Thinking Beyond the Device: An Overview of Human- and Equity-Centered Approaches for Health Technology Design.

A shift in the traditional technocentric view of medical device design to a human-centered one is needed to bridge existing translational gaps and improve health equity. To ensure the successful and equitable adoption of health technology innovations, engineers must think beyond the device and the direct end user and must seek a more holistic understanding of broader stakeholder needs and the intended context of use early in a design process. The objectives of this review article are (a) to provide rationale for the need to incorporate meaningful stakeholder analysis and contextual investigation in health technology development and biomedical engineering pedagogy, (b) to review existing frameworks and human- and equity-centered approaches to stakeholder engagement and contextual investigation for improved adoption of innovative technologies, and (c) to present case studyexamples of medical device design that apply these approaches to bridge the gaps between biomedical engineers and the contexts for which they are designing.

Menstruating while homeless: navigating access to products, spaces, and services.

BACKGROUND: People experiencing homelessness (PEH) in the United States face substantial challenges related to menstruation, exacerbated by the COVID-19 pandemic. Limited access to period products, heightened stigma, and gynecological challenges contribute to increased hardships for PEH, highlighting the need for improved services and policies to address period equity and overall well-being for this vulnerable population. METHODS: We conducted semi-structured qualitative interviews with PEH (n = 12) and community healthcare and social service providers (e.g., case managers, shelter directors, community health workers, and nurses, n = 12) in Lafayette, Indiana, a city located between Indianapolis and Chicago in the United States. We used thematic analysis techniques for data analysis. RESULTS: PEH's limited access to products, services, and safe spaces hindered effective menstruation management within restrictive community contexts. Although community healthcare and service providers offered some support, complex interactions with the healthcare system, stigma, and limited access to spaces exacerbated barriers. The COVID-19 pandemic further intensified these difficulties by closing public spaces, worsening economic conditions, and straining service provider resources. CONCLUSIONS: Results highlight critical organizational and policy gaps in the United States for menstruation management resources and services, emphasizing the need for better integration into health and well-being programs for PEH. These insights will advance reproductive and public health research, shedding light on the disparities faced by PEH in managing menstruation in Indiana and contributing to the national discourse on addressing these barriers. Amid the complex landscape of public health, particularly during and after the pandemic, prioritizing menstrual health remains essential for all individuals' overall well-being, including those experiencing homelessness.

"COVID knocked me straight into the dirt": perspectives from people experiencing homelessness on the impacts of the COVID-19 pandemic.

BACKGROUND: People experiencing homelessness are uniquely susceptible and disproportionately affected by the impacts of the COVID-19 pandemic. Understanding context-specific challenges, responses, and perspectives of people experiencing homelessness is essential to improving pandemic response and mitigating the long-term consequences of the pandemic on this vulnerable population. METHODS: As part of an ongoing community-based participatory research study in partnership with a homeless service organization in Indiana, semi-structured interviews were conducted with a total of 34 individuals experiencing homelessness between January and July 2021. Guided by the NIMHD Health Disparities Research Framework, which builds on the socio-ecological model, data was thematically coded using Nvivo12 qualitative coding software and themes were organized by levels of influence (individual, interpersonal, community, societal) and domains of influence (biological, behavioral, physical/built environment, sociocultural environment, health care system). RESULTS: Narratives revealed numerous and compounding factors affecting COVID-19 risks and health outcomes among people experiencing homelessness across all levels and domains of influence. At the individual level, people experiencing homelessness face unique challenges that heightened their susceptibility to COVID-19, including pre-existing physical and mental health conditions, substance use and behavioral health risks, socioeconomic precarity, and low health literacy and COVID-related knowledge. At the interpersonal level, poor communication between people experiencing homelessness and service providers led to limited understanding of and poor compliance with COVID safety measures. At the community level, closures and service disruptions restricted access to usual spaces and resources to meet basic needs. At a policy level, people experiencing homelessness were disregarded in ways that made pandemic relief resources largely inaccessible to them. CONCLUSIONS: Our findings reveal important and mitigable issues with ongoing pandemic response efforts in homeless populations through direct, first-hand accounts of their experiences during COVID-19. These insights offer opportunities for multilevel interventions to improve outreach, communication, and impact mitigation strategies for people experiencing homelessness. This study highlights the importance of centering the voices of vulnerable communities to inform future pandemic response for homeless and other underserved and marginalized populations.

Update on Perioperative Pediatric Pulmonary Hypertension Management.

Pediatric pulmonary hypertension is a disease that has many etiologies and can present anytime during childhood. Its newly revised hemodynamic definition follows that of adult pulmonary hypertension: a mean pulmonary artery pressure >20 mmHg. However, the pediatric definition stipulates that the elevated pressure must be present after the age of three months. The definition encompasses many different etiologies, and diagnosis often involves a combination of noninvasive and invasive testing. Treatment often is extrapolated from adult studies or based on expert opinion. Moreover, although general anesthesia may be required for pediatric patients with pulmonary hypertension, it poses certain risks. A thoughtful, multidisciplinary approach is needed to deliver excellent perioperative care.

From crisis to crisis: impacts of the COVID-19 pandemic on people living with HIV and HIV/AIDS service organizations in Indiana.

BACKGROUND: The COVID-19 pandemic thrust people living with HIV (PLWH) and HIV/AIDS service organizations into an environment ripe with uncertainty. This study examined Indiana HIV/AIDS service provider perceptions of how COVID-19 affected the overall health and access to care of their clients, and how the organizations prepared for, adapted, and responded to the needs of PLWH during the pandemic. METHODS: Guided by the socioecological model, fifteen semi-structured interviews were conducted with ten different HIV/AIDS service organizations across the state of Indiana. RESULTS: Despite the profound disruptions experienced by HIV programs, HIV/AIDS service organizations responded quickly to the challenges posed by the COVID-19 pandemic through myriad innovative strategies, largely informed by prior experiences with the HIV epidemic. CONCLUSIONS: The lessons provided by HIV/AIDS service organizations are invaluable to informing future pandemic response for PLWH. Service delivery innovations in response to the COVID-19 crisis may provide insights to improve HIV care continuity strategies for vulnerable populations far beyond the pandemic.

Indiana community health workers: challenges and opportunities for workforce development.

BACKGROUND: An interest in, and the need for, Community Health Workers (CHWs) in the United States is growing exponentially. CHWs possess a unique ability to relate to and build trust with communities in order to improve clinical outcomes, while building individual and community capacity. Given their critical role in addressing social determinants of health, expanding the CHW workforce is crucial. However, creating CHW jobs, facilitating training and certification, and establishing sustainable financing models to support this workforce has been challenging. METHODS: A mixed-methods study consisting of an online survey and focus group discussions assessed the strengths, practices, and challenges to CHW workforce sustainability and expansion in the state of Indiana, including perspectives from both CHWs and employers. RESULTS: Across 8 topics, mixed data analysis revealed 28 findings that were both complementary and unique across focus group and survey results. Results highlighted CHW skills and attributes, illustrated the recruitment and hiring process, and provided insight into measuring outcomes and outputs. Findings also indicated a need to build position validation, professional development, and billing and reimbursement capacity. CONCLUSION: Building and sustaining the CHW workforce will require creating an evidence base of roles and impact, increasing awareness of existing reimbursement mechanisms, and sharing best practices across employer organizations to promote optimal recruitment, training, supervision, career development, and funding strategies.

Homelessness during COVID-19: challenges, responses, and lessons learned from homeless service providers in Tippecanoe County, Indiana.

BACKGROUND: The COVID-19 pandemic laid bare some of the United States' most devastating health and social inequities faced by people experiencing homelessness. Homeless populations experience disproportionate rates of underlying health conditions, stigma and marginalization that often disenfranchise them from health and social services, and living conditions that potentiate the risk of COVID-19 transmission and adverse outcomes. METHODS: Guided by the socio-ecological model, this community-based participatory research study examined the impacts of the COVID-19 public health crisis on people experiencing homelessness in Tippecanoe County, Indiana, and the ways in which homeless service providers prepared for, experienced, and responded to the pandemic. Eighteen (18) semi-structured interviews were conducted with representatives of 15 community-based organizations, including shelters and other homeless service providers. RESULTS: Qualitative content analysis revealed myriad challenges at the individual and interpersonal levels faced by people experiencing homelessness as a result of the pandemic, and multilevel responses for COVID-19 impact mitigation in this community. Many of the emergency measures put in place by homeless service providers in Tippecanoe County, Indiana created opportunities for innovative solutions to longstanding challenges faced by homeless populations that are informing better service delivery moving forward, even beyond the COVID-19 pandemic. CONCLUSIONS: Community-based organizations, including homeless shelters, are uniquely qualified to inform pandemic response and disaster risk mitigation in order to respond appropriately to the specific needs of people experiencing homelessness. The lessons learned and shared by homeless service providers on the frontline during the COVID-19 pandemic have important implications to improve future disaster response for homeless and other vulnerable populations.

Harvesting Health Knowledge: Breast Cancer Perceptions in the South Florida Latinx Farmworker Community.

South Florida agricultural regions, home to Latinx immigrant farmworkers, report higher rates of late-stage breast cancer diagnosis than national, state, and county-level averages. We conducted a community-based qualitative study on the needs, health knowledge gaps, barriers to breast cancer screening, and the role of community health workers (CHWs) in supporting the community's access to early detection services. We conducted three CHW focus groups (FGs) (n = 25) and in-depth interviews (n = 15), two FGs (n = 18) and in-depth interviews (n = 3) with farmworker community members, and informal interviews with cancer clinicians (n = 7). Using a grounded theory approach, five core themes regarding the community's barriers to accessing health care services emerged: (a) lack of information; (b) social and economic barriers; (c) cultural factors; (d) fears and mistrust; and (e) psychosocial concerns. Findings yield implications for community health practice, the potential impact of CHWs, and the production of breast cancer education to improve health equity along with the care continuum.

Solving the Global Crisis in Access to Pain Relief: Lessons From Country Actions.

Annually, more than 61 million people worldwide experience about 6 billion days of serious health-related suffering that could be alleviated with access to palliative care and pain relief. However, palliative care is limited or nonexistent in most parts of the world. The access abyss is so stark that 50% of the world's poorest populations live in countries that receive only 1% of the opioid analgesics distributed worldwide. By contrast, the richest 10% of the world's population live in countries that receive nearly 90% of the opioid pain relief medications.The Lancet Commission on Global Access to Palliative Care and Pain Relief developed a framework to measure the global burden of serious health-related suffering and generated the evidence base to address this burden.We present the inequities in access to pain relief and highlight key points from country responses, drawing from and building on recommendations of the Lancet Commission report "Alleviating the Access Abyss in Palliative Care and Pain Relief-An Imperative of Universal Health Coverage" to close the access abyss in relief of pain and other types of serious health-related suffering.

Defining priority medical devices for cancer management: a WHO initiative.

Medical devices are indispensable for cancer management across the entire cancer care continuum, yet many existing medical interventions are not equally accessible to the global population, contributing to disparate mortality rates between countries with different income levels. Improved access to priority medical technologies is required to implement universal health coverage and deliver high-quality cancer care. However, the selection of appropriate medical devices at all income and hospital levels has been difficult because of the extremely large number of devices needed for the full spectrum of cancer care; the wide variety of options within the medical device sector, ranging from small inexpensive disposable devices to sophisticated diagnostic imaging and treatment units; and insufficient in-country expertise, in many countries, to prioritise cancer interventions and to determine associated technologies. In this Policy Review, we describe the methods, process, and outcome of a WHO initiative to define a list of priority medical devices for cancer management. The methods, approved by the WHO Guidelines Review Committee, can be used as a model approach for future endeavours to define and select medical devices for disease management. The resulting list provides ready-to-use guidance for the selection of devices to establish, maintain, and operate necessary clinical units within the continuum of care for six cancer types, with the goal of promoting efficient resource allocation and increasing access to priority medical devices, particularly in low-income and middle-income countries.

Paper-Based RNA Extraction, in Situ Isothermal Amplification, and Lateral Flow Detection for Low-Cost, Rapid Diagnosis of Influenza A (H1N1) from Clinical Specimens.

The 2009 Influenza A (H1N1) pandemic disproportionately affected the developing world and highlighted the key inadequacies of traditional diagnostic methods that make them unsuitable for use in resource-limited settings, from expensive equipment and infrastructure requirements to unacceptably long turnaround times. While rapid immunoassay diagnostic tests were much less costly and more context-appropriate, they suffered from drastically low sensitivities and high false negative rates. An accurate, sensitive, and specific molecular diagnostic that is also rapid, low-cost, and independent of laboratory infrastructure is needed for effective point-of-care detection and epidemiological control in these developing regions. We developed a paper-based assay that allows for the extraction and purification of RNA directly from human clinical nasopharyngeal specimens through a poly(ether sulfone) paper matrix, H1N1-specific in situ isothermal amplification directly within the same paper matrix, and immediate visual detection on lateral flow strips. The complete sample-to-answer assay can be performed at the point-of-care in just 45 min, without the need for expensive equipment or laboratory infrastructure, and it has a clinically relevant viral load detection limit of 10(6) copies/mL, offering a 10-fold improvement over current rapid immunoassays.

Micropatterned multicolor dynamically adhesive substrates to control cell adhesion and multicellular organization.

We present a novel technique to examine cell-cell interactions and directed cell migration using micropatterned substrates of three distinct regions: an adhesive region, a nonadhesive region, and a dynamically adhesive region switched by addition of a soluble factor to the medium. Combining microcontact printing with avidin-biotin capture chemistry, we pattern nonadhesive regions of avidin that become adhesive through the capture of biotinylated fibronectin. Our strategy overcomes several limitations of current two-color dynamically adhesive substrates by incorporating a third, permanently nonadhesive region. Having three spatially and functionally distinct regions allows for the realization of more complex configurations of cellular cocultures as well as intricate interface geometries between two cell populations for diverse heterotypic cell-cell interaction studies. We can now achieve spatial control over the path and direction of migration in addition to temporal control of the onset of migration, enabling studies that better recapitulate coordinated multicellular migration and organization in vitro. We confirm that cellular behavior is unaltered on captured biotinylated fibronectin as compared to printed fibronectin by examining the cells' ability to spread, form adhesions, and migrate. We demonstrate the versatility of this approach in studies of migration and cellular cocultures, and further highlight its utility by probing Notch-Delta juxtacrine signaling at a patterned interface.

Infectious Disease Preparedness for Homeless Populations: Recommendations from a Community-Academic Partnership.

BACKGROUND: People experiencing homelessness are at increased risk of infectious disease transmission due to congregate living conditions, barriers to healthcare, and excess burden of underlying chronic disease. OBJECTIVES: We are a multisectoral community-academic partnership working to address the intersecting crises of homelessness and health disparities in Tippecanoe County, Indiana. We offer key recommendations for infectious disease preparedness and risk mitigation for homeless populations based on our ongoing community-based participatory research and lessons learned through COVID-19 response and Monkeypox preparations. LESSONS LEARNED: Infectious disease preparedness and response in homeless populations requires strong local partnerships; ongoing training and support for staff and volunteers of homeless shelters and service agencies; tailored outreach, education, and communication with people experiencing homelessness; and standardized processes for creating, disseminating, enforcing, and evaluating public health policies in homeless shelters. Consistency and open communication are key to a successful community-academic partnership. CONCLUSIONS: Community-academic partnerships are critical to effective infectious disease preparedness in homeless populations. The lessons learned from community-based participatory research with homeless communities and multisectoral partners on the frontline can improve future outbreak and pandemic response for people experiencing homelessness and other vulnerable communities in the United States.

Stakeholder-engaged development of a rapid test for detection of acute HIV infection.

Background/Objective: The utilization of rapid HIV tests has been effective at reducing transmission rates in high-risk populations by allowing individuals to receive diagnosis in as little as one minute and begin treatment. However, no current rapid tests can detect HIV immediately after infection in the acute HIV infection (AHI) phase, when the virus is at its most infectious, and instead require a waiting period of up to 90 days after exposure. Rapid HIV tests to detect AHI are currently under development. Investigation of stakeholder perspectives and context-specific needs are critical to ensure successful translation of novel AHI tests. The objectives of this study were to 1) understand context-specific factors such as barriers to HIV testing in Indiana, a state with one of 48 prioritized counties for HIV elimination; 2) assess the acceptability of a novel rapid AHI test, and 3) identify key implementation considerations for such a device, including ideal end-users. Methods: Semi-structured in-depth interviews were conducted with staff (n = 14) and clients (n = 5) of Indiana-based organizations that conduct HIV testing, including syringe service programs. Utilizing human-centered design frameworks, interview guides were developed and tailored to each participant group to understand their experiences with HIV testing, perspectives on a novel rapid AHI test in development, and preferences for self-testing versus testing by a community health worker (CHW) or a peer recovery coach. Thematic analysis was conducted to identify major themes, including barriers to HIV testing and perceived benefits and concerns of the proposed AHI test. Results: Overall acceptability for a novel AHI rapid test was high with a greater preference for CHW/Peerled testing. While self-testing was not a preferred modality, it was still seen as a potential tool to reach and address key barriers among high-risk individuals. Key considerations for implementation emphasized accuracy, cost-effectiveness, ease of use, ensuring access to counseling, education, and navigation to care while maintaining a human element to self-testing. Conclusion: Stakeholder engagement is meaningfully informing the design, development, and implementation of rapid AHI testing in order to facilitate adoption among populations at high-risk for HIV.

Feasibility and anticipated acceptability of community health worker-facilitated HPV self-sampling for cervical cancer screening around Lake County, Indiana.

Background/Objective: In light of calls to engage community health workers (CHWs) in the delivery of cervical cancer screening innovations, this study explores CHW perspectives on i) barriers to cervical cancer screening in a predominantly Hispanic community in Lake County, Indiana, the county with the highest cervical mortality in the state; and ii) the acceptability and feasibility of CHW-facilitated human papillomavirus (HPV) self-sampling as a means of reducing screening disparities. Methods: In 2021, in-depth interviews were conducted with 15 CHWs employed by Lake County community-based organizations including clinics, schools, and faith-based organizations. Results: Harnessing CHWs' voices as insiders with knowledge of their communities' health landscape, our analysis identified multilevel barriers to screening that spanned individual, interpersonal, and community levels of the socio-ecological model. CHW-facilitated HPV self-sampling shows promise of mitigating several barriers to cervical cancer screening. Privacy, time saved, and comfort were perceived to be facilitators for acceptability, with concerns about the novelty of this approach and trust in provider (as opposed to CHW) expertise emerging as key barriers. In terms of feasibility, synergies with existing CHW work, and some community members' prior experience with self-sampling were found to be facilitators, while CHW's time limitations and self-efficacy in providing adequate medical support were areas of concern. Considerations for adoption included CHW training, gender concordance, safety, and respect, among others. Conclusion: This study provides critical insights from CHWs as key stakeholders on a screening model that directly engages them, which can inform implementation to increase screening in medically-underserved communities in the US.

Human-centered design of a smartphone-based self-test for HIV viral load monitoring.

Background/Objective: HIV viral load self-testing could enable people living with HIV (PLHIV) to monitor their viral suppression status more easily, potentially facilitating medication adherence and safe behavior decision-making. Smartphone-based viral load testing innovations have the potential to reach resource-limited and vulnerable communities to address inequities in access to HIV care. However, successful development and translation of these tests requires meaningful investigation of end-user contexts and incorporation of those context-specific needs early in the design process. The objective of this study is to engage PLHIV and HIV healthcare providers in human-centered design research to inform key design and implementation considerations for a smartphone-based HIV viral load self-testing device prototype in development. Methods: Semi-structured in-depth interviews were conducted with PLHIV (n = 10) and HIV providers (n = 4) in Indiana, a state with suboptimal viral suppression rates and marked disparities in access to HIV care. Interview guides were developed based on contextual investigation and human-centered design frameworks and included a demonstration of the device prototype with feedback-gathering questions. Results: Thematic analysis of interview transcripts revealed important benefits, concerns, and user requirements for smartphone-based HIV VL self-testing within the context of PLHIV lived experience, knowledge, and barriers to care in Indiana. Conclusion: End-user needs and preferences were identified as key design specifications and implementation considerations to facilitate the acceptability and inform ongoing development and ultimately real-world translation of the HIV VL monitoring device prototype.

Clinician practices, knowledge, and attitudes regarding primary human papillomavirus testing for cervical cancer screening: A mixed-methods study in Indiana.

Primary human papillomavirus (HPV) testing, in which a high-risk HPV test is administered without cytology, was first included in 2018 US cervical cancer screening guidelines. Subsequent guidelines endorsed primary HPV testing as the preferred method for cervical cancer screening following evidence of its clinical and economic benefits, although many sources still indicate it as an option along with cytology and HPV/Pap co-testing. Primary HPV testing could be key to improving the declining cervical cancer screening rates in the US; however its adoption has been slow as clinicians are hesitant to make the change. Indiana ranks in the top ten states for cervical cancer mortality, with marked race-ethnic disparities in cervical cancer screening and low HPV vaccination rates. To examine clinician practices, knowledge, and attitudes regarding primary HPV testing, in 2021 we conducted an online cross-sectional survey (n = 224) and in-depth interviews (n = 20) with Indiana clinicians practicing cervical cancer screening. Only 3 % reported using primary HPV testing for eligible patients, and only 50 % were willing to adopt it as the preferred cervical cancer screening method for the recommended patient group. In a multivariable logistic regression model, knowledge of the effectiveness (aOR 2.58 [1.41-4.72]) and perceived benefit (aOR 7.35 [3.65-14.81]) of primary HPV testing predicted willingness to adopt. In-depth interviews revealed knowledge gaps, uncertainty, and perceived limitations of this method as the reasons for limited uptake of primary HPV testing. Targeted messages about the benefits and effectiveness may enhance clinician knowledge, acceptance, and adoption.