.

Patient-navigator working alliance and hepatitis C treatment cascade outcomes among persons who inject drugs: The HERO study.

Introduction: Integrating patient navigation (PN) interventions in hepatitis C virus (HCV) elimination efforts enhances HCV treatment cascade outcomes from screening to cure. Nonetheless, little is known about how the patient-navigator working alliance influences the effectiveness of PN interventions. This study among persons who inject drugs (PWID) living with HCV aimed to assess the association between patient-navigator working alliance and HCV treatment cascade outcomes.

Improvement in anxiety symptoms during treatment of Hepatitis C in people who inject drugs: The HERO study.

Background: Anxiety disorders frequently occur in people who inject drugs (PWID). This study aimed to explore changes in anxiety among PWID during and after treatment of hepatitis C virus (HCV) with direct-acting antiviral agents.

Methods: This study is a secondary analysis using a sample (N = 498) based on the per-protocol data from the HERO study, a multisite pragmatic randomized trial.

Risk Factors for Viral Coinfections in Blood Donors in Bahia, Brazil.

Human Immunodeficiency Virus (HIV), Human T Lymphotropic Virus (HTLV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) coinfection may lead to disease progression or worsen its clinical presentation. Viral coinfections screening during blood donation is critical. To identify risk factors for coinfection among blood donors, we assessed the blood donations at the Fundação de Hematologia e Hemoterapia da Bahia, from 2008 to 2017.

Interest in Injectable and Oral PrEP for HIV Prevention Among Women and Men Who Inject Drugs.

Background: People who inject drugs (PWID) are at increased risk for human immunodeficiency virus (HIV). Women who inject are a particularly vulnerable group. Preexposure prophylaxis (PrEP) is effective, but access and uptake has been limited.

Implementing a Patient-Centered, Rapid-Access Substance Use Treatment Pathway in Primary Care.

Despite the effectiveness of treating substance use disorders in primary care, access to such services remains limited. In this project, quality improvement methods were used to create and evaluate a rapid-access pathway for substance use treatment services in community health clinics. A "secret shopper" test gathered information about wait times and requirements.

Modeling of randomized hepatitis C vaccine trials: Bridging the gap between controlled human infection models and real-word testing.

Global elimination of chronic hepatitis C (CHC) remains difficult without an effective vaccine. Since injection drug use is the leading cause of hepatitis C virus (HCV) transmission in Western Europe and North America, people who inject drugs (PWID) are an important population for testing HCV vaccine effectiveness in randomized-clinical trials (RCTs). However, RCTs in PWID are inherently challenging.

Variability of Hepatitis C Treatment Cascade Outcomes among People Who Inject Drugs across Geographically Diverse Clinics in the US: The HERO Study.

Heterogeneity of outcomes across different clinical trial study sites is often inevitable. Understanding how outcomes differ by site is important for planning future programs and studies. We examined the extent of heterogeneity of hepatitis C virus (HCV) treatment cascade outcomes among persons who inject drugs (PWIDs) across sixteen clinical sites utilized in the HERO Study-a pragmatic randomized trial of HCV treatment support.

High concordance between urine toxicology results and self-reported fentanyl use in Nevada and New Mexico.

Background: Co-use of stimulants and opioids is often deliberate. However, the possibility remains that some people are unintentionally consuming fentanyl. To advance understanding of overdose risk, we examined the rate of concordance between self-reported fentanyl use and corresponding urine toxicology screen results.

Hepatitis C Virus Reinfection Among People Who Inject Drugs: Long-Term Follow-Up of the HERO Study.

Importance: Hepatitis C virus (HCV) reinfection after curative treatment remains a concern for people who inject drugs.

Objective: To assess the incidence of HCV reinfection and associated risk factors.

Design, Setting, And Participants: This cohort study is a secondary analysis of a randomized clinical trial that was conducted across opioid treatment programs and community health centers in the US between September 2016 and August 2018.

Effect of self-efficacy among persons who inject drugs treated with direct-acting antivirals on Hepatitis C treatment initiation, duration, completion, adherence, and cure.

Background: Self-efficacy, a patient-level factor, has been shown to facilitate patient engagement in treatment and optimize treatment-related outcomes in various health contexts. Research on interventions supporting hepatitis C virus (HCV) direct-acting antiviral (DAA) treatment uptake and adherence among persons who inject drugs (PWID) is needed, but whether self-efficacy factors influence DAA treatment cascade outcomes in this population has been less studied.

Methods: Using the HERO study data, we analyzed a subset of participants with any general health self-efficacy data (n=708) measured at baseline and end-of-treatment time points using a 5-items instrument (facets: 'goal setting', 'goal attainment', 'having a positive effect', 'being in control', and 'working to improve').

Safety strategies and harm reduction for methamphetamine users in the era of fentanyl contamination: A qualitative analysis.

Introduction: In the United States, methamphetamine use is increasing and the context of its use has changed, with reports of illicitly manufactured fentanyl being mixed with methamphetamine (either deliberately or inadvertently). We explore risk-mitigating actions taken by people who use drugs to protect their health when using methamphetamine in that context.

Methods: We conducted qualitative interviews with 48 adults (18+) who used methamphetamine in the past three months at two sites in Nevada, USA and two sites in New Mexico, USA.

Voices of the unhoused from Santa Fe, New Mexico: A mixed methods study of health status, substance use, and community harm reduction program perspectives.

No published studies have examined the community service priorities and harm reduction perspectives of unhoused people in Santa Fe, New Mexico. We conducted a mixed methods pilot study of 56 unhoused people at community locations in Santa Fe to: (1) assess the current prevalence of chronic medical conditions and substance use; (2) highlight community service priorities; and (3) explore views of innovative community harm reduction programs. Our first hypothesis was there would be high prevalence of chronic medical conditions, for which we found high prevalence of post-traumatic stress disorder, major depression, substance use disorders, chronic pain, and hypertension.

Contextual barriers and enablers to establishing an addiction-focused consultation team for hospitalized adults with opioid use disorder.

Background: Hospitalization presents an opportunity to begin people with opioid use disorder (OUD) on medications for opioid use disorder (MOUD) and link them to care after discharge; regrettably, people admitted to the hospital with an underlying OUD typically do not receive MOUD and are not connected with subsequent treatment for their condition. To address this gap, we launched a multi-site randomized controlled trial to test the effectiveness of a hospital-based addiction consultation team (the Substance Use Treatment and Recovery Team (START)) consisting of an addiction medicine specialist and care manager team that provide collaborative care and a specified intervention to people with OUD during the inpatient stay. Successful implementation of new practices can be impacted by organizational context, though no previous studies have examined context prior to implementation of addiction consultation services (ACS).

Reducing Sample Size While Improving Equity in Vaccine Clinical Trials: A Machine Learning-Based Recruitment Methodology with Application to Improving Trials of Hepatitis C Virus Vaccines in People Who Inject Drugs.

Despite the availability of direct-acting antivirals that cure individuals infected with the hepatitis C virus (HCV), developing a vaccine is critically needed in achieving HCV elimination. HCV vaccine trials have been performed in populations with high incidence of new HCV infection such as people who inject drugs (PWID). Developing strategies of optimal recruitment of PWID for HCV vaccine trials could reduce sample size, follow-up costs and disparities in enrollment.

Overreporting of adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs in the HERO study.

Background: Self-reported adherence to direct-acting antivirals (DAAs) to treat hepatitis C virus (HCV) among persons who inject drugs (PWID) is often an overreport of objectively measured adherence. The association of such overreporting with sustained virologic response (SVR) is understudied. This study among PWID aimed to determine a threshold of overreporting adherence that optimally predicts lower SVR rates, and to explore correlates of the optimal overreporting threshold.

Self-reported and measured adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs: The HERO study.

Background: Objective adherence measures, such as electronic blister pack (BP), for direct-acting antivirals (DAAs) for hepatitis C virus (HCV) treatment have high accuracy, but their use is limited in real practice settings. We examined the association of self-reported adherence using a visual analogue scale (VAS) with objective BP adherence and sustained virologic response (SVR) among people who inject drugs.

Methods: We conducted secondary analyses using a subset of participants (N = 493) from the per-protocol sample of the HERO study, a pragmatic randomized trial of HCV treatment interventions that used both VAS and BP to measure adherence to a 12-week sofosbuvir/velpatasvir DAA regimen.

Reduction in Depressive Symptoms in People who Inject Drugs who Are Cured of Hepatitis C Virus Infection: The HERO Study.

Background: Depressive symptoms are prevalent among people who inject drugs (PWID) and people with hepatitis C virus (HCV). We examined changes in depressive symptoms among HCV-infected PWID following direct-acting antiviral treatments to evaluate whether these changes differed by history of depressive symptoms, substance use, or HCV treatment outcome.

Methods: We conducted a secondary analysis of the HERO Study (NCT02824640), a pragmatic randomized clinical trial among PWID, to test the effectiveness of HCV care models.

Prevalence of fentanyl in methamphetamine and cocaine samples collected by community-based drug checking services.

Background: Overdose deaths involving stimulants and opioids simultaneously have raised the specter of widespread contamination of the stimulant supply with fentanyl.

Methods: We quantified prevalence of fentanyl in street methamphetamine and cocaine, stratified by crystalline texture, analyzing samples sent voluntarily to a public mail-in drug checking service (May 2021-June 2023). Samples from 77 harm reduction programs and clinics originated in 25 US states.