Critical lessons from a pragmatic randomized trial of home-based COVID-19 testing in rural Native American and Latino communities.

PURPOSE: Native Americans and Latinos have higher COVID-19 infection and mortality rates and may have limited access to diagnostic testing. Home-based testing may improve access to care in rural and underserved populations. This study tests the effect of community health worker (CHW) support on accessibility, feasibility, and completion of COVID-19 home testing among Native American and Latino adults living on the Flathead Reservation in Montana and in Yakima Valley, Washington. METHODS: A two-arm, multisite, pragmatic randomized controlled trial was conducted using block randomization stratified by site and participant age. Active arm participants received CHW assistance with online COVID-19 test kit registration and virtual swabbing support. The passive arm participants received standard-of-care support from the kit vendor. Logistic regression modeled the association between study arm and test completion (primary outcome) and between study arm and test completion with return of valid test results (secondary outcome). Responses to posttest surveys and interviews were summarized using deductive thematic analysis. FINDINGS: Overall, 63% of participants (n = 268) completed COVID-19 tests, and 50% completed tests yielding a valid result. Active arm participants had higher odds of test completion (odds ratio: 1.66, 95% confidence interval [1.01, 2.75]). Differences were most pronounced among adults ≥60 years. Participants cited ease of use and not having to leave home as positive aspects, and transportation and mailing issues as negative aspects of home-based testing. CONCLUSIONS: CHW support led to higher COVID-19 test completion rates, particularly among older adults. Significant testing barriers included language, educational level, rurality, and test kit issues.

The community voices program to facilitate community-academic researcher partnerships: Stakeholder perspectives on the program's usefulness.

Introduction: The Institute of Translational Health Sciences (Clinical and Translational Science Awards Program hub) developed a program coined Community Voices to invite communities to submit project ideas and be matched with academic researchers. We describe formative research to understand community and academic researcher perspectives on how the program could facilitate collaborations addressing community priorities. Methods: We conducted four focus groups with 31 community-based organization (CBO) representatives and 11 semi-structured interviews with academic researchers in the Washington, Wyoming, Alaska, Montana, and Idaho regions. Questions included the appeal of Community Voices to engage community and academic partners, potential program usefulness, and Community Voices' potential role in building community-academic partnerships. We used an inductive, constant comparison approach to code transcripts and thematic analysis to generate themes. Results: Most CBO representatives were female (87.1%) and Hispanic/Latino (61.3%). Most academic researchers had a PhD (63.6%) and worked at a university (81.8%). The themes were: (1) community-academic partnerships built on trust will offer mutual benefit, (2) community-initiated project ideas should prioritize community needs, (3) matchmaking will accelerate connections but should not replace time to foster partnership, (4) Community Voices should go beyond matchmaking and provide ongoing support/training, and (5) fostering effective communication is key to partnership success. Conclusions: Community Voices is a novel, bidirectional community engagement program model that advances current practices of prioritizing researchers' project ideas. This community-driven program may shift the future direction of community engagement practices where prioritizing community's ideas becomes the norm of community-academic partnerships in clinical and translational science.

Factors influencing COVID-19 testing among Native Americans and Latinos in two rural agricultural communities: a qualitative study.

Objective: To examine factors influencing decisions to test for COVID-19 among Native Americans on the Flathead Reservation in Montana and the Latino community in the Yakima Valley of Washington state. Methods: We conducted 30 key informant interviews with community leaders and six focus groups with community members to examine factors impacting decisions to test for COVID-19 during the second year of the COVID-19 pandemic from May 2021 to June 2021. Results: Three major themes that impacted testing for COVID-19 were identified: (1) Social factors, including the influence of families and friends and employment practices; (2) health factors, including testing procedures, home-based testing, and health communication; and (3) contextual factors, including distrust for government and medical communities and the impact on cultural practices and celebrations. Conclusions: Social, health, and contextual factors influence the decision to test for COVID-19. Understanding the community's perception is critical for successful implementation of preventive strategies.

An agricultural community's perspectives on COVID-19 testing to support safe school reopening.

Introduction: School-based COVID-19 testing may be an effective strategy for reducing transmission in schools and keeping schools open. The study objective was to examine community perspectives on school-based COVID-19 testing as a mitigation strategy to support safe school reopening. Methods: We conducted a qualitative study in Yakima County, an agricultural region of Washington state, where over half of residents are Hispanic/Latino. From June to July 2021, we interviewed 18 students (13 years old, on average) and 19 school employees, and conducted four focus groups (2 in Spanish, 2 in English) with 26 parents. We audio-recorded the semi-structured interviews and focus group discussions which were then transcribed. We used an inductive, constant comparison approach to code the transcripts and conducted a thematic analysis to generate themes. Results: We identified four main themes. Students, parents, and school employees desired a return to in-person learning (Theme 1). Schools implemented numerous COVID-19 mitigation strategies (e.g., masking) to facilitate a safe return to school but felt that adding testing would not be feasible due to a lack of resources and overworked staff (Theme 2). Parents and school employees' familiarity with COVID-19 testing procedures influenced their support for testing (Theme 3). Parents and school employees felt there were inadequate resources for individuals who test positive for COVID-19 (Theme 4). Discussion: Schools require adequate resources and medical personnel to implement COVID-19 testing. Individuals also need resources after testing positive, including physical space to isolate, financial resources for those without paid time off, and delivery of food and other necessities to households in rural communities.

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.

Feasibility of connecting regional research programs to national multisite trials emanating from the CTSA Trial Innovation Network.

A collaborative research model was developed and tested to enable regional healthcare systems to join multisite clinical trials emanating from the Clinical and Translational Science Award (CTSA) Trial Innovation Network (TIN) by the Institute of Translational Health Sciences at the University of Washington and the Northwest Participant and Clinical Interactions (NW PCI) Network. The NW PCI is a collaborative group of regional research programs located at medical centers, healthcare systems, and universities across Washington, Wyoming, Alaska, Montana, and Idaho. This article describes the purpose, development, barriers, and initial experience with feasibility assessment for TIN-supported studies in the NW PCI. The tools and processes of the NW PCI Network were adapted to enable network sites to assess studies for clinical relevance and feasibility. Seven of seventeen TIN-supported studies were reviewed for consideration; three of which resulted in successful completion of study documentation for site selection by NW PCI sites. The NW PCI/TIN model can be adapted by other CTSAs to increase involvement of regional research programs in national multisite clinical research studies. Barriers to expanding TIN-supported trials to regional networks include short timelines for study document submissions, insufficient site reimbursement rates, and non-feasible study designs.

The Northwest Participant and Clinical Interactions Network: Increasing opportunities for patients to participate in research across the Northwestern United States.

INTRODUCTION: The Institute of Translational Health Sciences (ITHS) promotes and supports translational research collaboration between clinicians, communities, and investigators across the five-state Washington, Wyoming, Alaska, Montana, and Idaho (WWAMI) region. The ITHS has developed a collaborative regional clinical research network, the Northwest Participant & Clinical Interactions Network (NW PCI), involving 12 diverse clinical health systems and academic institutions. METHODS: This descriptive article details NW PCI's development, infrastructure and governance, tools, characteristics, and initial outcomes. RESULTS: Regional NW PCI sites are conducting largely industry-sponsored studies; they are interested in including more grant-funded research. Regional NW PCI sites had over 1,240 open studies involving over 6700 patients in 2016. NW PCI trials are largely industry-sponsored; NW PCI sites are interested in including more grant-funded research. In its first three years, the NW PCI Coordinating Center facilitated regional sites' participation in 34 new grant and contract applications across diverse topics. CONCLUSION: The NW PCI model supports the goals of the developing CTSA Trial Innovation Network by increasing access to cutting-edge research across the Northwestern U.S., by supporting investigators seeking diverse populations, including those with rare diseases, for their research studies, and by providing settings to test implementation and dissemination of effective interventions.

Role for CTSAs in leveraging a distributed research infrastructure to engage diverse stakeholders in emergent research policy development.

This paper is a case study of our regional Clinical Translational Science Award's (CTSA) development of a coordinated response to the advanced notice of proposed rulemaking on Human Subjects Research Protections during the fall of 2011. Our CTSA was well positioned to quickly activate and coordinate a response to this important and time sensitive issue because we had established infrastructure and resources both within our CTSA and through our partnering institutions, existing relationships with key individuals in the institutions, and credibility as a trusted source of information. Three town hall meetings were organized and a Website was created to collect online comments. Ultimately, comments were collected, prioritized, and organized into a single, coordinated response. This case study demonstrates the value of a distributed research infrastructure and the role CTSAs like our Institute of Translational Health Sciences can play to engage the regional research community about important developments in the research landscape and to respond to requests for feedback to policy makers.