Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04979858 |
| Other study ID # |
H21218 |
| Secondary ID |
75D30121C10545 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 6, 2021 |
| Est. completion date |
March 15, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
Georgia Institute of Technology |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The primary aim of the proposed research is to test the role of a newly developed reusable
form-fitting fabric mask in reducing the spread of COVID-19 in a community setting comprising
undergraduate students living in dormitories at the Georgia Institute of Technology (Georgia
Tech). A corollary aim is to assess the role of wearing any type of face covering in reducing
spread in the same community setting. A final aim is to assess the social, behavioral,
aesthetic, and usability aspects of wearing face coverings in public settings.
Description:
The primary aim of the proposed research is to test the role of a newly developed reusable
form-fitting fabric mask in reducing the spread of COVID-19 in a community setting comprising
undergraduate students living in dormitories at Georgia Tech. The study has been designed
such that it also leads to the corollary aim of assessing the role of wearing any type of
face covering in reducing spread in the same community setting. Yet another aim is to assess
the social, behavioral, aesthetic, and usability aspects of wearing face coverings in public
settings. The study design is to assign student users of masks randomly to the Treatment
group of focal mask users (n=100) and a Control group of other mask users (n=100).
The Study Population and Data Collection: The subject population will comprise 200
undergraduate students staying in the dormitories at Georgia Tech, preferably freshmen and
sophomores with meal plans. There will be no restriction of race, gender, or sexual
orientation for this study. The final cohort chosen will attempt to reflect the demographics
of the undergraduate student body at Georgia Tech. The participating subjects will have the
option to withdraw from the study at any time. The recruitment of subjects will be carried
out in collaboration with Georgia Tech Housing through e-mail and web announcements. The
research team will be accessible to the subjects at all times during the study.
As part of the informed consent process during recruitment, the Treatment Group will be told
about the use, care and laundering of the focal mask during the study. The planned sample
size of 200 accounts for dropouts, which are likely to occur so that a statistically
significant sample is present to assess the effect of the mask. A randomized study cannot be
undertaken for ethical and practical reasons (e.g., the fact that the behaviors of students
cannot be controlled leading to heterogeneity); therefore, a DID (Difference-in-Difference)
approach that has been used extensively in public health research will be utilized in this
study . The DID method assumes that unobserved heterogeneity in participation is present but
that such factors are time invariant. With data on observations before and after the
treatment intervention, this fixed component can be differenced out. For this reason, the
study is spread over six weeks consisting of three phases: Pre-treatment, Treatment, and
Post-treatment, with each phase lasting two weeks. The two-week period for each phase is
based on the following rationale: The incubation period of COVID-19 virus has been found to
be five days. About 97% of the people who get infected and develop symptoms will do so within
11 to 12 days, and about 99% will within 14 days, which is the basis for the 14-day
quarantine recommended by Centers of Disease Control. The health and well-being of the
subjects will be tracked during the study. Any student falling sick will be given medical
help using on-campus health services. Georgia Tech has a system in place with the ability to
conduct 1,500 tests per day, going to possibly 3,000 per day. If the COVID-19 test is
positive, the subject will be excluded from the remainder of the study. The subject will,
however, be compensated at the end of the study.
Data Collection: During the study, demographic, behavioral, and mask use data will be
recorded and appropriately de-identified. No specimens will be obtained from the subjects.
All the collected data will be access limited, and destroyed when no longer needed to perform
the study or analysis or after completion and publication of the study, whichever comes
first. COVID-19 diagnoses will be self-reported by the subjects.
At the beginning of the study, each subject will provide the following data:
- Subject Profile: Demographic information, class schedule, dining plans
- Baseline Practice Data: Mask usage practice (type, duration), typical social
interactions
- During the study, each subject will provide the following data every day:
- Health Metrics: Temperature, Typical COVID-19 symptoms (if any)
- Mask Usage Data: Type and duration of mask usage including washing
- Activity Data: Classes attended, group meetings, social and dining interactions
At the end of the study, each subject will provide the following data:
- Usability: Comfort, Ease of Donning/Doffing, Impact on Communication
- Shape Conformability: Conforms to face, Shape retention after washing
- Ease of Care: Ease of washing
- Aesthetic and Social Perceptions: Style, Perceptions of others, Impact on personal
behavior and degree of social interactions
The Difference-in-Difference (DID) methodology will be used to analyze the data from the
Control and Treatment groups. The difference in infection rates between the groups will help
determine the role of the focal mask.
