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Background: Despite success in HIV treatment, diagnosis and management of hypertension (HTN) and cardiovascular disease (CVD) remains suboptimal among people living with HIV (PLWH) in Botswana, with an overall HTN control of only 19% compared to 98% HIV viral suppressed. These gaps persist despite CVD primary care national guidelines and availability of free healthcare including antihypertensive medications. Our study aims to develop and test strategies to close the HTN care gap in PLWH, through integration into HIV care, leveraging the successful national HIV care and treatment program and strategies., Methods: The InterCARE trial is a cluster randomized controlled hybrid type 2 effectiveness-implementation trial at 14 sites designed to enroll 4652 adults living with HIV and HTN plus up to 2326 treatment partners. Primary outcomes included effectiveness (HTN control) and implementation outcomes using the Reach Effectiveness Adoption Implementation and Maintenance framework, with explanatory mixed methods used to understand variability in outcomes. InterCARE trial's main strategies include healthcare worker HTN and CVD care training plus long-term practice facilitation, electronic health record (EHR) documentation of key indicators and use of reminders, and use of treatment partners to provide social support to people living with HIV and HTN. InterCARE started with formative research to identify contextual factors influencing care gaps using the Consolidated Framework for Implementation Research. Results were used to adapt initial and develop additional implementation strategies to address barriers and leverage facilitators. The package was pilot tested in two clinics, with findings used to further adapt or add strategies for the clinical trial., Discussion: If successful, the InterCARE model can be scaled up to HIV clinics nationwide to improve diagnosis, management, and support in Botswana. The trial will provide insights for scale-up of HTN integration into HIV care in the region., Trial Registration: ClinicalTrials.gov reference NCT05414526. Registered 18 May 2022, https://clinicaltrials.gov/study/NCT05414526?term=NCT05414526.&rank=1 ., (© 2024. The Author(s).)

Background: Successful HIV treatment programs have turned HIV into a chronic condition, but noncommunicable diseases such as hypertension jeopardize this progress. Hypertension control rates among people with HIV (PWH) are low owing to gaps in patient awareness, diagnosis, effective treatment, and management of both conditions at separate clinic visits. Integrated management, such as in our study, InterCARE, can enhance HIV-hypertension integration and blood pressure (BP) control., Methods: Our pilot study was conducted in two Botswana HIV clinics between October 2021 and November 2022. Based on our formative work, we adopted three main strategies; Health worker training on HTN/cardiovascular disease (CVD) management, adaptation of HIV Electronic Health Record (EHR) for HTN/CVD care, and use of treatment partners to support PWH with hypertension for implementation. We employed the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework to assess implementation effectiveness and outcomes for BP control at baseline, 6 and 12 months. HIV viral load (VL) suppression was also measured to assess impact of integration on HIV care., Results: We enrolled 290 participants; 35 (12.1%) were lost to follow-up, leaving 255 (87.9%) at 12-months. Median age was 54 years (IQR 46-62), and 77.2% were females. Our interventions significantly improved BP control to < 140/90 mmHg (or < 130/80 mmHg if diagnosis of diabetes or chronic kidney disease), from 137/290 participants, 47.2% at baseline to 206/290 participants, 71.0%, at 12 months (p < 0.001). Among targeted providers, 94.7% received training, with an associated significant increase in counseling on exercise, diet, and medication (all p < 0.001) but EHR use for BP medication prescribing and cardiovascular risk factor evaluation showed no adoption. In the intention-to-treat analysis, HIV VL suppression at 12 months decreased (85.5% vs 93.8%, p = 0.002) due to loss to follow-up but the per protocol analysis showed no difference in VL suppression between baseline and 12 months (97.3% vs 93.3%, p = 0.060)., Conclusion: The InterCARE pilot study demonstrated that low-cost practical support measures involving the integration of HIV and hypertension/CVD management could lead to improvements in BP control. These results support the need for a large implementation and effectiveness trial., Trial Registration: ClinicalTrials.gov NCT05414526. Registered 18th May 2022., (© 2024. The Author(s).)

Background: Most implementation science resources (e.g., taxonomies) are published in English. Linguistic inaccessibility creates a barrier to the conduct of implementation research among non-English-speaking populations, so translation of resources is needed. Translation into Spanish can facilitate widespread reach, given the large proportion of Spanish speakers around the world. This research aimed to systematically translate the Expert Recommendations for Implementation Change (ERIC) compilation into Spanish as an exemplar for the linguistic translation process., Methods: Using the World Health Organization guidelines, this work translated the ERIC compilation strategy names, short definitions, and thematic clusters through a three-step process: 1) forward translation into Spanish by a native Spanish-speaking implementation scientist, 2) back-translation into English by a bilingual global health researcher, and 3) piloting via virtual focus group discussions with bilingual researchers not conducting implementation research. To achieve a generalizable translation, recruitment targeted a multicultural group of Spanish-speaking researchers. At the conclusion of each step, the transdisciplinary research team (N = 7) met to discuss discrepancies and refine translations. The Spanish version of the ERIC compilation was finalized through group consensus. Reflections from research team meetings and focus group discussions were synthesized qualitatively., Results: Given that dialectical nuances exist between Spanish-speaking regions, efforts prioritized universally accepted terminology. Team discussions focused on difficult translations, word choice, and clarity of concepts. Seven researchers participated in two focus groups, where discussion surrounded clarity of concepts, alternative word choice for Spanish translations, linguistic formality, grammar, and conciseness. Translation difficulties highlighted lack of precision in implementation science terminology, and the lack of conceptual clarity of words underscored limitations in the application of the compilation., Conclusions: The work demonstrated the feasibility of translating implementation science resources. As one of the first systematic efforts to translate implementation resources, this study can serve as a model for additional efforts, including translation into other languages and the expansion to conceptual modifications. Further, this work yielded insights into the need to provide conceptual clarity in implementation science terminology. Importantly, the development of Spanish resources will increase access to conduct implementation research among Spanish-speaking populations., (© 2024. The Author(s).)

Background: Botswana serves as a model of success for HIV with 95% of people living with HIV (PLWH) virally suppressed. Yet, only 19% of PLWH and hypertension have controlled blood pressure. To address this gap, InterCARE, a care model that integrates HIV and hypertension care through a) provider training; b) adapted electronic health record; and c) treatment partners (peer support), was designed. This study presents results from our baseline assessment of the determinants and factors used to guide adaptations to InterCARE implementation strategies prior to a hybrid type 2 effectiveness-implementation study., Methods: This study employed a convergent mixed methods design across two clinics (one rural, one urban) to collect quantitative and qualitative data through facility assessments, 100 stakeholder surveys (20 each PLWH and hypertension, existing HIV treatment partners, clinical healthcare providers (HCPs), and 40 community leaders) and ten stakeholder key informative interviews (KIIs). Data were analyzed using descriptive statistics and deductive qualitative analysis organized by the Consolidated Framework for Implementation Research (CFIR) and compared to identify areas of convergence and divergence., Results: Although 90.3% of 290 PLWH and hypertension at the clinics were taking antihypertensive medications, 52.8% had uncontrolled blood pressure. Results from facility assessments, surveys, and KIIs identified key determinants in the CFIR innovation and inner setting domains. Most stakeholders (> 85%) agreed that InterCARE was adaptable, compatible and would be successful at improving blood pressure control in PLWH and hypertension. HCPs agreed that there were insufficient resources (40%), consistent with facility assessments and KIIs which identified limited staffing, inconsistent electricity, and a lack of supplies as key barriers. Adaptations to InterCARE included a task-sharing strategy and expanded treatment partner training and support., Conclusions: Integrating hypertension services into HIV clinics was perceived as more advantageous for PLWH than the current model of hypertension care delivered outside of HIV clinics. Identified barriers were used to adapt InterCARE implementation strategies for more effective intervention delivery., Trial Registration: ClinicalTrials.gov, ClinicalTrials.gov Identifier: NCT05414526 . Registered 18 May 2022 - Retrospectively registered., (© 2024. The Author(s).)

Background: Participatory design approaches can improve successful selection and tailoring of implementation strategies by centering the voices of key constituents. To reduce incidence of the human immunodeficiency virus (HIV) in the USA, co-design of implementation strategies is needed for long-acting injectable cabotegravir (CAB-LA), a new form of HIV pre-exposure prophylaxis, among the disproportionately impacted population of sexual minority men (SMM). This manuscript describes the protocol for participatory design approaches (i.e., innovation tournament and implementation mapping) to inform implementation of CAB-LA among SMM (≥ 12 years), particularly Black and Latino populations, in Chicago., Methods: This research incorporates innovative methods to accomplish two objectives: (1) to crowdsource ideas for the design of implementation strategies for CAB-LA through a virtual innovation tournament and (2) to leverage the ideas from the innovation tournament to operationalize implementation strategies for CAB-LA thorough the systematic process of implementation mapping. A committee of constituents with diverse expertise and perspectives (e.g., SMM, implementation scientists, HIV clinicians, public health leadership, and community partners) will provide input throughout the design process., Discussion: This research will produce a menu of co-designed implementation strategies, which can guide plans for CAB-LA integration in Chicago and provide insights for other EHE regions. Further, as the first innovation tournament focused on HIV prevention, this research can provide a framework for participatory approaches across the care continuum. Given that the co-design of implementation strategies often does not involve the participation of individuals with lived experiences, this work will center the voices of those who will benefit most., (© 2024. The Author(s).)

Background: To meet the growing demand for implementation science expertise, building capacity is a priority. Various training opportunities have emerged to meet this need. To ensure rigor and achievement of specific implementation science competencies, it is critical to systematically evaluate training programs., Methods: The Penn Implementation Science Institute (PennISI) offers 4 days (20 h) of virtual synchronous training on foundational and advanced topics in implementation science. Through a pre-post design, this study evaluated the sixth PennISI, delivered in 2022. Surveys measures included 43 implementation science training evaluation competencies grouped into four thematic domains (e.g., items related to implementation science study design grouped into the "design, background, and rationale" competency category), course-specific evaluation criteria, and open-ended questions to evaluate change in knowledge and suggestions for improving future institutes. Mean composite scores were created for each of the competency themes. Descriptive statistics and thematic analysis were completed., Results: One hundred four (95.41% response rate) and 55 (50.46% response rate) participants completed the pre-survey and post-survey, respectively. Participants included a diverse cohort of individuals primarily affiliated with US-based academic institutions and self-reported as having novice or beginner-level knowledge of implementation science at baseline (81.73%). In the pre-survey, all mean composite scores for implementation science competencies were below one (i.e., beginner-level). Participants reported high value from the PennISI across standard course evaluation criteria (e.g., mean score of 3.77/4.00 for overall quality of course). Scores for all competency domains increased to a score between beginner-level and intermediate-level following training. In both the pre-survey and post-survey, competencies related to "definition, background, and rationale" had the highest mean composite score, whereas competencies related to "design and analysis" received the lowest score. Qualitative themes offered impressions of the PennISI, didactic content, PennISI structure, and suggestions for improvement. Prior experience with or knowledge of implementation science influenced many themes., Conclusions: This evaluation highlights the strengths of an established implementation science institute, which can serve as a model for brief, virtual training programs. Findings provide insight for improving future program efforts to meet the needs of the heterogenous implementation science community (e.g., different disciplines and levels of implementation science knowledge). This study contributes to ensuring rigorous implementation science capacity building through the evaluation of programs., (© 2023. The Author(s).)

Introduction: To end the HIV epidemic in Philadelphia, implementation of evidence-based practices (EBP) to increase viral suppression and retention in HIV care is critical. Managed problem solving (MAPS), an EBP for antiretroviral therapy adherence, follows a problem-solving approach to empower people living with HIV (PWH) to manage their health. To overcome barriers to care experienced by PWH in Philadelphia, the EBP was adapted to include a focus on care retention and delivery by community health workers (CHWs). The adapted intervention is MAPS+. To maximise the clinical impact and reach of the intervention, evaluation of the effectiveness and implementation of MAPS+ is necessary., Methods and Analysis: This manuscript describes the protocol for a stepped-wedge cluster-randomised type 2 hybrid effectiveness-implementation trial in 10 clinics in Philadelphia. This research incorporates innovative approaches to accomplish three objectives: (1) to evaluate the effectiveness of the CHW-led MAPS+ intervention to improve viral suppression and retention in care 1 year after the individual implementation period (N=390 participants), (2) to examine the effect of the menu of implementation strategies on reach and implementation cost and (3) to examine processes, mechanisms, and sustainment of the implementation strategies for MAPS+ (N=56 participants). Due to various factors (eg, COVID-19), protocol modifications have occurred., Ethics and Dissemination: The institutional review board (IRB) at the city of Philadelphia serves as the primary IRB; initial approval was granted on 21 December 2020. The University of Pennsylvania and Northwestern University executed reliance agreements. A safety monitoring committee comprised experts in implementation science, biostatistics and infectious diseases oversee this study. This research will offer insights into achieving the goals to end the HIV epidemic in Philadelphia as well as implementation efforts of MAPS+ and other behavioural interventions aimed at increasing medication adherence and retention in care. Dissemination will include deliverables (eg, peer-reviewed manuscripts and lay publications) to reach multiple constituents., Trial Registration Number: NCT04560621., Competing Interests: Competing interests: RSB is principal at Implementation Science & Practice. She receives royalties from Oxford University Press, consulting fees from United Behavioral Health and OptumLabs, and serves on the advisory boards for Optum Behavioral Health, AIM Youth Mental Health Foundation, and the Klingenstein Third Generation Foundation outside of the submitted work., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Despite evidence supporting HIV pre-exposure prophylaxis (PrEP) effectiveness, very few women with opioid use disorder (OUD) take PrEP. Interventions that improve medication assisted treatment (MAT) uptake and adherence may also be beneficial for PrEP. The reSET-O mobile phone app is a component of the evidence-based Therapeutic Education System, which improves retention and abstinence for people with OUD. To better understand use of this mobile health tool as a support for PrEP among women with OUD, pre-implementation contextual inquiry is needed. Therefore, we set out to assess target user characteristics, implementation barriers, feasibility, and acceptability of reSET-O. We recruited women with OUD receiving care from a community-based organization in Philadelphia to complete semi-structured interviews. All participants were prescribed reSET-O. We interviewed 20 participants (average age 37 years; 70% white, 15% Hispanic, 5% Black) from 5/2021 to 2/2022. We used an integrated analysis approach combining modified grounded theory and implementation science constructs. Half reported recent injection drug use, and 6 were taking buprenorphine. Mental health symptoms were common, and half described engaging in transactional sex. The majority expressed strong interest in PrEP. Participants reported the app would be highly acceptable for PrEP and MAT adherence support, but only two redeemed the prescription. The most common barriers included phone and internet access. Our findings highlight potential implementation challenges for the use of such an app to support PrEP use in this population. Poor uptake of the app at follow-up indicates that initial prescription redemption is a major barrier to reSET-O implementation., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Human immunodeficiency virus (HIV) infection is prevalent among children and adolescents in Botswana, but standardized neurocognitive testing is limited. The Penn Computerized Neurocognitive Battery (PennCNB) attempts to streamline evaluation of neurocognitive functioning and has been culturally adapted for use among youth in this high-burden, low-resource setting. However, its reliability across measurements (i.e., test-retest reliability) is unknown. This study examined the test-retest reliability of the culturally adapted PennCNB in 65 school-age children (age 7-17) living with HIV in Botswana. Intraclass correlation coefficients (ICCs) for PennCNB summary scores (ICCs > 0.80) and domain scores (ICCs = 0.66-0.88) were higher than those for individual tests, which exhibited more variability (ICCs = 0.50-0.82), with the lowest reliability on memory tests. Practice effects were apparent on some measures, especially within memory and complex cognition domains. Taken together, the adapted PennCNB exhibited adequate test-retest reliability at the domain level but variable reliability for individual tests. Differences in reliability should be considered in implementation of these tests., (© The Author(s) 2022. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

HIV infection and in utero exposure, common in Sub-Saharan Africa, are associated with pediatric neurocognitive impairment. Cognitive screening can identify impairments, but it is rarely used in this setting. The Penn Computerized Neurocognitive Battery (PennCNB), an evidence-based cognitive screening tool, was adapted for use in Botswana. To facilitate future implementation, 20 semi-structured interviews were conducted to elicit key stakeholders' perspectives on factors likely to be related to successful uptake of the PennCNB in clinical settings. An integrated analytic approach combining constructs from the Consolidated Framework for Implementation Research and modified grounded theory was used. Results underscore the need for cognitive screening in Botswana and the acceptability of the PennCNB. Implementation barriers include limited time and resources, whereas facilitators include standard procedures for introducing new tools into medical settings and for training implementers. Recommended implementation strategies include integrating screening into the existing workflow, implementing the tool in the medical and educational sectors, and targeting selection of children for assessment. This research addresses the research-to-practice gap by engaging in pre-implementation inquiry and designing for implementation. Results will inform the development of strategies to maximize the likelihood of successful implementation of the PennCNB to identify neurocognitive impairment in children in this high-need setting.

Importance: The COVID-19 pandemic has claimed nearly 6 million lives globally as of February 2022. While pandemic control efforts, including contact tracing, have traditionally been the purview of state and local health departments, the COVID-19 pandemic outpaced health department capacity, necessitating actions by private health systems to investigate and control outbreaks, mitigate transmission, and support patients and communities., Objective: To investigate the process of designing and implementing a volunteer-staffed contact tracing program at a large academic health system from April 2020 to May 2021, including program structure, lessons learned through implementation, results of case investigation and contact tracing efforts, and reflections on how constrained resources may be best allocated in the current pandemic or future public health emergencies., Design, Setting, and Participants: This case series study was conducted among patients at the University of Pennsylvania Health System and in partnership with the Philadelphia Department of Public Health. Patients who tested positive for COVID-19 were contacted to counsel them regarding safe isolation practices, identify and support quarantine of their close contacts, and provide resources, such as food and medicine, needed during isolation or quarantine., Results: Of 5470 individuals who tested positive for COVID-19 and received calls from a volunteer, 2982 individuals (54.5%; median [range] age, 42 [18-97] years; 1628 [59.4%] women among 2741 cases with sex data) were interviewed; among 2683 cases with race data, there were 110 Asian individuals (3.9%), 1476 Black individuals (52.7%), and 817 White individuals (29.2%), and among 2667 cases with ethnicity data, there were 366 Hispanic individuals (13.1%) and 2301 individuals who were not Hispanic (82.6%). Most individuals lived in a household with 2 to 5 people (2125 of 2904 individuals with household data [71.6%]). Of 3222 unique contacts, 1780 close contacts (55.2%; median [range] age, 40 [18-97] years; 866 [55.3%] women among 1565 contacts with sex data) were interviewed; among 1523 contacts with race data, there were 69 Asian individuals (4.2%), 705 Black individuals (43.2%), and 573 White individuals (35.1%), and among 1514 contacts with ethnicity data, there were 202 Hispanic individuals (12.8%) and 1312 individuals (83.4%) who were not Hispanic. Most contacts lived in a household with 2 to 5 people (1123 of 1418 individuals with household data [79.2%]). Of 3324 cases and contacts who completed a questionnaire on unmet social needs, 907 (27.3%) experienced material hardships that would make it difficult for them to isolate or quarantine safely. Such hardship was significantly less common among White compared with Black participants (odds ratio, 0.20; 95% CI, 0.16-0.25)., Conclusions and Relevance: These findings demonstrate the feasibility and challenges of implementing a case investigation and contact tracing program at an academic health system. In addition to successfully engaging most assigned COVID-19 cases and close contacts, contact tracers shared health information and material resources to support isolation and quarantine, thus filling local public health system gaps and supporting local pandemic control.

Children living with HIV (HIV+) experience increased risk of neurocognitive deficits, but standardized cognitive testing is limited in low-resource, high-prevalence settings. The Penn Computerized Neurocognitive Battery (PennCNB) was adapted for use in Botswana. This study evaluated the criterion validity of a locally adapted version of the PennCNB among a cohort of HIV+ individuals aged 10-17 years in Botswana. Participants completed the PennCNB and a comprehensive professional consensus assessment consisting of pencil-and-paper psychological assessments, clinical interview, and review of academic performance. Seventy-two participants were classified as cases (i.e., with cognitive impairment; N = 48) or controls (i.e., without cognitive impairment; N = 24). Sensitivity, specificity, positive predictive value, negative predictive value, and the area under receiver operating characteristic curves were calculated. Discrimination was acceptable, and prediction improved as the threshold for PennCNB impairment was less conservative. This research contributes to the validation of the PennCNB for use among children affected by HIV in Botswana., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Children born to mothers infected with the human immunodeficiency virus (HIV) during pregnancy experience increased risk of neurocognitive impairment. In Botswana, HIV infection is common among youth, but standardized cognitive screening is limited. The Penn Computerized Neurocognitive Battery (PennCNB), a tool that streamlines evaluation of neurocognitive functioning, was culturally adapted for use among youth in this high-burden, low-resource setting. The present study examined the structural validity of the culturally adapted PennCNB. A cohort of 7-17-year-old children living with HIV (HIV +) and HIV-exposed-uninfected (HEU) children were enrolled from the Botswana-Baylor Children's Clinical Centre of Excellence in Gaborone, Botswana. Confirmatory and exploratory factor analyses were performed on speed, accuracy, and efficiency measures for 13 PennCNB tests. Fit of the confirmatory factor analysis was acceptable, which supports the design of the battery measuring four neurocognitive domains: Executive functioning, episodic memory, complex cognition, and sensorimotor/processing speed. However, the model revealed high interfactor correlation. Exploratory factor analysis suggested that tests assessing executive functioning and sensorimotor/processing speed clustered together rather than forming differentiable factors. Overall, this research provides valuable insight into the structural validity of a neurocognitive battery adapted for use in a non-Western setting, suggesting that the PennCNB could serve as a useful tool for the assessment of neurocognitive function in Botswana and, potentially, other resource-limited settings. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Many children and adolescents around the world suffer from neurocognitive deficits due to chronic disorders, such as Human Immunodeficiency Virus (HIV) and malaria. Resource-limited settings exacerbate the risk of negative cognitive outcomes due to high prevalence of associated disorders, poverty, and limited access to interventions. Current literature does not provide consensus regarding the efficacy of interventions to support children with cognitive impairments in low-resource settings. This research aimed to identify and evaluate interventions for youth with neurocognitive deficits in resource-limited settings. A systematic review of peer-reviewed literature was conducted within five databases (PubMed, Web of Science, CINAHL, PsycInfo, and WHO Index Medicus). Cognitive impairment was broadly defined to be inclusive of aspects of intellectual and cognitive functioning (e.g., working memory, attention, executive function). The income status of the country or countries in which each study was located was determined according to World Bank Income Status. Studies conducted in countries classified as low- or middle-income were included. Since low-resource areas exist within high-income countries, the resource availability within study settings in high-income countries was systematically evaluated for inclusion. The search yielded 19 articles that met all inclusion criteria. Interventions included strategies involving caregiver training, computerized and non-computerized cognitive training, physical activity, and nutritional supplementation. Interventions were administered in medical facilities, educational facilities, or the home. The majority of the interventions targeted the domains of memory and attention. Overall, the efficacy of interventions was inconsistent. Further, results indicated that the relationship between cognitive improvement and intervention types was not consistent across cognitive domains. However, when evaluating studies on an individual basis, some strategies demonstrated clinically- and statistically-significant improvement in cognitive function among specific groups of children. The low article yield highlights that few researchers have evaluated pediatric cognitive support interventions in low-resource contexts. This review suggests support strategies that should be considered for future studies as neurocognitive screening capacity improves in resource-limited settings., Competing Interests: Declaration of Competing Interests None.

Introduction: Neurodevelopmental delays and cognitive impairments are common in youth living with HIV. Unfortunately, in resource-limited settings, where HIV infection impacts millions of children, cognitive and neurodevelopmental disorders commonly go undetected because of a lack of appropriate assessment instruments and local expertise. Here, we present a protocol to culturally adapt and validate the Penn Computerized Neurocognitive Battery (PennCNB) and examine its validity for detecting both advanced and subtle neurodevelopmental problems among school-aged children affected by HIV in resource-limited settings., Methods and Analysis: This is a prospective, observational cohort study. The venue for this study is Gaborone, Botswana, a resource-limited setting with high rates of perinatal exposure to HIV and limited neurocognitive assessment tools and expertise. We aim to validate the PennCNB in this setting by culturally adapting and then administering the adapted version of the battery to 200 HIV-infected, 200 HIV-exposed uninfected and 240 HIV-unexposed uninfected children. A series of analyses will be conducted to examine the reliability and construct validity of the PennCNB in these populations., Ethics and Dissemination: This project received ethical approval from local and university Institutional Review Boards and involved extensive input from local stakeholders. If successful, the proposed tools will provide practical screening and streamlined, comprehensive assessments that could be implemented in resource-limited settings to identify children with cognitive deficits within programmes focused on the care and treatment of children affected by HIV. The utility of such assessments could also extend beyond children affected by HIV, increasing general access to paediatric cognitive assessments in resource-limited settings., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Importance: The rate of youth suicide has increased steadily over the past several decades due, in part, to an increase in suicide by firearm. Implementation of evidence-based approaches to increase safe firearm storage practices are important for reducing youth suicide., Objective: To assess the needs of stakeholders who would be affected by implementing an evidence-based approach to firearm safety promotion-Firearm Safety Check, which includes screening for the presence of firearms in the home, brief motivational interviewing-informed counseling regarding safe firearm storage, and provision of free firearm locks-in pediatric primary care settings., Design, Setting, and Participants: In this qualitative study, 58 stakeholders were interviewed over a 7-month period across 9 stakeholder groups from 2 large and diverse health systems. Participants included parents of youth; physicians; nurses and nurse practitioners; leaders of pediatric primary care practices, behavioral health, and quality improvement; system leaders; third-party payers; and members of national credentialing bodies. Data analysis were conducted from September 2017 to April 2018., Main Outcomes and Measures: Interview guides were informed by the Consolidated Framework for Implementation Research. An integrated analysis approach was used in which a priori attributes of interest were identified (Consolidated Framework for Implementation Research constructs, eg, intervention characteristics), and an inductive approach was used with regard to new themes that emerged., Results: A total of 58 stakeholders were interviewed (mean [SD] age, 48.38 [10.65] years; 27 men and 31 women). Stakeholders indicated that firearm safety promotion is a health system priority and reported favorable perceptions of the Firearm Safety Check approach for suicide prevention. The importance of leveraging existing infrastructures, such as electronic health record systems and brevity, were frequently noted. Distribution of firearm locks was endorsed as the most complicated component to implement., Conclusions and Relevance: By including multiple service system stakeholder perspectives, these results support the development of implementation strategies to change clinician, organization, and system behaviors around firearm safety promotion in pediatric primary care as a universal suicide prevention strategy.

Injection injuries occur most commonly in the hand and digits; however, there are a limited number of reports in the literature describing injection injuries involving the orbit. High-pressure orbital injection injuries pose a number of unique challenges to the treating physician, and the approach to treating these injuries remains controversial. Often times, the extent of tissue damage is not fully appreciated at presentation, which may lead to missed diagnoses or inadequate initial treatment. In this study, the authors describe a rare incidence of high-pressure orbital injection injury. A 19-year-old male presented to the emergency department after injection of his left orbit with oil-based paint. Worsening clinical symptoms and increasing intraocular pressures within the first 24 hours necessitated take back to the operating room for orbital decompression and debridement. After an initial improvement in symptoms, the patient's clinical status deteriorated again, requiring further orbital decompression and additional periorbital debridement. Two weeks after initial presentation, soft tissue reconstruction of the surgical wounds was performed with full thickness skin grafts. The patient's globe and vision were both preserved. Orbital injection injuries, though rare, are potential globe threatening injuries. Physicians should have a low threshold for intervention and patient's must be observed closely over the first 72 hours after injury. Early diagnosis, prompt debridement, and a multidisciplinary approach are keys to improving patient outcomes.

Foodborne illness burdens individuals around the world and may be caused by consuming fresh produce contaminated with bacterial, parasite, and viral pathogens. Pathogen contamination on produce may originate at the farm and packing facility. This research aimed to determine the prevalence of human pathogens (bacteria, parasites, and viruses) on fresh produce (fruits, herbs, and vegetables) on farms and in packing facilities worldwide through a systematic review of 38 peer-reviewed articles. The median and range of the prevalence was calculated, and Kruskal-Wallis tests and logistic regression were performed to compare prevalence among pooled samples of produce groups, pathogen types, and sampling locations. Results indicated a low median percentage of fresh produce contaminated with pathogens (0%). Both viruses ( p -value = 0.017) and parasites ( p -value = 0.033), on fresh produce, exhibited higher prevalence than bacteria. No significant differences between fresh produce types or between farm and packing facility were observed. These results may help to better quantify produce contamination in the production environment and inform strategies to prevent future foodborne illness.

Background and Purpose: Orthotic helmets and active repositioning are the most common treatments for deformational plagiocephaly (DP). Existing evidence is not sufficient to objectively inform decisions between these options. A three-dimensional (3D), whole-head asymmetry analysis was used to rigorously compare outcomes of these 2 treatment methods., Patients and Methods: Whole-head 3D surface scans of 70 infants with DP were captured before and after treatment by using stereophotogrammetric imaging technology. Helmeted (n=35) and nonhelmeted/actively repositioned (n=35) infants were matched for severity of initial deformity. Surfaces were spatially registered to a symmetric template, which was deformed to achieve detailed right-to-left point correspondence for every point on the head surface. A ratiometric asymmetry value was calculated for each point relative to its contralateral counterpart. Maximum and mean asymmetry values were determined. Change in mean and maximum asymmetry with treatment was the basis for group comparison., Results: The helmeted group had a larger reduction than the repositioned group in both maximum (4.0% vs 2.5%; P=.02) and mean asymmetry (0.9% vs 0.5%; P=.02). The greatest difference was localized to the occipital region., Conclusions: Whole-head 3D asymmetry analysis is capable of rigorously quantifying the relative efficacy of the 2 common treatments of DP. Orthotic helmets provide statistically superior improvement in head symmetry compared with active repositioning immediately after therapy. Additional studies are needed to (1) establish the clinical significance of these quantitative differences in outcome, (2) define what constitutes pathologic head asymmetry, and (3) determine whether superiority of orthotic treatment lasts as the child matures.

Object: Deformational plagiocephaly (DP) is the leading cause of head shape abnormalities in infants. Treatment options include conservative measures and cranial molding. Pediatric neurosurgeons and craniofacial plastic surgeons have yet to agree on an ideal therapy, and no definable standards exist for initiating treatment with helmets. Furthermore, there may be differences between specialties in their perceptions of DP severity and need for helmet therapy., Methods: Requests to participate in a web-based questionnaire were sent to diplomates of the American Board of Pediatric Neurological Surgery and US and Canadian members of the Pediatric Joint Section of the American Association of Neurological Surgeons and the Congress of Neurological Surgeons and the American Cleft Palate-Craniofacial Association. Questions focused on educational background; practice setting; volume of DP patients; preferences for evaluation, treatment, follow-up; and incentives or deterrents to treat with helmet therapy. Six examples of varying degrees of DP were presented to delineate treatment preferences., Results: Requests were sent to 302 neurosurgeons and 470 plastic surgeons, and responses were received from 71 neurosurgeons (24%) and 64 plastic surgeons (14%). The following responses represented the greatest variations between specialties: 1) 8% of neurosurgeons and 26% of plastic surgeons strongly agreed with the statement that helmet therapy is more beneficial than conservative therapy (p < 0.01); and 2) 25% of neurosurgeons and 58% of plastic surgeons would treat moderate to severe DP with helmets (p < 0.01)., Conclusions: Survey responses suggest that neurosurgeons are less likely to prescribe helmet therapy for DP than plastic surgeons. Parents of children with DP are faced with a costly treatment decision that may be influenced more strongly by referral and physician bias than medical evidence.

Trastuzumab/chemotherapy combinations have already shown superior results in metastatic breast cancer patients. The purpose of this study is to determine the clinical efficacy of neoadjuvant trastuzumab and docetaxel in women with locally advanced breast cancer, with or without metastatic disease. Treatment-naive women with HER2-overexpressing locally advanced breast cancer, with or without metastatic disease, were included. Patients received trastuzumab 4 mg/kg loading dose intravenously then 2 mg/kg weekly. On day 22, docetaxel 100 mg/m2 every 3 weeks for 4 cycles was added to weekly trastuzumab. Patients then underwent surgery and subsequent 4 cycles of AC (doxorubicin/cyclophosphamide; 60/600 mg/m2) without trastuzumab. Weekly trastuzumab was resumed 1 month after completion of AC and continued for a year. Preliminary results from the first 22 patients with median follow-up of 15.5 months (range, 2-38 months) are reported. Of these, 9 patients (40.9%) had inflammatory breast cancer, and 6 patients (27.3%) had stage IV breast cancer. Seventeen of 22 patients (77.3%) had objective clinical response, with a clinical complete response in 9 patients (40.9%). Two patients (9.1%) had decline in cardiac function and 7 patients (31.8%) experienced neutropenia, with 2 deaths (9.1%) from neutropenic sepsis. Eight patients (36.4%) have relapsed, 3 with local skin recurrence (13.6%) and 5 with distant recurrence, of whom 1 had liver metastasis (4.5%) and 4 had brain metastasis (18.2%). Combined neoadjuvant trastuzumab and docetaxel induced high clinical response rates for HER2-overexpressing breast cancer, in particular for inflammatory breast cancer. A high rate of brain metastasis was noted, particularly in patients with baseline metastatic disease.