CATCH-UP vaccines: protocol for a randomized controlled trial using the multiphase optimization strategy (MOST) framework to evaluate education interventions to increase COVID-19 vaccine uptake in Oklahoma.

BACKGROUND: Oklahoma's cumulative COVID-19 incidence is higher in rural than urban counties and higher than the overall US incidence. Furthermore, fewer Oklahomans have received at least one COVID-19 vaccine compared to the US average. Our goal is to conduct a randomized controlled trial using the multiphase optimization strategy (MOST) to test multiple educational interventions to improve uptake of COVID-19 vaccination among underserved populations in Oklahoma. METHODS: Our study uses the preparation and optimization phases of the MOST framework. We conduct focus groups among community partners and community members previously involved in hosting COVID-19 testing events to inform intervention design (preparation). In a randomized clinical trial, we test three interventions to improve vaccination uptake: (1) process improvement (text messages); (2) barrier elicitation and reduction (electronic survey with tailored questions/prompts); and (2) teachable moment messaging (motivational interviewing) in a three-factor fully crossed factorial design (optimization). DISCUSSION: Because of Oklahoma's higher COVID-19 impact and lower vaccine uptake, identifying community-driven interventions is critical to address vaccine hesitancy. The MOST framework provides an innovative and timely opportunity to efficiently evaluate multiple educational interventions in a single study. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05236270, First Posted: February 11, 2022, Last Update Posted: August 31, 2022.

Ethical priority of the most actionable system of biomolecules: the metabolome.

The metabolome is a system of small biomolecules (metabolites) and a direct result of human bioculture. Consequently, metabolomics is well poised to impact anthropological and biomedical research for the foreseeable future. Overall, we provide a perspective on the ethical, legal, and social implications (ELSI) of metabolomics, which we argue are often more alarming than those of genomics. Given the current mechanisms to fund research, ELSI beyond human DNA is stifled and in need of considerable attention.

Continued development of the Rural Active Living Perceived Environmental Support Scale (RALPESS): preliminary evidence for validity among American Indians.

INTRODUCTION: Much of the US adult population does not engage in regular physical activity or meet the recommended guidelines for exercise. Moreover, many rural Americans disproportionately experience lower health status and life expectancy attributed to obesity, poor diet, and lack of physical activity. Evidence supports the role of perceived physical and social-environmental factors as potential influencers of exercise. However, measurement of these influencers, particularly within diverse, rural populations, has been sparse. A substantial number of American Indians live in federally defined rural areas, and many rural American Indians are at elevated risk for being overweight and obese due to physical inactivity. Therefore, this study established the validity and reliability of the Rural Active Living Perceived Environmental Support Scale (RALPESS) within a predominantly rural American Indian sample. METHODS: In this cross-sectional pilot study, the 33-item RALPESS was administered to 130 adults, across 19 rural localities within Oklahoma, who were recruited from community events hosted by local partners of the tribal Head Start program. Confirmatory factor analysis was used to examine the hypothesized factor structure of the RALPESS. RESULTS: Confirmatory factor analysis showed an adequate fit between the hypothesized model and the data. Analyses produced an acceptable χ2 goodness of fit index with two degrees of freedom. The comparative fit index and parsimony goodness of fit index were acceptable. The root mean square error of approximation and its 90% confidence interval were also acceptable. Overall, the RALPESS showed suitable internal consistency for the full measure and its subscales, resulting in Cronbach's alpha between 0.82 and 0.96. CONCLUSIONS: This pilot study produced confirmatory evidence that the RALPESS is likely a valid and reliable tool for use with rural American Indian populations. Continued validation of this scale, particularly in international rural communities, will support further investigation into this important public health issue, and may further efforts towards the development and promotion of effective programming to increase exercise engagement.

Values and Practices to Strengthen Genetic Research Partnerships with Indigenous Communities.

Genetic datasets lack diversity and include very few data from Indigenous populations. Research models based on equitable partnership have the potential to increase Indigenous participation and have led to successful collaborations. We report here on a meeting of participants in four Indigenous community-university partnerships pursuing research on precision medicine. The goal of the meeting was to define values and practices that strengthen opportunities for genetic research. The group accorded the highest priority to developing trusting relationships, ensuring respect for Indigenous community authority, and pursuing research that has the potential to lead to community benefit. Supporting priorities included incorporation of Indigenous expertise in research planning, transparent communication, and development of community capacity, including capacity to participate in formulating research questions, informing research methodology, and leading research projects. Participants also noted the importance of attention to social determinants of health so that genetic contributors to health are evaluated in the appropriate context.

Deliberations with American Indian and Alaska Native People about the Ethics of Genomics: An Adapted Model of Deliberation Used with Three Tribal Communities in the United States.

BACKGROUND: This paper describes the design, implementation, and process outcomes from three public deliberations held in three tribal communities. Although increasingly used around the globe to address collective challenges, our study is among the first to adapt public deliberation for use with exclusively Indigenous populations. In question was how to design deliberations for tribal communities and whether this adapted model would achieve key deliberative goals and be well received. METHODS: We adapted democratic deliberation, an approach to stakeholder engagement, for use with three tribal communities to respect tribal values and customs. Public deliberation convenes people from diverse backgrounds in reasoned reflection and dialogue in search of collective solutions. The deliberation planning process and design were informed by frameworks of enclave deliberation and community-based participatory research, which share key egalitarian values. The deliberations were collaboratively designed with tribal leadership and extensive partner input and involvement in the deliberations. Each deliberation posed different, locally relevant questions about genomic research, but used the same deliberation structure and measures to gauge the quality and experience of deliberation. RESULTS: A total of 52 individuals participated in the deliberations across all three sites. Deliberants were balanced in gender, spanned decades in age, and were diverse in educational attainment and exposure to health research. Overall, the deliberations were positively evaluated. Participant perceptions and external observer datasets depict three deliberations that offered intensive conversation experiences in which participants learned from one another, reported feeling respected and connected to one another, and endorsed this intensive form of engagement. CONCLUSION: The adapted deliberations achieved key deliberative goals and were generally well received. Limitations of the study are described.

An Alaska Native community's views on genetic research, testing, and return of results: Results from a public deliberation.

As genetic testing technology advances, genetic testing will move into standard practice in the primary care setting. Genetic research, testing, and return of results are complex topics that require input from Alaska Native and American Indian (ANAI) communities as policies are developed for implementation. This study employed a day and half long public deliberation with ANAI primary care patients to elicit value-laden views of genetic research, testing, and return of results. Participants emphasized the need for a balance between the potential for genetics research, testing, and return of results to empower individuals and improve health with the potential to expose individuals and communities to privacy breaches, discrimination, and emotional harms. Public deliberation was well received by this group of participants and elicited rich discussion on the complex topic of genetic research, testing, and return of results.

Deliberations About Genomic Research and Biobanks With Citizens of the Chickasaw Nation.

Amid the rapid growth of precision medicine and biobanking initiatives, there have been few efforts at cataloging the implications of these initiatives for Indigenous communities. A consortium involving a university and three American Indian/Alaska Native (AIAN) community partners is working to promote deliberation and dialog in AIAN communities about the potential benefits and risks of genomic research for those communities. The first of the consortium's three planned deliberations was held in September 2018 with citizens of the Chickasaw Nation, a federally recognized tribe in south-central Oklahoma with a full-service medical center and growing research capacity and oversight. Consortium members and the Chickasaw Nation Department of Health Administration designed a deliberative forum for Chickasaw citizens to consider the potential benefits and risks of participating in genomic research and biobanks. In this manuscript, we describe the deliberative method used in this event and report on the ideas discussed during the tribal citizens' deliberations. Chickasaw citizens identified many risks and benefits associated with genomic research and biobanks, including the potential for medical advancements that might benefit the Chickasaw community as well as the possibility of discrimination against the Chickasaw people. Although participants thought the potential benefits outweighed the potential risks, that moral calculation was contingent on whether control of the research and biobanks rested with Chickasaw leadership, researchers, and citizens.

Fostering Ethical, Legal, and Social Implications Research in Tribal Communities: The Center for the Ethics of Indigenous Genomic Research.

Genomic research raises unique ethical concerns among Alaska Native and American Indian (AN/AI) people and their communities. The Center for the Ethics of Indigenous Genomic Research (CEIGR) was created to foster research that takes these concerns into account while considering the sovereign status of AN/AI tribal nations. Relationships developed within CEIGR have allowed for effective, collaborative research among individuals who come from diverse cultures, political and historical backgrounds, and academic disciplines, and who work for organizations with varying resources, capacities, and expectations. The CEIGR framework may inform other groups seeking to conduct social science research related to genomic research with tribal people and their communities.

Community Protections in American Indian and Alaska Native Participatory Research-A Scoping Review.

Experiences with unethical research practices have caused some American Indian and Alaska Native (AIAN) individuals, organizations, and tribes to mistrust health research. To build trust and repair relationships, current research with AIAN peoples often involves participatory research (PR) approaches. This article assesses community-level protections described in the scientific literature on PR involving AIAN communities. A scoping review search in PubMed and PsychInfo for articles published between January 2000 and June 2017 yielded an AIAN PR article dataset. Of 178 articles, a subset of 23 articles that described aspects of community protections were analyzed for descriptions of community-level protection practices. We identified the presence or absence of a description of four community protection measures in each article: a tribal research department, the development of community-level mechanisms for research regulation if not present, community collaboration throughout the research process, and project employment of a community member. The development of community-level mechanisms for research regulation was described in 39% of the articles. Ninety-one percent of these articles described community collaboration during the research process. Seventeen percent included descriptions of all four community-level protection measures. The extent and consistency to which community-level protections are described is variable; the current literature lacks reporting on community-level protection practices specific to tribal communities.

The Human Microbiome Project: lessons from human genomics.

The Human Microbiome Project (HMP) is following in the footsteps of the Human Genome Project (HGP), which will include exciting discoveries, but also potential disappointment and resentment over the lack of medical applications. There is a wiser path for the HMP. This path includes a greater attention to rare variation, an early commitment to an ethical inclusion of indigenous communities, and a recruitment strategy in which medical benefits are de-emphasized.