Use of Random Domain Intercept Technology to Track COVID-19 Vaccination Rates in Real Time Across the United States: Survey Study.

BACKGROUND: Accurate and timely COVID-19 vaccination coverage data are vital for informing targeted, effective messaging and outreach and identifying barriers to equitable health service access. However, gathering vaccination rate data is challenging, and efforts often result in information that is either limited in scope (eg, limited to administrative data) or delayed (impeding the ability to rapidly respond). The evaluation of innovative technologies and approaches that can assist in addressing these limitations globally are needed. OBJECTIVE: The objective of this survey study was to assess the validity of Random Domain Intercept Technology (RDIT; RIWI Corp) for tracking self-reported vaccination rates in real time at the US national and state levels. RDIT-a form of online intercept sampling-has the potential to address the limitations of current vaccination tracking systems by allowing for the measurement of additional data (eg, attitudinal data) and real-time, rapid data collection anywhere there is web access. METHODS: We used RDIT from June 30 to July 26, 2021, to reach a broad sample of US adult (aged ≥18 years) web users and asked questions related to COVID-19 vaccination. Self-reported vaccination status was used as the focus of this validation exercise. National- and state-level RDIT-based vaccination rates were compared to Centers for Disease Control and Prevention (CDC)-reported national and state vaccination rates. Johns Hopkins University's and Emory University's institutional review boards designated this project as public health practice to inform message development (not human subjects research). RESULTS: By using RDIT, 63,853 adult web users reported their vaccination status (6.2% of the entire 1,026,850 American web-using population that was exposed to the survey). At the national level, the RDIT-based estimate of adult COVID-19 vaccine coverage was slightly higher (44,524/63,853, 69.7%; 95% CI 69.4%-70.1%) than the CDC-reported estimate (67.9%) on July 15, 2021 (ie, midway through data collection; t63,852=10.06; P<.001). The RDIT-based and CDC-reported state-level estimates were strongly and positively correlated (r=0.90; P<.001). RDIT-based estimates were within 5 percentage points of the CDC's estimates for 29 states. CONCLUSIONS: This broad-reaching, real-time data stream may provide unique advantages for tracking the use of a range of vaccines and for the timely evaluation of vaccination interventions. Moreover, RDIT could be harnessed to rapidly assess demographic, attitudinal, and behavioral constructs that are not available in administrative data, which could allow for deeper insights into the real-time predictors of vaccine uptake-enabling targeted and timely interventions.

Ethically designing research to inform multidimensional, rapidly evolving policy decisions: Lessons learned from the PROMISE HIV Perinatal Prevention Trial.

Research in rapidly evolving policy contexts can lead to the following ethical challenges for sponsors and researchers: the study's standard of care can become different than what patients outside the study receive, there may be political or other pressure to move ahead with unproven interventions, and new findings or revised policies may decrease the relevance of ongoing studies. These ethical challenges are considerable, but not unprecedented. In this article, we review the case of a multinational, randomized, controlled perinatal HIV prevention trial, the "PROMISE" (Promoting Maternal Infant Survival Everywhere) study. PROMISE compared the relative efficacy and safety of interventions to prevent mother to child transmission of HIV. The sponsor engaged an independent international ethics panel to address controversy about the study's standard of care and relevance as national and international guidelines changed. This ethics panel concluded that continuing the PROMISE trial as designed was ethically permissible because: (1) participants in all arms received interventions that were effective, and there was insufficient evidence about whether one intervention was more effective or safer than the other, and (2) data from PROMISE could be useful for a diverse range of stakeholders. In general, trials designed to inform rapidly evolving policy issues should develop mechanisms to revisit social value while recognizing that the value of research varies for diverse stakeholders with legitimate reasons to weigh evidence differently. We conclude by providing four reasons that trials may depart from the standard of care after a change in policy, while remaining ethically justifiable, and by suggesting how to improve existing trial oversight mechanisms to address evolving social value.

Malaria outbreak response in urban Santo Domingo, Dominican Republic: lessons learned for community engagement.

Community engagement is crucial for public health initiatives, yet it remains an under-studied process within national disease elimination programs. This report shares key lessons learned for community engagement practices during a malaria outbreak response in the Los Tres Brazos neighborhood of urban Santo Domingo, Dominican Republic from 2015-2016. In this two-year period, 233 cases of malaria were reported-more than seven times the number of cases (31) reported in the previous two years. The initial outbreak response by the national malaria program emphasized "top-down" interventions such as active surveillance, vector control, and educative talks within the community. Despite a transient reduction in reported cases in mid-2015, transmission resurged at the end of 2015. The program responded by introducing active roles for trained community members that included door-to-door fever screening, testing with rapid diagnostic tests and treatment. Malaria cases declined significantly throughout 2016 and community-based active surveillance infrastructure helped to detect and limit a small episode of transmission in 2017. Results from qualitative research among community members revealed two key factors that facilitated their cooperation with community-based surveillance activities: motivation to help one's community; and trust among stakeholders (community health workers, their neighbors and other key figures in the community, and malaria program staff and leadership). This experience suggests that community-led interventions and the program's willingness to learn and adapt under changing circumstances can help control malaria transmission and pave the way for elimination.

La participación de la comunidad es crucial para las iniciativas de salud pública, pero sigue siendo un proceso poco estudiado dentro de los programas nacionales de eliminación de enfermedades. En este informe se presentan las principales lecciones aprendidas respecto de las prácticas de participación comunitaria durante la respuesta al brote de malaria en el barrio Los Tres Brazos de la zona urbana de Santo Domingo, República Dominicana, de 2015 a 2016. En este período de dos años se notificaron 233 casos de malaria, más de siete veces el número de casos (31) notificados en los dos años anteriores. La respuesta inicial al brote por parte del programa nacional de malaria hizo hincapié en intervenciones "de arriba abajo" como la vigilancia activa, el control de vectores y las charlas educativas dentro de la comunidad. A pesar de la reducción transitoria de los casos notificados hacia mediados de 2015, la transmisión resurgió a finales de ese año. El programa respondió introduciendo funciones activas para miembros de la comunidad capacitados que incluían la detección de fiebre de casa en casa, pruebas de diagnóstico rápido y tratamiento. Los casos de malaria disminuyeron significativamente durante 2016 y la infraestructura de vigilancia activa basada en la comunidad ayudó a detectar y contener un episodio pequeño de transmisión en 2017. Los resultados de la investigación cualitativa entre los miembros de la comunidad revelaron dos factores clave que facilitaron su cooperación con las actividades de vigilancia basadas en la comunidad: la motivación para ayudar a la propia comunidad y la confianza entre las partes interesadas (los trabajadores sanitarios de la comunidad, los vecinos y otros actores clave de la comunidad, y el personal y la dirección del programa de lucha contra la malaria). Esta experiencia indica que las intervenciones dirigidas por la comunidad y la voluntad del programa de aprender y adaptarse a las circunstancias cambiantes pueden ayudar a controlar la transmisión de la malaria y facilitar el camino para su eliminación.

The role of community engagement in the adoption of new agricultural biotechnologies by farmers: the case of the Africa harvest tissue-culture banana in Kenya.

BACKGROUND: The tissue culture banana (TCB) is a biotechnological agricultural innovation that has been adopted widely in commercial banana production. In 2003, Africa Harvest Biotech Foundation International (AH) initiated a TCB program that was explicitly developed for smallholder farmers in Kenya to help them adopt the TCB as a scalable agricultural business opportunity. At the heart of the challenge of encouraging more widespread adoption of the TCB is the question: what is the best way to introduce the TCB technology, and all its attendant practices and opportunities, to smallholder farmers. In essence, a challenge of community or stakeholder engagement (CE). RESULTS: In this paper, we report the results of a case study of the CE strategies employed by AH to introduce TCB agricultural practices to small-hold farmers in Kenya, and their impact on the uptake of the TCB, and on the nature of the relationship between AH and the relevant community of farmers and other stakeholders. We identified six specific features of CE in the AH TCB project that were critical to its effectiveness: (1) adopting an empirical, "evidence-based" approach; (2) building on existing social networks; (3) facilitating farmer-to-farmer engagement; (4) focusing engagement on farmer groups; (5) strengthening relationships of trust through collaborative experiential learning; and (6) helping farmers to "learn the marketing game". We discuss the implications of AH's "values-based" approach to engagement, and how these guiding values functioned as "design constraints" for the key features of their CE strategy. And we highlight the importance of attention to the human dimensions of complex partnerships as a key determinant of successful CE. CONCLUSION: Our findings suggest new ways of conceptualizing the relationship between CE and the design and delivery of new technologies for global health and global development.

Ethics of health research with prisoners in Canada.

BACKGROUND: Despite the growing recognition for the need to improve the health of prisoners in Canada and the need for health research, there has been little discussion of the ethical issues with regards to health research with prisoners in Canada. The purpose of this paper is to encourage a national conversation about what it means to conduct ethically sound health research with prisoners given the current realities of the Canadian system. Lessons from the Canadian system could presumably apply in other jurisdictions. MAIN TEXT: Any discussion regarding research ethics with Canadian prisoners must begin by first taking into account the disproportionate number of Indigenous prisoners (e.g., 22-25% of prisoners are Indigenous, while representing approximately 3% of the general Canadian population) and the high proportion of prisoners suffering from mental illnesses (e.g., 45% of males and 69% of female inmates required mental health interventions while in custody). The main ethical challenges that researchers must navigate are (a) the power imbalances between them, the correctional services staff, and the prisoners, and the effects this has on obtaining voluntary consent to research; and (b), the various challenges associated to protecting the privacy and confidentiality of study participants who are prisoners. In order to solve these challenges, a first step would be to develop clear and transparent processes for ethical health research, which ought to be informed by multiple stakeholders, including prisoners, the correctional services staff, and researchers themselves. CONCLUSION: Stakeholder and community engagement ought to occur in Canada with regards to ethical health research with prisoners that should also include consultation with various parties, including prisoners, correctional services staff, and researchers. It is important that national and provincial research ethics organizations examine the sufficiency of existing research ethics guidance and, where there are gaps, to develop guidelines and help craft policy.

Environmental enteric dysfunction: pathogenesis, diagnosis, and clinical consequences.

Stunting is common in young children in developing countries, and is associated with increased morbidity, developmental delays, and mortality. Its complex pathogenesis likely involves poor intrauterine and postnatal nutrition, exposure to microbes, and the metabolic consequences of repeated infections. Acquired enteropathy affecting both gut structure and function likely plays a significant role in this outcome, especially in the first few months of life, and serve as a precursor to later interactions of infection and malnutrition. However, the lack of validated clinical diagnostic criteria has limited the ability to study its role, identify causative factors, and determine cost-effective interventions. This review addresses these issues through a historical approach, and provides recommendations to define and validate a working clinical diagnosis and to guide critical research in this area to effectively proceed. Prevention of early gut functional changes and inflammation may preclude or mitigate the later adverse vicious cycle of malnutrition and infection.

Community engagement and the human infrastructure of global health research.

BACKGROUND: Biomedical research is increasingly globalized with ever more research conducted in low and middle-income countries. This trend raises a host of ethical concerns and critiques. While community engagement (CE) has been proposed as an ethically important practice for global biomedical research, there is no agreement about what these practices contribute to the ethics of research, or when they are needed. DISCUSSION: In this paper, we propose an ethical framework for CE. The framework is grounded in the insight that relationships between the researcher and the community extend beyond the normal bounds of the researcher-research participant encounter and are the foundation of meaningful engagement. These relationships create an essential "human infrastructure" - a web of relationships between researchers and the stakeholder community-i.e., the diverse stakeholders who have interests in the conduct and/or outcomes of the research. Through these relationships, researchers are able to address three core ethical responsibilities: (1) identifying and managing non-obvious risks and benefits; (2) expanding respect beyond the individual to the stakeholder community; and (3) building legitimacy for the research project. SUMMARY: By recognizing the social and political context of biomedical research, CE offers a promising solution to many seemingly intractable challenges in global health research; however there are increasing concerns about what makes engagement meaningful. We have responded to those concerns by presenting an ethical framework for CE. This framework reflects our belief that the value of CE is realized through relationships between researchers and stakeholders, thereby advancing three distinct ethical goals. Clarity about the aims of researcher-stakeholder relationships helps to make engagement programs more meaningful, and contributes to greater clarity about when CE should be recommended or required.

The 6I model: an expanded 4I framework to conceptualise interorganisational learning in the global health sector.

INTRODUCTION: An organisation's ability to learn and adapt is key to its long-term performance and success. Although calls to improve learning within and across health organisations and systems have increased in recent years, global health is lagging behind other sectors in attention to learning, and applications of conceptual models for organisational learning to this field are needed. LEVERAGING THE 4I FRAMEWORK: This article proposes modifications to the 4I framework for organisational learning (which outlines the processes of intuition, interpretation, integration and institutionalisation) to guide the creation, retention and exchange of knowledge within and across global health organisations. PROPOSED EXPANSIONS: Two expansions are added to the framework to account for interorganisational learning in the highly interconnected field: (1) learning pathways across organisations via formal or informal partnerships and communities of practice and (2) learning pathways to and from macro-level 'coordinating bodies' (eg, WHO). Two additional processes are proposed by which interorganisational learning occurs: interaction across partnerships and communities of practice, and incorporation linking global health organisations to coordinating bodies. Organisational politics across partnerships, communities of practice and coordinating bodies play an important role in determining why some insights are institutionalised while others are not; as such, the roles of the episodic influence and systemic domination forms of power are considered in the proposed additional organisational learning processes. DISCUSSION: When lessons are not shared across partnerships, communities of practice or the research community more broadly, funding may continue to support global health studies and programmes that have already been proven ineffective, squandering research and healthcare resources that could have been invested elsewhere. The '6I' framework provides a basis for assessing and implementing organisational learning approaches in global health programming, and in health systems more broadly.

Implications of acquired environmental enteric dysfunction for growth and stunting in infants and children living in low- and middle-income countries.

Changes in small bowel function early in infancy in developing countries are increasingly being demonstrated, probably accompanied by altered mucosal architecture in most individuals, including reduced enterocyte mass and evidence of immune activation and inflammation in the mucosa. These alterations appear to be the result of factors of uncertain nature in the environment, and may be a cause of growth faltering and stunting in young children. For these reasons, this constellation of findings is being referred to as environmental enteropathy, or as we propose herein, environmental enteric dysfunction. If the causes were known and effective interventions were available, strategies and policies to intervene at--or possibly before--birth could be developed and promoted in order to prevent subsequent malnutrition and recurrent infection, which are known to interact in a cyclical and synergistic manner in a downward clinical course often ending in death. Resources would be mobilized and applied differently, and the emphasis would change from treatment to prevention. In order to move in this highly desired direction, investments in research will be required to establish the criteria to assess environmental enteric dysfunction, determine its predictive value for growth faltering and stunting, identify the causes, and propose and test potential interventions. The concepts and tools are available. What is required is the decision to move forward along this pathway to better health for infants and children in low-income countries.

Cascading failures in COVID-19 vaccine equity.

Ethical analysis should encompass upstream decisions and their downstream consequences.

Evaluation of online videos to engage viewers and support decision-making for COVID-19 vaccination: how narratives and race/ethnicity enhance viewer experiences.

Background: Vaccine hesitancy has hampered the control of COVID-19 and other vaccine-preventable diseases. Methods: We conducted a national internet-based, quasi-experimental study to evaluate COVID-19 vaccine informational videos. Participants received an informational animated video paired with the randomized assignment of (1) a credible source (differing race/ethnicity) and (2) sequencing of a personal narrative before or after the video addressing their primary vaccine concern. We examined viewing time and asked video evaluation questions to those who viewed the full video. Results: Among 14,235 participants, 2,422 (17.0%) viewed the full video. Those who viewed a personal story first (concern video second) were 10 times more likely to view the full video (p < 0.01). Respondent-provider race/ethnicity congruence was associated with increased odds of viewing the full video (aOR: 1.89, p < 0.01). Most viewers rated the informational video(s) to be helpful, easy to understand, trustworthy, and likely to impact others' vaccine decisions, with differences by demographics and also vaccine intentions and concerns. Conclusion: Using peer-delivered, personal narrative, and/or racially congruent credible sources to introduce and deliver vaccine safety information may improve the openness of vaccine message recipients to messages and engagement.

Brokered dialogue: A new research method for controversial health and social issues.

BACKGROUND: Dialogue is a foundational feature of social life and an important way in which we come to understand one another. In situations of controversy dialogue is often absent because of a range of social barriers. We have developed a new film-based qualitative research method for studying controversial issues in healthcare and social policy. We call this method Brokered Dialogue. Theoretically informed by the traditions in narrative inquiry and visual anthropology, the method is premised on the idea that dialogue possesses features making it unique as a generator of new knowledge and opportunities for social intervention. Film is not only an extraordinarily rich data source, but an excellent medium for knowledge transfer and dissemination. DISCUSSION: The paper introduces the Brokered Dialogue method. We outline its critical steps, including the procedures for sampling, data collection and data analysis of both textual and visual data. Participants in a Brokered Dialogue engage in filmed interviews that capture their perspectives on a given topic; they then share their perspectives with, and pose questions of, one another through the medium of film. Using a participatory editing process, only footage that participants feel comfortable showing to others is incorporated. This technique offers participants a 'safe' space for respectful interaction. The editing process itself is analytic, and the final assembly of footage approximates a dialogue on the topic at hand. A link to a film produced from a project piloting the method is provided to demonstrate its real world application. SUMMARY: Brokered Dialogue is a method for promoting respectful interactions among those with seemingly divergent views on a controversial topic and for discovering critical points of divergence that may represent pathways for improvement. While the end product is a 'film', the goal is to have these films used as catalysts for ongoing respectful dialogue and problem-solving concerning the topic at hand informing relevant practice and policy change. In this paper, we consider Brokered Dialogue's potential future uses and impacts, and how these might be evaluated.

Key ethical considerations to guide the adjudication of a single-dose HPV vaccine schedule.

There is a high burden of human papillomavirus (HPV) associated cancers in low- and middle-income countries (LMICs). Reducing the recommended dosing schedule from two doses to one makes the vaccine schedule logistically simpler and lowers the cost. This could make the distribution of the current vaccine supply more equitable and lead to the protection of more people. However, the clinical trials studying the efficacy of a single-dose schedule have not yet delivered final results. Against this background, the question is whether a single-dose HPV vaccine recommendation is appropriate now, and if so, what are the ethical considerations of such a recommendation? We developed three ethical recommendations: (1) adopt a holistic view of evidence to justify policy decisions; (2) prioritize the reduction in global disparities in decision-making at all levels; and (3) be transparent in the reporting of how key stakeholder interests have shaped the collection and interpretation of the evidence, and ultimate decisions. The complex discussion regarding the HPV single-dose vaccine schedule highlights the need for in-depth engagement globally to improve our understanding of country-specific contexts, and how those contexts influence decisions regarding the HPV vaccine single-dose recommendation.

Masks, money, and mandates: A national survey on efforts to increase COVID-19 vaccination intentions in the United States.

Various efforts to increase COVID-19 vaccination rates have been employed in the United States. We sought to rapidly investigate public reactions to these efforts to increase vaccination, including self-reported responses to widespread reduced masking behavior, monetary incentive programs to get vaccinated, and work vaccination requirements. Using a unique method for data collection (Random Domain Intercept Technology), we captured a large (N = 14,152), broad-based sample of the United States Web-using population (data collected from June 30 -July 26, 2021). About 3/4 of respondents reported being vaccinated. The likelihood of vaccination and vaccination intention differed across various demographic indicators (e.g., gender, age, income, political leaning). We observed mixed reactions to efforts aimed at increasing vaccination rates among unvaccinated respondents. While some reported that specific efforts would increase their likelihood of getting vaccinated (between 16% and 32%), others reported that efforts would decrease their likelihood of getting vaccinated (between 17% and 42%). Reactions differed by general vaccination intention, as well as other demographic indicators (e.g., race, education). Our results highlight the need to fully understand reactions to policy changes, programs, and mandates before they are communicated to the public and employed. Moreover, the results emphasize the importance of understanding how reactions differ across groups, as this information can assist in targeting intervention efforts and minimizing potentially differential negative impact.

Impact of vaccine pause due to Thrombosis with thrombocytopenia syndrome (TTS) following vaccination with the Ad26.COV2.S vaccine manufactured by Janssen/Johnson & Johnson on vaccine hesitancy and acceptance among the unvaccinated population.

BACKGROUND: In response to reports of thrombosis with thrombocytopenia syndrome (TTS) post-vaccination, the Johnson & Johnson (J&J) vaccine was paused and then restarted in April 2021. Our objective was to assess whether this pause adversely impacted vaccine confidence. METHODS: Two large internet-based surveys were conducted in the US among adults to measure knowledge, attitudes and perceptions of the J&J vaccine pause and rates of vaccine hesitancy among unvaccinated persons before, during and after the pause. RESULTS: Among 66% of respondents aware of the pause, 44% identified blood clots as the reason for the pause without prompting. The impact of the pause on vaccine behavior among unvaccinated persons and perception of the vaccine safety system was mixed and modified by trust in the public health authorities. Those who were less willing to get vaccinated because of the pause were less inclined for all vaccines, not only the J&J product. Moreover, a notable proportion (22.1%) of the small number of persons (n = 30) vaccinated with the J&J vaccine after the pause reported not receiving information about the risk of TTS. The proportion of unvaccinated persons who were hesitant was increasing before and during the pause and then leveled off after the pause. CONCLUSIONS: The J&J vaccine pause is unlikely to be a major barrier to vaccine uptake. Public attitudes about vaccines may be more resilient than appreciated, especially when safety issues are investigated with transparent communication. This paper has important implications for messaging and program administration with future vaccine-specific adverse events. Efforts may be warranted to ensure all persons being offered the J&J vaccine are made aware of the risk of TTS.