A risk assessment tool for resumption of research activities during the COVID-19 pandemic for field trials in low resource settings.

RATIONALE: The spread of severe acute respiratory syndrome coronavirus-2 has suspended many non-COVID-19 related research activities. Where restarting research activities is permitted, investigators need to evaluate the risks and benefits of resuming data collection and adapt procedures to minimize risk. OBJECTIVES: In the context of the multicountry Household Air Pollution Intervention (HAPIN) trial conducted in rural, low-resource settings, we developed a framework to assess the risk of each trial activity and to guide protective measures. Our goal is to maximize the integrity of reseach aims while minimizing infection risk based on the latest scientific understanding of the virus. METHODS: We drew on a combination of expert consultations, risk assessment frameworks, institutional guidance and literature to develop our framework. We then systematically graded clinical, behavioral, laboratory and field environmental health research activities in four countries for both adult and child subjects using this framework. National and local government recommendations provided the minimum safety guidelines for our work. RESULTS: Our framework assesses risk based on staff proximity to the participant, exposure time between staff and participants, and potential viral aerosolization while performing the activity. For each activity, one of four risk levels, from minimal to unacceptable, is assigned and guidance on protective measures is provided. Those activities that can potentially aerosolize the virus are deemed the highest risk. CONCLUSIONS: By applying a systematic, procedure-specific approach to risk assessment for each trial activity, we were able to protect our participants and research team and to uphold our ability to deliver on the research commitments we have made to our staff, participants, local communities, and funders. This framework can be tailored to other research studies conducted in similar settings during the current pandemic, as well as potential future outbreaks with similar transmission dynamics. The trial is registered with clinicaltrials.gov NCT02944682 on October 26. 2016 .

A Risk Assessment Tool for Resumption of Research Activities During the COVID-19 Pandemic.

RATIONALE: The spread of severe acute respiratory syndrome coronavirus-2 has suspended many non-COVID-19 related research activities. Where restarting research activities is permitted, investigators need to evaluate the risks and benefits of resuming data collection and adapt procedures to minimize risk. OBJECTIVES: In the context of the multicountry Household Air Pollution Intervention (HAPIN) trial, we developed a framework to assess the risk of each trial activity and to guide protective measures. Our goal is to maximize integrity of reseach aims while minimizing infection risk based on the latest understanding of the virus. METHODS: We drew on a combination of expert consultations, risk assessment frameworks, institutional guidance and literature to develop our framework. We then systematically graded clinical, behavioral, laboratory and field environmental health research activities in four countries for both adult and child subjects using this framework. RESULTS: Our framework assesses risk based on staff proximity to the participant, exposure time between staff and participants, and potential aerosolization while performing the activity. One of of four risk levels, from minimal to unacceptable, is assigned and guidance on protective measures is provided. Those activities which can potentially aerosolize the virus are deemed the highest risk. CONCLUSIONS: By applying a systematic, procedure-specific approach to risk assessment for each trial activity, we can compare trial activities using the same criteria. This approach allows us to protect our participants and research team and to uphold our ability to deliver on the research commitments we have made to our participants, local communities, and funders. The trial is registered with clinicaltrials.gov (NCT02944682).

Air Pollutant Exposure and Stove Use Assessment Methods for the Household Air Pollution Intervention Network (HAPIN) Trial.

BACKGROUND: High quality personal exposure data is fundamental to understanding the health implications of household energy interventions, interpreting analyses across assigned study arms, and characterizing exposure-response relationships for household air pollution. This paper describes the exposure data collection for the Household Air Pollution Intervention Network (HAPIN), a multicountry randomized controlled trial of liquefied petroleum gas stoves and fuel among 3,200 households in India, Rwanda, Guatemala, and Peru. OBJECTIVES: The primary objectives of the exposure assessment are to estimate the exposure contrast achieved following a clean fuel intervention and to provide data for analyses of exposure-response relationships across a range of personal exposures. METHODS: Exposure measurements are being conducted over the 3-y time frame of the field study. We are measuring fine particulate matter [PM < 2.5µm in aerodynamic diameter (PM2.5)] with the Enhanced Children's MicroPEM™ (RTI International), carbon monoxide (CO) with the USB-EL-CO (Lascar Electronics), and black carbon with the OT21 transmissometer (Magee Scientific) in pregnant women, adult women, and children <1 year of age, primarily via multiple 24-h personal assessments (three, six, and three measurements, respectively) over the course of the 18-month follow-up period using lightweight monitors. For children we are using an indirect measurement approach, combining data from area monitors and locator devices worn by the child. For a subsample (up to 10%) of the study population, we are doubling the frequency of measurements in order to estimate the accuracy of subject-specific typical exposure estimates. In addition, we are conducting ambient air monitoring to help characterize potential contributions of PM2.5 exposure from background concentration. Stove use monitors (Geocene) are being used to assess compliance with the intervention, given that stove stacking (use of traditional stoves in addition to the intervention gas stove) may occur. CONCLUSIONS: The tools and approaches being used for HAPIN to estimate personal exposures build on previous efforts and take advantage of new technologies. In addition to providing key personal exposure data for this study, we hope the application and learnings from our exposure assessment will help inform future efforts to characterize exposure to household air pollution and for other contexts. https://doi.org/10.1289/EHP6422.

Clean cooking and the SDGs: Integrated analytical approaches to guide energy interventions for health and environment goals.

Development and implementation of clean cooking technology for households in low and middle income countries (LMICs) offer enormous promise to advance at least five Sustainable Development Goals (SDGs): 3. Good health and well-being; 5. Gender equality; 7. Affordable and clean energy; 13. Climate action; 15. Life on land. Programs are being implemented around the world to introduce alternative cooking technologies, and we are well on the way to achieving the goal set by the Global Alliance for Clean Cookstoves to reach 100 million homes with cleaner and more efficient cooking methods by 2020. Despite evidence that household air pollution (HAP) from solid fuel combustion is responsible for 3-4 million early deaths per year, many cookstove programs are motivated and/or financed by climate change mitigation schemes and deploy alternative stoves that use solid fuels such as wood and charcoal. However, recent studies have demonstrated that improved biomass-burning stoves typically only incrementally improve air quality and yield modest or minimal health benefits. Likewise, their contributions to climate change mitigation and other SDGs may be limited. Evidence indicates that cleaner fuels, such as liquefied petroleum gas (LPG), ethanol and biogas, offer greater potential benefits not only to health, but also greater progress towards climate goals and other relevant SDGs. We present a modeled estimate of these potential gains for a diverse group of 40 LMICs. Our model suggests that cookstove programs using LPG stoves and fuel will yield greater reductions in both Disability Adjusted Life Years and Global Warming Commitment in these countries than those using improved biomass stoves. Cost and infrastructure requirements for clean fuels such as LPG are widely recognized constraints. In view of these constraints we present an analytical method to simultaneously consider health and climate needs at the national level for the same 40 countries in the context of estimated LPG expansion potentials. Comparative analyses integrating priorities across SDGs at the national and regional levels may guide more practical and effective household energy development choices going forward.

International Approach to Environmental and Lung Health. A Perspective from the Fogarty International Center.

The global burden of lung disease is substantial, accounting for an estimated 7.5 million deaths per year, approximately 14% of annual deaths worldwide. The prime illnesses include, in descending order, chronic obstructive pulmonary disease, lung cancer, tuberculosis, acute respiratory infections, asthma, and interstitial lung fibrosis. Key risk factors include smoking, both indoor and outdoor air pollution, and occupational exposures. Although the distribution of both the diseases and the risk factors varies greatly by age, geography, and setting, the greatest burden falls on populations living in low- and middle-income countries. Improvements in these metrics will require major public health interventions to curb smoking; improving air quality both in the community and the household; addressing the ever-present burden of infections, including tuberculosis, flu, and the many agents that cause acute respiratory disease; and identifying and protecting workers from the hazards of exposure to toxic substances. Although research over the years has identified many ways to reduce or prevent the enormous burden of disease, a huge gap exists between what we know and what we can do. This "implementation gap" is the greatest challenge we face in this field today. Research on how best to address and implement the changes needed will require not only biomedical advances to improve treatment but also social, economic, and policy research. We still need to elaborate more effective evidence-based policies and interventions to control tobacco use, address ambient and household air pollution, and improve the prevention and treatment of tuberculosis and acute respiratory infections with vaccines and drugs and reduce exposures to environmental and occupational hazards. Until these efforts receive greater prioritization, the burden of disease is unlikely to diminish a great deal more.

Climate change, human health, and biomedical research: analysis of the National Institutes of Health research portfolio.

BACKGROUND: According to a wide variety of analyses and projections, the potential effects of global climate change on human health are large and diverse. The U.S. National Institutes of Health (NIH), through its basic, clinical, and population research portfolio of grants, has been increasing efforts to understand how the complex interrelationships among humans, ecosystems, climate, climate variability, and climate change affect domestic and global health. OBJECTIVES: In this commentary we present a systematic review and categorization of the fiscal year (FY) 2008 NIH climate and health research portfolio. METHODS: A list of candidate climate and health projects funded from FY 2008 budget appropriations were identified and characterized based on their relevance to climate change and health and based on climate pathway, health impact, study type, and objective. RESULTS: This analysis identified seven FY 2008 projects focused on climate change, 85 climate-related projects, and 706 projects that focused on disease areas associated with climate change but did not study those associations. Of the nearly 53,000 awards that NIH made in 2008, approximately 0.17% focused on or were related to climate. CONCLUSIONS: Given the nature and scale of the potential effects of climate change on human health and the degree of uncertainty that we have about these effects, we think that it is helpful for the NIH to engage in open discussions with science and policy communities about government-wide needs and opportunities in climate and health, and about how NIH's strengths in human health research can contribute to understanding the health implications of global climate change. This internal review has been used to inform more recent initiatives by the NIH in climate and health.

International environmental and occupational health: From individual scientists to networked science Hubs.

For the past 16 years, the International Training and Research in Environmental and Occupational Health program (ITREOH) has supported projects that link U.S. academic scientists with scientists from low- and middle-income countries in diverse research and research training activities. Twenty-two projects of varied duration have conducted training to enhance the research capabilities of scientists at 75 institutions in 43 countries in Asia, Africa, Eastern Europe, and Latin America, and have built productive research relationships between these scientists and their U.S. partners. ITREOH investigators and their trainees have produced publications that have advanced basic sciences, developed methods, informed policy outcomes, and built institutional capacity. Today, the changing nature of the health sciences calls for a more strategic approach. Data-rich team science requires greater capacity for information technology and knowledge synthesis at the local institution. More robust systems for ethical review and administrative support are necessary to advance population-based research. Sustainability of institutional research capability depends on linkages to multiple national and international partners. In this context, the Fogarty International Center, the National Institute of Environmental Sciences and the National Institute for Occupational Safety and Health, have reengineered the ITREOH program to support and catalyze a multi-national network of regional hubs for Global Environmental and Occupational Health Sciences (GEOHealth). We anticipate that these networked science hubs will build upon previous investments by the ITREOH program and will serve to advance locally and internationally important health science, train and attract first-class scientists, and provide critical evidence to guide policy discussions.