Who is conducting this study?
Susan Kline, MD, MPH
Professor, Division of Infectious Diseases and International Medicine, Department of Medicine
Medicine Research Operations and Resources (MED ROAR), Department of Medicine
What happens if I agree to participate in this study?
If you decided to join the study, you will:
- sign a consent form and answer some questions about your medical history in an eDairy app
- be randomized into a group that gets the vaccine immediately or a group that follows the Standard of Care. If you do not want to get a COVID-19 vaccine, you can still join the study
- take daily swabs of your nose for 4 months and return them to the study staff twice a week
- answer questionnaires in an eDiary app about your health
- provide blood samples
- identify close contacts who will be invited to join the study
- receive compensation for your participation
- complete additional procedures if you test positive for SARS-CoV-2
Schedule of Visits
Will I receive a COVID-19 vaccine as part of this study?
Part of this study is to be vaccinated with the Moderna EUA vaccine. If you choose to get the vaccine as part of the study, you will be randomly assigned to either the immediate group (to get the vaccine right away) or to the standard of care group. In the standard of care group, you are free to get the vaccine on your own as you would if you were not in the study. If after 4 months, you have not received a COVID-19 vaccine, you can get one from the study.
If you prefer not to get vaccinated, that is also an option. If after 4 months, you have not received a COVID-19 vaccine, you will be offered the option of getting one from the study.
Will I receive compensation for participating?
Yes, you will receive compensation for completing study visits and certain study activities, like returning your nasal swabs and completing eDairy questionnaires.
How long would I be in this study?
Your participation in this study will last 4-5 months.
Who are close contacts and why are they needed?
When you join the study, we will ask you to identify some “close contacts,” such as family members, roommates, partners, or friends; anyone you have frequent close physical proximity with. Your close contacts will be asked to complete questionnaires via an eDiary app twice weekly.
If you or they test positive for SARS-CoV-2, these contacts will be asked to answer weekly questionnaires via the eDiary app, provide two blood samples, and take daily swabs of their nose for two weeks.
Close contacts are important in measuring the spread of the SARS-CoV-2 virus to others and will help researchers find out if the vaccine prevents transmission of the virus to others