Screening Date Today M-D-Y
RC Number
Thank you for your interest in this study. Please answer the following questions to check eligibility. If you are volunteering your child, all references to "you" or "your" in the questions below means your child.
Thank you for your interest in this study. I'll ask you the following questions to check if you are eligible. If you are volunteering your child, all references to "you" or "your" means your child.
1. How did you hear about this study?* must provide value
Friend
Family member
Social media
News
Other
Please specify how you heard about the study:
2. What is your/your child's (if your child is the volunteer) date of birth? Please enter in the format MM-DD-YYYY, and click outside the box to move to the next question. * must provide value
Today M-D-Y
Age at Screening View equation
The birthdate entered indicates the volunteer is a minor (< 18 years of age). * must provide value
Yes
No
Only a parent or legal guardian is able to provide consent for a minor to participate in the study. Please have a parent or guardian complete the remaining questions on this form or call 800-468-9700 if you have questions. Only a parent or legal guardian is able to provide consent for a minor to participate in the study. I'll need to speak with a parent or guardian to complete the remaining questions. 3. What is your home zip code? (click outside the box to move to the next question)* must provide value
Zip Eligibility Calc
View equation
4. What type of residence do you live in?* must provide value
Single family home
Condo or apartment building
Nursing home
Assisted living
Other
Refused
Residence Calculation
View equation
5. Are you planning to move out of central Wisconsin in the next 12 months? * must provide value
Yes
No
6. Are you planning to be out of the central Wisconsin area for more than 21 days in a row in the next 12 months? * must provide value
Yes
No
7. Are you currently participating in a clinical trial of a COVID-19 drug, vaccine, or intervention?* must provide value
Yes
No
8. Is anyone else in your home already enrolled in this study?* must provide value
Yes
No
How many other people in your home are enrolled in this study?* must provide value
Thank you for your interest. Unfortunately, you are not eligible to participate in this study. Please check the box below that the survey is complete. Thank you for your time. Thank you for your interest. Unfortunately, you are not eligible to participate in this study. Thank you for your time.Please check the box below that the survey is complete.
Thank you for your interest in the study. Please complete the contact information fields below. Study Volunteer's Name Study Volunteer's First Name* must provide value
Study Volunteer's Last Name* must provide value
Please re-enter volunteer's * must provide value
Today M-D-Y
Gender
Male
Female
Address
Street Address * must provide value
Street 2
City* must provide value
State* must provide value
Zip* must provide value
Please enter contact information for a parent or guardian below. Collect the parent's/guardian's contact numbers and email below.
Cell Phone
Home Phone
Email
What is the best time for research staff to call you?* must provide value
Mornings
Afternoons
Evenings
What is the best number to reach you? * must provide value
Please review the study information below to learn more about the study. Next, I need to talk through the details of the study with you. IRB Approved Information Sheet Provided What is the purpose of this research study?
This study is needed to learn more about how many people of all ages will get COVID-19 in a rural community in the next year. This study will identify infections with SARS-CoV-2, the new coronavirus that causes COVID-19. Some people may be infected without feeling sick (asymptom You were asked to join this study because you live in or near Marshfield, Wisconsin. We want about 1500 people to participate for one year. You will not receive any treatments or vaccines as part of this study. This study is being funded by the U.S. Centers for Disease Control and Prevention (CDC). Who can be part of this study?
People living in the Marshfield area were selected by chance to be in this study. Being in this study is voluntary. You do not have to participate. Whether or not you join this study is completely up to you. If you join this study and decide later to join a COVID-19 clinical trial (vaccine or treatment), you will have to stop being in this study. What will happen if I volunteer for this study? What you will need to do is listed in the table below.
WHAT will I have to do? WHEN will I do this? WHERE will I do this? HOW LONG will it take? Answer questions about your household, health, job/school, symptoms and exposures.Before your first visit Online or by phone About 10-15 minutes Answer questions about your symptoms and exposures.Once a week for 52 weeks Online or by phone 5 minutes or less each week Answer questions about your health, household, and job/schoolMiddle of the study and End of the study Online or by phone 5 minutes or less each time Collect and mail in a sample from inside the front of your nose. We will give you instructions and a kit. This sample may be tested for the new coronavirus, influenza, and other viruses. When requested Everyone will collect a nose sample if they have a new COVID-19-like illness.
Some will collect a nose sample every week for 26 weeks in a row, even without an illness.
At home About 5 minutes each time Come in for up to 3 study visits to provide a blood sample (about 2 tablespoons). When you begin the study, and about every 12 weeks after the first visit.
Marshfield Clinic About 60 minutes for the first visit and 30 minutes each for the remaining visits.
If you receive COVID-19 vaccine during the study period, we may ask you to come in for up to 2 additional blood draws.
We estimate you will spend between 7 and 10 hours on this study in the next 12 months.
What happens if I have a positive test for COVID-19?
You will be notified of your positive test result. We will ask you to: Answer additional questions about your illness and health about 1 month after your positive test. Come to the Marshfield Medical Center in Marshfield for 2 additional study visits to provide a blood sample (about 2 tablespoons or less). The visits will take about 30 minutes and occur about 1 month and 4 months after your positive test. Public health authorities may be notified of your positive test and may contact you for more information. What potential benefits are there to participating in this study?
If you provide a nose sample and it is tested for SARS-CoV-2 or influenza, you will get the result of that test. Information from this study will help public health agencies and doctors better understand COVID-19 in rural communities, and help efforts to prevent spread of the virus in rural areas. What potential risks do I face in this study?
There are no major risks from being in this study. The risks of having blood drawn include some pain when the needle goes in and a small risk of bruising or swelling at the site of the blood draw. Some people get lightheaded or faint. As with all research, there is a chance that confidentiality could be compromised. However, we take precautions to minimize this risk. What personal information will be used for this study?
Study staff will use the following protected information for study purposes such as to contact you and determine study eligibility: name, birth date, address, email, phone number, and medical history number. We may use protected health information from your medical records such as diagnoses, treatments, vaccinations, medications, procedures, laboratory results, imaging results, and conditions that may affect your protection against viruses for this study. Who will be able to see my personal information?
Representatives from the Institutional Review Board (IRB), whose job is to protect research subjects, and approved study staff may have access to your records. All study staff have completed required training for protection of research participants and personal information. Marshfield Clinic researchers may share test results, nose or blood samples, and study data with the University of Wisconsin-Madison and CDC or a designated laboratory. If these outside groups share the information it may not be covered by the HIPAA Privacy Rule. No directly identifying information will be shared outside the Marshfield Clinic Health System unless required for public health. How will my health information be protected?
Collected information will be stored in a restricted access area, or on a secure data server. Your authorization to use your protected health information does not expire, but you may take back your authorization by notifying us in writing at the address listed below: Huong McLean, PhD Center for Clinical Epidemiology & Population Health Marshfield Clinic Research Institute 1000 N. Oak Ave, ML2 Marshfield, WI 54449
What are my rights as a research subject?
You may choose not to participate in this study at any time. If you decide not to participate, it will not affect your relationship with the Marshfield Clinic Health System in terms of treatment, payment or eligibility for benefits. If you have any questions about your rights as a research subject, you may contact the IRB at 1-800-782-8581, ext. 9-3022. How will my left over samples be used?
Your leftover nose and blood samples will be stored for use in future research. We are asking to use your medical record information along with the sample for future research. Samples and medical information are most useful for research when they are studied together. Researchers at Marshfield Clinic Research Institute will be allowed to use your sample and information for research only if the research has been approved by the Institutional Review Board. The only risk to you for taking part in this bio-bank is the slight risk that personal information that can identify you could be seen by someone not authorized by the research study. Marshfield Clinic security and confidentiality practices will control the use of your sample and information in order to decrease the chance of this happening. If you change your mind about taking part in the bio-bank later, you may ask that your sample and information be removed. Any samples that are not currently in use as part of an approved project will be destroyed. Will there be any financial cost to me if I take part in this study?
There will be no cost to you for participating in this study. The study will pay for any laboratory testing on the samples you provide for this study. Will I be paid to be in this study?
Yes. You will be paid for your time to complete study activities. You may receive between $358 and $644, depending on which study activities are done. Payments include: $50 after each blood draw. A check for each blood draw study visit will be sent after the visit is completed. $4 for completing each weekly survey. Checks for the weekly surveys will be sent every 8 weeks. $4 for collection and return of each nose sample when requested. Checks for nose sample will be sent every 8 weeks. Payments you receive from Marshfield Clinic for being in any and all research studies are considered income by the Internal Revenue Service. If Marshfield Clinic anticipates that the total amount of participant payments you receive will reach or exceed $600 in a calendar year, we will ask you to complete a Form W-9, which will include providing your social security number. What if I have more questions about this study?
If you have any questions about this study or need information at any time, please call 800-468-9700 or email pacc@marshfieldresearch.org Please answer the following questions to continue. C1. The main purpose of this study is to learn more about how many people of all ages will get COVID-19 in a rural community in the next year.* must provide value
True
False
C1 Correct = 1
View equation
C2. Blood samples will not be collected from you during this study.* must provide value
True
False
C2 Correct = 1
View equation
C3. You can refuse to participate in this study.* must provide value
True
False
C3 Correct = 1
View equation
C4. If you are in this study, you may be asked to collect a sample from your nose using a swab each week for 26 weeks in a row.* must provide value
True
False
C4 Correct = 1
View equation
C5. You will be in this study for about 1 year.* must provide value
True
False
C5 Correct = 1
View equation
Calculation of total correct. Will be 0 if no answers entered.
View equation
IRB approved information sheet provided again if failing to correctly answer 4 of 5 questions You must correctly answer 4 of the 5 questions to continue. Please re-review the study information and try the questions again.
What is the purpose of this research study?
This study is needed to learn more about how many people of all ages will get COVID-19 in a rural community in the next year. This study will identify infections with SARS-CoV-2, the new coronavirus that causes COVID-19. Some people may be infected without feeling sick (asymptom You were asked to join this study because you live in or near Marshfield, Wisconsin. We want about 1500 people to participate for one year. You will not receive any treatments or vaccines as part of this study. This study is being funded by the U.S. Centers for Disease Control and Prevention (CDC). Who can be part of this study?
People living in the Marshfield area were selected by chance to be in this study. Being in this study is voluntary. You do not have to participate. Whether or not you join this study is completely up to you. If you join this study and decide later to join a COVID-19 clinical trial (vaccine or treatment), you will have to stop being in this study. What will happen if I volunteer for this study? What you will need to do is listed in the table below.
WHAT will I have to do? WHEN will I do this? WHERE will I do this? HOW LONG will it take? Answer questions about your household, health, job/school, symptoms and exposures.Before your first visit Online or by phone About 10-15 minutes Answer questions about your symptoms and exposures.Once a week for 52 weeks Online or by phone 5 minutes or less each week Answer questions about your health, household, and job/schoolMiddle of the study and End of the study Online or by phone 5 minutes or less each time Collect and mail in a sample from inside the front of your nose. We will give you instructions and a kit. This sample may be tested for the new coronavirus, influenza, and other viruses. When requested Everyone will collect a nose sample if they have a new COVID-19-like illness.
Some will collect a nose sample every week for 26 weeks in a row, even without an illness.
At home About 5 minutes each time Come in for up to 3 study visits to provide a blood sample (about 2 tablespoons). When you begin the study, and about every 12 weeks after the first visit.
Marshfield Clinic About 60 minutes for the first visit and 30 minutes each for the remaining visits.
If you receive COVID-19 vaccine during the study period, we may ask you to come in for up to 2 additional blood draws.
We estimate you will spend between 7 and 10 hours on this study in the next 12 months.
What happens if I have a positive test for COVID-19?
You will be notified of your positive test result. We will ask you to: Answer additional questions about your illness and health about 1 month after your positive test. Come to the Marshfield Medical Center in Marshfield for 2 additional study visits to provide a blood sample (about 2 tablespoons or less). The visits will take about 30 minutes and occur about 1 month and 4 months after your positive test. Public health authorities may be notified of your positive test and may contact you for more information. What potential benefits are there to participating in this study?
If you provide a nose sample and it is tested for SARS-CoV-2 or influenza, you will get the result of that test. Information from this study will help public health agencies and doctors better understand COVID-19 in rural communities, and help efforts to prevent spread of the virus in rural areas. What potential risks do I face in this study?
There are no major risks from being in this study. The risks of having blood drawn include some pain when the needle goes in and a small risk of bruising or swelling at the site of the blood draw. Some people get lightheaded or faint. As with all research, there is a chance that confidentiality could be compromised. However, we take precautions to minimize this risk. What personal information will be used for this study?
Study staff will use the following protected information for study purposes such as to contact you and determine study eligibility: name, birth date, address, email, phone number, and medical history number. We may use protected health information from your medical records such as diagnoses, treatments, vaccinations, medications, procedures, laboratory results, imaging results, and conditions that may affect your protection against viruses for this study. Who will be able to see my personal information?
Representatives from the Institutional Review Board (IRB), whose job is to protect research subjects, and approved study staff may have access to your records. All study staff have completed required training for protection of research participants and personal information. Marshfield Clinic researchers may share test results, nose or blood samples, and study data with the University of Wisconsin-Madison and CDC or a designated laboratory. If these outside groups share the information it may not be covered by the HIPAA Privacy Rule. No directly identifying information will be shared outside the Marshfield Clinic Health System unless required for public health. How will my health information be protected?
Collected information will be stored in a restricted access area, or on a secure data server. Your authorization to use your protected health information does not expire, but you may take back your authorization by notifying us in writing at the address listed below: Huong McLean, PhD Center for Clinical Epidemiology & Population Health Marshfield Clinic Research Institute 1000 N. Oak Ave, ML2 Marshfield, WI 54449
What are my rights as a research subject?
You may choose not to participate in this study at any time. If you decide not to participate, it will not affect your relationship with the Marshfield Clinic Health System in terms of treatment, payment or eligibility for benefits. If you have any questions about your rights as a research subject, you may contact the IRB at 1-800-782-8581, ext. 9-3022. How will my left over samples be used?
Your leftover nose and blood samples will be stored for use in future research. We are asking to use your medical record information along with the sample for future research. Samples and medical information are most useful for research when they are studied together. Researchers at Marshfield Clinic Research Institute will be allowed to use your sample and information for research only if the research has been approved by the Institutional Review Board. The only risk to you for taking part in this bio-bank is the slight risk that personal information that can identify you could be seen by someone not authorized by the research study. Marshfield Clinic security and confidentiality practices will control the use of your sample and information in order to decrease the chance of this happening. If you change your mind about taking part in the bio-bank later, you may ask that your sample and information be removed. Any samples that are not currently in use as part of an approved project will be destroyed. Will there be any financial cost to me if I take part in this study?
There will be no cost to you for participating in this study. The study will pay for any laboratory testing on the samples you provide for this study. Will I be paid to be in this study?
Yes. You will be paid for your time to complete study activities. You may receive between $358 and $644, depending on which study activities are done. Payments include: $50 after each blood draw. A check for each blood draw study visit will be sent after the visit is completed. $4 for completing each weekly survey. Checks for the weekly surveys will be sent every 8 weeks. $4 for collection and return of each nose sample when requested. Checks for nose sample will be sent every 8 weeks. Payments you receive from Marshfield Clinic for being in any and all research studies are considered income by the Internal Revenue Service. If Marshfield Clinic anticipates that the total amount of participant payments you receive will reach or exceed $600 in a calendar year, we will ask you to complete a Form W-9, which will include providing your social security number. What if I have more questions about this study?
If you have any questions about this study or need information at any time, please call 800-468-9700 or email pacc@marshfieldresearch.org C1. The main purpose of this study is to learn more about how many people of all ages will get COVID-19 in a rural community in the next year.* must provide value
True
False
C1 Correct = 1
View equation
C2. Blood samples will not be collected from you during this study.* must provide value
True
False
C2 Correct = 1
View equation
C3. You can refuse to participate in this study.* must provide value
True
False
C3 Correct = 1
View equation
C4. If you are in this study, you may be asked to collect a sample from your nose using a swab each week for 26 weeks in a row.* must provide value
True
False
C4 Correct = 1
View equation
C5. You will be in this study for about 1 year.* must provide value
True
False
C5 Correct = 1
View equation
Calculation of total correct. Will be 0 if no answers entered.
View equation
Confirmation of understanding and verbal consent received from ______ ______ .* must provide value
Yes
No
We will be using email, text messaging, and phone calls to communicate with participants in this study. Participants will also have the option to complete study surveys online when it is convenient for them. If you would like to complete surveys online, we would need your email address or cell phone number to send a survey link to you each week. Please indicate below which method you would like to receive research communications? * must provide value
Text message
Email
Both text message and email
Phone
Which method would you prefer to receive links for survey completion? * must provide value
Text message
Email
What is your email address?* must provide value
Please re-enter your email address to confirm:* must provide value
The two email addresses don't match.
Later today, you will receive an email with a link. You will need to review the consent document in the link and fill in your email and name at the bottom of the page to confirm that you allow research staff to communicate with you electronically. If you are selected for the study, you will receive an email with a link. You will need to review the consent document in the link and fill in your email and name at the bottom of the page to confirm that you allow research staff to communicate with you electronically. What is the phone number where you would like to receive texts?* must provide value
Please re-enter the phone number where you would like to receive texts to confirm:* must provide value
The two phone numbers don't match.
Later today, you will receive two text messages. The first will confirm that you wish to receive messages. After you reply to the first message, you will receive a second with a link. You will need to review the consent document in the link and fill in your phone number and name at the bottom of the page to confirm that you allow research staff to communicate with you electronically. If you are selected for the study, you will receive two text messages. The first will confirm that you wish to receive messages. After you reply to the first message, you will receive a second with a link. You will need to review the consent document in the link and fill in your phone number and name at the bottom of the page to confirm that you allow research staff to communicate with you electronically. Please check the box once the survey is completed* must provide value
Please check the box once the survey is completed* must provide value
(Screening Completed...Change status to COMPLETE below. Go to next form.) Thank you for your time. Research staff will contact you by phone if you are selected for the study.
Working...