MedStar Health Investigator Develops Risk Assessment Tool for Resuming Research in Low Resource Settings During the COVID-19 Pandemic

This collaborative research project sought to develop a framework to assess the risk of conducting clinical trial activity during the COVID-19 pandemic in rural, low resource settings. This research specifically looked at the continuation of the multi-country Household Air Pollution Intervention (HAPIN) trial, which is a randomized controlled trial in rural areas of Guatemala, India, Peru, and Rwanda that is assessing the health benefits of providing liquefied petroleum gas (LPG) stoves and an 18-month supply of free LPG to 3200 households that otherwise depend on solid biomass fuel (wood, animal dung, or crop residue) for cooking. While the study was conducted overseas, it has application for any rural area.

In 2020, the spread of COVID-19 led to the temporary suspension of many non-COVID-19 related research activities worldwide. Where restarting research activities is permitted, investigators need to evaluate the risks and benefits of resuming data collection and adapt procedures to minimize risk. The goal of this study is to maximize the integrity of research aims while minimizing infection risk based on the latest scientific understanding of the virus.

The HAPIN study collects measurements of cooking behavior, personal and in-home exposure to air pollution, biological samples and clinical measurements from pregnant women and their newborns in every household, along with an older, non-pregnant adult woman, if she resides in the house. The study involves home visits, as well as visits to health centers and hospitals during the woman’s pregnancy and the first year of the child’s life.

In developing the risk assessment tool in the context of COVID-19, the research team used a combination of expert consultations, risk assessment frameworks, institutional guidance and literature and systematically graded clinical, behavioral, laboratory and field environmental health research activities in four countries for both adult and child subjects using this framework.

The framework assessed 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, was assigned and guidance on protective measures was provided.

The researchers assessed research activities that included LPG fuel delivery, administration of tablet-based surveys, data downloads from environmental monitors, personal exposure assessment to household air pollution, biological sample collection (e.g. urine, nasal swabs, venous blood) and lab processing of biological samples in the field laboratories, clinical, observations in homes of pregnant women/new mothers, children, and vascular procedures in adults.

The study results show that almost all of the research activities were deemed to pose potentially manageable risks. The activities with the highest level of risk were those that potentially aerosolize the virus during the procedure.

The study team concluded that by applying a systematic, procedure-specific approach to risk assessment for each research activity, it can minimize the disruption in trials due to the pandemic and continue to protect participants and research team and support the completion of primary outcomes. The study team also believes their framework can be applied be tailored to other research studies conducted in similar settings during the current pandemic to guide investigators in assessing the risk of each research activity and implementing appropriate safety measures, where the level of risk is acceptable.

This research was led by one of our newest MedStar Health investigators, Suzanne M. Simkovich MD, MS, Physician Investigator, MedStar Health Research Institute, Assistant Professor of Medicine, Georgetown University.