Researchers at the University of California Berkeley’s School of Public Health are launching a new study to better understand the current spread of SARS-CoV-2 or novel “coronavirus” (the virus that causes COVID-19) in the Bay Area and the effects of social (physical) distancing strategies.
Initial screening will only take 10 minutes.
This study is designed to understand the prevalence of undetected coronavirus infections among adults in the Bay Area without symptoms, and to determine how many people may have been previously infected with the virus without knowing it, because they had a mild illness or did not have access to testing while they were sick. The results will help demonstrate the extent to which the novel coronavirus has spread undetected in the Bay Area and provide insights into which communities and populations are most affected. These critical data will help us measure the impact of the current public health efforts (such as Shelter-in-Place) and will help guide the COVID-19 response moving forward. In the first phase of this study, all households in the East Bay communities of Berkeley, Oakland, Emeryville, Albany, El Cerrito, Richmond, San Pablo, El Sobrante, Pinole, Kensington and Hercules are invited to participate. This website will be updated when recruitment expands to other communities.
How do I get started?
Every home address within the study sampling region was mailed a postcard invitation. If your household received this postcard, one volunteer per household who is 18 years of age or older is invited to participate in the study. You may have also heard about the study from our community outreach efforts or social media; you are welcome to participate but only one adult per household is eligible. Note: If there is more than one person in the household who is 18 years of age or older, the person with the very next birthday should participate. This is very important for our sampling strategy, in order to conduct the most informative study.
Volunteers are asked to consent to enrollment for initial screening here. After enrollment, study participants complete a health assessment questionnaire and provide contact information, basic demographic information (including age, race, ethnicity, sex, occupation), and other information about their immediate household members.
What happens after screening?
The investigators will randomly select 5,000 to 6,000 individuals from the study participants who provided screening information to participate in the study for at-home swab, saliva and fingerprick blood sample collection and completion of further questionnaires. Each study participant will receive an at-home sample collection test kit with detailed instructions on collecting samples (including an instructional video link) and returning the kit to UC Berkeley for further analysis in the laboratory.
The at-home sample collection kits are safe and easy-to-use. By providing these samples, study participants can help researchers fight COVID-19 from the privacy of their homes. Investigators will test oral and nasal swab and saliva samples for the presence of the SARS-CoV-2 virus (active infection) and blood samples for the presence of SARS-CoV-2 antibodies, which are proteins produced by the immune system in response to a specific infectious agent and indicate a previous infection.
Sampling and data collection from each participant will take place up to 5 times over 8-10 months – approximately every 6-8 weeks.
If you are interested in participating, please go here.
Your privacy is very important to us. Any personal contact information you provide for the screening questionnaire will be stored securely, used only for secure research-related communication with you, and not shared with anyone outside of the study investigators at UC Berkeley.
For more information on this study, see the additional information below. To learn more about the U.S. government response to the COVID-19 pandemic, visit www.coronavirus.gov.
Who is conducting the study?
The study is being conducted by a team of investigators at the University of California, Berkeley. The study is led by Lisa F. Barcellos, PhD, MPH, Professor in the Division of Epidemiology and Biostatistics, School of Public Health and Eva Harris, PhD, Professor in the Division of Infectious Diseases and Vaccinology, School of Public Health. In addition, the research team includes: Joseph Lewnard, PhD, Josefina Coloma, PhD, Nicholas Jewell, PhD, William Dow, PhD, of UC Berkeley School of Public Health and Patrick Hsu, PhD of UC Berkeley College of Engineering.
Funding is being provided by Open Philanthropy, Emergent Ventures, Silicon Valley Community Foundation, and UC Berkeley School Public Health, and in collaboration with the Innovative Genomics Institute and CZ Biohub, UC San Francisco.
Where will the study take place?
This study will take place at UC Berkeley and will focus on participants recruited from communities across the San Francisco Bay Area. Volunteers will not have to leave their homes to participate. Participants will be shipped kits that allow them to collect small amounts of their own oral, nasal, and blood samples and send them back to UC Berkeley. Screening and other study questionnaires will be administered online through a secure platform that can be accessed via computer, tablet, or mobile device connected to the internet.
Who is eligible to participate?
Volunteers must be at least 18 years old and residents of the East Bay. One volunteer per household is invited to participate in the study by a postcard mailed to each home address within the study sampling region. Volunteers may also learn about our study through social media and community outreach. Volunteers must be willing to complete an online consent form and screening, and if selected for further study, undergo up to five at-home oral, nasal, and blood sample collections; complete a study questionnaire up to five times; and have samples and data stored for future research (samples and data will be “coded”, meaning they will be labeled with identifying numbers that cannot be linked to participants except with a key that is kept confidential and secure by study staff at UC Berkeley). Volunteers will need access to a computer, tablet, mobile phone, or other device that can connect to the internet.
Note: If there is more than one person in the household who is 18 years of age or older, the person with the very next birthday should participate. This is very important for our sampling strategy, in order to conduct the most informative study.
What is the study design?
This is a longitudinal study (over time) of a large, population-representative sample. Volunteers will consent, enroll, and complete a short screening questionnaire online using a secure, web-based platform. In the first phase of this study, all households in the East Bay communities of Berkeley, Oakland, Emeryville, Albany, El Cerrito, Richmond, San Pablo, El Sobrante, Pinole, Kensington and Hercules are invited to participate. This website will be updated when recruitment expands to other communities. Specifically, the investigators will randomly select 5,000-6,000 individuals from study participants who provide screening information to participate in at-home sampling and further data collection. Data from enrolled participants will be collected repeatedly over time (up to 5 times in 8-10 months) to better understand the spread and distribution of SARS-CoV-2 infections and the effects of mitigation strategies and potential adjustments to the guidelines. Participants will provide oral, nasal, and blood samples and complete an online study questionnaire every 6-8 weeks. All procedures will be done by participants in their own homes. For individuals who are selected to participate in at-home sample and data collection, the following will take place:
Online study questionnaire: Participants will receive an email with a secure link to complete an online questionnaire within 48 hours of receiving it. The questionnaire will ask questions about demographic information, tobacco and alcohol use, recent travel, income, employment status, physical and mental health, medical conditions, healthcare coverage, activities, and description of recent close contacts with others. The questionnaire will also ask several questions about the participant’s household such as number of members, age, sex, occupation, and COVID-19 symptoms. This questionnaire will take approximately 20 minutes to complete.
Shipped kit: As soon as the questionnaire is completed, a “biospecimen kit” will be shipped to the participant’s home address. Participants will be asked to read the instructions and watch a video which demonstrates how to provide oral samples using two collection methods: 1) spitting into a saliva collection tube and 2) swabbing the inside of their mouth. The instructions and video will also walk participants through swabbing the nose/nostril with a swab and providing a small sample of blood by pricking a finger once with a small, close-to-painless needle-like device (a lancet like those used for glucose measurements). Once completed, participants will return the samples to UC Berkeley in the original box using a prepaid Federal Express (FedEx) label. Sample collection and preparation for shipping will take about 40 minutes to complete. All samples should be collected on a single day with time recorded, and shipped to UC Berkeley via local FedEx drop off within 24-48 hours.
Is it safe to provide blood, nasal, and oral samples at home?
Yes. Easy-to-read instructions and a video link will be provided to participants on how to safely collect the oral, nasal, and blood samples. At-home blood sampling may cause temporary discomfort from the finger prick, or very rarely, infection. However, the needle is very thin and shallow, and is generally not painful. The package includes alcohol wipes, bandages and gauze to reduce the risk of infection. It is also safe to ship the samples in the original collection kit box. All samples will be sealed in spill-proof containers and wiped down with alcohol wipes before shipping back to UC Berkeley via FedEx. Regardless of the infection status of the volunteer, there is no risk of SARS-CoV-2 transmission to the mail carrier or others who handle the package.
Will individual results be communicated to study participants?
Participants will be individually notified by study investigators of their results of current SARS-CoV-2 infection (positive, negative or inconclusive). Participants will be provided educational materials from the Centers for Disease Control and Prevention (CDC) about what the results mean and recommendations for what to do if they test positive or are feeling sick (see CDC recommendations). Current SARS-CoV-2 viral testing results, including positive, negative and inconclusive test results, will also be reported to the California Department of Public Health as currently mandated under the authority of California Health and Safety Code Sections 101040, 101085, and 120175.
Individual results for past SARS-CoV-2 infection using antibody testing will not be returned to participants; however, both viral and antibody testing results will be released as summary data along with basic demographic information (for example, rates by zip code or age). Results of the study in summary form will be found on this website. The site will be regularly updated in order to show how SARS-CoV-2 infection, both current and past, is distributed throughout the community, and how this changes over time. The identity of all participants will remain anonymous. Any information released that maps infection to a geographic region will be released on the level of zip code or census block, never individual addresses.
Content last reviewed on April 28, 2020
Form approved IRB#: 2020-03-13121, EXP. DATE: April 2, 2030