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.

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').

Substance use Attitudes, Beliefs, Experience, and Knowledge Among Nursing and Nursing Assistant Students.

Stigma is a public health concern. Stigmatizing attitudes toward persons with substance use disorders (SUDs) can adversely impact clinical care and outcomes. Beliefs about SUD, prior experience and familiarity to persons with SUD, and educational curricula drive attitudes among health-care workers.

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.

A Video-Observed Treatment Strategy to Improve Adherence to Treatment Among Persons Who Inject Drugs Infected With Hepatitis C Virus: Qualitative Study of Stakeholder Perceptions and Experiences.

Background: Direct-acting antiviral medications have the potential to eliminate the hepatitis C virus (HCV) epidemic among people who inject drugs; yet, suboptimal adherence remains a barrier. Directly observed treatment (DOT), an effective strategy for optimizing adherence, has been frequently implemented in opioid treatment programs but less commonly in community health settings due to the heavy burden of daily visits. An alternative is video-observed therapy (VOT), which uses mobile health technology to monitor adherence.

Injecting practices during and after hepatitis C treatment and associations with not achieving cure among persons who inject drugs.

Background: Persons who inject drugs (PWID) are a key population for hepatitis C virus (HCV) treatment. Study aims were to describe injection practices of PWID during HCV treatment with direct-acting antivirals (DAAs) and assess whether injection practices were associated with not achieving a sustained virologic response (SVR).

Methods: Secondary analysis of the HERO Study (ClinicalTrials.

Patient-centred models of hepatitis C treatment for people who inject drugs: a multicentre, pragmatic randomised trial.

Background: To achieve WHO targets for the elimination of hepatitis C virus (HCV) as a public threat, an increased uptake of HCV treatment among people who inject drugs (PWID) is urgently needed. Optimal HCV co-located treatment models for PWID have not yet been identified. We aimed to compare two patient-centred models of HCV care in PWID with active drug use.

HIV clinic-based extended-release naltrexone versus treatment as usual for people with HIV and opioid use disorder: a non-blinded, randomized non-inferiority trial.

Background And Aim: Opioid agonist medications for treatment of opioid use disorder (OUD) can improve human immunodeficiency virus (HIV) outcomes and reduce opioid use. We tested whether outpatient antagonist treatment with naltrexone could achieve similar results.

Design: Open-label, non-inferiority randomized trial.

Perspectives on extended-release naltrexone induction among patients living with HIV and opioid use disorder: a qualitative analysis.

Background: The CHOICES study randomized participants with HIV and opioid use disorder (OUD) to HIV clinic-based extended-release naltrexone (XR-NTX), which requires complete cessation of opioid use, versus treatment-as-usual (i.e., buprenorphine, methadone).

Associations between fentanyl use and initiation, persistence, and retention on medications for opioid use disorder among people living with uncontrolled HIV disease.

Background: Associations between fentanyl use and initiation and retention on medications for opioid use disorder (MOUD) are poorly understood.

Methods: Data were from a multisite clinical trial comparing extended-release naltrexone (XR-NTX) with treatment as usual (TAU; buprenorphine or methadone) to achieve HIV viral suppression among people with OUD and uncontrolled HIV disease. The exposure of interest was fentanyl use, as measured by urine drug screening.

Accumulation of HIV-1 Drug Resistance Mutations and Methamphetamine Use.

Background: Antiretroviral therapy (ART) non-adherence and methamphetamine use are associated with higher HIV drug resistance prevalence. How they affect drug resistance mutations accumulation is less studied.

Objective: We assessed factors associated with drug resistance mutations accumulation.

Randomized Trial of a Vaccine Regimen to Prevent Chronic HCV Infection.

Background: A safe and effective vaccine to prevent chronic hepatitis C virus (HCV) infection is a critical component of efforts to eliminate the disease.

Methods: In this phase 1-2 randomized, double-blind, placebo-controlled trial, we evaluated a recombinant chimpanzee adenovirus 3 vector priming vaccination followed by a recombinant modified vaccinia Ankara boost; both vaccines encode HCV nonstructural proteins. Adults who were considered to be at risk for HCV infection on the basis of a history of recent injection drug use were randomly assigned (in a 1:1 ratio) to receive vaccine or placebo on days 0 and 56.

Time to ACT: launching an Addiction Care Team (ACT) in an urban safety-net health system.

Across the USA, morbidity and mortality from substance use are rising as reflected by increases in acute care hospitalisations for substance use complications and substance-related deaths. Patients with substance use disorders (SUD) have long and costly hospitalisations and higher readmission rates compared to those without SUD. Hospitalisation presents an opportunity to diagnose and treat individuals with SUD and connect them to ongoing care.

Dismantling racism against Black, Indigenous, and people of color across the substance use continuum: A position statement of the association for multidisciplinary education and research in substance use and addiction.

The Association for Multidisciplinary Education and Research in Substance Use and Addiction (AMERSA) acknowledges that racism profoundly affects persons who use alcohol and other drugs. Racism's deadly effects compounded with other social determinants of health result in a cascade of negative impacts. The AMERSA Board of Directors (BOD) proposes an initial set of strategies to promote diversity, equity, and inclusion using a framework that speaks to four key AMERSA experiences: engagement, education, mentorship, and leadership.

Barriers and facilitators to recruitment and enrollment of HIV-infected individuals with opioid use disorder in a clinical trial.

Background: The CTN-0067 CHOICES trial tests implementation of extended-release naltrexone (XR-NTX) versus treatment-as-usual (TAU) for opioid use disorders (OUD) in HIV clinics to improve HIV viral suppression. The study team investigated recruitment strategies to elucidate the barriers and facilitators to recruitment and enrollment in the study.

Main Text: Methods: Semi-structured, in-depth, digitally recorded interviews were completed with study recruitment-related staff and medical providers (n = 26) from six participating HIV clinics in the fall of 2018.

Rationale and design of a randomized pragmatic trial of patient-centered models of hepatitis C treatment for people who inject drugs: The HERO study.

Background: Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk. As direct-acting antiviral agents (DAAs) have achieved sustained virologic response (SVR) rates of 95% or more, evidence-based strategies are urgently needed to demonstrate real-world effectiveness in marginalized patient populations such as PWID. The objectives of this study are: 1) to determine whether either of two patient-centered treatment models - patient navigation (PN) or modified directly observed therapy (mDOT) - results in more forward movement along the HCV care cascade including treatment initiation, adherence, and SVR; 2) using quantitative and qualitative methods, to understand factors associated with lack of treatment uptake, poor adherence (<80%), failure to achieve SVR, DAA resistance, and HCV reinfection.

Low barrier buprenorphine treatment for persons experiencing homelessness and injecting heroin in San Francisco.

Background: Opioid overdose is a leading cause of death in persons experiencing homelessness (PEH), despite effective medications for opioid use disorder (OUD). In 2016, the San Francisco Street Medicine Team piloted a low barrier buprenorphine program with the primary goal of engaging and retaining PEH with OUD in care as a first step toward reducing opioid use and improving overall health.

Objective: To characterize the patients; assess treatment retention, retention on buprenorphine, and opioid use; and to describe adverse events.

Computer-Facilitated 5A's for Smoking Cessation: A Randomized Trial of Technology to Promote Provider Adherence.

Introduction: Although evidence-based, the 5A's (Ask, Advise, Assess, Assist, and Arrange) for smoking cessation are often incompletely delivered by primary care providers. This study examines whether a computer tablet 5A's intervention improves primary care provider adherence to the 5A's.

Study Design: Cluster RCT.

Development and differentiability of three brief interventions for risky alcohol use that include varying doses of motivational interviewing.

Background: While brief intervention (BI) for risky alcohol use generally yields positive effects among those identified by screening, effect sizes are small and there is unexplained heterogeneity in outcome. The heterogeneity may be related to differences in intervention style and content, including elements of motivational interviewing (MI). To date, it has been difficult to interpret the role of MI in BI and these gaps in knowledge interfere with efforts to train, disseminate and implement BI that retains and maximizes efficacy.