Track COVID at Home! is a health study about how COVID-19 spreads between people who live together. It is important for this research to get information from as many people who live together as soon as possible after a person has a positive COVID-19 test. People who just recently received a positive COVID-19 test and the people that they live with are being asked to participate in this research study.

The study will last about 4-6weeks. Completing screening, consent and enrollment into the study will take approximately 30 minutes. We recommend you plan to do all three components in one sitting. If you stop after completing the screening, you will need to complete it again if you come back to the website. Then you collect a COVID-19 test sample and answer questions on the study website for 10 days. This will take 15-20 minutes each day. The first day, we also will ask you to collect a small amount of blood from your upper arm using a small collection device. This should take just about 5 minutes. We will ask you to complete a few more questions on the 10th day of the collection period. These questions will take about 10 minutes. Approximately 4 weeks after starting the study, you will be asked to collect a small amount of blood from your upper arm again, using the same small collection device and complete a final set of questions. This will take 10-15 minutes.

The Centers for Disease Control and Prevention (CDC) is sponsoring the study. Westat, a research company, is managing the study and collecting information from you and the people you live with.

We would like you and other people living in your household to start study activities as soon as possible after you (or another household contact) tests positive for COVID-19. If several of your household contacts do not agree to be in the study within 1 to 3 days of the test date of the household contact who was COVID-19 positive, your household may not be eligible for the study. The exact timing depends on whether the person who was COVID-19 positive had symptoms and when they began.

The majority of people in the household need to participate for the household to be eligible. If the household is only two people, then both people need to agree to be in the study. If three people are living in the household, then two of the three must agree to participate. One of the household participants must be the person who had the recent COVID-19 positive test.

This is a web-based study. This means all of the questions and forms to complete are on the study website. Everyone will create an account and use it log into the website. Once you agree to be a part of the study, you will be asked to create an account. After creating an account, we will ask you to answer questions on the study website. The questions ask about you and your health. Questions also ask about which ways you think you might have a chance of getting COVID-19 and if you have had a COVID-19 vaccine. It will take about 20 minutes to answer all the questions.

We want everyone you live with to be in the study if possible. The study will start when most of the people you live with agree to do the study. Then, study supplies will be sent to where you live.

When you get the test supplies at home, the next steps you have to take for the study are:

• Collect a COVID-19 test every day for 10 days in a row. The test is done by a swab in your nose or putting your saliva in a tube (like drooling). We call the first day you collect a COVID-19 test Day 1, and we count every day that you should collect a test up to Day 10.
• Every day for 10 days, answer a few questions after collecting the COVID-19 test about how you are feeling, medications and how much time you are around the people in the household for 10 days in a row. It takes 15-20 minutes to complete the COVID-19 test and answer the questions every day.
• Day 1 Only: Collect a small amount of blood. We will send a small collection device that is used to prick your upper arm so the blood goes directly into a small container. The blood will be used for testing for antibodies to see if you may have already had COVID-19.
• Send your COVID-19 test kits and blood sample to a laboratory for testing using mailing packages that we give you.
• Day 10 Only: Complete questions about what you have done in the past 10 days.
• About 4 weeks later: Again, collect a little bit of blood from your upper arm using a small device that we send you. You will send the blood sample to a laboratory in the mailing package we give you. Answer a few questions on the study website about the people you live with and if you saw a doctor or other healthcare worker during the past few weeks.

We would like all people who live together to be in the study, including children over 2 years old, but it is not required that every person in the household participates. We want to have at least 2/3 of all people in the household to participate in the study if they are eligible.

To thank each person in the study for their time and effort, including children, the study gives each person up to $100. Exactly how much depends on what study activities are completed. Each person may get:

• $50 after you answer the questions at the beginning of the study, collect 7 days of COVID-19 tests and the small blood sample from your arm and answer daily questions on the study website for 7 days
• $25 more if you finish all 10 days of COVID-19 tests and answer all 10 days of daily questions on the study website (after you complete all the tasks in the previous 7 days)

If all of those activities are done, then each person that finishes the study activities 4 weeks later will get:

• $25 for collecting the second sample of a little bit of blood from your arm and answering the final questions 4 weeks after you started the study.

Please complete the study questions, COVID - 19 test samples and blood as noted in the instructions.

It should take you just a few seconds to complete the COVID-19 test. It will take a few more minutes to answer about 12 questions on the study website about the COVID-19 test collection and report any symptoms you experienced in the day before you collected the COVID-19 test sample and how you interacted with other people in your home and outside your home in the past day.

Please contact the study using the study website help function www.TrackCOVIDatHome.org, the study email at COVIDatHome@westat.com or toll-free number 1-855-981-0720. We will let you know what to do and decide how best to resolve this issue.

If you missed one of the COVID-19 tests, just be sure to complete your test the next day and answer the daily diary questions. It is important to collect at least 7 tests during the 10-day testing period.

The Contact Person for your household will receive reminders to collect the COVID-19 test sample every day. This adult is responsible for reminding all household members to complete the COVID-19 test and the daily diary questions. However, each person age 13 and over with individual contact information will receive reminders by text and/or email and may be contacted directly by phone by the evening if they have not completed their COVID-19 test or their daily diary questions on the study website.

The Contact Person for your household will receive reminders to collect the COVID-19 test sample. They are responsible for reminding all household members to complete the COVID-19 test and complete the daily diary questions on the study website every day.

If you are late completing the daily diary questions, please complete them as soon as possible if the questions for that day are still open to you on the study website. The daily diary questions for one day will not be available for you to answer the next day. We will have only one set of questions – with the date – available for you to answer at one time. If you don’t know the answer to a question, answer “don’t know”.

Yes. Please also use the special device that is included in the study supplies to collect a few drops of blood. The blood drops will be tested to see if you ever had COVID-19.

All COVID-19 samples will be tested for COVID-19 at a certified testing laboratory. If your COVID-19 test shows that you have COVID-19, the laboratory is required by law to share your name, telephone number, age, and sex with the local health department. Testing laboratories are required by public health law to report positive COVID-19 test results to the local health department.

If you give the Contact Person for the household permission to enter your study information, they will see all your answers. You still can decide if you want this person to help you enter your answers to questions or if you complete them yourself.

Other than required reporting of positive COVID-19 results, we will share information that you give us for the study only with other study researchers, and those records will not contain your name or other information that could identify you.

This research study has a Certificate of Confidentiality from the Centers for Disease Control and Prevention (CDC). Unless you say it is okay, study staff cannot release information that may identify you for a legal action, a lawsuit, or as evidence. This protection applies to requests from federal, state, or local civil, criminal, administrative, legislative, or other proceedings. As an example, the Certificate would protect your information from a court subpoena.

There are some important things that you need to know. The Certificate DOES NOT protect your information if a federal, state, or local law says it must be reported. For example, some laws require reporting of abuse, communicable diseases, and threats of harm to yourself or others. The Certificate CANNOT BE USED to stop a federal or state government agency from checking records or evaluating programs. The Certificate DOES NOT stop reporting required by the U.S. Food and Drug Administration (FDA). The Certificate also DOES NOT stop your information from being used for other studies if allowed by federal regulations.

Study staff may release your information when you say it is okay. For example, you may give them permission to release information to insurers, your doctors, or any other person not connected with the study. The Certificate of Confidentiality does not stop you from releasing your own information. It also does not stop you from getting copies of your own information.

A household is a shared living space between two or more people. For this study, correctional facilities, long-term care facilities, boarding schools, hostels, dormitories, or other similar institutionalized/congregate settings are not considered households

You will receive a box with a FedEx or UPS shipping label. The study instructions will tell you how to pack the COVID-19 test sample and blood kits into the box and send it back to the testing laboratory.

It does not cost anything to take part in this research study.

For questions about the study, contact study staff at 1-855-981-0720 or email TrackCOVIDatHome@westat.com.

If you have questions about your rights as a research participant or if you feel you have experienced a research related injury, please call the Westat Human Subjects Protections office at 1-888-920-7631. Please leave a message with your full name, the name of the research study that you are calling about (Track COVID at Home!) and a phone number beginning with the area code. Someone will return your call as soon as possible.

You may learn more information by visiting the study website at www.TrackCOVIDatHome.org. The study is sponsored by the Centers for Disease Control and Prevention (CDC) and you can find more information about this study on the CDC website.

When you agree to be in the study, you will also be asked to agree or not for your COVID-19 test sample and small amount of blood to be stored for future research studies. If you agree, you will not be notified if your samples are used for future research. However, your name or address will not be shared. The researchers will only see your ID number.

Yes. This study is voluntary and you can stop being in the study at any time. We hope you will not, but it is up to you.

If you tested positive for a COVID-19 test you took at a national laboratory, you received an invitation to this study when you saw your COVID-19 test results online in your account with the national laboratory.

If you lived with someone who tested positive for COVID-19 from a test at a national laboratory, this person was asked for the names and email addresses of the people they live with and you were sent an email about the study to see if you wanted to participate.

All household members are asked to participate in the study. However, children under the age of 2 do not need to participate.

The COVID-19 saliva and antibody research test results will be available on the study website. You will need to log in to see the results. If you are age 7 or over and gave permission for the Contact Person (who is an adult living in the household), that person also will be able to see the test results.

The Centers for Disease Control and Prevention (CDC) is sponsoring the study. Two testing laboratories, Quest Diagnostics Inc. and Vault, COVID-19 test kits are used to collect samples to test for COVID-19.

Your COVID-19 samples will be tested for COVID-19 at a certified testing laboratory. If your COVID-19 test sample shows a positive COVID-19 test result, your personal identifiable information such as your name, telephone number, age, and gender will be shared with the local health department. Testing laboratories are required by law to report positive COVID-19 test results to the local health department so that they can identify, monitor, assess or investigate the COVID-19 outbreak.

Other than required reporting of positive COVID-19 results, we will share information that you give us for the study only with other study researchers, and those records will not contain your name or other information that could identify you.

Antibodies come from a past COVID-19 infection and/or vaccination against COVID-19. An antibody test does NOT tell you if you have a current infection. The research test results should not be used to decide if you or someone else could return to work or school. People with antibodies may get COVID-19 again.