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Toshko Lissitchkov,1 Anna Klukowska,2 Evgeny Buevich,3 Irina Maltceva,3 Guenter Auerswald,4 Oleksandra Stasyshyn,5 Wilfried Seifert,6 Tobias Rogosch6 1Specialized Hospital for Active Treatment (SHAT), Sofia, Bulgaria; 2Department of Paediatrics, Haematology and Oncology of Warsaw Medical University, Warsaw, Poland; 3GOUVPO Altaysky State Medical University of Roszdrav, Bernaul, Russian Federation; 4Prof. Hess Kinderklinik, Klinikum Bremen-Mitte, Bremen, Germany; 5Institute of Pathology and Transfusion Medicine AMN, Lviv, Ukraine; 6Clinical Development, CSL Behring, Marburg, GermanyCorrespondence: Toshko LissitchkovSpecialized Hospital for Active Treatment (SHAT) “JOAN PAVEL”, 67A Stoletov Blvd, Sofia 1233, BulgariaTel +35 989 436 9096Email t_lissitchkov@yahoo.comObjective: Plasma-derived von Willebrand factor/factor VIII (pdVWF/FVIII; VONCENTO®, CSL Behring) is a high-concentration, low-volume, high-purity concentrate, which contains a high level of high-molecular-weight multimers and a VWF/FVIII ratio of ∼ 2.4:1. The SWIFT (“Studies with von Willebrand factor/Factor VIII”) program is evaluating pdVWF/FVIII in patients with von Willebrand disease (VWD). The long-term efficacy and safety profile of pdVWF/FVIII was investigated in this multicenter, open-label, extension study.Methods: Pediatric, adolescent, and adult patients with VWD who required treatment of non-surgical bleeds (NSBs), treatment during surgical events or who were receiving prophylaxis and who had completed one of two previous clinical trials of pdVWF/FVIII were included. Efficacy and safety analyses were performed for on-demand (n=10), prophylaxis (n=8), or on-demand and prophylaxis (n=2) treatment in patients pre-treated with pdVWF/FVIII for ≥ 12 months.Results: Seven patients experienced a total of 402 NSBs in the on-demand arm, of which 77 required treatment and nine NSB events in three patients were considered major. Nine patients reported 118 NSBs in the prophylaxis arm, with 96 events requiring treatment and seven patients experiencing 12 major NSB events. Excellent or good hemostatic efficacy was reported by the investigator for 98.7% (on-demand) and 97.9% (prophylaxis) of NSB events treated with pdVWF/FVIII, without relevant differences between subgroups by age. pdVWF/FVIII was well tolerated, and the adverse events seen were mild-moderate and consistent with the safety profile for this product seen in other studies. There were no cases of anaphylactic reactions and angioedema, development of VWF/FVIII inhibitors, thromboembolic events, or viral infections.Conclusion: This contemporary comprehensive development program evaluating pdVWF/FVIII across all ages demonstrates long-term safety and efficacy for treatment and prevention of bleeds in patients with severe VWD, supporting the benefit–risk profile of pdVWF/FVIII.Keywords: von Willebrand disease, hemostatic efficacy, safety, prophylaxis, on-demand, surgery

Guenter Auerswald,1 Claudia Djambas Khayat,2 Oleksandra Stasyshyn,3 Genadi Iosava,4 Irina Romashevskaya,5 Marta Julia López,6 Wilfried Seifert,7 Tobias Rogosch7 1Hess Kinderklinik, Klinikum Bremen-Mitte, Bremen, Germany; 2Hotel Dieu de France Hospital, St Joseph University, Beirut, Lebanon; 3Institute of Blood Pathology and Transfusion Medicine, Academy of Medical Sciences of Ukraine, Lviv, Ukraine; 4Institute for Hematology and Transfusiology, Tbilisi, Georgia; 5Republican Research Centre for Radiation Medicine and Human Ecology, Gomel, Belarus; 6Hematology, Hospital Roosevelt, Guatemala, Guatemala; 7Clinical Development, CSL Behring, Marburg, GermanyCorrespondence: Guenter AuerswaldHess Kinderklinik, Klinikum Bremen-Mitte, Bremen, GermanyTel +49 176-10113362Email guenterauerswald@aol.comPurpose: Formulation V (VONCENTO®) is a plasma-derived high-concentration/low-volume, high-purity von Willebrand factor (VWF)/factor VIII (FVIII) concentrate, originally indicated for von Willebrand disease (VWD) in adults and adolescents. This multicenter, open-label study (SWIFTLY-VWD) evaluated the pharmacokinetics (PK), as well as hemostatic efficacy and safety, of Formulation V in pediatric patients (< 12 years) with severe VWD requiring treatment or prophylaxis of bleedings.Methods: PK investigations were performed following one dose of Formulation V at Day 1 and 180. Nonsurgical bleeds were analyzed, while hemostatic efficacy was graded as excellent/good/moderate/none. Safety assessments included adverse events, and presence of VWF and/or FVIII inhibitors.Results: Formulation V was administered as on-demand (N=13) or prophylaxis therapy (N=4) for 12 months (< 6 years, N=9; 6 to < 12 years, N=8). PK parameters for VWF markers were generally comparable to adults but showed lower VWF:ristocetin cofactor (RCo) exposure. Incidence of major bleeds was lower for prophylaxis (3.3%) than on-demand therapy (27.1%); joint bleeds were also lower (3.3% vs 11.5%, respectively). Investigator-reported excellent/good hemostatic efficacy against nonsurgical bleeds was 100%. No clinically relevant differences in PK, hemostatic efficacy, or safety were observed between age-groups (< 6 years and 6 to < 12 years). Formulation V was well tolerated. Adverse events were mild–moderate and consistent with the adult safety profile. No cases of anaphylactic reactions or angioedema, development of FVIII/VWF inhibitors, thromboembolic events, or viral infections were reported.Conclusion: This study provides evidence for use of Formulation V to treat and prevent bleeding in pediatric patients with severe VWD, and led to the European approval of Formulation V in children.Keywords: von Willebrand disease, clinical trial, pediatrics, prophylaxis, von Willebrand factor-factor VIII concentrate

Introduction: Due to the circumstances of the Covid-19 pandemic, the teaching during the block internship at the Department for Otorhinolaryngology was switched to digital learning. Various online courses were created and the utilisation by the students was analyzed. Material & methods: Examination videos, surgical images and videos were created and live lectures were held. In addition, patient cases of common otorhinolaryngological diseases were reconstructed on an interactive platform. A total of 16 cases were offered in weekly rotation. These cases are provided with gap texts, open and selection questions, links and videos and thematically appropriate digression offers. The time-consuming creation was carried out as a HTML 5 learning package with the authoring program Exelearning 2.5. Each case was to be evaluated separately after being worked on by the students. Results: The direct feedback and the evaluation results of the students on the internship and case presentations were consistently positive. However, on average only 50.72% of the registered students took part in the weekly video meetings. In the course of the semester, the willingness to participate decreased. In addition, the willingness to evaluate the patient cases was low.Discussion: With the case presentation tool, concrete patient examples can be well presented, especially when patient contact is not possible (especially in an ENT clinic due to violation of distance and hygienic rules). Even though the evaluations were positive in terms of content, the frequency of utilisation and also the motivation for feedback seems disappointing. This seems to be associated above all with an increasing return to everyday life after the end of the lockdown.

Clear health and mortality disparities exist both in transgenderpopulations and for youth experiencing homelessness (YEH).  Transgender youth are overrepresented within populations of YEH. 1 in 100 youth is transgender, but an estimated 1 in 11 youth experiencing homelessness is transgender.  No peer-reviewed research has yet explored the structural factors that underlie health disparities experienced bytransgender YEH.

Services for youth experiencing homelessness (YEH) are designed with limited input from the youth themselves. This study explored the experiences and recommendations for services aimed at mitigating the negative effects of homelessness among youth. A total of 45 interviews were conducted with YEH (ages 15 to 24, M = 21.5 years) who experienced at least one night of homelessness. Transcripts were coded by using a modified constructivist grounded theory approach. YEH reported myriad challenges to navigating disjointed programming and misguided policies. Recommendations from YEH for policy and programmatic change include peacekeeping and diffusion training for program staff, trauma-informed approaches, and conflict resolution among agency staff; and integrate creative outlets and transitional services into existing programs. Programming supporting YEH must extend beyond meeting only basic needs to creating opportunities for safety, autonomy, and growth. Programs targeting youth homelessness need input from YEH in their design and implementation.

Adolescents comprise approximately 15% of new HIV infections in Kenya. Impoverished living conditions in informal settlements place residents at high risk for HIV infection. We assessed factors associated with HIV infection among adolescents residing in urban informal settlements in Kisumu. We recruited 3,061 adolescent boys and girls aged 15-19. HIV prevalence was 2.5% overall, all newly identified cases were among girls and infection was positively associated with not completing a secondary education (p < .001). Girls who had ever been pregnant (p < .001) or out-of-school without completing a secondary education (p < .001) were more likely to be HIV-positive. Our findings of higher HIV prevalence among adolescent girls who had been pregnant or did not complete secondary school highlight the need to facilitate access to HIV testing, HIV pre-exposure prophylaxis, and sexual and reproductive health services as components of a comprehensive prevention strategy to decrease HIV infections in this priority population.

Despite their documented benefits, the widespread adoption of community-engaged and participatory approaches among health researchers remains limited. Institutional practices and policies influence the uptake of community engagement and participatory approaches. We examine the role of financial arrangements between university researchers and community partners, by exploring efforts to bridge the gap between research administration and researchers at two research-intensive institutions. The type of financial arrangement a researcher has with a community partner plays an important role in setting the stage for the structure of the partnership as it relates to shared decision-making and ownership of the research. Continued efforts to clarify and streamline subcontracting processes are needed as is infrastructure to support community partners and researchers as they navigate financial arrangements if progress is to be made.

Rising homelessness in the United States has been a considerable source of concern, with policymakers and community members calling for “solutions.” Stigma, as a societal barrier to addressing inequity, is a significant cause of morbidity and mortality for people experiencing homelessness (PEH) and presents a barrier to the proposed solutions. Given that using surveys to study stigma against PEH carries potential social desirability bias, our research team used Twitter, a microblogging platform comprised of 140-character messages (aka, tweets), to get a snapshot of how American Twitter users stigmatize PEH. We conducted a content analysis of 6,400 tweets regarding homelessness collected over 3 months. Our analysis was informed by Erving Goffman’s theoretical framework regarding stigma. Consistent with Goffman’s work, we illustrate the ways that Twitter users rationalized the situation of PEH by creating a “stigma theory,” in which they attribute undesirable characteristics to PEH, highlight the multiple ways in which they “deserve” to be homeless because of their character flaws, and emphasize their devalued “bottom of the heap” status. We describe the ways that this stigma theory of homelessness is expressed in tweets regarding interactions between PEH and housed individuals. Complementing Goffman’s work as applied to PEH, we also describe the ways in which Twitter users impute additional stigmatized identities onto PEH and the role that disgust plays in stigma against PEH. Our findings suggest the need for a multi-level response to stigma, including addressing stigma at the individual and structural levels and providing housing to PEH across communities. (PsycInfo Database Record (c) 2021 APA, all rights reserved)

ImportanceThe US faces a pivotal moment of opportunity and risk regarding issues affecting children (aged 0-17 years). Although the US remains the only United Nations member state to not have ratified the Convention on the Rights of the Child (CRC), a child rights framework is essential for child health professionals seeking to advance many issues affecting children in the US. The Reimagining Children's Rights project (2020-2021) conducted an in-depth environmental scan of relevant literature and policy analysis using the Three Horizons design process to assess strategies that could advance the rights and well-being of children in the US. The project was overseen by a steering committee and informed by an advisory committee composed of youth leaders and experts in children's rights, advocacy, health, law, and a range of child-specific issues (eg, youth justice, early childhood development), who provided expert input on strategic considerations for advancing children's rights.ObservationsSeven findings about advancing children's rights in the US are notable, all reflecting current gaps and opportunities for using a whole-child rights framework in the US, even without formal adoption of the CRC. Actionable strategies, tactics, and tools to leverage sustainable change in the multitude of issue areas can advance the current state of children's rights. High-potential strategies for catalyzing advancement of children's rights include youth activism, innovations in governance and accountability, legislative action, impact litigation, place-based initiatives, education and public awareness, alignment with other children's movements, and research. The child rights framework is unifying and adaptive to future unforeseen challenges.Conclusions and relevanceChildren's rights provide a powerful, synergistic framework for child health professionals-in partnership with youth and other leaders-to increase equity and protect the rights and well-being of all children in the US.

BackgroundGiven the housing instability and frequent residential relocation (both volitional and hegemonic) of people who inject drugs, we sought to determine whether residential relocation (defined as sleeping in a different place in the past 30 days) is associated with health outcomes in a sample of people who inject drugs (PWID).MethodsWe recruited 601 PWID using targeted sampling and interviewed them between 2016 and 2018 in San Francisco and Los Angeles, CA about housing, drug use practices, and service utilization. We then developed multivariable regression models to investigate how residential relocation is associated with violence, health outcomes, and social service access. We analyzed our data between June 2018 and October 2019.ResultsParticipants who relocated in the past 30 days had lower odds of being in substance use treatment (Adjusted Odds Ratio [AOR] = 0.62, 95% Confidence Interval [CI] = 0.42, 0.89) and higher odds of nonfatal overdose (AOR = 2.50, CI = 1.28, 4.90), receptive syringe sharing (AOR = 2.26, CI = 1.18, 4.32), severe food insecurity (AOR = 1.69, CI = 1.14, 2.50), having belongings stolen (AOR = 2.14, CI = 1.42, 3.21), experiencing physical assault (AOR = 1.58, CI = 1.03, 2.43), arrest (AOR = 1.64, CI = 1.02, 2.65), and jail (AOR = 1.90, CI = 1.16, 3.13) in the past 6 months when compared to those who did not relocate.ConclusionsPWID who have relocated in the past 30 days have higher odds of experiencing violence and life- threatening adverse outcomes, and policies that disrupt living circumstances of PWID should be ended in favor of those that support housing stability.

IntroductionYouth Participatory Action Research (YPAR) is an approach to conducting research with youth populations in order to effectively engage youth in research that impacts their lives. Young people experiencing homelessness (YEH) are vulnerable to power and social environments in ways that call attention to their experiences in research.MethodsThe context for this paper was a qualitative YPAR project to incorporate youth voice into the operations of a larger research study that hired youth as researchers. Participant-researchers provided feedback and consultation with senior staff in order to improve their access to resources, safety, and stability.ResultsThemes that emerged from thematic analysis of reflections, discussions, and meetings showed the need for consistent access to food, the risk of environmental violence targeting youth researchers, the structural and experiential barriers to professional engagement, and the benefits that young researchers experienced as part of their work in the study.DiscussionRecommendations and lessons learned are described, notably to ensure that youth are paid and provided food, to construct effective safety plans during fieldwork, and to provide a flexible, inclusive, trauma-responsive approach to supervision of project tasks.