Publications by authors named "Alain Litwin"

85 Publications

Using community-based participatory methods to design a digital intervention for mothers with substance use disorders: Qualitative results from focus group discussions.

Perspect Psychiatr Care 2021 May 3. Epub 2021 May 3.

Department of Medicine, Prisma Health, Greenville, South Carolina, USA.

Purpose: This community-based participatory research project explored the feasibility of delivering parenting and recovery supports through digital technology for mothers recovering from addictive substances.

Design And Methods: A community advisory board of key stakeholders (n = 7) served as a focus group of advisors to discuss needed supports. Data were analyzed through qualitative descriptive analysis.

Findings: Results revealed themes about challenges and supports needed, and whether supports delivered through digital technology may improve recovery and parenting.

Practice Implications: Future exploration needs to examine the extent to which the use of community-guided, tailored digital support applications that supplement prescribed treatment can enhance parenting and recovery.
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http://dx.doi.org/10.1111/ppc.12823DOI Listing
May 2021

The Impact of the Disease Model of Substance Use Disorder on Evidence Based Practice Adoption and Stigmatizing Attitudes: A Comparative Analysis.

Pain Manag Nurs 2021 Apr 24. Epub 2021 Apr 24.

University of Cincinnati, College of Nursing, Cincinnati, Ohio.

Background: Evidence-based practices are shown to improve health outcomes in persons with substance use disorder (SUD), but practice adoption is often limited by stigma. Stigma towards these patients leads to poor communication, missed diagnoses, and treatment avoidance.

Aims: The purpose of this study was to survey a rural community to conceptualize knowledge and attitudes towards SUD and opioid use disorder.

Design: The study design was cross-sectional survey using a convenience sample in a rural community in southwestern Ohio.

Methods: A 25-item electronic survey was created to assess knowledge and attitudes of the community towards SUD, evidenced-based practices, and stigma. Questions were grouped into five subcategories to meaningfully address high-priority areas. Descriptive statistics included frequencies and percentages. A comparative analysis was performed using Chi-square and phi to evaluate response rates from the first question, A substance use disorder is a real illness like diabetes and heart disease, to the other survey questions.

Results: A total of 173 people responded to the survey. The response to "A substance use disorder is a real illness like diabetes and heart disease" resulted in two groups of similar size, with 83 (48.5%) of the respondents agreeing with the statement. There was a significant difference (p < .001) in 15 questions between the two groups.

Conclusions: People who believe SUD is a real illness were more likely to support evidence-based treatment practices, show less stigma towards those suffering from SUD, and support harm reduction services.
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http://dx.doi.org/10.1016/j.pmn.2021.03.004DOI Listing
April 2021

Hepatitis C virus DAA treatment adherence patterns and SVR among people who inject drugs treated in opioid agonist therapy programs.

Clin Infect Dis 2021 Apr 20. Epub 2021 Apr 20.

Clemson University School of Health Research, Clemson University, Clemson, SC, USA.

Background: Adequate medication adherence is critical for achieving sustained viral response (SVR) of hepatitis C virus (HCV) among people who inject drugs (PWID). However, it is less known which patterns of direct-acting antiviral (DAA) treatment adherence are associated with SVR in this population or what factors are associated with each pattern.

Methods: The randomized three-arm PREVAIL study utilized electronic blister packs to obtain daily time frame adherence data in opiate agonist therapy program settings. Exact logistic regressions were applied to test the associations between SVR and six types of treatment adherence patterns.

Results: Of the 113 participants treated with combination DAAs, 109 (96.5%) achieved SVR. SVR was significantly associated with all pattern parameters except for number of switches between adherent and missed days: total adherent daily doses (exact AOR=1.12; 95%CI=1.04-1.22), percent total doses (1.09; 1.03-1.16), days on treatment (1.16; 1.05-1.32), maximum consecutive adherent days (1.34; 1.06-2.04), maximum consecutive non-adherent days (.85; .74-.95=.003). SVR was significantly associated with total adherent doses in the first two months of treatment, it was not in the last month. Compared to White participants (30.7±11.8(se)), Black (18.4±7.8) and Hispanic participants (19.2±6.1) had significantly shorter maximum consecutive adherent days. While alcohol intoxication was significantly associated with frequent switches, drug use was not associated with any adherence pattern.

Conclusion: Consistent maintenance of adequate total dose adherence over the entire course of HCV treatment is important in achieving SVR among PWID. Additional integrative addiction and medical care may be warranted for treating PWID experiencing alcohol intoxication.
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http://dx.doi.org/10.1093/cid/ciab334DOI Listing
April 2021

Design and methods of a multi-site randomized controlled trial of an integrated care model of long-acting injectable buprenorphine with infectious disease treatment among persons hospitalized with infections and opioid use disorder.

Contemp Clin Trials 2021 Apr 7;105:106394. Epub 2021 Apr 7.

Yale School of Medicine, Department of Internal Medicine, Section of Infectious Disease, Yale AIDS Program, New Haven, CT, USA. Electronic address:

Background: Hospitalization with co-occurring opioid use disorder (OUD) and infections presents a critical time to intervene to improve outcomes for these intertwined epidemics that are typically managed separately. A surge in life-threatening infectious diseases associated with injection drug use, including bacterial and fungal infections, HIV, and HCV accounts for substantial healthcare utilization, morbidity, and mortality. Infectious Disease (ID) specialists manage severe infections that require hospitalization and are a logical resource to engage patients in medication treatment for OUD (MOUD). An injectable long-acting monthly formulation of buprenorphine (LAB) has a potential advantage for initiating MOUD within hospital settings and bridging to treatment after discharge.

Methods: A randomized multi-site trial tests a new model of care (ID/LAB) in which OUD and infections are managed by ID specialists and hospitalists using LAB coupled with referrals to community resources for long-term MOUD. A sample of 200 adults admitted to three U.S. hospitals for OUD and infections are randomly assigned 1:1 to ID/LAB or treatment as usual (TAU). The primary outcome measure is the proportion of patients enrolled in effective MOUD at 12 weeks after randomization. Secondary outcomes include relapse to opioid use, adherence to infectious disease treatment, infection morbidity and mortality, and drug overdose.

Results: We describe the design, procedures, statistical analysis, and early implementation issues of this randomized trial.

Conclusions: Study findings will provide insight into the feasibility and effectiveness of integrated treatment of OUD and serious infections and have the potential to reduce morbidity and mortality in this vulnerable population.
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http://dx.doi.org/10.1016/j.cct.2021.106394DOI Listing
April 2021

Accounting for confounding by time, early intervention adoption, and time-varying effect modification in the design and analysis of stepped-wedge designs: application to a proposed study design to reduce opioid-related mortality.

BMC Med Res Methodol 2021 03 16;21(1):53. Epub 2021 Mar 16.

Department of Biostatistics, Harvard T.H. Chan School of Public Health, Harvard University, Boston, USA.

Background: Beginning in 2019, stepped-wedge designs (SWDs) were being used in the investigation of interventions to reduce opioid-related deaths in communities across the United States. However, these interventions are competing with external factors such as newly initiated public policies limiting opioid prescriptions, media awareness campaigns, and the COVID-19 pandemic. Furthermore, control communities may prematurely adopt components of the intervention as they become available. The presence of time-varying external factors that impact study outcomes is a well-known limitation of SWDs; common approaches to adjusting for them make use of a mixed effects modeling framework. However, these models have several shortcomings when external factors differentially impact intervention and control clusters.

Methods: We discuss limitations of commonly used mixed effects models in the context of proposed SWDs to investigate interventions intended to reduce opioid-related mortality, and propose extensions of these models to address these limitations. We conduct an extensive simulation study of anticipated data from SWD trials targeting the current opioid epidemic in order to examine the performance of these models in the presence of external factors. We consider confounding by time, premature adoption of intervention components, and time-varying effect modification- in which external factors differentially impact intervention and control clusters.

Results: In the presence of confounding by time, commonly used mixed effects models yield unbiased intervention effect estimates, but can have inflated Type 1 error and result in under coverage of confidence intervals. These models yield biased intervention effect estimates when premature intervention adoption or effect modification are present. In such scenarios, models incorporating fixed intervention-by-time interactions with an unstructured covariance for intervention-by-cluster-by-time random effects result in unbiased intervention effect estimates, reach nominal confidence interval coverage, and preserve Type 1 error.

Conclusions: Mixed effects models can adjust for different combinations of external factors through correct specification of fixed and random time effects. Since model choice has considerable impact on validity of results and study power, careful consideration must be given to how these external factors impact study endpoints and what estimands are most appropriate in the presence of such factors.
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http://dx.doi.org/10.1186/s12874-021-01229-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7962436PMC
March 2021

Comparing Routine HIV and Hepatitis C Virus Screening to Estimate the Effect of Required Consent on HIV Screening Rates Among Hospitalized Patients.

Public Health Rep 2021 Mar 5:33354921999170. Epub 2021 Mar 5.

368074 Department of Medicine, University of South Carolina School of Medicine, Greenville, SC, USA.

Objectives: Routine screening for HIV and hepatitis C virus (HCV) among specified age cohorts is recommended. New York State requires consent before screening for HIV but not HCV. We sought to estimate the effect of the consent requirement on screening rates for HIV.

Methods: We performed a retrospective study of patients hospitalized in 2015-2016 at a tertiary care hospital in the Bronx, New York, during a period when prompts in the electronic health record facilitated screening for HIV and HCV among specified age cohorts. We compared proportions of patients eligible for screening for HIV and/or HCV who underwent screening and used generalized estimating equations and a meta-analytic weighted average to estimate an adjusted risk difference between undergoing HIV screening and undergoing HCV screening.

Results: Among 11 938 hospitalized patients eligible for HIV and/or HCV screening, 38.5% underwent screening for HIV and 59.1% underwent screening for HCV. The difference in screening rates persisted after adjusting for patient and admission characteristics (adjusted risk difference = 22.0%; 95% CI, 20.6%-23.4%).

Conclusions: Whereas the requirement for consent was the only difference in the processes of screening for HIV compared with screening for HCV, differences in how the 2 viruses are perceived may also have contributed to the difference in screening rates. Nevertheless, our findings suggest that requiring consent continues to impede progress toward the public health goal of routine HIV screening.
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http://dx.doi.org/10.1177/0033354921999170DOI Listing
March 2021

High HCV cure rates among people who inject drugs and have suboptimal adherence: A patient-centered approach to HCV models of care.

Int J Drug Policy 2021 Mar 1;93:103135. Epub 2021 Mar 1.

Department of Medicine, University of South Carolina School of Medicine - Greenville, Greenville, SC, United States; Department of Medicine, Prisma Health-Upstate, Greenville, SC, United States; Clemson University School of Health Research, Clemson, SC, United States.

Background: Though people who inject drugs (PWID) make up the majority of the hepatitis C virus (HCV) epidemic, concerns about adherence often exclude PWID from receiving direct-acting antiviral (DAA) medication. The most effective models of HCV care to promote sustained virologic response (SVR) and high adherence need to be evaluated.

Methods: We conducted a prospective cohort study in three opioid treatment programs (OTPs) in the Bronx, NY. Participants, in collaboration with providers, chose one of three models of onsite care: directly observed therapy (mDOT), group treatment (GT), or self-administered individual treatment (SIT).  SVR12, daily adherence, and participant characteristics were compared between groups.

Results: Of 61 participants, the majority were male (62%) and Latino (67%), with a mean age of 53 (SD 9). Participants received DAAs via one of three models of care: mDOT (21%), GT (25%), or SIT (54%). The majority (59%) used illicit drugs during treatment. Overall, SVR12 was 98% with no differences between models of care: mDOT (100%), GT (100%), and SIT (97%) (p = 1.0). Overall, daily adherence was 73% (SD 16); 86% among those who chose mDOT compared to 71% among those who chose GT (p<0.01) and 73% among those who chose SIT (p<0.01).

Conclusion: Despite ongoing illicit drug use and suboptimal adherence, SVR12 was high among PWID treated onsite at an OTP using any one of three models of care. Shared decision making in real world settings may be key to choosing the appropriate model of care for PWID.
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http://dx.doi.org/10.1016/j.drugpo.2021.103135DOI Listing
March 2021

Declines in Depressive Symptoms Among People who Inject Drugs Treated With Direct-Acting Antivirals While on Opioid Agonist Therapy.

Open Forum Infect Dis 2020 Oct 10;7(10):ofaa380. Epub 2020 Oct 10.

Clemson University School of Health Research, Clemson, South Carolina, USA.

Background: Hepatitis C virus (HCV) frequently co-occurs with symptoms of depression, which are aggravated on interferon-based regimens. However, it is unknown whether HCV treatment with direct-acting antivirals (DAAs) has effects on depressive symptoms among people who inject drugs (PWID). In this study, we examined changes in depressive symptoms during and after HCV treatment among PWID on opioid agonist therapies (OATs).

Methods: Participants were 141 PWID who achieved sustained viral response after on-site HCV treatment at 3 OAT programs.Depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II) at baseline, every 4 weeks during treatment, and 12 and 24 weeks after treatment completion. Current diagnosis of depression or other psychiatric diagnoses were obtained through chart review. Use of illicit drugs was measured by urine toxicology screening. Alcohol use was measured using the Addiction Severity Index-Lite.

Results: Of the 141 PWID infected with HCV, 24.1% had severe, 9.9% had moderate, 15.6% had mild, and 50.4% had minimal levels of depression as per BDI-II scores at baseline. HCV treatment was significantly associated with reductions in depressive symptoms that persisted long term, regardless of symptom severity ( < .001) or presence of depression ( ≤ .01) or other psychiatric diagnoses ( ≤ .01) at baseline. Concurrent drug use ( ≤ .001) or hazardous alcohol drinking ( ≤ .001) did not interfere with reductions in depressive symptoms.

Conclusions: Depressive symptoms are highly prevalent among HCV-infected PWID. HCV treatment was associated with sustained reductions in depressive symptoms. HCV therapy with DAAs may have important implications for PWID that go beyond HCV cure.
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http://dx.doi.org/10.1093/ofid/ofaa380DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7751182PMC
October 2020

Factors and HCV treatment outcomes associated with smoking among people who inject drugs on opioid agonist treatment: secondary analysis of the PREVAIL randomized clinical trial.

BMC Infect Dis 2020 Dec 4;20(1):928. Epub 2020 Dec 4.

School of Health Research, Clemson University, Clemson, SC, USA.

Background: Cigarette smoking has emerged as a leading cause of mortality among people with hepatitis C virus (HCV). People who inject drugs (PWID) represent the largest group of adults infected with HCV in the US. However, cigarette smoking remains virtually unexplored among this population. This study aimed at (1) determining prevalence and correlates of cigarette smoking among HCV-infected PWID enrolled in opiate agonist treatment programs; (2) exploring the association of smoking with HCV treatment outcomes including adherence, treatment completion and sustained virologic response (SVR); and 3) exploring whether cigarette smoking decreased after HCV treatment.

Methods: Participants were 150 HCV-infected PWID enrolled in a randomized clinical trial primarily designed to test three intensive models of HCV care. Assessments included sociodemographics, presence of chronic health and psychiatric comorbidities, prior and current drug use, quality of life, and HCV treatment outcomes.

Results: The majority of the patients (84%) were current cigarette smokers at baseline. There was a high prevalence of psychiatric and medical comorbidities in the overall sample of PWID. Alcohol and cocaine use were identified as correlates of cigarette smoking. Smoking status did not influence HCV treatment outcomes including adherence, treatment completion and SVR. HCV treatment was not associated with decreased cigarette smoking.

Conclusions: The present study showed high prevalence of cigarette smoking among this population as well as identified correlates of smoking, namely alcohol and cocaine use. Cigarette smoking was not associated with HCV treatment outcomes. Given the detrimental effects that cigarette smoking and other co-occurring, substance use behaviors have on HCV-infected individuals' health, it is imperative that clinicians treating HCV also target smoking, especially among PWID. The high prevalence of cigarette smoking among PWID will contribute to growing morbidity and mortality among this population even if cured of HCV. Tailored smoking cessation interventions for PWID along with HCV treatment may need to be put into clinical practice.

Trial Registration: NCT01857245 . Registered May 20, 2013.
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http://dx.doi.org/10.1186/s12879-020-05667-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7718688PMC
December 2020

Knowledge, attitudes, and acceptability of direct-acting antiviral hepatitis C treatment among people incarcerated in jail: A qualitative study.

PLoS One 2020 2;15(12):e0242623. Epub 2020 Dec 2.

Correctional Health Services, New York City Health + Hospitals, New York, NY, United States of America.

Introduction: While U.S. jails are critical sites for engagement in HCV care, short lengths-of-stay often do not permit treatment in jail. Therefore, linkage to HCV care after incarceration is crucial. However, little is known about HCV treatment acceptability among justice-involved individuals in U.S. jails. The goal of this study was to understand knowledge, attitudes, and acceptability of HCV treatment among people living with HCV in the New York City (NYC) jail system.

Methods: We recruited 36 HCV-antibody-positive individuals in the NYC jails using clinical data reports and performed semi-structured interviews to explore participants' attitudes toward HCV treatment in jail and following return to the community. We continued interviews until reaching thematic saturation and analyzed interviews using an inductive, thematic approach.

Results: Participants were mostly male, Latina/o, with a mean age of 40 years. Nearly all were aware they were HCV antibody-positive. Two thirds of participants had some awareness of the availability of new HCV therapies. Key themes included: 1) variable knowledge of new HCV therapies affecting attitudes toward HCV treatment, 2) the importance of other incarcerated individuals in communicating HCV-related knowledge, 3) vulnerability during incarceration and fear of treatment interruption, 4) concern for relapse to active drug use and HCV reinfection, 5) competing priorities (such as other medical comorbidities, ongoing substance use, and housing), 6) social support and the importance of family.

Conclusions: Patient-centered approaches to increase treatment uptake in jail settings should focus on promoting HCV-related knowledge including leveraging peers for knowledge dissemination. In addition, transitional care programs should ensure people living with HCV in jail have tailored discharge plans focused on competing priorities such as housing instability, social support, and treatment of substance use disorders.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0242623PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7710033PMC
January 2021

Rates of perfect self-reported adherence to direct-acting antiviral therapy and its correlates among people who inject drugs on medications for opioid use disorder: The PREVAIL study.

J Viral Hepat 2021 Mar 9;28(3):548-557. Epub 2020 Dec 9.

Clemson University School of Health Research, Clemson University, Clemson, SC, USA.

Adequate adherence to direct-acting antivirals (DAAs) for hepatitis C virus (HCV) is critical to attaining sustained virologic response (SVR). In this PREVAIL study's secondary analyses, we explored the association between self-reported and objective DAAs adherence among a sample of people who inject drugs (PWID) receiving medications for opioid use disorder (MOUD) (N = 147). Self-reported adherence was recoded 3 times during treatment (weeks 4, 8 and 12) using a visual analog scale (VAS), whereas objective adherence was collected continuously during treatment using electronic blister packs. Participants who reported being perfectly adherent had significantly higher blister pack adherence in each period (weeks 4, 8 and 12; ps < .05) and over the 12-week study (p < .001) compared to those who reported being non-perfectly adherent. Whites were more likely to report perfect adherence (91.7%) than Blacks (48.7%), Latinos (52.2%) and other (75.0%) race groups. Participants who reported recent use of cocaine (63.9%) or polysubstance use (60.0%) and those who had a positive result for cocaine (62.8%) were more likely to be non-perfectly adherent, although none of these factors were associated with blister pack adherence. This study showed that the VAS could serve as a reliable option for assessing DAAs adherence among PWID on MOUD. The implementation of VAS may be an ideal option for monitoring adherence among PWID on MOUD, especially in clinical settings with limited resources. PWID on MOUD who are Black or other races than White, as well as those who report recent cocaine or polysubstance use may require additional support to maintain optimal DAA adherence.
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http://dx.doi.org/10.1111/jvh.13445DOI Listing
March 2021

Accounting for Confounding by Time, Early Intervention Adoption, and Time-Varying Effect Modification in the Design and Analysis of Stepped-Wedge Designs: Application to a Proposed Study Design to Reduce Opioid-Related Mortality.

Res Sq 2020 Nov 12. Epub 2020 Nov 12.

Department of Biostatistics, Harvard T.H. Chan School of Public Health, Harvard University, Boston, U.S.A.

Stepped-wedge designs (SWDs) are currently being used in the investigation of interventions to reduce opioid-related deaths in communities located in several states. However, these interventions are competing with external factors such as newly initiated public policies limiting opioid prescriptions, media awareness campaigns, and COVID-19 social distancing mandates. Furthermore, control communities may prematurely adopt components of the intervention as they become available. The presence of time-varying external factors that impact study outcomes is a well-known limitation of SWDs; common approaches to adjusting for them make use of a mixed effects modeling framework. However, these models have several shortcomings when external factors differentially impact intervention and control clusters. We discuss limitations of commonly used mixed effects models in the context of proposed SWDs to investigate interventions intended to reduce opioid-related mortality, and propose extensions of these models to address these limitations. We conduct an extensive simulation study of anticipated data from SWD trials targeting the current opioid epidemic in order to examine the performance of these models in the presence of external factors. We consider confounding by time, premature adoption of components of the intervention, and time-varying effect modificationâ€" in which external factors differentially impact intervention and control clusters. In the presence of confounding by time, commonly used mixed effects models yield unbiased intervention effect estimates, but can have inflated Type 1 error and result in under coverage of confidence intervals. These models yield biased intervention effect estimates when premature intervention adoption or effect modification are present. In such scenarios, models incorporating fixed intervention-by-time interactions with an unstructured covariance for intervention-by-cluster-by-time random effects result in unbiased intervention effect estimates, reach nominal confidence interval coverage, and preserve Type 1 error. Mixed effects models can adjust for different combinations of external factors through correct specification of fixed and random time effects; misspecification can result in bias of the intervention effect estimate, under coverage of confidence intervals, and Type 1 error inflation. Since model choice has considerable impact on validity of results and study power, careful consideration must be given to choosing appropriate models that account for potential external factors.
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http://dx.doi.org/10.21203/rs.3.rs-103992/v1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7668751PMC
November 2020

Low Adherence Achieves High HCV Cure Rates Among People Who Inject Drugs Treated With Direct-Acting Antiviral Agents.

Open Forum Infect Dis 2020 Oct 26;7(10):ofaa377. Epub 2020 Aug 26.

Department of Medicine, University of South Carolina School of Medicine - Greenville, Greenville, South Carolina, USA.

We measured hepatitis C virus (HCV) adherence via electronic blister packs for 145 people who inject drugs treated on-site in a methadone program. The overall sustained virologic response (SVR) rate was 96% (95% CI, 91%-98%), and overall daily adherence was 78% (95% CI, 76%-81%). Participants who achieved at least 50% adherence had an overall SVR rate of 99%, with each 5% adherence interval >50% achieving at least 90% adherence. Suboptimal adherence may still lead to cure in the direct-acting antiviral era.
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http://dx.doi.org/10.1093/ofid/ofaa377DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7590860PMC
October 2020

Artificial Intelligence Platform Demonstrates High Adherence in Patients Receiving Fixed-Dose Ledipasvir and Sofosbuvir: A Pilot Study.

Open Forum Infect Dis 2020 Aug 20;7(8):ofaa290. Epub 2020 Jul 20.

Clemson University School of Health Research, Clemson, South Carolina, USA.

This study evaluated health outcomes among people who inject drugs who are infected with hepatitis C virus using an artificial intelligence platform. Mean (SD) cumulative adherence (visual confirmation of administration) was 91.3% (10.5%). Most subjects (88.2%) achieved ≥80% adherence to treatment, and 88.2% (15 of 17) achieved a sustained virologic response.
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http://dx.doi.org/10.1093/ofid/ofaa290DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7423287PMC
August 2020

Accounting for external factors and early intervention adoption in the design and analysis of stepped-wedge designs: Application to a proposed study design to reduce opioid-related mortality.

medRxiv 2020 Jul 29. Epub 2020 Jul 29.

Department of Biostatistics, Harvard T.H. Chan School of Public Health, Harvard University, Boston, U.S.A.

Background: Stepped-wedge designs (SWDs) are currently being used to investigate interventions to reduce opioid overdose deaths in communities located in several states. However, these interventions are competing with external factors such as newly initiated public policies limiting opioid prescriptions, media awareness campaigns, and social distancing orders due to the COVID-19 pandemic. Furthermore, control communities may prematurely adopt components of the proposed intervention as they become widely available. These types of events induce confounding of the intervention effect by time. Such confounding is a well-known limitation of SWDs; a common approach to adjusting for it makes use of a mixed effects modeling framework that includes both fixed and random effects for time. However, these models have several shortcomings when multiple confounding factors are present.

Methods: We discuss the limitations of existing methods based on mixed effects models in the context of proposed SWDs to investigate interventions intended to reduce mortality associated with the opioid epidemic, and propose solutions to accommodate deviations from assumptions that underlie these models. We conduct an extensive simulation study of anticipated data from SWD trials targeting the current opioid epidemic in order to examine the performance of these models under different sources of confounding. We specifically examine the impact of factors external to the study and premature adoption of intervention components.

Results: When only external factors are present, our simulation studies show that commonly used mixed effects models can result in unbiased estimates of the intervention effect, but have inflated Type 1 error and result in under coverage of confidence intervals. These models are severely biased when confounding factors differentially impact intervention and control clusters; premature adoption of intervention components is an example of this scenario. In these scenarios, models that incorporate fixed intervention-by-time interaction terms and an unstructured covariance for the intervention-by-cluster-by-time random effects result in unbiased estimates of the intervention effect, reach nominal confidence interval coverage, and preserve Type 1 error, but may reduce power.

Conclusions: The incorporation of fixed and random time effects in mixed effects models require certain assumptions about the impact of confounding by time in SWD. Violations of these assumptions can result in severe bias of the intervention effect estimate, under coverage of confidence intervals, and inflated Type 1 error. Since model choice has considerable impact on study power as well as validity of results, careful consideration needs to be given to choosing an appropriate model that takes into account potential confounding factors.
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http://dx.doi.org/10.1101/2020.07.26.20162297DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7402056PMC
July 2020

Community Attitudes Toward Opioid Use Disorder and Medication for Opioid Use Disorder in a Rural Appalachian County.

J Rural Health 2021 01 1;37(1):29-34. Epub 2020 Aug 1.

Accountable Communities/Prisma Health, Prisma Health Addiction Research Center, Greenville, South Carolina.

Purpose: To evaluate community attitudes concerning opioid use disorder (OUD) and medication for opioid use disorder (MOUD) in a rural community, and to plan educational initiatives to reduce stigma surrounding OUD and treatment.

Methods: Dissemination of a 24-question survey to people living in a rural community followed by comparative analysis of survey results between 2 groups classified by recognition of OUD as a real illness.

Findings: Three hundred sixty-one individuals responded. Overall, 69% agreed that OUD is a real illness. Respondents recognizing OUD as a real illness were less likely to agree that individuals with OUD are dangerous (P = .014), more likely to agree that MOUD is effective (P < .001), that individuals with OUD should have the same right to a job (P < .001), and that naloxone should be administered for every overdose every time (P = .002).

Conclusions: Significant stigma exists toward individuals with OUD in rural communities, and recognizing OUD as a real illness is associated with less stigmatizing attitudes and better understanding of MOUD. Further study should focus on how to effectively convince communities that OUD is a real illness.
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http://dx.doi.org/10.1111/jrh.12503DOI Listing
January 2021

Group-Based Care in Adults and Adolescents With Hypertension and CKD: A Feasibility Study.

Kidney Med 2020 May-Jun;2(3):317-325. Epub 2020 Apr 18.

Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY.

Rationale & Objective: Group-based care provides an opportunity to increase patient access to providers without increasing physician time and is effective in the management of chronic diseases in the general population. This model of care has not been investigated in chronic kidney disease (CKD).

Study Design: Randomized controlled trial in adults (n = 50); observational study in adolescents (n = 10).

Setting & Participants: Adults and adolescents with CKD and hypertension in the Bronx, NY.

Intervention: Group-based care (monthly sessions over 6 months) versus usual care in adults. All adolescents received group-based care and were analyzed separately.

Outcomes: Participant attendance and satisfaction with group-based care were used to evaluate intervention feasibility. The primary clinical outcome was change in mean 24-hour ambulatory blood pressure. Secondary outcomes included physical activity, medication adherence, quality of life, and sodium intake as assessed by 24-hour urinary sodium excretion and food frequency questionnaires.

Results: Among adults randomly assigned to group-based care, attendance was high (77% of participants attended ≥3 sessions) and most reported higher satisfaction. Mean 24-hour ambulatory systolic blood pressure decreased by -4.2 (95% CI, -13.3 to 5.8) mm Hg in group-based care patients compared with usual care at 6 months but this was not statistically significant. Similarly, we did not detect significant differences in health-related behaviors (such as medication adherence, sodium intake, and physical activity) or quality-of-life measures between the 2 groups. Among the adolescents, attendance was very poor; self-reported satisfaction, although high, did not change from baseline compared with the 6-month follow-up.

Limitations: Small study size, missing data.

Conclusions: Group-based care is feasible and acceptable among adults with hypertension and CKD. However, a larger trial is needed to determine the effect on blood pressure and health-related behaviors. Patient participation may limit the effectiveness of group-based care models in adolescents.

Funding: National Institutes of Health R34 DK102174.

Trial Registration: https://clinicaltrials.gov/show/NCT02467894.
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http://dx.doi.org/10.1016/j.xkme.2020.01.013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7380347PMC
April 2020

Reinfection Following Successful Direct-acting Antiviral Therapy for Hepatitis C Virus Infection Among People Who Inject Drugs.

Clin Infect Dis 2021 Apr;72(8):1392-1400

The Kirby Institute, University of New South Wales Sydney, Sydney, Australia.

Background: The aim of this analysis was to calculate the incidence of hepatitis C virus (HCV) reinfection and associated factors among 2 clinical trials of HCV direct-acting antiviral treatment in people with recent injecting drug use or currently receiving opioid agonist therapy (OAT).

Methods: Participants who achieved an end-of-treatment response in 2 clinical trials of people with recent injecting drug use or currently receiving OAT (SIMPLIFY and D3FEAT) enrolled between March 2016 and February 2017 in 8 countries were assessed for HCV reinfection, confirmed by viral sequencing. Incidence was calculated using person-time of observation and associated factors were assessed using Cox proportional hazard models.

Results: Seventy-three percent of the population at risk of reinfection (n = 177; median age, 48 years; 73% male) reported ongoing injecting drug use. Total follow-up time at risk was 254 person-years (median, 1.8 years; range, 0.2-2.8 years). Eight cases of reinfection were confirmed for an incidence of 3.1/100 person-years (95% confidence interval [CI], 1.6-6.3) overall and 17.9/100 person-years (95% CI, 5.8-55.6) among those who reported sharing needles/syringes. Younger age and needle/syringe sharing were associated with HCV reinfection.

Conclusions: These data demonstrate the need for ongoing monitoring and improved strategies to prevent HCV reinfection following successful treatment among people with ongoing injecting drug use to achieve HCV elimination.

Clinical Trials Registration: NCT02336139 and NCT02498015.
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http://dx.doi.org/10.1093/cid/ciaa253DOI Listing
April 2021

A Phylogenetic Analysis of Hepatitis C Virus Transmission, Relapse, and Reinfection Among People Who Inject Drugs Receiving Opioid Agonist Therapy.

J Infect Dis 2020 07;222(3):488-498

Prisma Health, University of South Carolina School of Medicine, Clemson University School of Health Research.

Background: Understanding hepatitis C virus (HCV) transmission among people who inject drugs (PWID) is essential for HCV elimination. We aimed to differentiate reinfections from treatment failures and to identify transmission linkages and associated factors in a cohort of PWID receiving opioid agonist therapy (OAT).

Methods: We analyzed baseline and follow-up specimens from 150 PWID from 3 OAT clinics in the Bronx, New York. Next-generation sequencing data from the hypervariable region 1 of HCV were analyzed using Global Hepatitis Outbreak and Surveillance Technology.

Results: There were 3 transmission linkages between study participants. Sustained virologic response (SVR) was not achieved in 9 participants: 7 had follow-up specimens with similar sequences to baseline, and 2 died. In 4 additional participants, SVR was achieved but the participants were viremic at later follow-up: 2 were reinfected with different strains, 1 had a late treatment failure, and 1 was transiently viremic 17 months after treatment. All transmission linkages were from the same OAT clinic and involved spousal or common-law partnerships.

Conclusion: This study highlights the use of next-generation sequencing as an important tool for identifying viral transmission and to help distinguish relapse and reinfection among PWID. Results reinforce the need for harm reduction interventions among couples and those who report ongoing risk factors after SVR.
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http://dx.doi.org/10.1093/infdis/jiaa100DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7336560PMC
July 2020

Adherence to Once-daily and Twice-daily Direct-acting Antiviral Therapy for Hepatitis C Infection Among People With Recent Injection Drug Use or Current Opioid Agonist Therapy.

Clin Infect Dis 2020 10;71(7):e115-e124

The Kirby Institute, University of New South Wales, Sydney, Australia.

Background: This study investigated adherence and associated factors among people with recent injection drug use (IDU) or current opioid agonist therapy (OAT) and compared once-daily to twice-daily hepatitis C virus (HCV) direct-acting antiviral (DAA) therapy.

Methods: SIMPLIFY and D3FEAT are international, multicenter studies that recruited participants with recent IDU (previous 6 months; SIMPLIFY, D3FEAT) or current OAT (D3FEAT) between March 2016 and February 2017 in 8 countries. Participants received sofosbuvir/velpatasvir (once daily; SIMPLIFY) or paritaprevir/ritonavir/ombitasvir, dasabuvir (twice daily) ± ribavirin (D3FEAT) for 12 weeks administered in electronic blister packs. We evaluated overall adherence (proportion of prescribed doses taken) and nonadherence (<90% adherent) between dosing patterns.

Results: Of 190 participants, 184 (97%) completed treatment. Median adherence was 92%, with higher adherence among those receiving once-daily vs twice-daily therapy (94% vs 87%, P = .005). Overall, 40% of participants (n = 76) were nonadherent (<90% adherent). Recent stimulant injecting (odds ratio [OR], 2.48 [95% confidence interval {CI}, 1.28-4.82]), unstable housing (OR, 2.18 [95% CI, 1.01-4.70]), and twice-daily dosing (OR, 2.81 [95% CI, 1.47-5.36]) were associated with nonadherence. Adherence decreased during therapy. Sustained virologic response was high in nonadherent (89%) and adherent populations (95%, P = .174), with no difference in SVR between those who did and did not miss 7 consecutive doses (92% vs 93%, P = .897).

Conclusions: This study demonstrated high adherence to once- and twice-daily DAA therapy among people with recent IDU or currently receiving OAT. Nonadherence described did not impact treatment outcomes, suggesting forgiveness to nonadherence.
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http://dx.doi.org/10.1093/cid/ciz1089DOI Listing
October 2020

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

Contemp Clin Trials 2019 12 24;87:105859. Epub 2019 Oct 24.

Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.

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.
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http://dx.doi.org/10.1016/j.cct.2019.105859DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7261375PMC
December 2019

Evaluating reimbursement of integrated support services using chronic care management (CCM) codes for treatment of hepatitis C among Medicare beneficiaries.

J Healthc Risk Manag 2019 Oct 30;39(2):31-40. Epub 2019 Aug 30.

The New York City Department of Health and Mental Hygiene (DOHMH) implemented Project INSPIRE, an integrated model of hepatitis C care coordination and telementoring services, from 2014 to 2017. We evaluated the use of chronic care management (CCM) codes to sustain the intervention. DOHMH data were collected as part of a Healthcare Innovation Award from the Centers for Medicare & Medicaid Services (CMS). A retrospective cohort medical billing study was conducted by assigning INSPIRE activities to procedure codes in both facility and nonfacility settings. Rates for procedures were extracted from the CMS's 2018 fee schedules and added across the eligibility periods for Medicare enrollees. Reimbursement was adjusted on the basis of expected patient attrition and compared to costs. The minimum number needed to treat (NNT) to break even was calculated in each setting. Facility reimbursement was higher than costs, whereas nonfacility reimbursement was lower (both P < .01). The NNT was 23 patients in facilities and 33 patients in nonfacilities; 24 patients per care coordinator were treated annually in INSPIRE. CCM fees alone were insufficient to fully reimburse the costs in either setting. Implementation of an appropriate risk financing strategy is necessary to mitigate financial shortfalls when providing CCM services in facility settings.
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http://dx.doi.org/10.1002/jhrm.21389DOI Listing
October 2019

Linkage to hepatitis C care after incarceration in jail: a prospective, single arm clinical trial.

BMC Infect Dis 2019 Aug 8;19(1):703. Epub 2019 Aug 8.

New York University School of Medicine, New York, NY, USA.

Background: Hepatitis C virus (HCV) is a major public health problem in correctional settings. HCV treatment is often not possible in U.S. jails due to short lengths of stay. Linkage to care is crucial in these settings, but competing priorities complicate community healthcare engagement and retention after incarceration.

Methods: We conducted a single arm clinical trial of a combined transitional care coordination (TCC) and patient navigation intervention and assessed the linkage rate and factors associated with linkage to HCV care after incarceration.

Results: During the intervention, 84 participants returned to the community after their index incarceration. Most participants were male and Hispanic, with a history of mental illness and a mean age of 45 years. Of those who returned to the community, 26 (31%) linked to HCV care within a median of 20.5 days; 17 (20%) initiated HCV treatment, 15 (18%) completed treatment, 9 (11%) had a follow-up lab drawn to confirm sustained virologic response (SVR), and 7 (8%) had a documented SVR. Among those with follow-up labs the known SVR rate was (7/9) 78%. Expressing a preference to be linked to the participant's existing health system, being on methadone prior to incarceration, and feeling that family or a loved one were concerned about the participant's wellbeing were associated with linkage to HCV care. Reporting drinking alcohol to intoxication prior to incarceration was negatively associated with linkage to HCV care.

Conclusion: We demonstrate that an integrated strategy with combined TCC and patient navigation may be effective in achieving timely linkage to HCV care. Additional multicomponent interventions aimed at treatment of substance use disorders and increasing social support could lead to further improvement.

Trial Registration: Clinicaltrials.gov NCT04036760 July 30th, 2019 (retrospectively registered).
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http://dx.doi.org/10.1186/s12879-019-4344-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6686449PMC
August 2019

Low Hepatitis C Reinfection Following Direct-acting Antiviral Therapy Among People Who Inject Drugs on Opioid Agonist Therapy.

Clin Infect Dis 2020 06;70(12):2695-2702

Department of Medicine, University of South Carolina School of Medicine-Greenville, Greenville.

Background: Direct-acting antiviral (DAA) therapy is highly effective in people who inject drugs (PWID); however, rates, specific injection behaviors, and social determinants associated with hepatitis C virus (HCV) reinfection following DAA therapy among PWID on opioid agonist therapy (OAT) are poorly understood.

Methods: PREVAIL was a randomized controlled trial that assessed models of HCV care for 150 PWID on OAT. Those who achieved sustained virologic response (SVR) (n = 141; 94%) were eligible for this extension study. Interviews and assessments of recurrent HCV viremia occurred at 6-month intervals for up to 24 months following PREVAIL. We used survival analysis to analyze variables associated with time to reinfection.

Results: Of 141 who achieved SVR, 114 had a least 1 visit in the extension study (62% male; mean age, 52 years). Injection drug use (IDU) was reported by 19% (n = 22) in the extension study. HCV reinfection was observed in 3 participants. Over 246 person-years of follow-up, the incidence of reinfection was 1.22/100 person-years (95% CI, 0.25-3.57). All reinfections occurred among participants reporting ongoing IDU. The incidence of reinfection in participants reporting ongoing IDU (41 person-years of follow-up) was 7.4/100 person-years (95% CI, 1.5-21.6). Reinfection was associated with reporting ongoing IDU in the follow-up period (P < .001), a lack confidence in the ability to avoid contracting HCV (P < .001), homelessness (P = .002), and living with a PWID (P = .007).

Conclusions: HCV reinfection was low overall, but more common among people with ongoing IDU following DAA therapy on OAT, as well as those who were not confident in the ability to avoid contracting HCV, homeless, or living with a PWID. Interventions to mediate these risk factors following HCV therapy are warranted.
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http://dx.doi.org/10.1093/cid/ciz693DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7456350PMC
June 2020

Patterns of Drug and Alcohol Use and Injection Equipment Sharing Among People With Recent Injecting Drug Use or Receiving Opioid Agonist Treatment During and Following Hepatitis C Virus Treatment With Direct-acting Antiviral Therapies: An International Study.

Clin Infect Dis 2020 05;70(11):2369-2376

Kirby Institute, University of New South Wales, Australia.

Background: In many settings, recent or prior injection drug use remains a barrier to accessing direct-acting antiviral treatment (DAA) for hepatitis C virus (HCV) infection. We examined patterns of drug and alcohol use and injection equipment sharing among people with recent injecting drug use or receiving opioid agonist treatment (OAT) during and following DAA-based treatment.

Methods: SIMPLIFY and D3FEAT are phase 4 trials evaluating the efficacy of DAA among people with past 6-month injecting drug use or receiving OAT through a network of 25 international sites. Enrolled in 2016-2017, participants received sofosbuvir/velpatasvir (SIMPLIFY) or paritaprevir/ritonavir/dasabuvir/ombitasvir ± ribavirin (D3FEAT) for 12 weeks and completed behavioral questionnaires before, during, and up to 2 years posttreatment. The impact of time in HCV treatment and follow-up on longitudinally measured longitudinally measured behaviors was estimated using generalized estimating equations.

Results: At screening, of 190 participants (mean age, 47 years; 74% male), 62% reported any past-month injecting 16% past-month injection equipment sharing, and 61% current OAT. Median alcohol use was 2 (Alcohol Use Disorders Identification Test-Consumption; range, 1-12). During follow-up, opioid injecting (odds ratio [OR], 0.95; 95% confidence interval [CI], 0.92-0.99) and sharing (OR, 0.87; 95% CI, 0.80-0.94) decreased, whereas no significant changes were observed for stimulant injecting (OR, 0.98; 95% CI, 0.94-1.02) or alcohol use (OR, 0.99; 95% CI, 0.95-1.04).

Conclusions: Injecting drug use and risk behaviors remained stable or decreased following DAA-based HCV treatment. Findings further support expanding HCV treatment to all, irrespective of injection drug use.

Clinical Trials Registration: SIMPLIFY, NCT02336139; D3FEAT, NCT02498015.
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http://dx.doi.org/10.1093/cid/ciz633DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7245153PMC
May 2020

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Int J Environ Res Public Health 2019 06 2;16(11). Epub 2019 Jun 2.

School of Medicine, University of South Carolina, Greenville Health System, 701 Grove Road, Greenville, SC 29605, USA.

Background: Hepatitis C virus (HCV) among young suburban people who inject drugs (PWID) is a growing epidemic in the United States, yet little is known about the factors contributing to increased exposure. The goal of this study was to explore and assess HCV knowledge and attitudes about treatment and identify risk behaviors among a cohort of young suburban PWID. We conducted interviews with New Jersey (NJ) service providers and staff from the state's five syringe service programs to inform a semistructured survey addressing HCV knowledge, treatment, and risk factors among young suburban PWID. We then used this survey to conduct qualitative interviews with 14 young suburban PWID (median age 26 years) in NJ between April and May 2015. Data were analyzed using a modified grounded theory approach and coded to identify thematic relationships among respondents. Most participants had substantial gaps in several aspects of HCV knowledge. These included: HCV transmission, HCV symptoms, and the availability of new direct-acting antiviral therapy. Participants also downplayed the risk of past and current risk behaviors, such as sharing drug paraphernalia and reusing needles, which also reflected incomplete knowledge regarding these practices. Young suburban PWID are not receiving or retaining accurate and current HCV information. Innovative outreach and prevention messages specifically tailored to young suburban PWID may help to disseminate HCV prevention and treatment information to this population.
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http://dx.doi.org/10.3390/ijerph16111958DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6604001PMC
June 2019

Telementoring of primary care providers delivering hepatitis C treatment in New York City: Results from Project INSPIRE.

Learn Health Syst 2018 Jul 10;2(3). Epub 2018 May 10.

Heathcare Policy & Research, Weill Cornell Medical College, New York City, New York.

Introduction: The recent availability of highly effective, easily administered, and relatively nontoxic treatments for hepatitis C virus (HCV) infection provides an opportunity for clinicians to treat HCV in nonspecialist settings with appropriate support. Project INSPIRE provides care coordination to HCV patients and a web-based training program (telementoring) on disease management and treatment by HCV specialists to primary care providers inexperienced in HCV treatment. Weekly telementoring sessions use a didactic and case-based approach to instruct non-HCV providers on how to identify and assess HCV treatment candidates and prescribe appropriate treatment.

Methods: We used mixed methods to assess the telementoring service, including provider surveys and semistructured interviews. Quantitative data were analyzed using descriptive statistics, and qualitative data were analyzed to identify dominant themes.

Results: Provider survey responses indicated an increased ability to identify and evaluate HCV treatment candidates and increased confidence in sharing knowledge with peers and patients. Interviews revealed a high degree of satisfaction with the telementoring service and Project INSPIRE overall. The telementoring service was viewed as having enhanced providers' knowledge, confidence, and ability to treat their own HCV-infected patients rather than having to refer them to an HCV specialist with resulting benefits for continuity of care. Providers reported comradery and collegiality with other INSPIRE providers and satisfaction with professional growth from attaining new knowledge and skills via the telementoring service.

Conclusions: Using readily available web conferencing technology, telementoring can facilitate knowledge transfer between specialists and primary care providers, facilitating continuity of care for patients and increased provider satisfaction.
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http://dx.doi.org/10.1002/lrh2.10056DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6508766PMC
July 2018

Cost-effectiveness of Hepatitis C Virus Treatment Models for People Who Inject Drugs in Opioid Agonist Treatment Programs.

Clin Infect Dis 2020 03;70(7):1397-1405

Department of Medicine, Section of Infectious Diseases, Boston Medical Center, Massachusetts.

Background: Many people who inject drugs in the United States have chronic hepatitis C virus (HCV). On-site treatment in opiate agonist treatment (OAT) programs addresses HCV treatment barriers, but few evidence-based models exist.

Methods: We evaluated the cost-effectiveness of HCV treatment models for OAT patients using data from a randomized trial conducted in Bronx, New York. We used a decision analytic model to compare self-administered individual treatment (SIT), group treatment (GT), directly observed therapy (DOT), and no intervention for a simulated cohort with the same demographic characteristics of trial participants. We projected long-term outcomes using an established model of HCV disease progression and treatment (hepatitis C cost-effectiveness model: HEP-CE). Incremental cost-effectiveness ratios (ICERs) are reported in 2016 US$/quality-adjusted life years (QALY), discounted 3% annually, from the healthcare sector and societal perspectives.

Results: For those assigned to SIT, we projected 89% would ever achieve a sustained viral response (SVR), with 7.21 QALYs and a $245 500 lifetime cost, compared to 22% achieving SVR, with 5.49 QALYs and a $161 300 lifetime cost, with no intervention. GT was more efficient than SIT, resulting in 0.33 additional QALYs and a $14 100 lower lifetime cost per person, with an ICER of $34 300/QALY, compared to no intervention. DOT was slightly more effective and costly than GT, with an ICER > $100 000/QALY, compared to GT. In probabilistic sensitivity analyses, GT and DOT were preferred in 91% of simulations at a threshold of <$100 000/QALY; conclusions were similar from the societal perspective.

Conclusions: All models were associated with high rates of achieving SVR, compared to standard care. GT and DOT treatment models should be considered as cost-effective alternatives to SIT.
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http://dx.doi.org/10.1093/cid/ciz384DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7318779PMC
March 2020

Perceived barriers related to testing, management and treatment of HCV infection among physicians prescribing opioid agonist therapy: The C-SCOPE Study.

J Viral Hepat 2019 09 11;26(9):1094-1104. Epub 2019 Jun 11.

The Kirby Institute, UNSW Sydney, Sydney, Australia.

The aim of this analysis was to evaluate perceived barriers related to HCV testing, management and treatment among physicians practicing in clinics offering opioid agonist treatment (OAT). C-SCOPE was a study consisting of a self-administered survey among physicians practicing at clinics providing OAT in Australia, Canada, Europe and the United States between April and May 2017. A 5-point Likert scale (1 = not a barrier, 3 = moderate barrier, 5 = extreme barrier) was used to measure responses to perceived barriers for HCV testing, evaluation and treatment across the domains of the health system, clinic and patient. Among the 203 physicians enrolled (40% USA, 45% Europe, 14% Australia/Canada), 21% were addiction medicine specialists, 29% psychiatrists and 69% were metro/urban. OAT physicians in this study reported poor access to on-site venepuncture (35%), point-of-care HCV testing (16%), and noninvasive liver disease assessment (25%). Only 30% of OAT physicians reported personally treating HCV infection. Major perceived health system barriers to HCV management included the lack of funding for noninvasive liver disease testing, long wait times to see an HCV specialist, lack of funding for new HCV therapies, and reimbursement restrictions based on drug/alcohol use. Major perceived clinic barriers included the lack of peer support programmes and/or HCV case managers to facilitate linkage to care, the need to refer people off-site for noninvasive liver disease staging, the lack of support for on-site phlebotomy and the lack of on-site delivery of HCV therapy. This study highlights several important modifiable barriers to enhance HCV testing, evaluation and treatment among PWID attending OAT clinics.
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http://dx.doi.org/10.1111/jvh.13119DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6771477PMC
September 2019