Adapting an In-Home Randomized Intervention Trial Protocol for COVID-19 Precautions.

ABSTRACT

BACKGROUND: The COVID-19 pandemic has significantly impacted the status of clinical trials in the United States, requiring researchers to reconsider their approach to research studies. In light of this, we discuss the changes we made to the protocol of the Home Air Filtration for Traffic-Related Air Pollution (HAFTRAP) study, a randomized crossover trial of air filtration in homes next to a major highway. The senior authors designed the trial prior to the pandemic and included in-person data collection in participants' homes. Because of the pandemic, we delayed the start of our trial in order to revise our study protocol to ensure the health and well-being of participants and staff during home visits. To our knowledge, there have been few reports of attempts to continue in-home research during the pandemic. METHODS: When pandemic-related protective measures were imposed in March 2020, we were close to launching our trial. Instead, we postponed recruitment, set a new goal of starting in September 2020, and spent the summer of 2020 revising our protocol by developing increased safety precautions. We reviewed alternative approaches to installing portable air filtration units in study participants' homes, in order to reduce or eliminate entry into homes. We also developed a COVID-19 safety plan that covered precautionary measures taken to protect both field team staff and study participants. RESULTS: Our primary approach was to minimize contact with participants when collecting the following measures in their homes (1) placing portable air filtration units; (2) conducting indoor air quality monitoring; (3) obtaining blood samples and blood pressure measurements; and (4) administering screening, consent, and follow-up questionnaires that coincided with collection of biological measures. Adapting our public health trial resulted in delays, but also helped ensure ethical and safe research practices. Perceived risk of COVID-19 infection appeared to have been the primary factor for an individual in deciding whether or not to participate in our trial, particularly at the beginning of the pandemic, when less was known about COVID-19. CONCLUSIONS: We needed to be flexible, creative, and calm when collaborating with community members, the IRB, and the universities, while repeatedly adjusting to changing guidelines as we determined what worked and what did not for in-home data collection. We learned that high-quality air monitoring data could be collected with minimal in-person contact and without compromising the integrity of the trial. Furthermore, we were able to collect blood pressure and phlebotomy data with minimal risk to the participant.