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

Abstract:

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. METHODS:The HERO study is a multi-site, pragmatic randomized clinical trial conducted in eight states where 754 HCV-infected PWID were randomly assigned to either PN or mDOT. CONCLUSIONS:This study addresses an urgent need for timely and accurate information on optimal models of care to promote HCV treatment initiation, adherence, treatment completion and SVR among PWID, as well as rates and factors associated with reinfection and resistance after treatment. This clinical trial has the potential to provide valuable information on how to reduce the burden of the HCV epidemic in PWID.

journal_name

Contemp Clin Trials

authors

Litwin AH,Jost J,Wagner K,Heo M,Karasz A,Feinberg J,Kim AY,Lum PJ,Mehta SH,Taylor LE,Tsui JI,Pericot-Valverde I,Page K,HERO Study Group.

doi

10.1016/j.cct.2019.105859

subject

Has Abstract

pub_date

2019-12-01 00:00:00

pages

105859

eissn

1551-7144

issn

1559-2030

pii

S1551-7144(19)30574-9

journal_volume

87

pub_type

杂志文章,多中心研究,随机对照试验
  • Informatics tools to improve clinical research study implementation.

    abstract:BACKGROUND:There are numerous potential sources of problems when performing complex clinical research trials. These issues are compounded when studies are multi-site and multiple personnel from different sites are responsible for varying actions from case report form design to primary data collection and data entry. M...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2005.11.013

    authors: Brandt CA,Argraves S,Money R,Ananth G,Trocky NM,Nadkarni PM

    更新日期:2006-04-01 00:00:00

  • Can lifestyle modification improve neurocognition? Rationale and design of the ENLIGHTEN clinical trial.

    abstract:BACKGROUND:Risk factors for cardiovascular disease (CVD) not only increase the risk for clinical CVD events, but also are associated with a cascade of neurophysiologic and neuroanatomic changes that increase the risk of cognitive impairment and dementia. Although epidemiological studies have shown that exercise and die...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2012.09.004

    authors: Blumenthal JA,Smith PJ,Welsh-Bohmer K,Babyak MA,Browndyke J,Lin PH,Doraiswamy PM,Burke J,Kraus W,Hinderliter A,Sherwood A

    更新日期:2013-01-01 00:00:00

  • The blind leading the blind: use and misuse of blinding in randomized controlled trials.

    abstract::The use of blinding strengthens the credibility of randomized controlled trials (RCTs) by minimizing bias. However, there is confusion surrounding the definition of blinding as well as the terms single, double, and triple blind. It has been suggested that these terms should be discontinued due to their broad misinterp...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2010.11.004

    authors: Miller LE,Stewart ME

    更新日期:2011-03-01 00:00:00

  • Rationale and design of the STAR randomized controlled trial to accelerate adoption of childhood obesity comparative effectiveness research.

    abstract:BACKGROUND:Comparative effectiveness research (CER) evidence on childhood obesity provides the basis for effective screening and management strategies in pediatric primary care. The uses of health information technology including decision support tools in the electronic health records (EHRs), as well as remote and mobi...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1016/j.cct.2012.10.005

    authors: Taveras EM,Marshall R,Horan CM,Gillman MW,Hacker K,Kleinman KP,Koziol R,Price S,Simon SR

    更新日期:2013-01-01 00:00:00

  • Use of a precious resource: parental decision making about using autologous umbilical cord blood in studies involving young children with type 1 diabetes.

    abstract:OBJECTIVE:To assess parental decision making and experiences in an autologous umbilical cord blood infusion study in young children with type 1 diabetes (T1D). METHODS:Surveys were completed with 22 parents of children with T1D who received infusion and 22 parents who declined infusion. RESULTS:Parents who stored umb...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2011.04.004

    authors: Driscoll KA,Johnson SB,Schatz DA,Haller MJ

    更新日期:2011-07-01 00:00:00

  • The BestFIT trial: A SMART approach to developing individualized weight loss treatments.

    abstract::Behavioral weight loss programs help people achieve clinically meaningful weight losses (8-10% of starting body weight). Despite data showing that only half of participants achieve this goal, a "one size fits all" approach is normative. This weight loss intervention science gap calls for adaptive interventions that pr...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2016.01.011

    authors: Sherwood NE,Butryn ML,Forman EM,Almirall D,Seburg EM,Lauren Crain A,Kunin-Batson AS,Hayes MG,Levy RL,Jeffery RW

    更新日期:2016-03-01 00:00:00

  • Trial study design to test a bilingual digital health tool for alcohol use disorders among Latino emergency department patients.

    abstract::We describe an emergency department (ED)-based, Latino patient focused, unblinded, randomized controlled trial to empirically test if automated bilingual computerized alcohol screening and brief intervention (AB-CASI), a digital health tool, is superior to standard care (SC) on measures of alcohol consumption, alcohol...

    journal_title:Contemporary clinical trials

    pub_type: 更正并重新发布的文章,已发布勘误

    doi:10.1016/j.cct.2020.106128

    authors: Vaca FE,Dziura J,Abujarad F,Pantalon MV,Hsiao A,Field CA,D'Onofrio G

    更新日期:2020-10-01 00:00:00

  • Analysis of duration of response in oncology trials.

    abstract::The fraction of patients who respond to treatment and the duration of response in the subset of responding patients are commonly evaluated in oncology trials of cytotoxic compounds. While formal, comparative analysis of the fraction of patients responding to treatment is straightforward in a randomised trial, analyses...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2007.10.008

    authors: Ellis S,Carroll KJ,Pemberton K

    更新日期:2008-07-01 00:00:00

  • COVID-19 hits a trial: Arguments against hastily deviating from the plan.

    abstract::The COVID-19 pandemic has substantially impacted the conduct of clinical trials. While initially preparing for a period of time, where it would likely be impossible to supervise trials in the usual way and precautionary measures had to be implemented to care for medication supply and general safety of study participan...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2020.106155

    authors: Großhennig A,Koch A

    更新日期:2020-11-01 00:00:00

  • On the design and analysis of clinical trials with correlated outcomes.

    abstract::The convention in clinical trials is to regard outcomes as independently distributed, possibly conditional on covariates, but in some situations they may be correlated. For example, in infectious diseases, correlation may be induced if participants have contact with a common infectious source, or share hygienic tips t...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2014.08.001

    authors: Follmann D,Proschan M

    更新日期:2014-09-01 00:00:00

  • Time-dependent effect of non-Hodgkin's lymphoma grade on disease-free survival of relapsed/refractory patients treated with high-dose chemotherapy plus autotransplantation.

    abstract::Evaluation of time to event outcomes usually is examined by the Kaplan-Meier method and Cox proportional hazards models. We developed a modified statistical model based on histologic grade and other variables to describe the time-dependent outcome for autologous stem cell transplant (autotransplant) performed for non-...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2007.07.005

    authors: Fu P,van Heeckeren WJ,Wadhwa PD,Bajor DJ,Creger RJ,Xu Z,Cooper BW,Laughlin MJ,Gerson SL,Koç ON,Lazarus HM

    更新日期:2008-03-01 00:00:00

  • Design of a pragmatic cluster randomised controlled trial: ecological approach to increasing physical activity in an urban community.

    abstract::This study was set up to test an ecological intervention using a pragmatic cluster randomised controlled design (RCT) aimed at increasing physical activity (PA) within the community in a deprived inner-city area in the UK. The research will provide a detailed mapping (using Graphical Information Systems GIS) of the en...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2008.03.005

    authors: Davey RC,Cochrane T,Gidlow C,Fairburn J,Smith G

    更新日期:2008-09-01 00:00:00

  • A randomized controlled trial of a trauma-informed school prevention program for urban youth: Rationale, design, and methods.

    abstract:INTRODUCTION:Youth in disadvantaged urban areas are frequently exposed to chronic stress and trauma, including housing instability, neighborhood violence, and other poverty-related adversities. These exposures increase risk for emotional, behavioral, and academic problems and ultimately, school dropout. Schools are a p...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2019.105895

    authors: Mendelson T,Clary LK,Sibinga E,Tandon D,Musci R,Mmari K,Salkever D,Stuart EA,Ialongo N

    更新日期:2020-03-01 00:00:00

  • Effects of exercise training programs on physical performance and quality of life in patients with metastatic lung cancer undergoing palliative chemotherapy--a study protocol.

    abstract:PURPOSE:The aims of the study protocol are to investigate different adapted physical training programs in patients with advanced lung cancer undergoing palliative chemo- or radiotherapy and to evaluate their effects on physical performance, quality of life, symptom burden, and efficacy of oncologic treatment. METHODS:...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2013.11.013

    authors: Jensen W,Oechsle K,Baumann HJ,Mehnert A,Klose H,Bloch W,Bokemeyer C,Baumann FT

    更新日期:2014-01-01 00:00:00

  • Fit and Strong! Plus: design of a comparative effectiveness evaluation of a weight management program for older adults with osteoarthritis.

    abstract::Osteoarthritis (OA) is the most common chronic condition and principal cause of disability among older adults. The current obesity epidemic has contributed to this high prevalence rate. Fortunately both OA symptoms and obesity can be ameliorated through lifestyle modifications. Physical activity (PA) combined with wei...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2013.11.014

    authors: Smith-Ray RL,Fitzgibbon ML,Tussing-Humphreys L,Schiffer L,Shah A,Huber GM,Braunschweig C,Campbell RT,Hughes SL

    更新日期:2014-03-01 00:00:00

  • Patient randomized trial of a targeted navigation program to improve rates of follow-up colonoscopy in community health centers.

    abstract:BACKGROUND:Colorectal cancer (CRC) screening by annual fecal immunochemical test (FIT) is an accessible and cost-effective strategy to lower CRC incidence and mortality. However, this mode of screening depends on follow-up colonoscopy after a positive FIT result. Unfortunately, nearly one-half of FIT-positive patients ...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2019.105920

    authors: Coronado GD,Johnson ES,Leo MC,Schneider JL,Smith D,Mummadi R,Petrik AF,Thompson JH,Jimenez R

    更新日期:2020-02-01 00:00:00

  • A web-based personalized risk communication and decision-making tool for women with dense breasts: Design and methods of a randomized controlled trial within an integrated health care system.

    abstract:BACKGROUND:Mammographic breast density is one of the strongest risk factors for breast cancer after age and family history. Mandatory breast density disclosure policies are increasing nationally without clear guidance on how to communicate density status to women. Coupling density disclosure with personalized risk coun...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1016/j.cct.2017.02.009

    authors: Knerr S,Wernli KJ,Leppig K,Ehrlich K,Graham AL,Farrell D,Evans C,Luta G,Schwartz MD,O'Neill SC

    更新日期:2017-05-01 00:00:00

  • Parent and child care provider partnerships: Protocol for the Healthy Me, Healthy We (HMHW) cluster randomized control trial.

    abstract:BACKGROUND:Formation of diet and physical activity habits begins during early childhood. However, many preschool-aged children in the United States do not achieve recommendations for a nutritious diet or active lifestyle. Two important spheres of influence, home and child care, could ensure that children receive consis...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2017.11.007

    authors: Hennink-Kaminski H,Vaughn AE,Hales D,Moore RH,Luecking CT,Ward DS

    更新日期:2018-01-01 00:00:00

  • "Do you expect me to receive PTSD care in a setting where most of the other patients remind me of the perpetrator?": Home-based telemedicine to address barriers to care unique to military sexual trauma and veterans affairs hospitals.

    abstract::Home-based telemedicine (HBT) is a validated method of evidence-based treatment delivery for posttraumatic stress disorder (PTSD), and justification for its use has centered on closing gaps related to provider availability and distance to treatment centers. However, another potential use of HBT may be to overcome barr...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2016.03.004

    authors: Gilmore AK,Davis MT,Grubaugh A,Resnick H,Birks A,Denier C,Muzzy W,Tuerk P,Acierno R

    更新日期:2016-05-01 00:00:00

  • Recruiting and retaining family caregivers to a randomized controlled trial on mindfulness-based stress reduction.

    abstract::Caregivers for a family member with dementia experience chronic long-term stress that may benefit from new complementary therapies such as mindfulness-based stress reduction. Little is known however, about the challenges of recruiting and retaining family caregivers to research on mind-body based complementary therapi...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2011.05.002

    authors: Whitebird RR,Kreitzer MJ,Lewis BA,Hanson LR,Crain AL,Enstad CJ,Mehta A

    更新日期:2011-09-01 00:00:00

  • Study to promote innovation in rural integrated telepsychiatry (SPIRIT): Rationale and design of a randomized comparative effectiveness trial of managing complex psychiatric disorders in rural primary care clinics.

    abstract:OBJECTIVE:Managing complex psychiatric disorders like PTSD and bipolar disorder is challenging in Federally Qualified Health Centers (FQHCs) delivering care to U.S residents living in underserved rural areas. This protocol paper describes SPIRIT, a pragmatic comparative effectiveness trial designed to compare two appro...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2019.105873

    authors: Fortney JC,Heagerty PJ,Bauer AM,Cerimele JM,Kaysen D,Pfeiffer PN,Zielinski MJ,Pyne JM,Bowen D,Russo J,Ferro L,Moore D,Nolan JP,Fee FC,Heral T,Freyholtz-London J,McDonald B,Mullins J,Hafer E,Solberg L,Unützer J

    更新日期:2020-03-01 00:00:00

  • Integrating palliative care into self-management of breast cancer: Protocol for a pilot randomized controlled trial.

    abstract:BACKGROUND:Despite evidence that palliative care increases quality and length of life, many patients and families remain uninformed about its nature and benefits. The purpose of this study is to test a psycho-educational intervention, Managing Cancer Care: A Personal Guide (MCC), intended to improve breast cancer patie...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2016.04.009

    authors: Schulman-Green D,Linsky S,Jeon S,Kapo J,Blatt L,Chagpar A

    更新日期:2016-05-01 00:00:00

  • Expansion of the modified Zelen's approach randomization and dynamic randomization with partial block supplies at the centers to unequal allocation.

    abstract::Modified Zelen's approach is a randomization technique useful in multi-center trials where balance in treatment assignments within a center is desired. It has great balancing properties in a study with equal allocation to several treatment arms. This technique can also be used in studies with unequal allocation, where...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,评审

    doi:10.1016/j.cct.2011.08.006

    authors: Kuznetsova OM,Tymofyeyev Y

    更新日期:2011-11-01 00:00:00

  • Long-term Exercise After Pulmonary Rehabilitation (LEAP): Design and rationale of a randomized controlled trial of Tai Chi.

    abstract:BACKGROUND:Persons with chronic obstructive pulmonary disease (COPD) have reduced exercise capacity and levels of physical activity. Supervised, facility-based pulmonary rehabilitation programs improve exercise capacity and reduce dyspnea, but novel long-term strategies are needed to maintain the benefits gained. Mind-...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2015.09.004

    authors: Moy ML,Wayne PM,Litrownik D,Beach D,Klings ES,Davis RB,Yeh GY

    更新日期:2015-11-01 00:00:00

  • Rationale and design for a pragmatic effectiveness-implementation trial of online behavioral obesity treatment in primary care.

    abstract:BACKGROUND:Current guidelines recommend behavioral intervention to achieve a modest weight loss (e.g., 3-5%) as a first-line obesity treatment. Online behavioral obesity treatment, delivered via the Rx Weight Loss (RxWL) program, produces clinically significant initial weight losses. However, the program's pragmatic ut...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2019.05.003

    authors: Espel-Huynh HM,Wing RR,Goldstein CM,Thomas JG

    更新日期:2019-07-01 00:00:00

  • Dose-response effects of exercise on abdominal obesity and risk factors for cardiovascular disease in adults: study rationale, design and methods.

    abstract::Although progress has been made to elucidate the effects of exercise as a strategy for reducing obesity and related cardiometabolic risk factors, the specific exercise exposures required to achieve optimal benefit continue to be the source of considerable uncertainty and debate. Despite the inference of a dose-depende...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2012.10.010

    authors: Ross R,Hudson R,Day AG,Lam M

    更新日期:2013-01-01 00:00:00

  • The safety of tai chi: A meta-analysis of adverse events in randomized controlled trials.

    abstract:OBJECTIVES:To review current publications to examine safety of tai chi (TC). DESIGN:Cochrane Library, EBSCO host and MEDLINE/PubMed were searched for randomized controlled trials (RCTs) including TC as the core intervention and reporting adverse events (AEs). Data were extracted considering active vs. inactive control...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,meta分析

    doi:10.1016/j.cct.2019.06.004

    authors: Cui H,Wang Q,Pedersen M,Wang Q,Lv S,James D,Larkey L

    更新日期:2019-07-01 00:00:00

  • Family-based obesity prevention for infants: Design of the "Mothers & Others" randomized trial.

    abstract:OBJECTIVE:Our goal is to test the efficacy of a family-based, multi-component intervention focused on infants of African-American (AA) mothers and families, a minority population at elevated risk for pediatric obesity, versus a child safety attention-control group to promote healthy weight gain patterns during the firs...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2017.06.002

    authors: Wasser HM,Thompson AL,Suchindran CM,Hodges EA,Goldman BD,Perrin EM,Faith MS,Bulik CM,Heinig MJ,Bentley ME

    更新日期:2017-09-01 00:00:00

  • Pregnancy, exercise and nutrition research study with smart phone app support (Pears): Study protocol of a randomized controlled trial.

    abstract:OBJECTIVE:Maternal adiposity confers an increased risk of GDM in pregnancy. A low glycemic index (GI) dietary intervention has been found to improve glucose homeostasis and reduce gestational weight gain. Mobile Health (mHealth) Technology-assisted interventions are becoming commonplace as an aid to treating many chron...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2015.11.018

    authors: Kennelly MA,Ainscough K,Lindsay K,Gibney E,Mc Carthy M,McAuliffe FM

    更新日期:2016-01-01 00:00:00

  • Pain relief for osteoarthritis through combined treatment (PROACT): Protocol for a randomized controlled trial of mindfulness meditation combined with transcranial direct current stimulation in non-Hispanic black and white adults with knee osteoarthritis.

    abstract::Knee osteoarthritis (OA) is a leading cause of late life pain and disability, and non-Hispanic black (NHB) adults experience greater OA-related pain and disability than non-Hispanic whites (NHWs). Recent evidence implicates psychosocial stress, cognitive-attentional processes, and altered central pain processing as co...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2020.106159

    authors: Fillingim RB,Woods AJ,Ahn H,Wu SS,Redden DT,Lai S,Deshpande H,Deutsch G,Sibille KT,Staud R,Zeidan F,Goodin BR

    更新日期:2020-11-01 00:00:00