Overreporting of adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs in the HERO study.

BACKGROUND: Self-reported adherence to direct-acting antivirals (DAAs) to treat hepatitis C virus (HCV) among persons who inject drugs (PWID) is often an overreport of objectively measured adherence. The association of such overreporting with sustained virologic response (SVR) is understudied. This study among PWID aimed to determine a threshold of overreporting adherence that optimally predicts lower SVR rates, and to explore correlates of the optimal overreporting threshold. METHODS: This study analyzed per-protocol data of participants with adherence data (N = 493) from the HERO (Hepatitis C Real Options) study. Self-reported and objective adherence to a 12-week DAA regimen were measured using visual analogue scales and electronic blister packs, respectively. The difference (Δ) between self-reported and objectively measured adherence was calculated. We used the Youden index based on receiver operating characteristic (ROC) curve analysis to identify an optimal threshold of overreporting for predicting lower SVR rates. Factors associated with the optimal threshold of overreporting were identified by comparing baseline characteristics between participants at/above versus those below the threshold. RESULTS: The self-reported, objective, and Δ adherence averages were 95.1% (SD = 8.9), 75.9% (SD = 16.3), and 19.2% (SD = 15.2), respectively. The ≥ 25% overreporting threshold was determined to be optimal. The SVR rate was lower for ≥ 25% vs. < 25% overreporting (86.7% vs. 95.8%, p <.001). The factors associated with ≥ 25% Δ adherence were unemployment; higher number of days and times/day of injecting drugs; higher proportion of positive urine drug screening for amphetamine, methamphetamine, and oxycodone, and negative urine screening for THC (tetrahydrocannabinol)/cannabis. CONCLUSIONS: Self-reported DAA adherence was significantly greater than objectively measured adherence among PWID by 19.2%. Having ≥ 25% overreported adherence was associated with optimal prediction of lower SVR rates. PWID with risk factors for high overreporting may need to be more intensively managed to promote actual adherence.

Outpatient Opioid Dispensing Patterns for SC Medicaid Children 1-36 Months Old.

OBJECTIVES: We sought to identify the most common diagnostic categories linked to dispensed opioid prescriptions among children 1-36 months old and changes in patterns over the years 2000 to 2017. METHODS: This study used South Carolina's Medicaid claims data of pediatric dispensed outpatient opioid prescriptions between 2000 and 2017. The major opioid-related diagnostic category (indication) for each prescription was identified using visit primary diagnoses and the Clinical Classification System (AHRQ-CCS) software. The variables of interest were the rate of opioid prescriptions per 1,000 visits for each diagnostic category and the relative percentage of opioid prescriptions assigned to each category compared to all categories. RESULTS: Six major diagnostic categories were identified; Diseases of the respiratory system (RESP), Congenital anomalies (CONG), Injury (INJURY), Diseases of the nervous system and sense organs (NEURO), Diseases of the digestive system (GI), and Diseases of the genitourinary system (GU). The overall rate of dispensed opioid prescriptions per category declined significantly for four diagnostic categories throughout the study period, RESP by 15.13, INJURY by 8.49, NEURO by 7.33, and GI by 5.93. Two categories increased during the same time, CONG (by 9.47) and GU (by 6.98). RESP was the most prevalent category linked to a dispensed opioid prescription within 2010-2012 (almost 25%) but CONG was the most prevalent by 2014 (17.77%). CONCLUSIONS FOR PRACTICE: Among Medicaid children 1-36 months old, annual dispensed opioid prescription rates declined for most major diagnostic categories (RESP, INJURY, NEURO, and GI). Future studies should explore alternatives to current opioid dispensing practices for GU and CONG cases.

Variability of Hepatitis C Treatment Cascade Outcomes among People Who Inject Drugs across Geographically Diverse Clinics in the US: The HERO Study.

Heterogeneity of outcomes across different clinical trial study sites is often inevitable. Understanding how outcomes differ by site is important for planning future programs and studies. We examined the extent of heterogeneity of hepatitis C virus (HCV) treatment cascade outcomes among persons who inject drugs (PWIDs) across sixteen clinical sites utilized in the HERO Study-a pragmatic randomized trial of HCV treatment support. Treatment cascade outcomes included averages of overall treatment adherence and proportions of treatment initiation, treatment completion, sustained virologic response (SVR) test completion, and SVR achievement. The HERO study utilized 16 clinical sites across the United States (US): eight opioid treatment programs (OTPs) and eight community health centers (CHCs). Variability of the outcomes across the 16 clinical sites was assessed using ranges and intraclass correlation coefficients (ICC) estimated from mixed-effects linear or logistic regression models. Treatment initiation was analyzed in the intention-to-treat (ITT) sample (N = 755); treatment completion, adherence, and SVR test completion in the modified ITT (mITT) sample, which is the sample that initiated treatment (N = 623); and SVR achievement in the mITT and per-protocol (PP, N = 501) samples. Across the 16 clinical sites, the range observed in the averages of overall treatment adherence was from 68% to 81% [ICC = 0.026 (0.005, 0.054)], and the ranges of proportions observed were from 68% to 96% for treatment initiation [ICC (95% CI) = 0.086 (0.051, 0.155)], 60% to 100% for treatment completion [ICC = 0.049 (0.008, 0.215)], 54% to 95% for SVR test completion [ICC = 0.096 (0.006, 0.177)], 46% to 90% for SVR achievement in the mITT sample [ICC = 0.070 (0.014, 0.122)], and 76% to 100% for SVR achievement in the PP sample [ICC = 0.143 (0.021, 0.422)]. The variability of the outcomes across 16 US sites treating HCV among PWIDs appears to be substantial in view of the ranges and ICC values of the outcomes. It is imperative to develop tailored interventions to target the sources of variability and reduce barriers at the patient, provider, clinic, and state policy levels to facilitate more equitable access to HCV treatment and reduce heterogeneity in treatment outcomes.

Self-reported and measured adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs: The HERO study.

BACKGROUND: Objective adherence measures, such as electronic blister pack (BP), for direct-acting antivirals (DAAs) for hepatitis C virus (HCV) treatment have high accuracy, but their use is limited in real practice settings. We examined the association of self-reported adherence using a visual analogue scale (VAS) with objective BP adherence and sustained virologic response (SVR) among people who inject drugs. METHODS: We conducted secondary analyses using a subset of participants (N = 493) from the per-protocol sample of the HERO study, a pragmatic randomized trial of HCV treatment interventions that used both VAS and BP to measure adherence to a 12-week sofosbuvir/velpatasvir DAA regimen. Multivariable mixed-effects regression models tested the association of self-report adherence level with longitudinal weekly objective adherence. Multivariable logistic regression tested the association of self-report adherence with SVR. RESULTS: The average VAS and BP adherences were 95.1 % (SD = 8.9 %) and 76.0 % (16.0 %), respectively, and the proportion of the participants achieving SVR was 92.9 %. The estimated adjusted mean objective adherence was significantly different (-16 %; 95 % CI: -22 %, -11 %, p < .001) between participants with 100 % and <80 % VAS adherence. The likelihood of SVR was significantly lower for those with <80 % VAS adherence [adjusted OR = 0.07; 95 % CI: 0.02, 0.24; p < .001] compared to those with 100 %. CONCLUSION: Self-reported adherence overestimated objective adherence. However, higher self-report adherence was significantly associated with higher objective adherence. Also, self-reported adherence ≥80 % was significantly associated with SVR. Thus, the self-report measure has utility as a monitoring tool for adherence during DAA treatment.

Effect of self-efficacy among persons who inject drugs treated with direct-acting antivirals on Hepatitis C treatment initiation, duration, completion, adherence, and cure.

BACKGROUND: Self-efficacy, a patient-level factor, has been shown to facilitate patient engagement in treatment and optimize treatment-related outcomes in various health contexts. Research on interventions supporting hepatitis C virus (HCV) direct-acting antiviral (DAA) treatment uptake and adherence among persons who inject drugs (PWID) is needed, but whether self-efficacy factors influence DAA treatment cascade outcomes in this population has been less studied. METHODS: Using the HERO study data, we analyzed a subset of participants with any general health self-efficacy data (n=708) measured at baseline and end-of-treatment time points using a 5-items instrument (facets: 'goal setting', 'goal attainment', 'having a positive effect', 'being in control', and 'working to improve'). The cascade outcomes included DAA treatment initiation, duration, adherence, completion, and sustained virologic response (SVR). The effect of baseline and change (Δ) scores for composite and item-level self-efficacy on the cascade outcomes was assessed using logistic regression and generalized linear models. RESULTS: Higher baseline composite self-efficacy [adjusted odds ratio (95 % confidence interval) =1.57 (1.07, 2.29)], 'goal attainment' [1.31 (1.03, 1.67)] and 'having a positive effect' [1.33 (1.03, 1.74)] were associated with greater likelihood of treatment initiation. 'Δ Goal attainment' was significantly associated with SVR [1.63 (1.04, 2.53)]. 'Δ Being in control' and 'Δ working to improve' were associated with treatment adherence and duration, respectively. CONCLUSIONS: General health self-efficacy positively influences DAA treatment initiation among PWID. 'Goal attainment' facilitates the achievement of DAA treatment-related outcomes. Further studies should assess the effect of self-efficacy related to performing healthcare tasks specific to DAAs on the treatment-related outcomes.

California's Comprehensive Perinatal Services Program and birth outcomes.

Introduction: California's Medicaid (Medi-Cal) sponsors Comprehensive Perinatal Services Program (CPSP), a program with enhanced perinatal care for women (more education, nutritional supplements, and psychosocial counseling/support). Past evaluations of CPSP's effectiveness in birth outcomes were limited to pilot programs and yielded mixed results. Methods: We used 2012-2016 California's statewide data about singleton live births with any receipt of prenatal care (N = 2,385,811) to examine whether Medi-Cal with CPSP enrollment was associated with lower odds of preterm birth (PTB), spontaneous PTB, and low birthweight (LBW) than non-CPSP births. With three binary variables of PTB, spontaneous PTB, and LBW as the response variables, three multilevel logistic models were used to compare the outcomes of participants enrolled in Medi-Cal with CPSP against those with private insurance, adjusting for maternal factors and county-level covariates. Results: Logistic models showed that participants enrolled to Medi-Cal with CPSP [n (%) = 89,009 (3.7)] had lower odds of PTB, spontaneous PTB and LBW, respectively, as compared with those with private insurance [n (%) = 1,133,140 (47.2)]. Within the Medi-Cal sub-population, the CPSP enrollment was associated with lower odds of PTB, SPTB and LBW than Medicaid beneficiaries without CPSP [n (%) = 967,094 (40.3)]. Discussion: With statewide data, these findings revealed a robust link between CPSP enrollment and better birth outcomes. Expanding access to comprehensive prenatal services could be an important strategy to improve birth outcomes.

Effectiveness of Transitional Care Program among High-Risk Discharged Patients: A Quasi-Experimental Study on Saving Costs, Post-Discharge Readmissions and Emergency Department Visits.

Transitional care programs (TCPs), where hospital care team members repeatedly follow up with discharged patients, aim to reduce post-discharge hospital or emergency department (ED) utilization and healthcare costs. We examined the effectiveness of TCPs at reducing healthcare costs, hospital readmissions, and ED visits. Centers for Medicare and Medicaid Services Bundled Payments for Care Improvement (BPCI) program adjudicated claims files and electronic health records from Greenville Memorial Hospital, Greenville, SC, were accessed. Data on post-discharge 30- and 90-day ED visits and readmissions, total costs, and episodes with costs over BPCI target prices were extracted from November 2017 to July 2020 and compared between the "TCP-Graduates" (N = 85) and "Did Not Graduate" (DNG) (N = 1310) groups. As compared to the DNG group, the TCP-Graduates group had significantly fewer 30-day (7.1% vs. 14.9%, p = 0.046) and 90-day (15.5% vs. 26.3%, p = 0.025) readmissions, episodes with total costs over target prices (25.9% vs. 36.6%, p = 0.031), and lower total cost/episode (USD 22,439 vs. USD 28,633, p = 0.018), but differences in 30-day (9.4% vs. 11.2%, p = 0.607) and 90-day (20.0% vs. 21.9%, p = 0.680) ED visits were not significant. TCP was associated with reduced post-discharge hospital readmissions, total care costs, and episodes exceeding target prices. Further studies with rigorous designs and individual-level data should test these findings.

Reduction in Depressive Symptoms in People who Inject Drugs who Are Cured of Hepatitis C Virus Infection: The HERO Study.

Background: Depressive symptoms are prevalent among people who inject drugs (PWID) and people with hepatitis C virus (HCV). We examined changes in depressive symptoms among HCV-infected PWID following direct-acting antiviral treatments to evaluate whether these changes differed by history of depressive symptoms, substance use, or HCV treatment outcome. Methods: We conducted a secondary analysis of the HERO Study (NCT02824640), a pragmatic randomized clinical trial among PWID, to test the effectiveness of HCV care models. Depressive symptoms (primary outcome) were measured using the Patient Health Questionnaire (PHQ-9) at baseline, end of treatment (EOT), and at follow-up 12 and 24 weeks after EOT. Sustained virologic response (SVR) was defined as undetectable HCV RNA at ≥12 weeks following EOT. Baseline drug use was defined as having a positive urine screening test for amphetamine, methamphetamine, benzodiazepine, cocaine, cannabis, opiate, or oxycodone. Results: The sample (n = 498) was 72.3% male, 64.2% White, and on average 43.9 years old. In patients who achieved SVR (F(3432) = 4.58; P = .004) and those with drug use at baseline (F(3478) = 5.11; P < .01), PHQ-9 scores significantly declined over time, with scores lower at EOT and both follow-ups as compared with baseline. Mean PHQ-9 scores at EOT and follow-ups were significantly lower than at baseline, except for those with no depression or mild depression at baseline. Conclusions: This study showed that HCV treatment in PWID is associated with sustained declines in depression up to 24 weeks post-treatment among those who achieve SVR and that drug use does not interfere with improvement in depressive symptoms.

Dispensed Opioid Prescription Patterns, by Racial/Ethnic Groups, Among South Carolina Medicaid-Funded Children Experiencing Limb Fracture Injuries.

OBJECTIVE: To examine dispensed opioid prescription patterns for limb fractures across racial/ethnic groups in a pediatric population. METHODS: We used South Carolina's Medicaid claims data 2000 to 2018 for pediatric limb fracture cases (under age 19) discharged from the emergency department. The key independent variable was the child's race/ethnicity. The outcomes were: 1) whether the patient had a dispensed opioid prescription; and 2) whether dispensed opioid supply was longer than 5 days among cases with any dispensed opioid prescriptions. Logistic regression models were used to test the association between race/ethnicity and the outcomes. Covariates included age-at-service, gender, service year, and having multiple fracture injuries. RESULTS: Compared with non-Hispanic White cases (NHW), the odds of receiving dispensed opioid prescriptions were lower for cases of non-Hispanic Black (NHB) (OR = 0.73; 95% confidence interval [CI]: 0.71, 0.75), Asian (OR = 0.69; CI: 0.53, 0.90), Other/Unknown (OR = 0.86; CI: 0.80, 0.92), and Hispanic (OR = 0.84; CI: 0.79, 0.90) race/ethnicity. The odds of receiving >5 days of dispensed opioid prescription supply did not differ significantly among race/ethnic categories. CONCLUSIONS: Our study confirms previous findings that as compared to NHW, the NHB children were less likely to receive dispensed opioid prescriptions. Also, it reveals that the different minority race/ethnic groups are not homogenous in their likelihoods of receiving dispensed opioid prescriptions after a limb fracture compared to NHW, findings underreported in previous studies. Children in the Other/Unknown race/ethnicity category have prescribing patterns different from those of other minority race/ethnic groups and should be analyzed separately.

A qualitative study on participants' experiences with a community-based mindful walking intervention and mobile device activity measurement.

BACKGROUND: Mindful walking (MW) interventions employ mindfulness training combined with physical activity. Wearable mobile devices have been increasingly used to measure outcomes of physical activity interventions. The purpose of this study was to understand MW participants' attitudes towards MW and the use of mobile devices in health promotion interventions, including barriers and facilitators of intervention engagement and adherence. Few qualitative studies have documented participant experience with these two types of interventions. METHOD: The pilot study involved a randomized MW intervention including 38 participants with self-reported inadequate physical activity. Half of them were randomized to receive MW intervention plus a FitBit device and the other received the FitBit device only. We used a qualitative thematic analysis of the narrative data collected through open-ended survey questions at three time points. Participants in the MW intervention were asked to describe their experiences with MW, while all participants were asked to describe their experience with wearing the FitBit to track their step counts. RESULTS: Participants reported a broad range of perceived benefits and challenges related to adopting the MW intervention and using the mobile device. Participants were generally willing to try to adopt the recommended MW practice and to see value of MW in increasing physical activity and improving overall health. Participants reported using a variety of additional device features beyond goal setting and step counts, indicating using the devices may have been effective in providing additional motivation for participants in meeting physical activity goals in both the control and intervention groups. While most of the feedback about MW (in the intervention group) and the device (all participants) was overwhelmingly positive, a minority of participants reported barriers such as lack of patience with meditation and discomfort with wearing the device. CONCLUSION: Most participants in the MW intervention see the health benefits of this program and most participants using the wearable physical activity tracking device reported the motivational benefits of this device. Issues with the MW intervention (e.g., lack of patience) and the wearable device (e.g., discomfort with wearing) need to be addressed in future interventions.