Pregnant Women and Opioid Use Disorder: Examining the Legal Landscape for Controlling Women's Reproductive Health.

Women with opioid use disorder ("OUD") are more likely than other women to experience sexual assault, unintentional pregnancy, transactional sex and coercion regarding reproductive health care choices than women without OUD. Laws described as family friendly may be punitive rather than helpful to women and rarely apply to men. Laws regarding reproductive health and OUD are unevenly enforced and therefore biased against poor, minority women. As part of a larger study oriented toward strengthening systems of care related to the intersection of HIV and OUD, we conducted an analysis of state laws related to pregnant and postpartum women with OUD. Data on disparities in child removals and pregnant women's use of evidence-based treatment for OUD by income and race were captured for the five states with the most restrictive laws in both categories. Laws that were purportedly designed to improve reproductive health outcomes for women with OUD and/or their children often have the opposite of the expressed intended outcome. There is a relationship between restrictive reproductive choice and coercive OUD treatment policy for women. Restrictive state regulations for pregnant women with OUD persist despite negative outcomes for maternal and child health. Altering coercive and/or criminalizing regulation and redefining 'family friendly' may improve outcomes for individuals and families.

Feasibility and impact of a guided symptom exposure augmented cognitive behavior therapy protocol to prevent symptoms of pharmacologically induced depression: A pilot study.

Depression is the leading cause of disability and a major cause of morbidity worldwide, with societal costs now upwards of 1 trillion dollars across the globe. Hence, extending current efforts to augment prevention outcomes is consistent with global public health interests. Although many prevention programs have been developed and have demonstrated efficacy, studies have yet to demonstrate that CBT is effective in preventing symptoms in populations at risk for developing depression induced by pharmacological substances. Using a randomized, controlled design, this pilot study reports on the feasibility and preliminary effects of a novel, guided symptom exposure augmented cognitive behavioral prevention intervention (GSE-CBT) in a sample diagnosed with Hepatitis C at risk for developing medication induced depression. Results demonstrated that the guided symptom exposure augmented CBT (GSE-CBT) was feasible in this population and was delivered with high integrity. Although not statistically different, we observed a pattern of lower depression levels in the GSE-CBT group versus those in the control group throughout. This pilot study demonstrates that a psychosocial prevention intervention is feasible for use in patients at risk for developing pharmacologically induced depression and that a guided symptom exposure augmented CBT protocol has the potential to prevent symptoms of depression that develop as a side effect to taking these medications. Results are preliminary and future studies should use larger samples and test the intervention in other populations.

Hepatitis C care cascade among persons born 1945-1965: 3 medical centers.

OBJECTIVES: Effective screening, diagnosis, and treatment are needed to reduce chronic hepatitis C virus (HCV) infection-associated morbidity and mortality. In order to successfully increase HCV treatment, it is necessary to identify and understand gaps in linkage of antibody-positive patients with newly identified HCV to subsequent HCV RNA testing, clinical evaluation, and treatment. STUDY DESIGN: To estimate attainment of HCV care cascade steps among antibody-positive patients with newly identified HCV, we conducted chart reviews of patients with a new positive HCV antibody test at 3 academic medical centers participating in the Birth-Cohort Evaluation to Advance Screening and Testing of Hepatitis C (BEST-C) study. METHODS: We tracked receipt of RNA testing, clinical evaluation, treatment initiation, and treatment completion among individuals born between 1945 and 1965 who were newly diagnosed as HCV antibody-positive between December 2012 and October 2015 at 3 BEST-C centers, predominantly from the participating medical centers' primary care practices and emergency departments. RESULTS: Of the 130 HCV-seropositive individuals identified, 118 (91%) had an RNA or genotype test, 75 (58%) were RNA-positive, 73 (56%) were linked to care, 22 (17% overall; 29% among RNA-positive) started treatment, and 21 (16%; 28% among RNA-positive) completed treatment. CONCLUSIONS: This analysis showed that although linkage to care was largely successful in the target birth cohort, the largest gap in the HCV care cascade was seen in initiating treatment. Greater emphasis on linking patients to clinical evaluation and treatment is necessary in order to achieve the public health benefits promised by birth-cohort testing.

Hepatitis C virus testing for case identification in persons born during 1945-1965: Results from three randomized controlled trials.

The Centers for Disease Control and Prevention and US Preventive Services Task Force recommend one-time hepatitis C virus (HCV) testing for persons born during 1945-1965 (birth cohort). However, few studies estimate the effect of birth cohort (BC) testing implementation on HCV diagnoses in primary care settings. We aimed to determine the probability of identifying HCV infections in primary care using targeted BC testing compared with usual care at three academic medical centers. From December 2012 to March 2014, each center compared one of three distinct interventions with usual care using an independently designed randomized controlled trial. Across centers, BC patients with no clinical documentation of previous HCV testing or diagnosis were randomly assigned to receive a one-time offering of HCV antibody (anti-HCV) testing via one of three independent implementation strategies (repeated-mailing outreach, electronic medical record-integrated provider best practice alert [BPA], and direct patient solicitation) or assigned to receive usual care. We estimated model-adjusted risk ratios (aRR) of anti-HCV-positive (anti-HCV+) identification using BC testing versus usual care. In the repeated mailing trial, 8992 patients (intervention, n = 2993; control, n = 5999) were included in the analysis. The intervention was eight times as likely to identify anti-HCV+ patients compared with controls (aRR, 8.0; 95% confidence interval [CI], 2.8-23.0; adjusted probabilities: intervention, 0.27%; control, 0.03%). In the BPA trial, data from 14,475 patients (BC, n = 8928; control, n = 5,547) were analyzed. The intervention was 2.6 times as likely to identify anti-HCV+ patients versus controls (aRR, 2.6; 95% CI, 1.1-6.4; adjusted probabilities: intervention, 0.29%; control, 0.11%). In the patient-solicitation trial, 8873 patients (BC, n = 4307; control, n = 4566) were analyzed. The intervention was five times as likely to identify anti-HCV+ patients compared with controls (aRR, 5.3; 95% CI, 2.3-12.3; adjusted probabilities: intervention, 0.68%; control, 0.11%). Conclusion: BC testing was effective in identifying previously undiagnosed HCV infections in primary care settings. (Hepatology 2018;67:524-533).

An Electronic Health Record-based Intervention to Promote Hepatitis C Virus Testing Among Adults Born Between 1945 and 1965: A Cluster-randomized Trial.

BACKGROUND: The Centers for Disease Control and Prevention (CDC) recommends one-time hepatitis C virus (HCV) antibody testing for "Birth Cohort" adults born during 1945-1965. OBJECTIVE: To examine the impact of an electronic health record (EHR)-embedded best practice alert (BPA) for HCV testing among Birth Cohort adults. DESIGN: Cluster-randomized trial was conducted from April 29, 2013 to March 29, 2014. SUBJECTS AND SETTING: Ten community and hospital-based primary care practices. Participants were attending physicians and medical residents during 25,620 study-eligible visits. INTERVENTION: Physicians in all practices received a brief introduction to the CDC testing recommendations. At visits for eligible patients at intervention sites, physicians received a BPA through the EHR to order HCV testing or medical assistants were prompted to post a testing order for the physician. Physicians in control sites did not receive the BPA. MAIN OUTCOMES: HCV testing; the incidence of HCV antibody positive tests was a secondary outcome. RESULTS: Testing rates were greater among Birth Cohort patients in intervention sites (20.2% vs. 1.8%, P<0.0001) and the odds of testing were greater in intervention sites after controlling for imbalances of patient and visit characteristics between comparison groups [odds ratio (OR), 9.0; 95% confidence interval, 7.6-10.7). The adjusted OR of identifying HCV antibody positive patients was also greater in intervention sites (OR, 2.1; 95% confidence interval, 1.3-11.2). CONCLUSIONS: An EHR-embedded BPA markedly increased HCV testing among Birth Cohort patients, but the majority of eligible patients did not receive testing indicating a need for more effective methods to promote uptake.

Uptake of hepatitis C screening, characteristics of patients tested, and intervention costs in the BEST-C study.

From December 2012 to March 2014, three randomized trials, each implementing a unique intervention in primary care settings (repeated mailing, an electronic health record best practice alert [BPA], and patient solicitation), evaluated hepatitis C virus (HCV) antibody testing, diagnosis, and costs for each of the interventions compared with standard-of-care testing. Multilevel multivariable models were used to estimate the adjusted risk ratio (aRR) for receiving an HCV antibody test, and costs were estimated using activity-based costing. The goal of this study was to estimate the effects of interventions conducted as part of the Birth-Cohort Evaluation to Advance Screening and Testing for Hepatitis C study on HCV testing and costs among persons of the 1945-1965 birth cohort (BC). Intervention resulted in substantially higher HCV testing rates compared with standard-of-care testing (26.9% versus 1.4% for repeated mailing, 30.9% versus 3.6% for BPA, and 63.5% versus 2.0% for patient solicitation) and significantly higher aRR for testing after controlling for sex, birth year, race, insurance type, and median household income (19.2 [95% confidence interval (CI), 9.7-38.2] for repeated mailing, 13.2 [95% CI, 3.6-48.6] for BPA, and 32.9 [95% CI, 19.3-56.1] for patient solicitation). The BPA intervention had the lowest incremental cost per completed test ($24 with fixed startup costs, $3 without) and also the lowest incremental cost per new case identified after omitting fixed startup costs ($1691). CONCLUSION: HCV testing interventions resulted in an increase in BC testing compared with standard-of-care testing but also increased costs. The effect size and incremental costs of BPA intervention (excluding startup costs) support more widespread adoption compared with the other interventions. (Hepatology 2017;65:44-53).

Implementation of Birth-Cohort Testing for Hepatitis C Virus.

Hepatitis C virus infection affects approximately 2.2 to 3.2 million Americans. In 2012, the Centers for Disease Control and Prevention recommended a one-time antibody test of all persons belonging to the 1945-1965 birth cohort. Efforts to implement this recommendation in clinical settings are in their infancy; this case study report therefore seeks to share the experiences of three sites that implemented interventions to increase birth-cohort testing through participation in the Birth-cohort Evaluation to Advance Screening and Testing for Hepatitis C. At each site, project managers completed standardized questionnaires about their implementation experiences, and a qualitative analysis was conducted of the responses. The testing interventions used in-person recruitment, mail recruitment, and an electronic health record prompt. Sites reported that early efforts to obtain stakeholder buy-in were critical to effectively implement and sustain interventions and that the intervention required additional staffing resources beyond those being used for risk-based testing. In each case, administrative barriers were more extensive than anticipated. For the electronic health record-based intervention, technological support was critical in achieving study goals. Despite these barriers, interventions in all sites were successful in increasing rates of testing and case identification, although future studies will need to evaluate the relative costs and benefits of each intervention.

Primary Care-Based Hepatitis C Treatment Outcomes With First-Generation Direct-Acting Agents.

OBJECTIVES: Vulnerable, urban populations with a history of substance use disorders have a high prevalence of hepatitis C virus (HCV). Primary care-based treatment has been proposed to improve access to care. In this study, we present outcomes from our urban, primary care-based HCV treatment program in patients treated with telaprevir or boceprevir in combination with pegylated-interferon and ribavirin ("triple therapy"). METHODS: We collected data from 126 consecutive patients with genotype 1 HCV monoinfection seen in our treatment program (2011-2013). Among the 40 who initiated treatment, we analyzed factors associated with achieving a sustained viral response (SVR). RESULTS: During the study period, 40 patients initiated triple therapy (32%), 80% with recent or past substance use disorders. Patients initiating treatment were younger than untreated patients (P = 0.002), but otherwise did not differ demographically, or in the severity of their liver fibrosis (P > 0.05). An SVR was achieved in 18 patients (45%) and was less likely in patients with recent or past substance use disorders or psychiatric illness (both P < 0.01). CONCLUSIONS: Nearly one third of patients initiated triple therapy with SVR rates comparable to other HCV treatment settings, despite a significant burden of mental illness and substance dependence. Our experience demonstrates that a primary care-based practice can successfully deliver HCV care to a vulnerable population. Additional interventions may be needed to improve outcomes in patients with recent or past substance use disorders or psychiatric illness.

HIV Infection Status as a Predictor of Hepatitis C Virus RNA Testing in Primary Care.

INTRODUCTION: Receipt of hepatitis C virus (HCV) RNA testing following a positive HCV antibody (anti-HCV+) test result to establish current infection is a quality indicator for HCV-related care. This study examines HIV infection status as a predictor of HCV RNA test receipt after an anti-HCV+ result in the primary care setting. METHODS: Electronic medical records of anti-HCV+ patients from a multisite retrospective study of patients aged ≥18 years who utilized one or more primary care outpatient services during 2005-2010 were analyzed in 2014. A multivariable logistic regression model examined the independent relationships between patient characteristics and receipt of HCV RNA testing. RESULTS: Among 1,115 anti-HCV+ patients, 133 (11.9%) were also HIV-positive. Of these, 77.4% (n=103) underwent HCV RNA testing to determine current infection status. By contrast, 66.7% (n=654/980) of anti-HCV+ patients who were HIV-negative received HCV RNA testing. Following multivariable adjustment, the odds of receiving HCV RNA testing were higher among anti-HCV+ patients who were also HIV-positive (AOR=1.9, 95% CI=1.2, 3.0), compared with their HIV-negative counterparts. Elevated alanine aminotransferase level was also associated with receipt of HCV RNA testing (AOR=1.9, 95% CI=1.4, 2.4). Black race was associated with decreased odds of receiving HCV RNA testing (AOR=0.7, 95% CI=0.5, 1.0). CONCLUSIONS: HIV infection status is independently associated with the likelihood of receiving HCV RNA testing following an anti-HCV+ result. One quarter of anti-HCV+ patients who were also HIV-positive and one third of their HIV-negative counterparts, respectively, did not receive testing to establish active HCV infection, which is imperative for appropriate care and treatment.