Health Consumer Engagement, Enablement, and Empowerment in Smartphone-Enabled Home-Based Diagnostic Testing for Viral Infections: Mixed Methods Study.

BACKGROUND: Health consumers are increasingly taking a more substantial role in decision-making and self-care regarding their health. A range of digital technologies is available for laypeople to find, share, and generate health-related information that supports their health care processes. There is also innovation and interest in home testing enabled by smartphone technology (smartphone-supported home testing [smart HT]). However, few studies have focused on the process from initial engagement to acting on the test results, which involves multiple decisions. OBJECTIVE: This study aimed to identify and model the key factors leading to health consumers' engagement and enablement associated with smart HT. We also explored multiple levels of health care choices resulting from health consumer empowerment and activation from smart HT use. Understanding the factors and choices associated with engagement, enablement, empowerment, and activation helps both research and practice to support the intended and optimal use of smart HT. METHODS: This study reports the findings from 2 phases of a more extensive pilot study of smart HT for viral infection. In these 2 phases, we used mixed methods (semistructured interviews and surveys) to shed light on the situated complexities of health consumers making autonomous decisions to engage with, perform, and act on smart HT, supporting the diagnostic aspects of their health care. Interview (n=31) and survey (n=282) participants underwent smart HT testing for influenza in earlier pilot phases. The survey also extended the viral infection context to include questions related to potential smart HT use for SARS-CoV-2 diagnosis. RESULTS: Our resulting model revealed the smart HT engagement and enablement factors, as well as choices resulting from empowerment and activation. The model included factors leading to engagement, specifically various intrinsic and extrinsic influences. Moreover, the model included various enablement factors, including the quality of smart HT and the personal capacity to perform smart HT. The model also explores various choices resulting from empowerment and activation from the perspectives of various stakeholders (public vs private) and concerning different levels of impact (personal vs distant). CONCLUSIONS: The findings provide insight into the nuanced and complex ways health consumers make decisions to engage with and perform smart HT and how they may react to positive results in terms of public-private and personal-distant dimensions. Moreover, the study illuminates the role that providers and smart HT sources can play to better support digitally engaged health consumers in the smart HT decision process.

A pragmatic randomized trial of home-based testing for COVID-19 in rural Native American and Latino communities: Protocol for the "Protecting our Communities" study.

BACKGROUND: Home-based testing for COVID-19 has potential to reduce existing health care disparities among underserved populations in the United States. However, implementation of home-based tests in these communities may face significant barriers. This study evaluates the acceptability, feasibility, and success of home-based testing and the potential added benefit of active support from trusted community health workers for Native Americans and Hispanic/Latino adults living in rural Montana and Washington states. METHODS/DESIGN: The academic-community research team designed the trial to be responsive to community needs for understanding barriers and supports to home-based COVID-19 testing. The "Protecting Our Community" study is a two-arm pragmatic randomized controlled trial in which a total of 400 participants are randomized to active or passive arms. Participants of both study arms receive a commercially available home collection COVID-19 test kit, which is completed by mailing a self-collected nasal swab to a central laboratory. The primary study outcome is return of the kit to the central lab within 14 days. The cultural, social, behavioral, and economic barriers to home-based COVID-19 testing are also assessed by qualitative research methods. A survey and semi-structured interviews are conducted after the trial to evaluate perceptions and experience of home-based testing. DISCUSSION: Implementing home-based testing in underserved populations, including among Native American and Hispanic/Latino communities, may require additional support to be successful. The Protecting Our Community trial examines the effect of trusted community health workers on use of home-based testing, which may be adaptable for community-driven models of home-based testing in other underserved populations.

Flu@home: the Comparative Accuracy of an At-Home Influenza Rapid Diagnostic Test Using a Prepositioned Test Kit, Mobile App, Mail-in Reference Sample, and Symptom-Based Testing Trigger.

At-home testing with rapid diagnostic tests (RDTs) for respiratory viruses could facilitate early diagnosis, guide patient care, and prevent transmission. Such RDTs are best used near the onset of illness when viral load is highest and clinical action will be most impactful, which may be achieved by at-home testing. We evaluated the diagnostic accuracy of the QuickVue Influenza A+B RDT in an at-home setting. A convenience sample of 5,229 individuals who were engaged with an on-line health research platform were prospectively recruited throughout the United States. "Flu@home" test kits containing a QuickVue RDT and reference sample collection and shipping materials were prepositioned with participants at the beginning of the study. Participants responded to daily symptom surveys. If they reported experiencing cough along with aches, fever, chills, and/or sweats, they used their flu@home kit following instructions on a mobile app and indicated what lines they saw on the RDT. Of the 976 participants who met criteria to use their self-collection kit and completed study procedures, 202 (20.7%) were positive for influenza by qPCR. The RDT had a sensitivity of 28% (95% CI = 21 to 36) and specificity of 99% (98 to 99) for influenza A, and 32% (95% CI = 20 to 46) and 99% (95% CI = 98 to 99), for influenza B. Our results support the concept of app-supported, prepositioned at-home RDT kits using symptom-based triggers, although it cannot be recommended with the RDT used in this study. Further research is needed to determine ways to improve the accuracy and utility of home-based testing for influenza.

Harmony COVID-19: A ready-to-use kit, low-cost detector, and smartphone app for point-of-care SARS-CoV-2 RNA detection.

RNA amplification tests sensitively detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, but their complexity and cost are prohibitive for expanding coronavirus disease 2019 (COVID-19) testing. We developed "Harmony COVID-19," a point-of-care test using inexpensive consumables, ready-to-use reagents, and a simple device. Our ready-to-use, multiplexed reverse transcription, loop-mediated isothermal amplification (RT-LAMP) can detect down to 0.38 SARS-CoV-2 RNA copies/µl and can report in 17 min for high­viral load samples (5000 copies/µl). Harmony detected 97 or 83% of contrived samples with ≥0.5 viral particles/µl in nasal matrix or saliva, respectively. Evaluation in clinical nasal specimens (n = 101) showed 100% detection of RNA extracted from specimens with ≥0.5 SARS-CoV-2 RNA copies/µl, with 100% specificity in specimens positive for other respiratory pathogens. Extraction-free analysis (n = 29) had 95% success in specimens with ≥1 RNA copies/µl. Usability testing performed first time by health care workers showed 95% accuracy.

Home testing for COVID-19 and other virus outbreaks: The complex system of translating to communities.

Home testing is an emerging innovation that can enable nations and health care systems to safely and efficiently test large numbers of patients to manage COVID-19 and other viral outbreaks.  In this position paper, we explore the process of moving home testing across the translational continuum from labs to households, and ultimately into practice and communities for optimal public health impact. We focus on the four translational science drivers to accelerate the implementation of systems-wide home testing programmes 1) collaboration and team science, 2) technology, 3) multilevel interventions, and 4) knowledge integration. We use the Socio Ecological Model (SEM) as a framework to illustrate our vision for the ideal future state of a comprehensive system of stakeholders utilising tech-enabled home testing for COVID-19 and other virus outbreaks, and we suggest SEM as a tool to address key translational readiness and response questions.

Evaluating an app-guided self-test for influenza: lessons learned for improving the feasibility of study designs to evaluate self-tests for respiratory viruses.

BACKGROUND: Seasonal influenza leads to significant morbidity and mortality. Rapid self-tests could improve access to influenza testing in community settings. We aimed to evaluate the diagnostic accuracy of a mobile app-guided influenza rapid self-test for adults with influenza like illness (ILI), and identify optimal methods for conducting accuracy studies for home-based assays for influenza and other respiratory viruses. METHODS: This cross-sectional study recruited adults who self-reported ILI online. Participants downloaded a mobile app, which guided them through two low nasal swab self-samples. Participants tested the index swab using a lateral flow assay. Test accuracy results were compared to the reference swab tested in a research laboratory for influenza A/B using a molecular assay. RESULTS: Analysis included 739 participants, 80% were 25-64 years of age, 79% female, and 73% white. Influenza positivity was 5.9% based on the laboratory reference test. Of those who started their test, 92% reported a self-test result. The sensitivity and specificity of participants' interpretation of the test result compared to the laboratory reference standard were 14% (95%CI 5-28%) and 90% (95%CI 87-92%), respectively. CONCLUSIONS: A mobile app facilitated study procedures to determine the accuracy of a home based test for influenza, however, test sensitivity was low. Recruiting individuals outside clinical settings who self-report ILI symptoms may lead to lower rates of influenza and/or less severe disease. Earlier identification of study subjects within 48 h of symptom onset through inclusion criteria and rapid shipping of tests or pre-positioning tests is needed to allow self-testing earlier in the course of illness, when viral load is higher.

An Exercise Using a Social Ecological Lens to Understand the Vast Network of Stakeholders Required to Manage a Pandemic

The COVID-19 pandemic is uniquely challenging due to pace and scale, calling for swift responses across a multitude of societal and organizational levels and a vast network of stakeholders to address its effects. Thus, COVID-19 provides an impactful case from which students can understand the relevance and importance of multiple and multilevel stakeholder engagement, within and outside the healthcare arena, in sustaining public health. We embrace this teachable opportunity to leverage the Social Ecological Model (SEM) as a valuable framework for identifying the stakeholders, the roles they fulfill, and the information and communication technologies that connect them in working toward positive outcomes for the numerous issues faced in pandemic situations. COVID-19 also illuminated how a stakeholder's inability to fulfill an important role can affect stakeholders at various levels, whether by intent or due to barriers beyond their control. We illustrate a progressive and interconnected approach that educators may use in varying educational formats (e.g., face-to-face, hybrid, or online) to apply this multilevel framework in engaging students to recognize the players, roles, and connecting technologies to map the courses of action needed to manage viral outbreaks, such as the COVID-19 pandemic.