Strategies for enhancing the representation of women in clinical trials: an evidence map.

BACKGROUND: Equitable sex- and gender-based representation in clinical trials is an essential step to ensuring evidence-based care for women. While multi-institutional actions have led to significant improvements in the inclusion of women in trials, inequity persists in areas like sex-neutral cancers and cardiovascular disease. We sought to identify strategies described or evaluated to boost the inclusion of women in clinical trials. METHODS: We used evidence mapping methodology to examine the breadth of relevant literature. We developed an a priori protocol and followed reporting guidance from the Preferred Reporting Items for Systematic Reviews and Meta-Analysis where applicable. We searched MEDLINE® (via PubMed) and EMBASE (via Elsevier) databases from inception through April 4, 2023, and used standardized procedures incorporating duplication and data verification. We included articles that described strategies to improve the recruitment and retention of women in clinical trials. RESULTS: We identified 122 articles describing recruitment and retention strategies for 136 trials (377,595 women). Only one article distinguished between the sex and gender identity of participants, and none defined their use of the terms such as "women" or "female". The majority of articles (95%) described recruitment for only women, and 64% were conducted in the USA. Ninety-two articles (75%) described strategies in the context of sex-specific conditions (e.g., gynecologic diagnosis). The majority of included articles evaluated a behavioral intervention (52%), with 23% evaluating pharmacologic interventions and 4% invasive interventions. The most common trial phase for reported strategies was during outreach to potential participants (116 articles), followed by intervention delivery (76), enrollment (40), outcomes assessment (21), analysis and interpretation (3), and dissemination (4). We describe specific types of strategies within each of these phases. CONCLUSIONS: Most of the existing literature describing strategies to improve the inclusion of women draws from trials for sex-specific conditions and is largely related to outreach to potential participants. There is little information about how and if studies have attempted to proportionally increase the inclusion of women in trials with both men and women or those focused on invasive and pharmacologic interventions. Future work in this area should focus on how to increase the participation of women in mixed-sex studies and on those areas with remaining inequities in trial participation.

A telehealth-delivered intervention to extend the veteran HIV treatment cascade for cardiovascular disease prevention: V-EXTRA-CVD study protocol for a randomized controlled trial.

Background: Veterans living with HIV have up to twice the risk of atherosclerotic cardiovascular disease (ASCVD) compared to those without HIV.Objective: Our study seeks to test a non-physician led virtual self-management implementation strategy to reduce ASCVD risk among people living with HIV (PWH). We aim to conduct a randomized control trial among PWH (n = 300) with a diagnosis of hypertension (HTN) who are enrolled in Veterans Health Administration (VHA) clinics, on suppressive antiretroviral therapy (ART), randomized 1:1 to intervention vs. education control for a 12-month duration.Methods: Using human centered design approach, we have adapted a previous 5-component telehealth focused, non-physician led intervention to a Veteran population. The education control arm receives enhanced education in addition to usual care. The primary outcome is 6 mmHg reduction in systolic BP over 12-month in the intervention arm compared to the control arm. The secondary outcome is a 12-month difference in non-HDL cholesterol. While each component of our intervention has an evidence base, they have not been tested together in an HIV context.Conclusion: The proposed multicomponent intervention has the potential to improve cardiovascular outcomes in PWH using novel virtual care methods in a patient centered care approach.

Team-Based Qualitative Rapid Analysis: Approach and Considerations for Conducting Developmental Formative Evaluation for Intervention Design.

Qualitative rapid analysis is one of many rapid research approaches that offer a solution to the problem of time constrained health services evaluations and avoids sacrificing the richness of qualitative data that is needed for intervention design. We describe modifications to an established team-based, rapid analysis approach that we used to rapidly collect and analyze semi-structured interview data for a developmental formative evaluation of a cardiovascular disease prevention intervention. Over 18 weeks, we conducted and analyzed 35 semi-structured interviews that were conducted with patients and health care providers in the Veterans Health Administration to identify targets for adapting the intervention in preparation for a clinical trial. We identified 12 key themes describing actionable targets for intervention modification. We highlight important methodological decisions that allowed us to maintain rigor when using qualitative rapid analysis for intervention adaptation and we provide practical guidance on the resources needed to execute similar qualitative studies. We additionally reflect on the benefits and challenges of the described approach when working within a remote research team environment.ClinicalTrials.gov: NCT04545489.

Reliving it All Over Again: Uncanny Temporalities of Injection Drug Use and Hepatitis C Diagnosis in Southwest Virginia, USA.

Clinicians typically view the intersection between hepatitis C and injection drug use in terms of simultaneity - with transmission occurring via shared needles - or sequentially - with some states requiring that people stop using drugs prior to treatment. Yet, for patients, the connection between substance use and HCV infection can follow a more complex temporal pathway. In this article, we explore the non-linear temporality of "reliving" as it shapes HCV illness experience, its complex intersection with injection drug use, and the barriers patients face as they reckon with existing healthcare system responses and treatment modalities.

Addressing Hypertension Outcomes Using Telehealth and Population Health Managers: Adaptations and Implementation Considerations.

PURPOSE OF REVIEW: There is a growing evidence base describing population health approaches to improve blood pressure control. We reviewed emerging trends in hypertension population health management and present implementation considerations from an intervention called Team-supported, Electronic health record-leveraged, Active Management (TEAM). By doing so, we highlight the role of population health managers, practitioners who use population level data and to proactively engage at-risk patients, in improving blood pressure control. RECENT FINDINGS: Within a population health paradigm, we discuss telehealth-delivered approaches to equitably improve hypertension care delivery. Additionally, we explore implementation considerations and complementary features of team-based, telehealth-delivered, population health management. By leveraging the unique role and expertise of a population health manager as core member of team-based telehealth, health systems can implement a cost-effective and scalable intervention that addresses multi-level barriers to hypertension care delivery. We describe the literature of telehealth-based population health management for patients with hypertension. Using the TEAM intervention as a case study, we then present implementation considerations and intervention adaptations to integrate a population health manager within the health care team and effectively manage hypertension for a defined patient population. We emphasize practical considerations to inform implementation, scaling, and sustainability. We highlight future research directions to advance the field and support translational efforts in diverse clinical and community contexts.

Is Tailoring of PrEP Programs Needed to Overcome Racial Disparities in PrEP Uptake in Local Health Departments? A Mixed-Methods Evaluation of PrEP Implementation in Virginia.

CONTEXT: African American and Hispanic adults share a disproportionate burden of HIV infections in the United States but continue to experience suboptimal uptake of HIV pre-exposure prophylaxis (PrEP). Increasing PrEP accessibility in nontraditional care settings is a potential strategy to increase PrEP uptake in these high-risk groups. PrEP implementation in local health departments (LHDs) is not well characterized. OBJECTIVE: To evaluate HIV PrEP implementation for African American and Hispanic adults receiving medical care in Virginia's LHDs. DESIGN: We conducted a retrospective, mixed-methods evaluation of PrEP services implementation at LHDs completing their first PrEP program year between June 1, 2016, and June 30, 2019. Using pharmacy records, we estimated PrEP coverage and adherence using PrEP to need ratios (PnRs) and medication possession ratios (MPRs), respectively. Thematic analysis was used to identify barriers to PrEP delivery in interviews with 6 multidisciplinary LHD workers. RESULTS: Of the 433 PrEP clients receiving an emtricitabine/tenofovir disoproxil fumarate (Truvada) prescription in year 1, 52.0% self-identified as African American and 8.9% self-identified as Hispanic. PnRs were greater for White adults in 50.0% of clinics. The average MPR (0.79) was consistent with protective medication adherence levels; however, 25.0% of clients filled only one prescription in the program year. Qualitative findings suggest incompatibilities between health PrEP services delivery and community preferences for African American and Hispanic adults; however, LHDs in one health region were able to link communities of color to PrEP at similar rates as Whites. CONCLUSIONS: Incorporating a metric sensitive to racial/ethnic differences in the burden of HIV infection improved recognition of PrEP disparities; however, population-specific targets are needed to enhance use of the PnR for program evaluation. Tailoring of PrEP services to communities with the greatest local PrEP burden may be needed to optimize the effectiveness of PrEP programs in LHDs.

Comparison of diet, muscle strength, steps per day and symptoms in people with HIV and HIV-negative peers.

People with HIV (PWH) experience a high frequency of symptoms that are associated with poor clinical outcomes. We conducted a secondary analysis of data from an observational study to examine whether diet, muscle strength, or physical activity were associated with symptoms among PWH and their HIV-uninfected peers. One-hundred ninety-one individuals (105 PWH and 86 HIV uninfected) with similar age and race were included. Symptoms were examined using the Patient-Reported Outcomes Measurement Information System (PROMIS-29) questionnaire, for which lower scores indicate higher function or fewer symptoms. The total healthy eating index score and carbohydrates, sugar sweet beverages, alcohol, and fiber consumption per day were obtained through 24-hour dietary recalls. A dynamometer was used to determine muscle strength. Steps per day were examined through 7 days of actigraphy. Linear regression analyses were used to determine the relationship between symptoms and diet, muscle strength, and steps per day. Participants were, on average, 54 years, 83% were African American, and 58% were male. In PWH, less healthy eating, fiber intake, and muscle strength were associated with poorer physical function; more steps per day were associated with fatigue; less daily carbohydrate consumption was associated with more pain. HIV-uninfected individuals demonstrated an association between fewer steps per day and poorer physical function and more pain, and less carbohydrate intake and more sleep disturbance. The relationships between diet, muscle strength, steps per day and PROMIS-29 health domains differed by HIV status.

An Implementation Strategy to Expand Mobile Health Use in HIV Care Settings: Rapid Evaluation Study Using the Consolidated Framework for Implementation Research.

BACKGROUND: Mobile health (mHealth) apps can provide support to people living with a chronic disease by offering resources for communication, self-management, and social support. PositiveLinks (PL) is a clinic-deployed mHealth app designed to improve the health of people with HIV. In a pilot study, PL users experienced considerable improvements in care engagement and viral load suppression. To promote its expansion to other HIV clinics, we developed an implementation strategy consisting of training resources and on-demand program support. OBJECTIVE: The objective of our study was to conduct an interim analysis of the barriers and facilitators to PL implementation at early adopting sites to guide optimization of our implementation strategy. METHODS: Semistructured interviews with stakeholders at PL expansion sites were conducted. Analysis of interviews identified facilitators and barriers that were mapped to 22 constructs of the Consolidated Framework for Implementation Research (CFIR). The purpose of the analysis was to identify the facilitators and barriers to PL implementation in order to adapt the PL implementation strategy. Four Ryan White HIV clinics were included. Interviews were conducted with one health care provider, two clinic managers, and five individuals who coordinated site PL activities. RESULTS: Ten common facilitators and eight common barriers were identified. Facilitators to PL implementation included PL's fit with patient and clinic needs, PL training resources, and sites' early engagement with their information technology personnel. Most barriers were specific to mHealth, including access to Wi-Fi networks, maintaining patient smartphone access, patient privacy concerns, and lack of clarity on how to obtain approvals for mHealth use. CONCLUSIONS: The CFIR is a useful framework for evaluating mHealth interventions. Although PL training resources were viewed favorably, we identified important barriers to PL implementation in a sample of Ryan White clinics. This enabled our team to expand guidance on identifying information technology stakeholders and procuring and managing mobile resources. Ongoing evaluation results continue to inform improvements to the PL implementation strategy, facilitating PL access for future expansion sites.

Understanding constraints on integrated care for people with HIV and multimorbid cardiovascular conditions: an application of the Theoretical Domains Framework.

BACKGROUND: People with HIV (PWH) experience increased cardiovascular disease (CVD) risk. Many PWH in the USA receive their primary medical care from infectious disease specialists in HIV clinics. HIV care teams may not be fully prepared to provide evidence-based CVD care. We sought to describe local context for HIV clinics participating in an NIH-funded implementation trial and to identify facilitators and barriers to integrated CVD preventive care for PWH. METHODS: Data were collected in semi-structured interviews and focus groups with PWH and multidisciplinary healthcare providers at three academic medical centers. We used template analysis to identify barriers and facilitators of CVD preventive care in three HIV specialty clinics using the Theoretical Domains Framework (TDF). RESULTS: Six focus groups were conducted with 37 PWH. Individual interviews were conducted with 34 healthcare providers and 14 PWH. Major themes were captured in seven TDF domains. Within those themes, we identified nine facilitators and 11 barriers to CVD preventive care. Knowledge gaps contributed to inaccurate CVD risk perceptions and ineffective self-management practices in PWH. Exclusive prioritization of HIV over CVD-related conditions was common in PWH and their providers. HIV care providers assumed inconsistent roles in CVD prevention, including for PWH with primary care providers. HIV providers were knowledgeable of HIV-related CVD risks and co-located health resources were consistently available to support PWH with limited resources in health behavior change. However, infrequent medical visits, perceptions of CVD prevention as a primary care service, and multiple co-location of support programs introduced local challenges to engaging in CVD preventive care. CONCLUSIONS: Barriers to screening and treatment of cardiovascular conditions are common in HIV care settings and highlight a need for greater primary care integration. Improving long-term cardiovascular outcomes of PWH will likely require multi-level interventions supporting HIV providers to expand their scope of practice, addressing patient preferences for co-located CVD preventive care, changing clinic cultures that focus only on HIV to the exclusion of non-AIDS multimorbidity, and managing constraints associated with multiple services co-location. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03643705.

A Review of Chronic Comorbidities in Adults Living With HIV: State of the Science.

ABSTRACT: People living with HIV are living longer, high-quality lives; however, as they age, this population is at increased risk for developing chronic comorbidities, including cardiovascular disease, certain types of cancer (e.g., lung, anal, and liver), and diabetes mellitus. The purpose of this state-of-the-science review is to provide an evidence-based summary on common physical comorbidities experienced by people living and aging with HIV. We focus on those chronic conditions that are prevalent and growing and share behavioral risk factors that are common in people living with HIV. We will discuss the current evidence on the epidemiology, physiology, prevention strategies, screening, and treatment options for people living with HIV across resource settings.

The influence of healthcare financing on cardiovascular disease prevention in people living with HIV.

BACKGROUND: People living with HIV are diagnosed with age-related chronic health conditions, including cardiovascular disease, at higher than expected rates. Medical management of these chronic health conditions frequently occur in HIV specialty clinics by providers trained in general internal medicine, family medicine, or infectious disease. In recent years, changes in the healthcare financing for people living with HIV in the U.S. has been dynamic due to changes in the Affordable Care Act. There is little evidence examining how healthcare financing characteristics shape primary and secondary cardiovascular disease prevention among people living with HIV. Our objective was to examine the perspectives of people living with HIV and their healthcare providers on how healthcare financing influences cardiovascular disease prevention. METHODS: As part of the EXTRA-CVD study, we conducted in-depth, semi-structured interviews with 51 people living with HIV and 34 multidisciplinary healthcare providers and at three U.S. HIV clinics in Ohio and North Carolina from October 2018 to March 2019. Thematic analysis using Template Analysis techniques was used to examine healthcare financing barriers and enablers of cardiovascular disease prevention in people living with HIV. RESULTS: Three themes emerged across sites and disciplines (1): healthcare payers substantially shape preventative cardiovascular care in HIV clinics (2); physician compensation tied to relative value units disincentivizes cardiovascular disease prevention efforts by HIV providers; and (3) grant-based services enable tailored cardiovascular disease prevention, but sustainability is limited by sponsor priorities. CONCLUSIONS: With HIV now a chronic disease, there is a growing need for HIV-specific cardiovascular disease prevention; however, healthcare financing complicates effective delivery of this preventative care. It is important to understand the effects of evolving payer models on patient and healthcare provider behavior. Additional systematic investigation of these models will help HIV specialty clinics implement cardiovascular disease prevention within a dynamic reimbursement landscape. TRIAL REGISTRATION: Clinical Trial Registration Number: NCT03643705 .

A qualitative study of perceived barriers to hepatitis C care among people who did not attend appointments in the non-urban US South.

BACKGROUND: Most people diagnosed with hepatitis C virus (HCV) have not linked to care, despite the availability of safe and effective treatment. We aimed to understand why people diagnosed with HCV have not pursued care in the non-urban Southern United States. METHODS: We conducted a survey and semi-structured interview with participants referred to an HCV clinic who did not attend an appointment between 2014 and 2018. Our clinic is located in a non-urban region of Virginia at a university hospital. Qualitative data collection was guided by the Health Belief Model (HBM). Data was analyzed using qualitative content analysis to identify key factors influencing patient perceptions regarding HCV and pursuit of care. RESULTS: Over half of previously referred patients (N = 200) could not be reached by phone. Eleven participants enrolled, including 7 men and 4 women. Based on survey responses, unreliable transportation, unstable housing, substance use, and lack of insurance were common. Participants demonstrated good knowledge of HCV disease, complications, and treatment. On qualitative analysis of semi-structured interviews, final themes emerged from within and between HBM constructs. Emerging themes influencing patient perceptions included (1) structural barriers, (2) stigma, (3) prior experiences of HCV disease and treatment, (4) discordance between the recognized severity of HCV and expected impacts on one's own health, and (5) patient-provider relationship. Substance use was not identified to be a barrier to care. CONCLUSIONS: Participants perceived individual and structural barriers to linking to care. A strong HCV knowledge base was not sufficient to motivate pursuit of care. Efforts to improve linkage to care must address barriers at multiple levels, and system-level changes are needed. As the majority of previously referred patients could not be contacted by phone, current approaches to patient engagement are not effective for reaching these populations. Expansion of HCV care to primary care settings with an established patient-provider relationship or co-located treatment within substance use treatment programs may serve to increase access to HCV treatment.

Why Do People Living with HIV Adhere to Antiretroviral Therapy and Not Comorbid Cardiovascular Disease Medications? A Qualitative Inquiry.

BACKGROUND: After achieving viral suppression, it is critical for persons living with HIV (PLWH) to focus on prevention of non-AIDS comorbidities such as cardiovascular disease (CVD) in order to enhance their quality of life and longevity of life. Despite PLWH elevated risk of developing CVD compared to individuals without HIV, PLWH do not often meet evidence-based treatment goals for CVD prevention; the reasons for PLWH not meeting guideline recommendations are poorly understood. The objective of this study was to identify the factors associated with adherence to CVD medications for PLWH who have achieved viral suppression. METHODS: Qualitative data were obtained from formative research conducted to inform the adaptation of a nurse-led intervention trial to improve cardiovascular health at three large academic medical centers in the United States. Transcripts were analyzed using content analysis guided by principles drawn from grounded theory. RESULTS: Fifty-one individuals who had achieved viral suppression (<200 copies/mL) participated: 37 in 6 focus groups and 14 in individual semi-structured interviews. Mean age was 57 years (SD: 7.8); most were African Americans (n=31) and majority were male (n=34). Three main themes were observed. First, participants reported discordance between their healthcare providers' recommendations and their own preferred strategies to reduce CVD risk. Second, participants intentionally modified frequency of CVD medication taking which appeared to be related to low CVD risk perception and perceived or experienced side effects with treatment. Finally, participants discussed the impact of long-term experience with HIV care on adherence to CVD medication and motivational factors that enhanced adherence to heart healthy behaviors. CONCLUSION: Findings suggest that future research should focus on developing interventions to enhance patient-provider communication in order to elicit beliefs, concerns and preferences for CVD prevention strategies. Future research should seek to leverage and adapt established evidence-based practices in HIV care to support CVD medication adherence.

Use of a human-centered design approach to adapt a nurse-led cardiovascular disease prevention intervention in HIV clinics.

Stakeholder-informed strategies addressing cardiovascular disease (CVD) burden among people living with HIV (PWH) are needed within healthcare settings. This study provides an assessment of how human-centered design (HCD) guided the adaptation of a nurse-led intervention to reduce CVD risk among PWH. Using a HCD approach, research staff guided two multidisciplinary "design teams" in Ohio and North Carolina, with each having five HCD meetings. We conducted acceptability and feasibility testing. Six core recommendations were produced by two design teams of key stakeholders and further developed after the acceptability and feasibility testing to produce a final list of 14 actionable areas of adaptation. Acceptability and feasibility testing revealed areas for adaptation, e.g. patient preferences for communication and the benefit of additional staff to support patient follow-up. In conclusion, along with acceptability and feasibility testing, HCD led to the production of 14 key recommendations to enhance the effectiveness and scalability of an integrated HIV/CVD intervention.

Impact of Perceived Cardiovascular Risk on Cardiovascular Disease Prevention Behaviors in People With and Without HIV Infection.

BACKGROUND: People living with HIV (PLHIV) are at elevated risk of developing atherosclerotic cardiovascular disease (ASCVD). PLHIV do not engage in recommended levels of ASCVD prevention behaviors, perhaps due to a reduced perception of risk for ASCVD. We examined how HIV status influences knowledge, beliefs, and perception of risk for ASCVD and ASCVD prevention behaviors. METHODS AND RESULTS: We conducted a mixed-methods study of 191 PLHIV and demographically similar HIV-uninfected adults. Participants completed self-reported surveys on CVD risk perceptions, adherence to CVD medication (aspirin, antihypertensives, and lipid-lowering medication) and 3 dietary intake interviews. All wore an accelerometer to measure physical activity. A subset of PLHIV (n = 38) also completed qualitative focus groups to further examine the influence of HIV on knowledge, perception of risk for ASCVD, and behavior. PARTICIPANTS: They were approximately 54 (±10) years, mostly men (n = 111; 58%), and African American (n = 151, 83%) with an average 10-year risk of an ASCVD event of 10.4 (±8.2)%. PLHIV were less likely to engage in physical activity (44% vs 65%, P < 0.05), and HIV status was associated with 43 fewer minutes of physical activity per week (P = 0.004). Adherence to ASCVD medications was better among PLHIV (P < 0.001). Diet composition was similar between groups (P > 0.05). HIV status did not influence ASCVD risk perceptions (P > 0.05) and modestly influenced physical activity and smoking. CONCLUSIONS: Although perceptions of ASCVD risk modestly influence some behaviors, additional barriers and insufficient cues to action result in suboptimal physical activity, dietary intake, and smoking rates. However, PLHIV have high adherence to ASCVD medications, which can be harnessed to reduce their high burden of ASCVD.

Rationale and design of a nurse-led intervention to extend the HIV treatment cascade for cardiovascular disease prevention trial (EXTRA-CVD).

Persons living with human immunodeficiency virus (PLHIV) are at increased risk of atherosclerotic cardiovascular disease (ASCVD). In spite of this, uptake of evidence-based clinical interventions for ASCVD risk reduction in the HIV clinic setting is sub-optimal. METHODS: EXTRA-CVD is a 12-month randomized clinical effectiveness trial that will assess the efficacy of a multi-component nurse-led intervention in reducing ASCVD risk among PLHIV. Three hundred high ASCVD risk PLHIV across three sites will be randomized 1:1 to usual care with generic prevention education or the study intervention. The study intervention will consist of four evidence-based components: (1) nurse-led care coordination, (2) nurse-managed medication protocols and adherence support (3) home BP monitoring, and (4) electronic health records support tools. The primary outcome will be change in systolic blood pressure and secondary outcome will be change in non-HDL cholesterol over the course of the intervention. Tertiary outcomes will include change in the proportion of participants in the following extended cascade categories: (1) appropriately diagnosed with hypertension and hyperlipidemia (2) appropriately managed; (3) at treatment goal (systolic blood pressure <130 mm Hg and non-HDL cholesterol < National Lipid Association targets). CONCLUSIONS: The EXTRA-CVD trial will provide evidence appraising the potential impact of nurse-led interventions in reducing ASCVD risk among PLHIV, an essential extension of the HIV care continuum beyond HIV viral suppression.

Efficacy of raltegravir, etravirine and darunavir/ritonavir for treatment-experienced HIV patients from a non-urban clinic population in the United States.

BACKGROUND: The regimen of raltegravir (RAL), ritonavir-boosted darunavir (DAR/r), and etravirine (ETR) for HIV treatment-experienced patients in a non-clinical trial setting in the rural/semi-urban United States had not been evaluated. OBJECTIVE: A retrospective cohort analysis was performed of adult patients prescribed the regimen from 2008 to 2013 at a HIV clinic serving such a population. RESULTS: In all, 51 patients met inclusion criteria including 15 with suppressed viral loads at regimen initiation. Of the 36 patients with detectable viral loads, 22 (61.1%) achieved a plasma HIV-1 RNA level < 50 copies/ml at 28 weeks and 17 maintained viral suppression at 56 weeks (50% of those surviving without death). Of 42 patients with long-term follow-up, mean of 216 ± 83 weeks following regimen initiation, 31 (73.8%) had viral suppression. Suppression was significantly more likely in those patients that maintained adherence. CONCLUSIONS: In a non-urban clinic population from the United States with considerable treatment experience, the combination of RAL, DAR/r, and ETR was well tolerated and resulted in viral suppression in those that maintained adherence. Future prospective studies may better define the role of such a regimen in the context of revised recommendations for first-line medications in the HIV treatment naïve.

Implementation Science: New Approaches to Integrating Quality and Safety Education for Nurses Competencies in Nursing Education.

Although quality and safety competencies were developed and disseminated nearly a decade ago by the Quality and Safety Education for Nurses (QSEN) project, the uptake in schools of nursing has been slow. The use of implementation science methods may be useful to accelerate quality and safety competency integration in nursing education. The article includes a definition and description of implementation science methods and practical implementation strategies for nurse educators to consider when integrating the QSEN competencies into nursing curriculum.

Characterizing Failure to Establish Hepatitis C Care of Baby Boomers Diagnosed in the Emergency Department.

BACKGROUND: Emergency departments (EDs) are high-yield sites for hepatitis C virus (HCV) screening, but data regarding linkage to care (LTC) determinants are limited. METHODS: Between September 2013 and June 2014, 4371 baby boomers unaware of their HCV status presented to the University of Alabama at Birmingham ED and underwent opt-out screening. A linkage coordinator facilitated referrals for positive cases. Demographic data, International Classification of Diseases, Ninth Revision codes, and clinic visits were collected, and patients were (retrospectively) followed up until February 2015. Linkage to care was defined as an HCV clinic visit within the hospital system. RESULTS: Overall, 332 baby boomers had reactive HCV antibody and detectable plasma ribonucleic acid. The mean age was 57.3 years (standard deviation = 4.8); 70% were male and 61% were African Americans. Substance abuse (37%) and psychiatric diagnoses (30%) were prevalent; 9% were identified with cirrhosis. During a median follow-up of 433 days (interquartile range, 354-500), 117 (35%) linked to care and 48% needed inpatient care. In multivariable analysis, the odds of LTC failure were significantly higher for white males (adjusted odds ratio [aOR], 2.57; 95% confidence interval [CI], 1.03-6.38) and uninsured individuals (aOR, 5.16; 95% CI, 1.43-18.63) and lower for patients with cirrhosis (aOR, 0.36; 95% CI, 0.14-0.92) and access to primary care (aOR, 0.20; 95% CI, 0.10-0.41). CONCLUSIONS: In this cohort of baby boomers with newly diagnosed HCV in the ED, only 1 in 3 were linked to HCV care. Although awareness of HCV diagnosis remains important, intensive strategies to improve LTC and access to curative therapy for diagnosed individuals are needed.