Publications by authors named "Alain Litwin"

96 Publications

Relationship between depressive symptoms and adherence to direct-acting antivirals: Implications for Hepatitis C treatment among people who inject drugs on medications for opioid use disorder.

Drug Alcohol Depend 2022 05 14;234:109403. Epub 2022 Mar 14.

Prisma Health Addiction Research Center, Greenville, SC, USA; Clemson University School of Health Research, Clemson University, Clemson, SC, USA; University of South Carolina School of Medicine, Department of Medicine, Greenville, SC, USA. Electronic address:

Background: Interferon-based regimens exacerbated depressive symptoms, which interfered with treating hepatitis C virus (HCV) among people who inject drugs (PWID). Direct-acting antivirals (DAA) are not associated with worsening depressive symptoms; however, the impact of depressive symptoms on adherence remains little known. We examined the association between depressive symptoms and adherence to DAA among HCV-infected PWID. A secondary aim was to identify the optimal cut-off for major depressive disorder for this population.

Methods: Participants were 150 HCV-infected PWID on maintenance treatment enrolled in a randomized clinical trial testing three HCV care models. Severity of depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II) at baseline and every 4 weeks during treatment. Current major depressive disorder at baseline was diagnosed by the Mini-International Neuropsychiatric Interview. Adherence was measured during treatment (weeks 1-12) using electronic blister packs RESULTS: BDI-II scores ≥ 18 were identified as the optimal threshold for diagnosing major depressive disorder. Participants with BDI scores ≥ 18 at baseline had significantly lower adherence rates at weeks 1-4 of treatment compared to those with BDI scores < 18 (b = -0.23, 95% CI: 0.45-0.01, p = 0.044), but not in any other time intervals (weeks 5-8, b = -0.03, 95% CI: -0.32, 0.26, p = 0.825; weeks 9-12, b = -0.33, 95% CI -0.70, 0.02, p = 0.066).

Conclusions: Elevated depressive symptoms were associated with lower adherence to DAA only during the first 4 weeks of HCV treatment. Neither severe depressive symptoms nor major depressive disorder appears to be a barrier to DAA adherence among PWID.
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http://dx.doi.org/10.1016/j.drugalcdep.2022.109403DOI Listing
May 2022

SARS-CoV-2 Viral Incidence, Antibody Point Prevalence, Associated Population Characteristics, and Vaccine Attitudes, South Carolina, February 2021.

Public Health Rep 2022 May-Jun;137(3):457-462. Epub 2022 Mar 10.

Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.

The SARS-CoV-2 outbreak from October 2020 through February 2021 was the largest outbreak as of February 2021, and timely information on current representative prevalence, vaccination, and loss of prior antibody protection was unknown. In February 2021, the South Carolina Department of Health and Environmental Control conducted a random sampling point prevalence investigation consisting of viral and antibody testing and an associated health survey, after selecting participants aged ≥5 years using a population proportionate to size of South Carolina residents. A total of 1917 residents completed a viral test, 1803 completed an antibody test, and 1463 completed ≥1 test and a matched health survey. We found an incidence of 2.16 per 100 residents and seroprevalence of 16.4% among South Carolina residents aged ≥5 years. Undetectable immunoglobulin G and immunoglobulin M antibodies were noted in 28% of people with a previous positive test result, highlighting the need for targeted education among people who may be susceptible to reinfection. We also found a low rate of vaccine hesitancy in the state (13%). The results of this randomly selected surveillance and associated health survey have important implications for prospective COVID-19 public health response efforts. Most notably, this article provides a feasible framework for prompt rollout of a statewide evidence-based surveillance initiative.
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http://dx.doi.org/10.1177/00333549221081128DOI Listing
May 2022

HIV Preexposure Prophylaxis Care Continuum Among Individuals Receiving Medication for Opioid Use Disorder, South Carolina, 2020-2021.

Am J Public Health 2022 01;112(1):34-37

Jamila Johnson, Carrie Baldwin, Michelle Bublitz, Smith F. Heavner, Prerana Roth, and Alain H. Litwin are with the Addiction Research Center, Prisma Health, Greenville, SC. Mirinda Ann Gormley is with the Department of Public Health Services, Clemson University, Clemson, SC. Susanne Bentley is with the Department of Medicine, University of South Carolina School of Medicine, Greenville.

We implemented the HIV preexposure prophylaxis (PrEP) care continuum among individuals receiving medication for opioid use disorder (MOUD). We screened HIV-negative MOUD participants for PrEP eligibility by assessing injection drug use risk factors and sexual behaviors. Implementation of the PrEP care continuum was challenging; less than a third of MOUD participants were aware of PrEP, and very few initiated PrEP. Findings should promote the development of effective interventions to increase engagement in PrEP during MOUD treatment. (. 2022;112(1):34-37. https://doi.org/10.2105/AJPH.2021.306566).
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http://dx.doi.org/10.2105/AJPH.2021.306566DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8713624PMC
January 2022

Effectiveness of peer recovery support services on stages of the opioid use disorder treatment cascade: A systematic review.

Drug Alcohol Depend 2021 12 9;229(Pt B):109123. Epub 2021 Oct 9.

Prisma Health Addiction Research Center, 605 Grove Rd. Suite 205, Greenville, SC, 29605, USA; University of South Carolina School of Medicine Greenville, Department of Medicine, 701 Grove road, Greenville, SC, 29605, USA; Clemson University School of Health Research, 605 Grove Road Suite 301, Clemson, SC, 29605, USA; Prisma Health Department of Internal Medicine, 876 W Faris Rd., Greenville, SC, 29605, USA.

Background: Peer recovery support services (PRSS) have been increasingly incorporated during the recovery process for opioid use disorder (OUD), yet little is known about the effects of PRSS on clinical outcomes of individuals who misuse opioids. This study systematically synthesized existing literature reporting the effectiveness of PRSS interventions on stages of the OUD treatment cascade.

Methods: A search conducted on five databases identified studies from database inception to January 26th 2021 that evaluated the effects of PRSS on PRSS engagement, medication for OUD (MOUD) initiation, MOUD retention, opioid and non-opioid misuse, and remission. Characteristics of PRSS interventions, study design, and clinical outcomes were extracted. Methodological quality was assessed with the quality assessment tool for quantitative studies by the Effective Public Health Practice Project.

Results: Of 123 titles, 22 were subjected to full-text review and 12 ultimately met inclusion criteria. Only two studies were randomized control trials, half compared the outcomes of PRSS participants to those of a counterfactual group. Most PRSS were unstandardized and broadly described, involving linkage to treatment (91.7%) or follow-up support (91.7%). MOUD initiation was reported the most often (66.7%), followed by PRSS engagement (33.3%) and opioid use (25.0%). No studies reported findings for MOUD retention or remission. Findings for available outcomes were inconsistent and difficult to compare due to the heterogeneity of PRSS interventions and methodological limitations.

Conclusion: Effectiveness of PRSS interventions on stages of the OUD treatment cascade remain inconclusive. Additional research is necessary before supporting the implementation of PRSS on a broad scale.
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http://dx.doi.org/10.1016/j.drugalcdep.2021.109123DOI Listing
December 2021

Hepatitis C Resistance-Associated Substitutions Among People Who Inject Drugs Treated With Direct-Acting Antiviral-Containing Regimens.

Open Forum Infect Dis 2021 Oct 30;8(10):ofab474. Epub 2021 Sep 30.

Prisma Health, Greenville, South Carolina, USA.

Background: Resistance-associated substitutions (RASs) to HCV direct-acting antivirals (DAAs) can contribute to virologic failure and limit retreatment options. People who inject drugs (PWID) are at highest risk for transmission of resistant virus. We report on RASs at baseline and after virologic failure in DAA-naive and protease inhibitor-experienced PWID.

Methods: We sequenced the NS3/4A, NS5A, and NS5B regions from 150 PWID with genotype 1 (GT1) viruses; 128 (85.3%) GT1a, 22 (14.7%) GT1b.

Results: Among the 139 (92.7%) DAA-naive PWID, 85 of 139 (61.2%) had baseline RASs-67 of 139 (48.2%) in NS3 (predominantly Q80K/L); 25 of 139 (18.0%) in NS5A; and 8 of 139 (5.8%) in NS5B. Of the 11 protease inhibitor-experienced participants, 9 had baseline NS3 RASs (V36L N = 1, Q80K N = 9) and 4 had baseline NS5A RASs (M28V N = 2, H58P N = 1, A92T N = 1). Among the 11 participants who had posttreatment samples with detectable virus (7 treatment failures, 1 late relapse, 3 reinfections), 1 sofosbuvir/ledipasvir failure had a baseline H58P. Two sofosbuvir/ledipasvir-treated participants developed new NS5A mutations (Q30H, Y93H, L31M/V). Otherwise, no RASs were detected.

Conclusions: Our results demonstrate RAS prevalence among DAA-naive PWID is comparable to that in the general population. Only 2 of 150 (1.3%) in our longitudinal cohort developed treatment-emergent RASs. Concern for transmission of resistant virus may therefore be minimal.
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http://dx.doi.org/10.1093/ofid/ofab474DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8530260PMC
October 2021

Attitudes toward syringe exchange programs in a rural Appalachian community.

J Addict Dis 2022 Apr-Jun;40(2):227-234. Epub 2021 Sep 22.

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

Objectives: To evaluate community attitudes concerning syringe exchange programs (SEPs) in a rural community as part of an effort to implement evidence-based harm reduction strategies and improve health outcomes related to opioid use disorder.

Methods: Dissemination of a 24-item survey to individuals living in a rural community followed by comparative analysis of survey results based on support for SEPs.

Results: Three hundred and sixty-one individuals responded. Overall, 49.3% of respondents indicated support for syringe exchange. Individuals who support syringe exchange as a harm reduction service are more likely to: agree that opioid use disorder is a real illness ( < 0.0001); agree that anyone can become addicted to pain medications ( = 0.01); agree that medication assisted treatment is effective ( < 0.0001); agree that individuals with OUD have the same right to a job ( < 0.0001); be willing to administer naloxone to a stranger ( < 0.0001); support HIV and HCV screening ( < 0.0001), condom distribution ( < 0.0001), and medication for opioid use disorder ( < 0.0001). They are less likely to believe that harm reduction services encourage drug use ( < 0.0001).

Conclusions: Positive correlations exist between support for SEPs, awareness of OUD as a chronic illness, less stigmatizing attitudes toward individuals with OUD, and support for other harm reduction strategies. Efforts to increase awareness of OUD as a chronic illness may lead to greater acceptance of harm reduction strategies in rural areas, easing evolution of evidence-based healthy policy.
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http://dx.doi.org/10.1080/10550887.2021.1979837DOI Listing
May 2022

HIV And HCV adherence and treatment outcomes among people who inject drugs receiving opioid agonist therapy.

AIDS Care 2021 Sep 17:1-5. Epub 2021 Sep 17.

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

Among people who inject drugs (PWID), 60% have HCV and 50-90% of HIV-infected PWID are co-infected with HCV. Data comparing adherence to direct-acting antiviral (DAA) therapy among HCV mono-infected and HIV/HCV co-infected PWID is limited. The impact of HCV treatment initiation on HIV antiretroviral therapy (ART) adherence is also poorly understood. We assessed DAA adherence in HCV mono-infected and HIV/HCV co-infected PWID and examined changes in ART adherence and HIV outcomes following HCV treatment. Study was conducted in three Medication for Opioid use Disorder (MOUD) programs in Bronx, New York. HCV treatment adherence was measured using electronic blister packs. 2-week DAA adherence rates were compared and controlled for study arm, psychiatric illness and alcohol intoxication within the past 30 days. ART adherence was measured using participant self-report and dichotomized to "excellent" or "other". ART adherence, CD4 count, and HIV viral load were identified six months prior to, during, and six months after HCV treatment. Statistical significance was assessed with mixed-effects regression linear or logistic models. Overall DAA adherence rates among HCV mono-infected and HIV/HCV co-infected PWID were 74% (95% CI=71-78%) and 76% (95%CI=70-83%), respectively (=.55). There were no significant changes in ART adherence, CD4 counts, or HIV viral loads prior to, during, or after HCV treatment. This is the first study assessing the impact of DAA therapy on ART adherence and HIV treatment outcomes among PWID. It is one of the first to compare DAA adherence among HCV and HIV/HCV co-infected PWID. Our data demonstrate no significant difference in DAA adherence and no significant impact of HCV treatment on ART adherence or HIV outcomes.
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http://dx.doi.org/10.1080/09540121.2021.1973659DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8926929PMC
September 2021

Advancing Best Practices for Hospitalized Patients with a Volunteer Addiction Consult Team.

Am J Med 2022 02 9;135(2):143-145. Epub 2021 Sep 9.

Department of Medicine, University of South Carolina School of Medicine, Greenville; Department of Medicine, Prisma Health, Greenville, SC.

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http://dx.doi.org/10.1016/j.amjmed.2021.07.047DOI Listing
February 2022

Changes in Health-related Quality of Life for Hepatitis C Virus-Infected People Who Inject Drugs While on Opioid Agonist Treatment Following Sustained Virologic Response.

Clin Infect Dis 2022 May;74(9):1586-1593

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

Background: Although efforts to treat hepatitis C virus (HCV) in people who inject drugs (PWID) yield high rates of sustained virologic response (SVR), the relationship between successful HCV treatment and health-related quality of life (HRQOL) among PWID is poorly understood. We examined HRQOL changes throughout HCV treatment and post-treatment for PWID achieving SVR.

Methods: Participants included 141 PWID who achieved SVR following HCV treatment onsite at 3 opioid agonist treatment (OAT) clinics in the Bronx, New York. EQ-5D-3L assesses 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), producing an index of HRQOL ranging from 0 to 1. EQ-5D-3L was measured at baseline; 4, 8, and 12 weeks during treatment; and 12 and 24 weeks post-treatment. Linear mixed effects regression models assessed changes in the mean EQ-5D-3L index over time.

Results: Mean EQ-5D-3L index baseline was 0.66 (standard error [SE] = 0.02). While over half the population reported no baseline problems with self-care (85.1%), usual activities (56.0%), and mobility (52.5%), at least two-thirds reported problems with pain/discomfort (78.0%) and anxiety/depression (66.0%). Twenty-four weeks post-treatment, proportions reporting pain/discomfort and anxiety/depression decreased by 25.7% and 24.0%, respectively. Mean EQ-5D-3L index significantly improved during treatment (P < .0001), and improvement was sustained following treatment completion, with mean EQ-5D-3L index of 0.77 (SE = 0.02) 12 weeks post-SVR.

Conclusions: HCV treatment led to sustained improvement in HRQOL for PWID on OAT who achieved SVR. Future research is necessary to determine whether improvements in HRQOL can be sustained beyond 12 weeks post-SVR.
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http://dx.doi.org/10.1093/cid/ciab669DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9070815PMC
May 2022

Utilizing patient perception of group treatment in exploring medication adherence, social support, and quality of life outcomes in people who inject drugs with hepatitis C.

J Subst Abuse Treat 2021 07 7;126:108459. Epub 2021 May 7.

Clemson University School of Health Research, Clemson, SC, USA; Department of Medicine, Prisma Health-Upstate, Greenville, SC, USA; University of South Carolina School of Medicine Greenville, Greenville, SC, USA. Electronic address:

People who inject drugs (PWID) have a high prevalence of hepatitis C virus (HCV). Group treatment is a practical option for addressing barriers to treatment in this population. Prior research on group treatment has resulted in mixed conclusions about its effectiveness in addressing barriers to treatment. A patient's perception of the group environment may help to explain this variability. This study sought to explore the association between indicators of group treatment environment and improved outcomes in HCV-infected PWID. This secondary analysis of a randomized controlled trial exploring different models of treatment for HCV in a PWID population consisted of 42 participants randomized to the group treatment branch of the trial. Independent variables consisted of group sessions attended and group climate constructs of engagement, conflict, and avoidance. Dependent variables consisted of medication adherence, social support, and health-related quality of life. The study implemented generalized estimating equations to assess associations with the outcomes at the end of treatment. Factors indicative of group treatment environment were related to medication adherence and other barriers to health for HCV-infected PWID: social support and health-related quality of life. Perceptions of conflict or avoidance were associated with worse outcomes, while increased session attendance was generally associated with better outcomes. The study attests to the importance of examining group environment factors during treatment interventions. Although preliminary, the study provides specific indicators of treatment success for HCV-infected PWID and practical implications to improve patients' health outcomes and better tailor treatment to the patient.
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http://dx.doi.org/10.1016/j.jsat.2021.108459DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8714173PMC
July 2021

Modeling the effect of stress on vaping behavior among young adults: A randomized cross-over pilot study.

Drug Alcohol Depend 2021 08 30;225:108798. Epub 2021 May 30.

Vermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA; Departments of Psychology and Psychiatry, University of Vermont, Burlington, VT, USA. Electronic address:

Background: Laboratory models have been useful in identifying the motivational processes underlying tobacco use. This pilot study aimed at (1)validating a human laboratory model initially developed for smokers to e-cigarette users; (2)applying this model to examine the effects of stress on the reinforcing value of nicotine among young adults.

Methods: Using a randomized cross-over design, young e-cigarette users (n = 30) who were nicotine deprived were exposed to a stress or a non-stress task, and then engaged in a laboratory task assessing vaping's reward value on two separate days. During the first part of the task, participants had the option of initiating an e-cigarette self-administration session or delaying initiation for up to 50 min in exchange for money. During the second part of the task, participants chose between vaping or receiving money. The length of the delay and the number of e-cigarette uses consumed were the primary outcomes. Craving and puff topography were secondary outcomes.

Results: There was no difference in the length of time that participants were able to refrain from vaping in the stress and control task (p = .90). Participants purchased and consumed more puffs after being exposed to the stress task compared to the control task (p<.001), puff topography and craving were unaffected.

Conclusions: Exposure to a stressor did not undermine the ability to resist vaping among deprived e-cigarette users (first part), but it influenced the number of uses purchased once users decided to vape (second part). This study evidences that these two parts of the task for assessing reward value are differentially sensitive to the stress manipulation.
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http://dx.doi.org/10.1016/j.drugalcdep.2021.108798DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8504555PMC
August 2021

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 2022 Apr 3;58(2):615-622. 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
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8919861PMC
April 2022

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 Oct 25;22(5):616-622. Epub 2021 Apr 25.

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
October 2021

Hepatitis C Virus Direct-Acting Antiviral Treatment Adherence Patterns and Sustained Viral Response Among People Who Inject Drugs Treated in Opioid Agonist Therapy Programs.

Clin Infect Dis 2021 12;73(11):2093-2100

Clemson University School of Health Research, Clemson University, Clemson, South Carolina, 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 3-arm PREVAIL study used 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 6 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 adjusted odds ratio [AOR] = 1.12; 95% confidence interval [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), and maximum consecutive nonadherent days (0.85; .74-.95 = 0.003). SVR was significantly associated with total adherent doses in the first 2 months of treatment, it was not in the last month. While alcohol intoxication was significantly associated with frequent switches, drug use was not associated with any adherence pattern.

Conclusions: 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 who experience alcohol intoxication.
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http://dx.doi.org/10.1093/cid/ciab334DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8664449PMC
December 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 06 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
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8172465PMC
June 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 2022 Jan-Feb;137(1):102-109. Epub 2021 Mar 5.

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
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8721757PMC
February 2022

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 07 2;93:103135. Epub 2021 Mar 2.

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
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8725059PMC
July 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 03 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
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8720498PMC
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 04;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
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