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

Area of Science:

• Environmental Health
• Clinical Trials
• Public Health

Background:

• The COVID-19 pandemic necessitated modifications to clinical trial protocols, particularly for studies involving in-person data collection.
• The Home Air Filtration for Traffic-Related Air Pollution (HAFTRAP) study, a randomized crossover trial, required protocol revisions due to its pre-pandemic design involving home visits.
• Adapting in-home research during the pandemic presented unique challenges to participant and staff safety.

Purpose of the Study:

• To revise the HAFTRAP study protocol to ensure participant and staff safety during the COVID-19 pandemic.
• To explore methods for conducting in-home data collection with minimal contact.
• To maintain ethical and safe research practices while continuing a public health trial.

Main Methods:

• Postponed trial recruitment and revised the protocol, implementing enhanced safety precautions for home visits.
• Developed alternative approaches for installing air filtration units to minimize entry into participants' homes.
• Created a comprehensive COVID-19 safety plan for field staff and participants.

Main Results:

• Minimized participant contact during the placement of air filtration units, air quality monitoring, and collection of biological samples (blood pressure, phlebotomy).
• Adapted screening, consent, and follow-up questionnaires for reduced in-person interaction.
• Observed that perceived risk of COVID-19 infection influenced participant enrollment, especially early in the pandemic.

Conclusions:

• High-quality air monitoring data can be collected with minimal in-person contact without compromising trial integrity.
• Blood pressure and phlebotomy data were successfully collected with minimal risk to participants.
• Flexibility and collaboration were crucial for adapting in-home data collection methods to evolving safety guidelines.