Integrating the Consolidated Framework for Implementation Research (CFIR) into a Culturally Responsive Evaluation (CRE) Approach to Conduct Mixed-Method Evaluations of Diabetes Prevention and Management Programs Reaching Underresourced Populations and Communities.

Diabetes is a significant population health threat. Evidence-based interventions, such as the Centers for Disease Control and Prevention's National Diabetes Prevention Program and diabetes self-management education and support programs, can help prevent, delay, or manage the disease. However, participation is suboptimal, especially among populations who are at an increased risk of developing diabetes. Evaluations of programs reaching populations who are medically underserved or people with lower incomes can help elucidate how best to tailor evidence-based interventions, but it is also important for evaluations to account for cultural and contextual factors. Culturally responsive evaluation (CRE) is a framework for centering an evaluation in the culture of the programs being evaluated. We integrated CRE with implementation and outcome constructs from the Adapted Consolidated Framework for Implementation Research (CFIR) to ensure that the evaluation produced useful evidence for putting evidence-based diabetes interventions to use in real-world settings, reaching populations who are at an increased risk of developing diabetes. The paper provides an overview of how we integrated CRE and CFIR approaches to conduct mixed-methods evaluations of evidence-based diabetes interventions.

Medicaid Medical Costs Associated with Hypertension by Diabetes Status among Women in Alabama.

Though a high proportion of Medicaid population in Alabama are women, little is known about their economic burdens of diabetes and hypertension. We used Alabama Medicaid claims data of 16,107 female enrollees aged 19-64 years to estimate per-capita total annual medical costs of hypertension by diabetes status. Hypertension prevalence was 60.0% and 17.3% among those with and without diabetes. The estimated annual medical cost for enrollees with hypertension was $6,689 (in 2017 $), of which $2,369 was associated with having hypertension. The hypertension-associated excess costs were $2,646 and $2,378 for enrollees with and without diabetes. All subgroups such as Blacks and those with Charlson Comorbidity Index ≥ 1, had higher medical costs when they had a combination of hypertension and diabetes compared with having diabetes without hypertension. Hypertension and diabetes increased medical costs substantially, and the findings can inform decision makers about effective resource utilizations for prevention and treatment strategies.

Prevalence and medical expenditures of diabetes-related complications among adult Medicaid enrollees with diabetes in eight U.S. states.

AIMS: To estimate the prevalence and medical expenditures of diabetes-related complications (DRCs) among adult Medicaid enrollees with diabetes. METHODS: We estimated the prevalence and medical expenditures for 12 diabetes-related complications by Medicaid eligibility category (disability-based vs. non-disability-based) in eight states. We used generalized linear models with log link and gamma distribution to estimate the total per-person annual medical expenditures for DRCs, controlling for demographics, and other comorbidities. RESULTS: Among non-disability-based enrollees (NDBEs), 40.1% (in California) to 47.5% (in Oklahoma) had one or more DRCs, compared to 53.6% (in Alabama) to 64.8% (in Florida) among disability-based enrollees (DBEs). The most prevalent complication was neuropathy (16.1%-27.1% for NDBEs; 20.2%-30.4% for DBEs). Lower extremity amputation (<1% for both eligibilities) was the least prevalent complication. The costliest per-person complication was dialysis (per-person excess annual expenditure of $22,481-$41,298 for NDBEs; $23,569-$51,470 for DBEs in 2012 USD). Combining prevalence and per-person excess expenditures, the three costliest complications were nephropathy, heart failure, and ischemic heart disease (IHD) for DBEs, compared to neuropathy, nephropathy, and IHD for NDBEs. CONCLUSIONS: Our study provides data that can be used for assessing the health care resources needed for managing DRCs and evaluating cost-effectiveness of interventions to prevent and management DRCs.

Estimated number of eligible Part B beneficiaries for the medicare diabetes prevention program at the county level and by urban-rural classification.

INTRODUCTION: Diabetes imposes large health and financial burdens on Medicare beneficiaries. Type 2 diabetes can be prevented or delayed through lifestyle modification programs. In 2018, Medicare began to offer the Medicare Diabetes Prevention Program (MDPP), a lifestyle intervention, to eligible beneficiaries nationwide. The number of MDPP-eligible beneficiaries is not known, but this information is essential in efforts to expand the program and increase enrollment. This study aimed to estimate the number and spatial variation of MDPP-eligible Part B beneficiaries at the county level and by urban-rural classification. METHODS: Data from 2011-2016 National Health and Nutrition Examination Surveys and a survey-weighted logistic regression model were used to estimate proportions of prediabetes in the United States by sex, age, and race/ethnicity based on the MDPP eligibility criteria. The results from the predictive model were applied to 2015 Medicare Part B beneficiaries to estimate the number of MDPP-eligible beneficiaries. The National Center for Health Statistics' Urban-Rural Classification Scheme for Counties from 2013 were used to define urban and rural categories. RESULTS: An estimated 5.2 million (95% CI = 3.5-7.0 million) Part B beneficiaries were eligible for the MDPP. By state, estimates ranged from 13,000 (95% CI = 8,500-18,000) in Alaska to 469,000 (95% CI = 296,000-641,000) in California. There were 2,149 counties with ≤1,000 eligible beneficiaries and 11 with >25,000. Consistent with demographic patterns, urban counties had more eligible beneficiaries than rural counties. CONCLUSIONS: These estimates could be used to plan locations for new MDPPs and reach eligible Part B beneficiaries for enrollment.

An Examination of Gender Differences in the National Diabetes Prevention Program's Lifestyle Change Program.

PURPOSE: The purpose of the study was to examine how gender was related to enrollment and number of sessions attended in the National Diabetes Prevention Program's Lifestyle Change Program (DPP LCP). METHODS: To better understand program uptake, a population of those who would be eligible for the LCP was compared to those who enrolled. Estimates of those eligible were computed using data from the National Health and Nutrition Examination Survey, whereas enrollment and sessions attended were computed using data from the Centers for Disease Control and Prevention's Diabetes Prevention Recognition Program. RESULTS: Results revealed that although similar numbers of males and females were eligible for the program, only 39 321 males versus 121 007 females had enrolled in the National DPP LCP by the end of 2017 (odds ratio = 3.20; 95% CI, 3.17-3.24). The gender differences persisted even when stratifying by age or race/ethnicity. In contrast, no significant gender differences were found between the average number of sessions attended for males (14.0) and females (13.8). DISCUSSION: Results of the study can help inform efforts to market and tailor programs to appeal more directly to men and other groups that are underrepresented in the National DPP LCP.

Opioid dispensing among adult Medicaid enrollees by diabetes status.

OBJECTIVE: Diabetes disproportionately affects low-income individuals, many of whom are covered by Medicaid. Comorbidities and complications of diabetes can lead to chronic pain; however, little is known about opioid use patterns among Medicaid enrollees with diabetes. This study examined opioid dispensing among Medicaid enrollees by diabetes status. METHODS: Medicaid claims data from 2014 were used to examine opioid dispensing by diabetes status among 622,992 adult enrollees aged 19-64 years. A logistic model adjusting for demographics and comorbidities was used to examine the association between diabetes and opioid dispensing among enrollees. Analyses were completed in 2019. RESULTS: Overall, 61.6% of enrollees with diabetes filled at least one opioid prescription compared to 31.8% of enrollees without diabetes. A higher proportion of enrollees with diabetes had long-term opioid prescriptions (>90 days' supply) (with diabetes: 51.0% vs. without: 32.1%, p < .001). Characteristics of individual prescriptions, including daily morphine milligram equivalents (45.9 vs. 49.4), formulation (percent short-acting: 91.5% vs. 90.7%), and type of opioids (i.e. percent hydrocodone: 46.7 vs. 45.3), were similar for those with and without diabetes. After adjustment, enrollees with diabetes were 1.43 times more likely to receive an opioid prescription compared to those without (95% CI, 1.40-1.46). CONCLUSIONS: Medicaid enrollees with diabetes were prescribed opioids more frequently and were more likely to have longer opioid supply than enrollees without diabetes. For practitioners who care for patients with diabetes, aligning pain management approaches with evidence-based resources, like the CDC Guideline for Prescribing Opioids for Chronic Pain, can encourage safer opioid prescribing practices.

Retention Among Participants in the National Diabetes Prevention Program Lifestyle Change Program, 2012-2017.

OBJECTIVE: To assess retention in the National Diabetes Prevention Program (DPP) lifestyle change program, which seeks to prevent type 2 diabetes in adults at high risk. RESEARCH DESIGN AND METHODS: We analyzed retention among 41,203 individuals who enrolled in Centers for Disease Control and Prevention (CDC)-recognized in-person lifestyle change programs at organizations that submitted data to CDC's Diabetes Prevention Recognition Program during January 2012-February 2017. RESULTS: Weekly attrition rates were typically <1-2% but were between 3.5% and 5% at week 2 and at weeks 17 and 18, where session frequency typically transitions from weekly to monthly. The percentage of participants retained through 18 weeks varied by age (45.9% for 18-29 year olds, 53.4% for 30-44 year olds, 60.2% for 45-54 year olds, 66.7% for 55-64 year olds, and 67.6% for ≥65 year olds), race/ethnicity (70.5% for non-Hispanic whites, 60.5% for non-Hispanic blacks, 52.6% for Hispanics, and 50.6% for other), mean weekly percentage of body weight lost (41.0% for ≤0% lost, 66.2% for >0% to <0.25% lost, 72.9% for 0.25% to <0.5% lost, and 73.9% for ≥0.5% lost), and mean weekly physical activity minutes (12.8% for 0 min, 56.1% for >0 to <60 min, 74.8% for 60 to <150 min, and 82.8% for ≥150 min) but not by sex (63.0% for men and 63.1% for women). CONCLUSIONS: Our results demonstrate the need to identify strategies to improve retention, especially among individuals who are younger or are members of racial/ethnic minority populations and among those who report less physical activity or less early weight loss. Strategies that address retention after the first session and during the transition from weekly to monthly sessions offer the greatest opportunity for impact.

The Importance of Addressing Depression and Diabetes Distress in Adults with Type 2 Diabetes.

People with type 2 diabetes often experience two common mental health conditions: depression and diabetes distress. Both increase a patient's risk for mortality, poor disease management, diabetes-related complications, and poor quality of life. The American Diabetes Association and the U.S. Preventive Services Task Force recommend routine evaluations for these conditions in adults for optimal disease management and prevention of life-threatening complications. However, barriers exist within primary care and specialty settings that make screening for depression and diabetes distress challenging. Depression and diabetes distress influence diabetes self-care and diabetes control and barriers in clinical care practice that can hinder detection and management of psychosocial issues in diabetes care. This paper highlights opportunities to increase mental health screenings and provides strategies to help providers address depression and diabetes distress in patients with type 2 diabetes.

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.

Results of Hepatitis C Birth-Cohort Testing and Linkage to Care in Selected U.S. Sites, 2012-2014.

OBJECTIVE: Following its recommendation for one-time hepatitis C virus (HCV) testing of people born between 1945 and 1965, CDC implemented the Hepatitis Testing and Linkage to Care (HepTLC) initiative to conduct birth-cohort hepatitis testing in U.S. health-care settings. We describe demographic characteristics, HCV infection prevalence, and HCV-related risk factors among people born between 1945 and 1965 who were tested as part of the program, which ran from 2012 to 2014. METHODS: As part of the HepTLC initiative, 14 grantees supporting 104 health-care sites in 21 U.S. municipalities tested participants born between 1945 and 1965 for HCV antibody (anti-HCV). Demographic characteristics and HCV risk factors were reported for people tested for anti-HCV and who were anti-HCV or HCV RNA positive. We evaluated outcomes along the HCV testing-to-care continuum using the following indicators: anti-HCV positive, HCV RNA test offered, HCV RNA positive, referred to care, and attended first medical appointment. RESULTS: Among 24,966 people tested for HCV infection, 2,900 (11.6%) were anti-HCV positive. Anti-HCV positivity was highest among those who self-identified as non-Hispanic black (n=1,701 of 12,202, 13.9%), men (n=2,073 of 12,130, 17.1%), and people born between 1951 and 1955 (n=795 of 5,768, 13.8%). Of the 2,900 people testing anti-HCV positive, 2,108 (72.7%) received an HCV RNA test, 1,497 (51.6%) were HCV RNA positive, 1,201 (41.4%) were referred to care, and 938 (32.3%) attended their first appointment. CONCLUSION: Testing for HCV infection among those born between 1945 and 1965 without soliciting HCV risk factors was successful. Providers implementing birth-cohort testing should develop and evaluate strategies to improve outcomes along the testing-to-care continuum.

Early Identification and Linkage to Care for People with Chronic HBV and HCV Infection: The HepTLC Initiative.

OBJECTIVE: In 2012, CDC's Division of Viral Hepatitis launched a public health initiative to increase hepatitis B virus (HBV) and hepatitis C virus (HCV) infection testing for those at risk and to improve linkage to medical care for those infected. We describe testing outcomes of previously unidentified people at risk for HBV and HCV infection and the lessons learned while linking patients to care. METHODS: CDC's Hepatitis Testing and Linkage to Care (HepTLC) initiative provided 34 financial awards to U.S. organizations that serve people at risk for viral hepatitis, 25 of which focused on HCV and nine of which focused on HBV. Grantees offered testing and test result notification to people at risk for HBV and/or HCV infection, as well as counseling, referral, and verification or notification of linkage to care for people with positive test results. We entered demographic data, self-reported risk factors, country of origin (for HBV), and testing outcomes into a confidential database. RESULTS: The 34 grantees tested 87,860 people at more than 260 sites in 17 states. Of the 23,144 people tested for HBV, 1,317 (6%) were positive. Of the 64,716 people tested for HCV, 57,570 (89%) received an HCV antibody (anti-HCV) test, of whom 7,580 (13%) tested anti-HCV positive. Of the 4,765 people who received an HCV RNA test, 3,449 (72%) tested positive. Of the 4,766 people who tested positive for either HBV or HCV infection, 2,116 (44%) were linked to care. CONCLUSION: Interventions targeting people at risk for HBV and HCV infection reached a substantial number of people for whom testing is recommended and identified a large proportion of those who had previously unrecognized infection. Patient navigation was critical for follow-up and linkage to care.

Hepatitis C Virus Testing and Linkage to Care in North Carolina and South Carolina Jails, 2012-2014.

OBJECTIVE: We evaluated a hepatitis C virus (HCV) testing and linkage-to-care post-release program among detainees of small- to medium-sized jails in North Carolina and South Carolina as part of the Hepatitis Testing and Linkage to Care initiative. METHODS: An HCV testing and linkage-to-care program was implemented in selected jails in North Carolina and South Carolina from December 2012 to March 2014. Health-care workers not affiliated with the jails conducted HCV antibody (anti-HCV) and HCV ribonucleic acid (RNA) testing and linkage-to-care activities. The North Carolina jail provided universal opt-out testing for HCV; South Carolina jails initially targeted high-risk individuals before expanding to routine testing. RESULTS: Of 669 detainees tested for HCV in North Carolina, 88 (13.2%) tested anti-HCV positive, of whom 81 (92.0%) received an HCV RNA test, 66 (81.5%) of whom tested HCV RNA positive (i.e., currently infected). Of the 66 detainees with current HCV infection, 18 were referred to HCV medical care post-release and 10 attended their first appointment. Of 224 detainees tested for HCV in South Carolina, 18 (8.0%) tested anti-HCV positive, of whom 13 received an HCV RNA test. Nine of 13 detainees tested HCV RNA positive, seven detainees were referred to post-release medical care, and two detainees attended their first appointment. Overall, 106 of 893 (11.9%) detainees were anti-HCV positive. CONCLUSION: This study demonstrated that HCV testing, identification of infection, and linkage to care are feasible among jail populations. The rate of anti-HCV positivity was lower than that found in national studies of incarcerated populations, suggesting that HCV infection prevalence in jails may vary across U.S. states or regions.

No Differences in Achieving Hepatitis C Virus Care Milestones Between Patients Identified by Birth Cohort or Risk-Based Screening.

BACKGROUND & AIMS: National hepatitis C virus (HCV) screening guidelines recommended 1-time testing of persons born between 1945 and 1965. METHODS: We performed a retrospective study to compare care milestones achieved by HCV-infected patients identified by birth cohort versus risk-based screens. RESULTS: We determined the proportions of patients newly identified with HCV infection who met care milestones (viral load, referral to and evaluation by a specialist, offer of treatment, initiation of treatment, and sustained viral response) and the time it took to reach them. We found no differences in HCV care milestones for patients identified via birth cohort testing versus risk-based screening. Overall, only 43% of HCV antibody-positive patients were referred to care, and less than 4% started treatment. The time to each care milestone was lengthy and varied greatly; treatment was initiated in a median of 308 days. CONCLUSIONS: Although birth cohort testing will likely increase identification of patients with HCV infection, it does not seem to increase the number of patients that meet management milestones. New methods are needed to increase access to care and establish efficient models of health care delivery.

A Birth-cohort testing intervention identified hepatitis c virus infection among patients with few identified risks: a cross-sectional study.

BACKGROUND: International guidelines and U.S. guidelines prior to 2012 only recommended testing for hepatitis C virus (HCV) infection among patients at risk, but adherence to guidelines is poor, and the majority of those infected remain undiagnosed. A strategy to perform one-time testing of all patients born during 1945-1965, birth cohort testing, may diagnose HCV infection among patients whose risk remains unknown. We sought to determine if a birth-cohort testing intervention for HCV antibody positivity helped identify patients with fewer documented risk factors or medical indications than a pre-intervention, risk-based testing strategy. METHODS: We used a cross-sectional design with retrospective electronic medical record review to examine patients identified with HCV antibody positivity (Ab+) during a pre-intervention (risk-based) phase, the standard of care at the time, vs. a birth-cohort testing intervention phase. We compared demographic and clinical characteristics and HCV risk-associated factors among patients whose HCV Ab + was identified during the pre-intervention (risk-based testing) vs. post birth-cohort intervention phases. Study subjects were patients identified as HCV-Ab + in the baseline (risk-based) and birth-cohort testing phases of the Hepatitis C Assessment and Testing (HepCAT) Project. RESULTS: Compared to the risk-based phase, patients newly diagnosed with HCV Ab + after the birth-cohort intervention were significantly less likely to have a history of any substance abuse (30.5% vs. 49.5%, p = 0.02), elevated alanine transaminase levels of > 40 U/L (22.0% vs. 46.7%, p = 0.002), or the composite any risk-associated factor (55.9% vs. 79.0%, p = 0.002). CONCLUSIONS: Birth-cohort testing is an useful strategy for identifying previously undiagnosed HCV Ab + because it does not require providers ask risk-based questions, or patients to disclose risk behaviors, and appears to identify HCV Ab + in patients who would not have been identified using a risk-based testing strategy.

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.

The cost-effectiveness, health benefits, and financial costs of new antiviral treatments for hepatitis C virus.

BACKGROUND: New hepatitis C virus (HCV) treatments deliver higher cure rates with fewer contraindications, increasing demand for treatment and healthcare costs. The cost-effectiveness of new treatments is unknown. METHODS: We conducted a microsimulation of guideline testing followed by alternative treatment regimens for HCV among the US population aged 20 and older to estimate cases identified, treated, sustained viral response, deaths, medical costs, quality-adjusted life-years (QALYs), and the incremental cost-effectiveness ratio (ICER) of different treatment options expressed as discounted lifetime costs and benefits from the healthcare perspective. RESULTS: Compared to treatment with pegylated interferon and ribavirin (PR), and a protease inhibitor for HCV genotype (G) 1 and PR alone for G2/3, treatment with PR and Sofosbuvir (PRS) for G1/4 and treatment with Sofosbuvir and ribavirin (SR) for G2/3 increased QALYs by 555 226, reduced deaths by 80 682, and increased costs by $26.2 billion at an ICER of $47 304 per QALY gained. As compared to PRS/SR, treating with an all oral regimen of Sofosbuvir and Simeprevir (SS) for G1/4 and SR for G2/3, increased QALYs by 1 110 451 and reduced deaths by an additional 164 540 at an incremental cost of $80.1 billion and an ICER of $72 169. In sensitivity analysis, where treatment with SS effectiveness was set to the list price of Viekira Pak and then Harvoni, treatment cost $24 921 and $25 405 per QALY gained as compared to PRS/SR. CONCLUSIONS: New treatments are cost-effectiveness per person treated, but pent-up demand for treatment may create challenges for financing.