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Direct-acting antivirals (DAAs) are highly effective for treating HCV infection even among people who inject drugs (PWID). Yet, little is known about patients' adherence patterns and their association with sustained virologic response (SVR) rates. We aimed to summarize various adherence patterns and determine their associations with SVR. Electronic blister packs were used to measure daily adherence to once-a-day sofosbuvir/velpatasvir during the 12-week treatment period among active PWIDs. Blister pack data were available for 496 participants who initiated DAAs for whom SVR status was known. Adherence was summarized in multiple patterns, such as total adherent days, consecutive missed days, and early discontinuations. Thresholds for adherence patterns associated with >90% SVR rates were also determined. The overall SVR rate was 92.7%, with a median adherence rate of 75%. All adherence patterns indicating greater adherence were significantly associated with achieving SVR. Participant groups with ≥50% (>42/84) adherent days or <26 consecutive missed days achieved an SVR rate of >90%. Greater total adherent days during 9-12 weeks and no early discontinuation were significantly associated with higher SVR rates only in those with <50% adherence. Participants with first month discontinuation and ≥2 weeks of treatment interruption had low SVR rates, 25% and 85%, respectively. However, greater adherent days were significantly associated with SVR (adjusted odds ratio 1.10; 95% CI 1.04–1.16; p <0.001) even among participants with ≥14 consecutive missed days. High SVR rates can be achieved in the PWID population despite suboptimal adherence. Encouraging patients to take as much medication as possible, with <2 weeks consecutive missed days and without early discontinuation, was found to be important for achieving SVR. People who inject drugs can be cured of HCV in >90% of cases, even with relatively low adherence to direct-acting antivirals, but early discontinuations and long treatment interruptions can significantly reduce the likelihood of achieving cure. Clinicians should encourage people who inject drugs who are living with HCV to adhere daily to direct-acting antivirals as consistently as possible, but if any days are interrupted, to continue and complete treatment. These results from the HERO study are important for patients living with HCV, clinicians, experts writing clinical guidelines, and payers. NCT02824640. [Display omitted] • The recent US nationwide HERO RCT study randomized 755 PWIDs living with HCV. • Electronic blister packs measured day-by-day adherence to 12-week DAA regimen. • Greater adherence is associated with SVR among those with <50% adherence rate. • Treatment interruption and early discontinuation are associated with lower SVR. • High SVR (>90%) can be achieved even with adherence as low as 50%. [ABSTRACT FROM AUTHOR]

Background The normal-weight BMI range (18.5–24.9 kg/m2) includes adults with body shape and cardiometabolic disease risk features of excess adiposity, although a distinct phenotype developed on a large and diverse sample is lacking. Objective To identify demographic, behavioral, body composition, and health-risk biomarker characteristics of people in the normal-weight BMI range who are at increased risk of developing cardiovascular and metabolic diseases based on body shape. Methods Six nationally representative waist circumference index (WCI, weight/height0.5) prediction formulas, with BMI and age as covariates, were developed using data from 17,359 non-Hispanic (NH) white, NH black, and Mexican-American NHANES 1999–2006 participants. These equations were then used to predict WCI in 5594 NHANES participants whose BMI was within the normal weight range. Men and women in each race/Hispanic-origin group were then separated into high, medium, and low tertiles based on the difference (residual) between measured and predicted WCI. Characteristics were compared across tertiles; P values for significance were adjusted for multiple comparisons. Results Men and women in the high WCI residual tertile, relative to their BMI and age-equivalent counterparts in the low tertile, had significantly lower activity levels; higher percent trunk and total body fat (e.g. NH white men, X ± SE, 25.3 ± 0.2% compared with 20.4 ± 0.2%); lower percent appendicular lean mass (skeletal muscle) and bone mineral content; and higher plasma insulin and triglycerides, higher homeostatic model assessment of insulin resistance (e.g. NH white men, 1.45 ± 0.07 compared with 1.08 ± 0.06), and lower plasma HDL cholesterol. Percent leg fat was also significantly higher in men but lower in women. Similar patterns of variable statistical significance were present within sex and race/ethnic groups. Conclusions Cardiometabolic disease risk related to body shape in people who are normal weight according to BMI is characterized by a distinct phenotype that includes potentially modifiable behavioral health risk factors. [ABSTRACT FROM AUTHOR]

Background: The United States has persistently high rates of preterm birth and low birthweight and is characterized by significant racial disparities in these rates. Innovative group prenatal care models, such as CenteringPregnancy, have been proposed as a potential approach to improve the rates of preterm birth and low birthweight and to reduce disparities in these pregnancy outcomes.Objective: This study aimed to test whether participation in group prenatal care would reduce the rates of preterm birth and low birthweight compared with individual prenatal care and whether group prenatal care would reduce the racial disparity in these rates between Black and White patients.Study Design: This was a randomized controlled trial among medically low-risk pregnant patients at a single study site. Eligible patients were stratified by self-identified race and ethnicity and randomly allocated 1:1 between group and individual prenatal care. The primary outcomes were preterm birth at <37 weeks of gestation and low birthweight of <2500 g. The primary analysis was performed according to the intent-to-treat principle. The secondary analyses were performed according to the as-treated principle using modified intent-to-treat and per-compliance approaches. The analysis of effect modification by race and ethnicity was planned.Results: A total of 2350 participants were enrolled, with 1176 assigned to group prenatal care and 1174 assigned to individual prenatal care. The study population included 952 Black (40.5%), 502 Hispanic (21.4%), 863 White (36.8%), and 31 "other races or ethnicity" (1.3%) participants. Group prenatal care did not reduce the rate of preterm birth (10.4% vs 8.7%; odds ratio, 1.22; 95% confidence interval, 0.92-1.63; P=.17) or low birthweight (9.6% vs 8.9%; odds ratio, 1.08; 95% confidence interval, 0.80-1.45; P=.62) compared with individual prenatal care. In subgroup analysis, greater attendance in prenatal care was associated with lower rates of preterm birth and low birthweight. This effect was most noticeable for the rates of low birthweight for Black participants in group care: intent to treat (51/409 [12.5%]), modified intent to treat (36/313 [11.5%]), and per compliance (20/240 [8.3%]). Although the rates of low birthweight were significantly higher for Black participants than White participants seen in individual care (adjusted odds ratio, 2.00; 95% confidence interval, 1.14-3.50), the difference was not significant for Black participants in group care compared with their White counterparts (adjusted odds ratio, 1.58; 95% confidence interval, 0.74-3.34).Conclusion: There was no difference in the overall rates of preterm birth or low birthweight between group and individual prenatal care. With increased participation in group prenatal care, lower rates of preterm birth and low birthweight for Black participants were observed. The role of group care models in reducing racial disparities in these birth outcomes requires further study. [ABSTRACT FROM AUTHOR]

Background Magnetic resonance imaging reveals macro- and microstructural correlates of neurodegeneration, which are often assessed using voxel-by-voxel t -tests for comparing mean image intensities measured by fractional anisotropy (FA) between cases and controls or regression analysis for associating mean intensity with putative risk factors. This analytic strategy focusing on mean intensity in individual voxels, however, fails to account for change in distribution of image intensities due to disease. New method We propose a method that aims to facilitate simple and clear characterization of underlying distribution. Our method consists of two steps: subject-level (Step 1) and group-level or a specific risk-level density function estimation across subjects (Step 2). Results The proposed method was demonstrated with a simulated data set and real FA data sets from two white matter tracts, where the proposed method successfully detected any departure of the FA distribution from the normal state by disease: p < 0.001 for simulated data; p = 0.047 for the posterior limb of internal capsule; p = 0.06 for the posterior thalamic radiation. Comparison with existing method(s) The proposed method found significant disease effect ( p < 0.001) while conventional 2-group t -test focused only on mean intensity did not ( p = 0.61) in a simulation study. While significant age effects were found for each white matter tract from conventional linear model analysis with real FA data, the proposed method further confirmed that aging also triggers distribution-wide change. Conclusion Our proposed method is powerful for detection of risk factors associated with any type of microstructural neurodegenerations with brain imaging data. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to determine whether group-based or didactic teaching is more effective to teach ACR Appropriateness Criteria to medical students.Methods: An identical pretest, posttest, and delayed multiple-choice test was used to evaluate the efficacy of the two teaching methods. Descriptive statistics comparing test scores were obtained.Results: On the posttest, the didactic group gained 12.5 points (P < .0001), and the group-based learning students gained 16.3 points (P < .0001). On the delayed test, the didactic group gained 14.4 points (P < .0001), and the group-based learning students gained 11.8 points (P < .001). The gains in scores on both tests were statistically significant for both groups. However, the differences in scores were not statistically significant comparing the two educational methods.Conclusions: Compared with didactic lectures, group-based learning is more enjoyable, time efficient, and equally efficacious. The choice of educational method can be individualized for each institution on the basis of group size, time constraints, and faculty availability. [ABSTRACT FROM AUTHOR]

Purpose Some studies suggest that anthropometric measures of abdominal obesity may be superior to body mass index (BMI) for the prediction of cardiometabolic risk factors; however, most studies have been cross-sectional. Our aim was to prospectively examine the association of change in BMI, waist-to-hip ratio (WHR), waist circumference (WC), and waist circumference-to-height ratio (WCHtR) with change in markers of cardiometabolic risk in a population of postmenopausal women. Methods We used a subsample of participants in the Women's Health Initiative aged 50 to 79 years at entry with available fasting blood samples and anthropometric measurements obtained at multiple time points over 12.8 years of follow-up ( n = 2672). The blood samples were used to measure blood glucose, insulin, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol (HDL-C), and triglycerides at baseline, and at years 1, 3, and 6. We conducted mixed-effects linear regression analyses to examine associations at baseline and longitudinal associations between change in anthropometric measures and change in cardiometabolic risk factors, adjusting for covariates. Results In longitudinal analyses, change in BMI, WC, and WCHtR robustly predicted change in cardiometabolic risk, whereas change in WHR did not. The strongest associations were seen for change in triglycerides, glucose, and HDL-C (inverse association). Conclusion Increase in BMI, WC, and WCHtR strongly predicted increases in serum triglycerides and glucose, and reduced HDL-C. WC and WCHtR were superior to BMI in predicting serum glucose, HDL-C, and triglycerides. WCHtR was superior to WC only in predicting serum glucose. BMI, WC, and WCHtR were all superior to WHR. [ABSTRACT FROM AUTHOR]

Objectives: To assess pediatrician adherence to the 2017 American Academy of Pediatrics' clinical practice guideline for high blood pressure (BP).Study Design: Pediatric primary care practices (n = 59) participating in a quality improvement collaborative submitted data for patients with high BP measured between November 2018 and January 2019. Baseline data included patient demographics, BP, body mass index (BMI), and actions taken. Logistic regression was used to test associations between patient BP level and BMI with provider adherence to guidelines (BP measurement, counseling, follow-up, evaluation).Results: A total of 2677 patient charts were entered for analysis. Only 2% of patients had all BP measurement steps completed correctly, with fewer undergoing 3-limb and ambulatory BP measurement. Overall, 46% of patients received appropriate weight, nutrition, and lifestyle counseling. Follow-up for high BP was recommended or scheduled in 10% of encounters, and scheduled at the appropriate interval in 5%. For patients presenting with their third high BP measurement, 10% had an appropriate diagnosis documented, 2% had appropriate screening laboratory tests conducted, and none had a renal ultrasound performed. BMI was independently associated with increased odds of counseling, but higher BP was associated with lower odds of counseling. Higher BP was independently associated with an increased likelihood of documentation of hypertension.Conclusions: In this multisite study, adherence to the 2017 American Academy of Pediatrics' guideline for high BP was low. Given the long-term health implications of high BP in childhood, it is important to improve primary care provider recognition and management.Trial Registration: ClinicalTrials.gov: NCT03783650. [ABSTRACT FROM AUTHOR]

PURPOSE: This study tests whether fat mass (FM) and fat free mass (FFM) have opposite associations with mortality in a nationally representative sample of females.METHODS: Data on 13,369 female participants from National Health and Nutrition Examination Surveys (NHANES) I and II (aged 25 to 75 years) were analyzed. Mean follow-up time was 16.1 years. Ninety-seven percent of the participants with 3020 deaths were successfully followed. Subscapular and triceps skinfolds thickness were used as a FM indicator (FMI). Upper arm circumference was used as a FFM indicator (FFMI). Cox regression tested the relationships of BMI, FM and FFM with all-cause mortality adjusting for various socio-demographic variables.RESULTS: BMI had a U-shaped relationship with mortality with a nadir of approximately 27 kg/m2. When FFMI was added to the model, the relationship between BMI and mortality became more monotonic increasing. FMI showed a significant negative relationship with mortality.CONCLUSIONS: Contrary to expectations, both FFMI and FMI had negative relationships with mortality. These results differ from patterns previously observed in males and may reflect sex differences in fat distribution. Research using superior measures of body fat amount and distribution may resolve these discrepancies. [Copyright &y& Elsevier]

Background: Limited research has been done to explore differences between ethnic groups, including Hispanic Americans (HAs), in the association between percentage body fat (PBF) and body mass index (BMI; in kg/m2); the numbers of HAs are increasing in the US population. Objective:We investigated whether the relation between PBF and BMI in adult HAs differed from that of African Americans (AAs) and European Americans (EAs). Design:We used a multiple regression model in which PBF measured with dual energy X-ray absorptiometry was predicted by the reciprocal of BMI (1/BMI; in m2/kg) in a sample of 487 men (nEA = 192, nAA = 148, and nHA = 147) and 933 women (nEA = 448, nAA = 304, and nHA = 181). Results: For men, our results showed no significant differences between HAs and EAs, AAs and EAs, or HAs and AAs in the slope of the line relating 1/BMI to PBF. In women, there were significant differences in PBF as predicted by BMI between HAs and EAs (P < 0.002) and AAs and HAs (P = 0.020), but not between AAs and EAs. When PBF was estimated on the basis of predicting equations, the trend of the predicted PBF value in women differed according to ethnic group and BMI category. At a BMI < 30, HAs tended to have more body fat than did EAs and AAs, and at a BMI > 35, EAs tended to have more body fat than did the other groups. Conclusions: Our results show that the relation between PBF and BMI in HA women differs from that of EA and AA women. [ABSTRACT FROM AUTHOR]

Introduction: The inter-relationships between smoking habits and weight gain are complex. However, few studies have examined the association of smoking habits with weight gain over the life course.Methods: Major smoking parameters and weight gain over time were examined in a large cohort of postmenopausal women aged 50-79 years at enrollment between 1993 and 1998 (N=161,808) and followed through 2014 (analyses conducted in 2016). Cross-sectional analyses were used to assess the association of smoking and body weight at baseline. Retrospective data were used to correlate smoking status with body weight over a 45-year period prior to enrollment. In addition, the association of smoking with weight gain over 6 years of follow-up was examined.Results: At baseline, women who had quit smoking prior to enrollment weighed 4.7 kg more than current smokers and 2.6 kg more than never smokers. Former, never, and current smokers all gained weight over the 45-year period from age 18 years to time of enrollment (average age, 63 years): 16.8, 16.4, and 14.6 kg, respectively. In prospective analyses, women who were current smokers at baseline but who quit smoking during follow-up gained more than 5 kg by Year 6 compared with current smokers at baseline who continued to smoke. Among long-term quitters, greater intensity of smoking and more recent quitting were associated with greater weight gain.Conclusions: These results suggest that excess weight gain associated with smoking cessation occurs soon after quitting and is modest relative to weight gain in never smokers over the adult lifespan. [ABSTRACT FROM AUTHOR]

Abstract: Background: The impact of adherence enhancing interventions on the relationship between active drug use and adherence is largely unknown. Methods: We conducted a 24-week randomized controlled trial of antiretroviral directly observed therapy (DOT) vs. treatment as usual (TAU) among HIV-infected methadone patients. Our outcome measure was pill count antiretroviral adherence, and our major independent variables were treatment arm (DOT vs. TAU) and active drug use (opiates, cocaine, or both opiates and cocaine). We defined any drug use as ≥1 positive urine toxicology result, and frequent drug use as ≥50% tested urines positive. We used mixed-effects linear models to evaluate associations between adherence and drug use, and included a treatment arm-by-drug use interaction term to evaluate whether DOT moderates associations between drug use and adherence. Results: 39 participants were randomized to DOT and 38 to TAU. We observed significant associations between adherence and active drug use, but these were limited to TAU participants. Adherence was worse in TAU participants with any opiate use than in TAU participants without (63% vs. 75%, p <0.01); and worse among those with any polysubstance (both opiate and cocaine) use than without (60% vs. 73%, p =0.01). We also observed significant decreases in adherence among TAU participants with frequent opiate or frequent polysubstance use, compared to no drug use. Among DOT participants, active drug use was not associated with worse adherence. Conclusions: Active opiate or polysubstance use decreases antiretroviral adherence, but the negative impact of drug use on adherence is eliminated by antiretroviral DOT. [Copyright &y& Elsevier]

Background: Studies suggest that stressful events increase risk for childhood anxiety and depression and hypothalamic-pituitary-adrenal (HPA) axis dysregulation. This prospective longitudinal study evaluated relationships among severe psychosocial stress, psychiatric morbidity, and HPA axis function in children. Methods: Forty-five children (mean age: 8.9 ± 2.9 years) suffering parent death from September 11, 2001 terror attacks and 34 nonbereaved children (mean age: 9.3 ± 2.5 years) were evaluated prospectively at 6-month intervals in this 2-year study. Assessments involved diagnostic interviews (Child Schedule for Affective Disorders and Schizophrenia [K-SADS]) for psychopathology and 3 days of baseline salivary cortisol and a salivary dexamethasone suppression test for HPA axis function. Results: Bereaved children, but not nonbereaved children, had significantly increased rates of psychiatric disorders involving anxiety disorders, especially posttraumatic stress disorder (PTSD), after September 11, 2001 compared with retrospective assessments before September 11, 2001. Morning (AM) and 4:00 pm baseline cortisol were significantly and persistently higher for bereaved than nonbereaved children. Compared with bereaved children without psychopathology, bereaved children with PTSD had significantly lower 4:00 pm baseline cortisol and significantly greater 4:00 pm cortisol suppression. Children with generalized anxiety disorder had significantly less AM cortisol suppression than children without psychopathology. Conclusions: Children bereaved by sudden, unexpected parent death had persistent psychological dysfunction and HPA axis dysregulation in this study. [Copyright &y& Elsevier]

Background: Executive dysfunction is common in geriatric depression and persists after improvement of depressive symptoms. This study examined the relationship of executive impairment to the course of depressive symptoms among elderly patients with major depression. Methods: A total of 112 nondemented elderly patients with major depression participated in an 8-week citalopram trial at a target daily dose of 40 mg. Executive functions were assessed with the initiation/perseveration subscale of the Dementia Rating Scale and the Stroop Color-Word test. Medical burden was rated with the Cumulative Illness Rating Scale. Results: Both abnormal initiation/perseveration and abnormal Stroop Color-Word scores were associated with an unfavorable response of geriatric depression to citalopram. In particular, initiation/perseveration scores below the median (≤35) and Stroop scores at the lowest quartile (≤22) predicted limited change in depressive symptoms. Impairment in other Dementia Rating Scale cognitive domains did not significantly influence the outcome of depression. Conclusions: Executive dysfunction increases the risk for poor response of geriatric depression to citalopram. Because executive functions require frontostriatal-limbic integrity, this observation provides the rationale for investigation of the role of specific frontostriatal-limbic pathways in perpetuating geriatric depression. Depressed elderly patients with executive dysfunction require vigilant clinical attention because they might be at risk to fail treatment with a selective serotonin reuptake inhibiting antidepressant. [Copyright &y& Elsevier]

Abstract: Objective: To determine if directly observed antiretroviral therapy (DOT) is more efficacious than self-administered therapy for improving adherence and reducing HIV viral load (VL) among methadone-maintained opioid users. Design: Two-group randomized trial. Setting: Twelve methadone maintenance clinics with on-site HIV care in the Bronx, New York. Participants: HIV-infected adults prescribed combination antiretroviral therapy. Main outcomes measures: Between group differences at four assessment points from baseline to week 24 in: (1) antiretroviral adherence measured by pill count, (2) VL, and (3) proportion with undetectable VL (<75copies/ml). Results: Between June 2004 and August 2007, we enrolled 77 participants. Adherence in the DOT group was higher than in the control group at all post-baseline assessment points; by week 24 mean DOT adherence was 86% compared to 56% in the control group (p <0.0001). Group differences in mean adherence remained significant after stratifying by baseline VL (detectable versus undetectable). In addition, during the 24-week intervention, the proportion of DOT participants with undetectable VL increased from 51% to 71%. Conclusions: Among HIV-infected opioid users, antiretroviral DOT administered in methadone clinics was efficacious for improving adherence and decreasing VL, and these improvements were maintained over a 24-week period. DOT should be more widely available to methadone patients. [ABSTRACT FROM AUTHOR]

Abstract: Background: Among patients with major depression with psychotic features, little is known about the extent to which those with and without somatic delusions differ. Methods: The first 183 participants in the STOP-PD study were divided into two groups based on the presence or absence of somatic delusions and were compared on multiple demographic and clinical characteristics. Results: In the multivariate analysis, those with somatic delusions reported more somatic symptoms, rated their health as worse, and were less likely to have persecutory delusions. Conclusions: Based on the methods we used, we could not detect meaningful differences between subjects with and without somatic delusions. This suggests that the presence of irrational somatic ideation does not define a distinct clinical subgroup among patients with psychotic depression. This finding needs to be replicated. [Copyright &y& Elsevier]

Background: Although delusions are the hallmark of major depression with psychotic features, a scale to measure the intensity of beliefs across multiple delusional domains in this condition has been unavailable. The development and assessment of the Delusional Assessment Scale (DAS) are described. Methods: Scale items were selected initially based on previous studies of delusional ideation in schizophrenia. A three-point item to assess mood congruence was added. A 15-item scale was assessed in 92 subjects participating in the four-site collaborative study of the pharmacotherapy of major depression with psychotic features. Maximum likelihood method was used to determine scale factors. The internal consistency of these factors was determined. Comparisons between scale scores and ratings from the Brief Psychiatric Rating Scale (BPRS) (Overall and Gorham 1962) were used to assess convergent and discriminant validity. Results: The data were fit by a five-factors model (impact, conviction, disorganization, bizarreness, and extension). Inter-rater reliability of the five factors ranged from .77 for conviction and .74 for impact to .37 for disorganization. Internal consistency for each of the five factors was ≥.72. Scores on specific domains were significantly correlated with the BPRS unusual thought content item and positive symptom subscale scores. Conclusions: The DAS is a reliable measure of 5 delusional domains. [Copyright &y& Elsevier]

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. [ABSTRACT FROM AUTHOR]

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. 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. 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. [ABSTRACT FROM AUTHOR]