Contact Consent Form

Purpose of the Study

This research is conducted by Donald Milton, MD, DrPH and researchers at the University of Maryland. It is funded by the University and federal government sources including the U.S. Department of Health and Human Services. The purpose is to find out how people transmit COVID-19 and how to prevent transmission. Frequent follow-up testing of close contacts of known cases will help us identify people with infections early and without symptoms. Breath testing of people who have recently been infected will help us answer several important questions. How much airborne virus does an infected person exhale? How much virus is released into the air when an infected person breathes, talks, or sings? How well do masks block release of airborne virus? This work will help us understand whether airborne transmission is important and how to prevent it. Another goal is to gather samples that can be used to better understand how the body fights the infection. This will help with future research to develop new medications and vaccines to treat and prevent COVID-19. We invite you to participate in this project because you have had recent close contact with a person who tested positive or is presumed to have COVID-19.

Procedures

➢Study Overview

We will follow you for up to 10 days from your last exposure to the COVID-19 case to see if you become infected.

To participate, you will visit a study clinic about every other day with more or less time between visits depending on your schedule and ours. You will:

  • Answer an online questionnaire

  • Have your temperature, heart rate and oxygen level measured

  • Provide swabs of your nose

  • Provide saliva

  • Provide blood

On day(s) between your visits, we will ask you to use a rapid test kit in the morning and to self-collect a saliva sample and a nasal swab with supplies we will provide.

If you become infected with COVID-19, we will ask you to provide additional nasal swabs, saliva, blood, and breath samples. Whether or not you become infected, we will ask you to return for a follow-up visit in about one month.

We will also invite you to participate in a separate part of our study for regular screening for COVID-19 (see details below).

➢Factsheet and Consent Form

Please read this consent form and “Factsheet – Understanding Your COVID-19 Test Results”. The fact sheet explains what the testing means and how the results will be handled. We are certified to provide an FDA authorized rapid diagnostic test and will perform this test when supplies are available. We will provide you with a copy of the results that you and your healthcare provider can use for diagnosis and treatment decisions. Our research tests cannot be used to diagnose you or make treatment decisions. The results are for research only.

If you decide to participate, you must correctly answer a few questions about the study to make sure you understand. After you complete the short quiz we will ask you to sign this form online. We will email you a copy of the signed form.

➢Enrollment Questionnaire

Immediately after you agree to participate (by signing this form) you will complete a secure online survey. The questionnaire asks for your:

  • Social Security number (for your compensation)

  • Contact information: name, email address, affiliation with UMD and UID (if any), mobile phone number, local residential address, and emergency contact including primary medical provider

  • Demographic information: date of birth, sex, race, ethnicity, education, employment, and income category

  • Medical history and health behaviors such as tobacco and alcohol use

  • Up-to-date vaccination status

  • Residential conditions

  • Current symptoms and medications

  • Close contacts within the last 48 hours

We will email a separate link to some of these questions so you can answer them just before coming to your visit.

➢Initial Study Visit

After completing the questionnaire, you will make an appointment with us at one of our research clinic sites, either in the School of Public Health (SPH) research clinic or the Laurel Regional Medical Center or another site such as Express Healthcare / Med-Ped Healthcare. Please call us when you arrive outside for your appointment and a research staff member will meet you and escort you to the testing area. We will provide you with a well-fitting mask if you don’t already have one and ask you to wear it before bringing you inside the building and/or exam room. You will wear the mask during the entire visit, except when it must be removed for sample collection. Study staff will review this form with you and give you a chance to ask questions before starting the visit.

During this visit we will:

  • Measure height, weight, oral temperature, heart rate and oxygen level

  • Collect nasal swabs

  • Collect a saliva sample

  • Collect a blood sample (up to 25 mL, a little less than 2 tablespoons)

  • Demonstrate how to use a home rapid test kit

Details of each type of collection are given below. We estimate this visit will take approximately 45-60 minutes.

➢Repeat Study Visits

We will ask you to return to one of our research clinics approximately every other day during the 10-day period since your last exposure to the COVID-19 case. We will call or text before each visit to ask if your symptoms have changed. We will also ask you to complete an online questionnaire before you arrive.

The questionnaire will ask about your:

  • Current symptoms and medications

  • Close contacts within the last 48 hours

  • Essential activities with potential exposures outside of the home in the last 48 hours

  • Time spent in your home or room and bedroom

At each of these visits, we will make the same measurements and collections as at the first visit except that we will not repeat the height and weight and will not collect another blood sample. We estimate these visits will take approximately 15-20 minutes.

Between Study Visits - home tests and sample collection

On the days between your study visits, we will also ask you to:

  • Perform the home rapid test early in the morning

  • Call or text us with the result of the rapid test

  • Collect a nasal swab for the lab

  • Collect a saliva sample

  • Return swab and saliva to the study site by noon

We will label the kits with your study ID, the StopCOVID phone number and ask that you write the date on them when you use them. If your rapid test is positive, we ask that you call the StopCOVID study right away as we would like to schedule you for a study the same day if possible.

At each visit, we will provide you kits for each day between visits. The kits will contain tubes and swabs that you can use to collect samples and instructions on how to collect these samples and how to package the sample with special zip-top bags.

➢ If You Have a Positive COVID-19 Test

If one of your research samples tests positive for COVID-19 we will inform you immediately. We will review the fact sheet with you. If the FDA authorized rapid diagnostic test we are certified to offer is not available, you will need to have a test in a certified clinical lab to diagnose infection. We will remind you that our research tests are for research only. We will ask you to contact the University Health Center or your medical provider. We will also notify the University Health Center or your medical provider and the county health department. The medical providers and the health department will decide what testing and treatment you need.

COVID-19 Case Assessment

If at one of your visits:

  • You have a strong exposure history and symptoms and we think that you are coming down with COVID-19 or

  • One of your samples tests positive for COVID-19

You may be invited to participate in the case testing part of the study.

We will test to see if you are shedding virus, if you might be contagious, and whether wearing a well-fitting mask helps limit spread of the virus. This is a critical part of the research because we want to study newly infected persons who are more likely to be shedding virus and how well masks work.

We will ask you to come to the research clinic for up to 2 shedding visits, approximately 1-2 days apart, if you continue to test positive for the virus at your shedding visits and we have adequate testing capacity.

During these visits we will measure and collect the following from you:

  • Temperature, heart rate and oxygen level

  • Nasal swabs

  • A swab of your phone

  • A saliva sample

  • Blood will be collected at your first case shedding visit, unless this visit immediately follows the first contact visit with a blood draw

  • Up to two 30-minute breath samples if feasible

We will ask you to complete an online questionnaire before coming to the research site. This is the same questionnaire as described above for repeat visits. We estimate these visits will take approximately 60 – 120 minutes, plus an additional 30 minutes if you have not completed the enrollment questionnaire before coming to the clinic, depending on the number of breath samples you provide.

We will not ask you to come to the research clinic if your symptoms suggest you may meet CDC or Maryland Department of Health criteria for triage to urgent medical care. If a supervising clinician determines that you require urgent medical intervention, we will instead advise you to seek medical attention by calling 911.

➢ Immune Response Follow-up Visit

We will ask you to return to the research clinic for a follow-up visit in approximately 1 month. If you don’t become infected, this visit should ideally occur 3-5 weeks after your last exposure. If you develop COVID-19, we would like to see you about 3-5 weeks after infection starts. If you are still not well by then, we can do it later. We will send you an online questionnaire and ask you to complete it just before coming to the visit. This questionnaire will ask about your symptoms, medications and treatment. If you were infected, we will also ask about the course of your illness.

At the visit, trained study or clinical personnel will measure your oral temperature, heart rate, and oxygen level and will collect two nasal swabs, saliva, and a blood sample. We estimate the follow-up visit will take 20-30 minutes.

Schedule and description of study procedures

* Time depends on the number of breath samples

➢ Oral Temperature

We will place the tip of the standard oral thermometer probe under your tongue on one side of your mouth next to the back molar. We will repeat this on the other side of your mouth.

➢ Oxygen Saturation and Heart Rate

We will place a small clip on the end of one of your fingers for approximately 30 seconds. The clip shines a light through your finger and is attached to a device that measures your oxygen level and heart rate.

➢ Nasal Swabs

We will use a small penlight to look inside your nostrils, and then collect 2 mid-turbinate nasal swabs. This swab is small, soft, contoured, and made specifically for this procedure. We will insert the swab approximately 1.5-2” into your nostril (stopper ensures proper depth). We will rotate the swab once and then withdraw it. A second swab will be collected from the other nostril, unless there is an obstruction or other reason to avoid sampling one side. In that case both swabs may be collected from the same nostril.

Depending on the availability of supplies, we may instead collect two nasopharyngeal or anterior nasal swabs in a similar manner. A nasopharyngeal swab is smaller than the mid-turbinate swab described above. It is inserted slightly deeper into the nasal passage. An anterior nasal swab is slightly larger but inserted just inside the nostril.

The nasal swabs you will collect at home are anterior nasal swabs. Once you insert the swab approximately ¾” inside one nostril, you will slowly rub the swab against nasal tissue for 5 rotations and withdraw from the nostril. You will insert the same swab in the other nostril and repeat the steps before placing the swab inside a collection tube. We will give you detailed printed instructions and demonstrate how to collect your home samples at your first contact visit.

Nasal swabs will be tested for the virus that causes COVID-19. They may also be tested for other viruses and bacteria that cause respiratory infections. If rapid testing is available, we will collect one additional swab for a rapid COVID-19 diagnostic test for immediate results at your contact visit. For this testing, we will insert a nasal swab approximately 1 inch into one of your nostrils until resistance is met. We will gently rotate the swab several times, remove it, and repeat the procedure in the other nostril.

➢ Saliva Samples

We will ask you to stop eating and drinking for 30 minutes before your visit. or before collecting your sample at home Just before saliva collection, we will ask you to clean your hands with hand sanitizer or soap and water. We will ask you to collect approximately 0.5-1 mL of saliva, which can usually be collected by spitting into the cup 2-3 times. We will give you detailed printed instructions and demonstrate how to collect your home samples at your first contact visit. Saliva will be tested for the virus that causes COVID-19.

➢ Blood Sampling

We will use a small butterfly needle and standard aseptic technique to collect a relatively small amount of your blood from a vein in your arm. If you are at least 18, up to 25 mL (less than 2 tablespoons) will be collected at your first contact visit and the first shedding visit if you become infected. However, if your first case visit immediately follows a contact visit with a blood draw, blood will not be collected at your first shedding visit. At the immune response-follow up visit, we will collect up to 25 mL. If you are under age 18, we will draw blood from you no more than once a week, and we will draw no more than 50 mL over an 8-week period.

The blood samples will be used to test for antibodies and biomarkers of infection and to develop countermeasures to control the SARS-CoV-2 virus.

➢ Phone Swab

Trained study personnel will use a swab dampened with universal transport medium to swab the four sides and the front surface of your phone. This is to test for infectious agents.

Exhaled Breath Sample (s)

If you become infected, we will ask you to give us up to two breath samples at each case shedding visit. We will collect one sample while you are wearing a provided well-fitting mask and the other sample without wearing the mask. We will ask you to sit in a booth with clean, filtered, warm humidified air and to breathe normally into a large funnel or cone. The cone is part of an apparatus that collects particles in your exhaled breath, coughs, and sneezes. You will sit in the booth for 30 minutes for each breath sample. During each session you may be asked periodically to talk and or sing loudly. We will also count the number of times you cough and sneeze while you are providing the exhaled breath sample. We will do this either by direct observation or by asking you to wear a microphone so that we can count your coughs and sneezes later. We will ask you to put a mask back on before leaving the booth. Breath samples will be tested for the virus that causes COVID-19 and possibly other viruses or bacteria.

Potential Risks and Discomforts

There is a risk of incorrect test results. We believe the risk is fairly small, but we don’t know for sure. The University of Maryland research lab performing the tests has years of experience with similar tests. We use a commercial test kit that is used by many clinical laboratories.

However, our research lab is not a certified clinical laboratory. Please see the “Factsheet – Understanding Your COVID-19 Test Results” for a detailed description of the tests and what to expect from the results.

Your risk of catching COVID-19 through study participation will be no greater than the risk you may encounter anytime you leave your home. We will follow strict infection control methods to minimize your risk of infection. We monitor all staff for possible infection and exclude anyone from work who might have COVID-19. We use UV light to kill germs in the air in the School of Public Health research clinic. We also ask all participants to wear well-fitting masks when entering the building or research site.

After each visit, we disinfect all surfaces that anyone might touch in the clinic. We use standard clinical practice guidelines for obtaining and handling specimens (i.e. proper hand washing, wearing gloves and other protective gear, etc.).

Your participation in this study may take time away from other activities or time you may have spent resting and recovering, if you become sick. We will try to keep your study visit as short as possible and to minimize wait times through efficient scheduling of appointments. We will try to make it as easy as possible for you to drop off samples on the days between study visits. If you become infected, you may not feel well while participating in the study due to symptoms of your illness. Study participation will not worsen your symptoms any more than a visit to a health care provider. You may feel some embarrassment when providing information about your medical history or habits. We will minimize your potential embarrassment by allowing you to answer the questions in a private setting. There is a small risk to your privacy and confidentiality because we will be collecting a variety of personal data from you. We will do our best to keep your personal information confidential and limit access to only essential study personnel. All data will be transmitted between the electronic device used to enter your data (a computer, tablet, or your phone) and the server via encrypted connections. The server will be housed in a high security data center as described below under confidentiality.

You may experience some mild pressure or discomfort, a tickling sensation, occasional eye watering, or sneezing when the nasal swabs are collected. In rare instances swabbing inside the nose may cause very minor bleeding. When having your blood drawn, you may feel some discomfort from having the tourniquet placed around your arm. You will likely experience a small amount of pain at the site where the needle enters the skin. There is also a very small risk of bruising or infection at the site where the blood is taken. Some people become lightheaded or feel faint at the sight of blood or when blood is drawn. The staff members who will collect your nasal swab and blood sample are trained to minimize these risks. If you are at least 18, the largest total amount of blood that will possibly be drawn for the study is 75 mL over several weeks. This amount of blood is much less than the amount typically removed at one time for blood donation (450-500 mL). We will only remove 75 mL blood if you become infected on one of your repeat contact visits, and then complete a case visit and the follow-up visit. If you don’t become infected, we will remove a total of up to 50 mL of blood over several weeks. If you are under age 18, we will draw blood from you no more than once a week, and we will draw no more than 50 mL over an 8-week period.

When providing a breath sample in the G-II booth, you may feel uncomfortable sitting in the booth with your face at the entrance to the large funnel. You are more likely to feel uncomfortable if you suffer from claustrophobia. You may wear headphones and listen to your own entertainment during this session. There is no known risk from breathing warm, humidified HEPA (High Efficiency Particulate Arresting -- removes ≥ 99.94% of particles in the air) filtered air when sitting in the booth.

Potential Benefits

You could potentially benefit from participating. If you test positive, you may be infected with COVID-19. Early detection of COVID-19 may give you the chance to get early medical treatment from a healthcare provider. Early detection may help you to avoid infecting family members. Please be aware that most of the tests we perform are for research only. Our research tests are not FDA-approved clinical diagnostic tests. If your sample is positive by using the research assay, we will offer rapid diagnostic testing immediately. We will give you a report with the clinical test results that you can take to your medical provider. If the rapid test kits are not available, we will immediately refer you for medical follow-up. The medical provider and the county health department will decide if you need an additional FDA-approved test and medical treatments. We will also suggest you stay away from others to decrease the chance of spreading the infection.

We hope that, in the future, other people might benefit from this study through improved understanding of COVID-19. We want to find out whether mild early infection is associated with shedding airborne viruses. This will help develop better ways to reduce the spread of the infection. If you become infected and participate in other parts of the study, your blood samples will be used to study the body’s immune response to the virus. This may assist in the development of medical treatments.

Confidentiality

Any potential loss of confidentiality will be minimized by storing all data in an encrypted database in a secure server housed in a high security data center. Only essential study personnel have access to this data. Access to data is limited. Only staff with an operational need for particular information will have access to sensitive information (for example social security numbers). Undergraduate research assistants only have access to the clinical research database while working in the clinic under senior staff supervision. You have been assigned a subject ID number which will be used by research staff to access your records in the database.

All biologic samples will be labeled with a unique sample ID number. This can only be linked to your personally identifiable information by Dr. Milton and his designated research staff. The sample labels will not contain your name or other personally identifiable information. Samples will be stored in laboratories with controlled access at the School of Public Health. Some samples may be deposited in a secured storage system maintained by the University of Maryland or the National Institutes of Health. This system is for long term storage and distribution of samples to other laboratories for research on respiratory infections, especially COVID-19. Samples will be retained indefinitely until used up or there is no longer sufficient scientific justification for the cost of maintaining them in storage.

We will not disclose personally identifiable information about you to anyone outside of the research team, unless you test positive for COVID-19 or another infection where public health reporting is required. If you test positive for COVID-19 we will inform you and the State and County Health Departments and CDC. We will immediately refer you for medical follow-up and isolation.

Collaborators within and outside the University of Maryland will conduct analyses on your samples or data for research purposes. All such samples or data will always be de-identified. We may report a summary of group results on our study website. If we post information on the website or write a report about this research project, your identity will be protected to the maximum extent possible.

Your information may be shared with representatives of the University of Maryland, College Park or governmental authorities in certain special situations. We must share your information if you or someone else is in danger or if we are required to do so by law. The Code of Maryland Regulations (COMAR) 10.06.01.03 C, requires reporting certain infectious diseases to the Maryland Department of Health and Mental Hygiene. This includes reporting personally identifiable information in the event of any disease outbreak that poses a danger to public health, such as COVID-19. It also requires reporting of cases of Measles, Mumps, Pertussis and Legionellosis, which may be tested for in samples that we collect. Measles is a highly contagious virus that causes respiratory infection and rash, and Mumps is a somewhat less contagious viral illness that typically causes swollen tender salivary glands. Pertussis, also known as whooping cough, is a highly contagious bacterial respiratory infection. Legionellosis (also known as Legionnaire’s Disease) is a bacterial infection that can cause pneumonia or flu- like illness. Measles, Mumps, and Pertussis can all be prevented through proper vaccination.

Any unanticipated problems involving risks to participants or others such as unexpected or serious adverse events, non-compliance, audits, and investigation reports will be promptly reported to the University of Maryland Institutional Review Board.

Medical Treatment

The University of Maryland does not provide any medical, hospitalization or other insurance for participants in this research study. The University of Maryland will not provide any medical treatment or compensation for any injury sustained as a result of participation in this research study, except as required by law.

Compensation

The chart below outlines the amount of compensation you can receive for each type of visit.

  • We will provide compensation using one of the following methods:

    • A University issued debit card onto which funds will be electronically transferred.

    • A virtual gift card.

    • If you are UMD affiliated, through your Terrapin Express account.

  • Payment methods will depend on the logistical capabilities of the University of Maryland Student Financial Services and Cashiering Office.

  • We will collect the information required by UMD Student Financial Services and Cashiering to make payments which may include but not be limited to your date of birth, address, and social security number. If you decline to provide this information you can still participate in the study, but you will not be able to receive compensation.

  • Payment will be made as soon as logistically possible, and may take up to 7-10 days.

  • If you earn $100 or more as a research participant in this study, we will be required to provide your name, address, and social security number to the Comptroller of the State of Maryland.

  • You will be responsible for any taxes assessed on the compensation you receive.

Right to Withdraw and Questions

Your participation in this research is completely voluntary. You may choose not to take part at all. If you decide to participate in this research, you may stop participating at any time. If you decide not to participate in this study or if you stop participating at any time, you will not be penalized. You will not lose any benefits to which you otherwise qualify. Your academic standing as a student or employability at UMD will not be affected by your participation or non-participation in this study.

Special notice for research assistants: If you are a student working on the study and are earning course credit for your work, your grade will not be affected by your decision to participate (or not participate) in this study.

If you decide to stop taking part in the study, if you have questions, concerns, or complaints, or if you need to report an injury related to the research, please contact the investigator:

Dr. Donald Milton

Room 2234V, SPH Building 255

University of Maryland

College Park, MD 20742

Telephone: 301-405-0389

Email: dmilton@umd.edu

Participant Rights

If you have questions about your rights as a research participant or wish to report a research-related injury, please contact:

University of Maryland College Park

Institutional Review Board Office

1204 Marie Mount Hall

College Park, Maryland, 20742

E-mail: irb@umd.edu

Telephone: 301-405-0678

This research has been reviewed according to the University of Maryland, College Park IRB procedures for research involving human subjects.

Statement of Consent or Assent and Permission

Your signature indicates the following:

  • You are age 18 or older. If you are younger, your signature indicates that you are either enrolled as a student at the University of Maryland or that your parent will also sign to give permission.

  • You have read this consent form or have had it read to you.

  • Your questions have been answered to your satisfaction.

  • You voluntarily agree to participate in this research study.

You will be sent a copy of this signed consent form via email, which you may print.

Use of samples: Your signature also indicates that you agree to use of your samples for research on COVID-19 and other infections, immune response to infections, and for similar future research studies for which they may be helpful. Your samples may be used by researchers both inside and outside of the University of Maryland. For example, researchers at the University of California, Irvine may measure antibody levels in your blood samples. We may also send your samples to the Walter Reed Army Institute for Research for viral DNA sequence analysis. Please note that no personally identifiable information will be provided to researchers outside of Dr. Milton’s laboratory. If you do not want us to use your samples in this manner you should not sign this consent form.