Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask
Primary Purpose
Covid19, SARS-CoV2 Infection
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Focal Mask
Sponsored by
About this trial
This is an interventional prevention trial for Covid19 focused on measuring Reusable masks, University Setting
Eligibility Criteria
Inclusion Criteria:
- Georgia Institute of Technology (Georgia Tech) student
- 18 years old or older
- Living on campus in Georgia Tech dorms
Exclusion Criteria:
- Not a Georgia Tech student
- Under the age of 18
- Not living on campus in Georgia Tech dorms
Sites / Locations
- Georgia Institute of Technology - Main Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Treatment Group
Arm Description
The subjects will choose their own mask and masking practices.
The treatment group will receive and use the focal mask.
Outcomes
Primary Outcome Measures
Number of Participants Not Infected by COVID-19
Number of participants not infected by COVID-19 in a university setting.
Secondary Outcome Measures
Full Information
NCT ID
NCT04979858
First Posted
July 22, 2021
Last Updated
March 9, 2023
Sponsor
Georgia Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT04979858
Brief Title
Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask
Official Title
Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask for Community Use
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 6, 2021 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
March 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Georgia Institute of Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, SARS-CoV2 Infection
Keywords
Reusable masks, University Setting
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One group will receive the focal mask and the other group will choose its own mask.
Masking
Investigator
Masking Description
The PI will not know which subjects have been assigned to which arm.
Allocation
Randomized
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The subjects will choose their own mask and masking practices.
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
The treatment group will receive and use the focal mask.
Intervention Type
Device
Intervention Name(s)
Focal Mask
Intervention Description
The treatment group will receive and use the focal mask.
Primary Outcome Measure Information:
Title
Number of Participants Not Infected by COVID-19
Description
Number of participants not infected by COVID-19 in a university setting.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Georgia Institute of Technology (Georgia Tech) student
18 years old or older
Living on campus in Georgia Tech dorms
Exclusion Criteria:
Not a Georgia Tech student
Under the age of 18
Not living on campus in Georgia Tech dorms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sundaresan Jayaraman, Ph.D
Organizational Affiliation
Georgia Institute of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia Institute of Technology - Main Campus
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30332
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask
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