Field Team SOP

COVID-19 Community Serosurvey

Standard Operating Procedures

3/30/2020

COVID-19 Epidemiology Studies Task Force

Table of Contents

COVID-19 Community Serosurvey 0

Standard Operating Procedures 0

BACKGROUND 2

OVERVIEW OF ASSESSMENT 2

PRE-FIELDWORK PREPARATIONS 3

TRAINING 3

EQUIPMENT (FOR CDC-BASED PERSONNEL) 3

FIELD DOCUMENTATION 3

IN THE FIELD 4

START OF DAY PROCEDURES 4

HOUSEHOLD SELECTION IN CLUSTER 4

Systematic random sampling 4

Household Replacement 5

Guidance for gated communities 6

Guidance for high rise apartments 6

HOUSEHOLD VISITS 6

Overview of Approaching, Enrolling, and Departing from a household 6

Consenting household members 8

Questionnaires 9

ASSIGNING HOUSEHOLD AND HOUSEHOLD MEMBER IDENTIFICATION NUMBERS 9

END OF DAY PROCEDURES 11

MEDIA 11

END OF DATA COLLECTION PERIOD PROCEDURES 11

TEAM ROLES AND RESPONSIBILITIES 11

DATA SECURITY 12

APPENDICES 12

Appendix A: Introduction and Consent script 12

Appendix B: FAQs and talking points 12

Appendix C: Instructions for entering data into RedCap App and uploading data to server 12

Appendix D: PPE guidelines and PPE and blood collection supplies 12

Appendix E: Instructions for using Google Earth App to visualize clusters 12

Appendix F: Contact information 12

BACKGROUND

Current epidemiologic data in the United States suggests that sustained community transmission of SARS-CoV-2 is occurring in certain areas. However, the extent of transmission in community settings is currently unknown. In the case of a novel virus, such as SARS-CoV-2, initial seroprevalence in the population is expected to be negligible; therefore, seroprevalence estimates can be useful to understand cumulative incidence in a given population. Antibody seropositivity may also provide data about asymptomatic or subclinical infections that would not be detected by surveillance that relies on medical visits. These data could supplement medically attended infection rates and contribute to understanding the overall burden of COVID-19. This information could also contribute to modeling estimates to inform decisions about prevention and control strategies as well as community mitigation interventions in the U.S. response to COVID-19.

The objectives of the evaluation are:

• To determine the extent of infection in communities as determined by overall SARS-CoV-2 seroprevalence

• To determine factors associated with SARS-CoV-2 seropositivity among persons residing in areas with evidence of community transmission.

OVERVIEW OF ASSESSMENT

Sixty census blocks have been selected by probability proportional to size in two counties with evidence of community transmission of SARS-CoV-2 (30 clusters per county). Survey teams will then select households by systematic random sampling to enroll 7 households per cluster. All members of enrolled households will be asked to participate, which will include providing information about their household and household members, basic demographics, COVID-19 exposure risks, underlying medical conditions, recent medical history (specifically relating to symptoms consistent with COVID-19 infection), and a venous blood sample to test for antibodies to SARS-CoV2.

Fifteen teams, with each team including one CDC-based surveyor and a phlebotomist, will be deployed to collect the data. Each survey team will be assigned 4 census blocks to complete and will be responsible for determining how to move through the census block (with support from the planning team); coordinating follow up household visits, where needed; ensuring appropriate Personal Protective Equipment (PPE) is worn for each household visit; and delivering collected blood samples and biohazard waste materials to the laboratory at the end of each day. By the end of the survey, a total of 60 census blocks, a maximum of 420 households, and an estimated 1,000 individuals (average members per household = 2.5) will be enrolled during a 4-day data collection period and a 2-day mop-up period.

CDC Human Research Protection Office has reviewed this evaluation and determined it to be “non-research public health surveillance”.

PRE-FIELDWORK PREPARATIONS

Prior to fieldwork, you will need to attend specific training provided by the COVID-19 Epidemiology Studies Task Force, review all training documents, pick up equipment as well as other items (for CDC-based personnel only), and meet/contact your fellow team members in order to arrange a plan for the upcoming week.

You will be introduced to your teammate, via email, prior to the start of fieldwork. Establish early on the best possible way to communicate and determine a meeting time and location between yourselves for the start of each day. We recommend planning to start data collection at 09:30 to allow time to pick up cool/ice packs from the laboratory each morning.

Teams will use a Privately-Owned Vehicle (POV) or be provided with a government vehicle. If using POV, surveyors will be reimbursed for mileage. If using a government vehicle, surveyors will need to complete a brief training before they will be allowed to collect the vehicle. Please inform the survey coordinating team if you will require a government vehicle.

TRAINING

1. Attend the scheduled training organized by the COVID-19 Epidemiology Studies Task Force (mandatory)

2. Deployer training (specifically to cover PPE donning and doffing)

3. Review SOP (mandatory)

EQUIPMENT (FOR CDC-BASED PERSONNEL)

Items you’ll need for data collection are listed below. You will be provided with all equipment at the scheduled training. If this changes, you will be notified by email or during the training.

1. GPS (for each driver)

2. Cell phone (with pre-loaded RedCap and Google Earth App)

3. Tablet (with pre-loaded RedCap and Google Earth App)

4. Mobile Wi-Fi hotspot (Mifi)

5. Backpack (if needed)

6. Blood collection supplies (Appendix X)

7. Blood collection supplies will be pre-packed for each team and will include labels, sharp boxes, and biohazard bags.

8. Cool box, cool packs, tube rack, plastic protective sheeting for car

9. Personal Protective Equipment (PPE)

   1. PPE will be pre-packed for each team and will be provided for both the surveyor and phlebotomist (Appendix X – PPE supplies and guidelines). Additional PPE supplies can be available if needed.

10. Survey ID badge (T-shirt, possibly)

11. Office supplies including plastic folders for transporting forms; highlighters/marker pens; pens

FIELD DOCUMENTATION

Make sure you have the following:

1. Official letter from CDC, State Department of Health, and County Health Departments recommending participation

2. CDC ethical review determination form

3. SOP, including the following appendices:

   1. Introduction and consent script

   2. FAQs & talking points

   3. Instructions for entering data into RedCap App and uploading data to server

   4. PPE Guidance and PPE and blood collection supplies

   5. Instructions for using Google Earth App to visualize clusters

   6. Contact information

4. Forms/documents needed for each cluster:

   1. Cluster tracking sheet (x1)

   2. Back-up paper questionnaires (x25)

   3. Cluster maps (x2)

   4. Electronic cluster map (via Google Earth app)

   5. Covid-19 information sheet (x10)

   6. Household informational letter (x10)

   7. Adult consent forms (x20)

   8. Minor consent forms (x20)

   9. CDC, State, County official letter of recommendation

All documents listed above will also be provided electronically.

IN THE FIELD

START OF DAY PROCEDURES

• Pick up cool/ice packs at the beginning of each day from the laboratory and prepare cool box.

  • Place clean protective sheeting under the cool box. Place frozen cool/ice packs in cool box and put a clux sheet on top of ice packs.

• Ensure you have sufficient blood collection and PPE supplies, tablets and phones are charged, and all the required documentation for one cluster.

• Drive to cluster that has been assigned to team for that day, then identify the pre-determined start point for the cluster.

• Coordinating the details of a team’s daily activities will be left to the team’s discretion, but it is recommended that there be a daily ‘sit-down’ to discuss schedules, progress and challenges.

HOUSEHOLD SELECTION IN CLUSTER

Within each cluster (e.g. census block), survey teams will need select households by systematic random sampling until they have enrolled 7 households. This is achieved by identifying a starting point in each cluster and then visiting every nth household (defined as the total number of occupied households in the cluster/7). For census blocks with >1 subdivision, apartment complex, or housing area, the visited households should represent all areas of the cluster so that those enrolled are roughly proportional to the distribution of households in the cluster. 

Households will be defined as all persons who occupy a housing unit (house or apartment), whether they are related to each other or not. Correctional facilities, long-term care facilities, boarding schools, hostels, dormitories, or other similar institutionalized settings are to be excluded. Households in which English is not well understood may be excluded from the survey if translation services are not available.

Systematic random sampling

• For clusters with sections and/or types of housing/subdivisions, estimate the proportion of households in each section/subdivision (e.g. single housing area, apartment block, gated community) and allocate the 7 households to be enrolled proportionately.

  • Use cluster map provided to make rough approximations

Example: Cluster includes a large apartment complex (~50% of households), a smaller apartment complex (~10% of households), and single-family homes (~40% of households). Plan to enroll 3-4 households from the large complex, 1 from the small complex, and 2-3 from the single-family homes. 

• If not pre-defined, identify starting point in cluster.

• If not pre-defined, identify route to be followed through cluster.

  • Teams should move through the cluster systematically following a serpentine route to ensure all households have an equal chance of being selected.

  • If the current number of households is quite different to the 2010 census data, please note this on the cluster tracking sheet.

    • If new apartment complexes or single-family household areas exist (or no longer exist) that weren’t/were on the cluster map, attempt to quickly reassess the current number of different sections/subdivisions and assign households to be enrolled to each section/subdivision proportionally, as described above.

• Use the estimated number of households from the 2010 census to determine the “nth household” counting frame (defined as the total number of occupied households in the cluster/7).

  • Use the number of households from 2010 census unless you can tell that the current situation is vastly different and are able to estimate a better n based off of the google earth map

• Proceed to first household (see household visit section below)

  • See household replacement section below if a household is not available or willing to participate

• Once this household visit is finished, following the pre-defined route, move to the next nth household.

  • We anticipate that you will need to drive between households

• Repeat this procedure until all 7 households have been enrolled or it is the end of the day (dusk).

• If the team was unable to enroll 7 households in the cluster, they can revisit the cluster during the mop-up period at the end of the data collection period, if deemed necessary.

• If you cannot access a particular subdivision of a cluster, please note this on the cluster tracking sheet and re-allocate the targeted number of households to other areas of your cluster so that you can still enroll 7 households.

• If an area or home has a “No trespassing sign”, do not enter the area as we would not want you to put yourselves at risk of harm.

Household Replacement

• If there is no response at a visited household that appears to be occupied, the survey team will leave the household information letter and revisit that household after the other 6 households have been visited.

  • We suggest leaving the letter in the most visible place possible; do not put it in the mailbox as only US postal personnel can officially place mail in the mailbox.

  • If the household is not available/does not answer at the second visit it will be replaced.

• If a household refuses to participate or is vacant it will be immediately replaced.

• To replace a household, visit the household next door (continuing in the same direction of travel). If this household also needs to be replaced according to the procedure outlined above, then go to the next household (i.e. the second household down from the original household).

• Continue in this manner if a 4^th replacement household is needed.

Figure 1: Household replacement scenarios

If HH3 also refuses or appears vacant, replace with the next household (HH4).

If HH2 needs to be replaced due to refusal or vacancy, proceed immediately to HH3. If HH2 does not answer the door at first visit, revisit any remaining HHs in the cluster and come back to HH2 for a revisit, then enroll or replace HH2 as outlined above.

Guidance for gated communities

For census blocks where there are apartments or single-family household neighborhoods with gated access:

• For apartments, use the apartment call box, if available, to contact the apartment office manager. Share information about the serosurvey and request approval. If no one answers and if possible, use the call box to call an apartment. If still unsuccessful in contacting anyone in the complex, wait a reasonable amount of time to see if anyone leaves or enters the complex and approach them.

• For single family household neighborhoods, wait a reasonable amount of time to see if anyone leaves or enters the area and approach them.

Alternate option for high rise apartments or apartment complexes with multiple buildings

• Use a random number generator on your phone to randomly select the floors/buildings to be visited based on the number of households that you need to enroll (1 household per floor or building).

• Use the random generator to randomly select the apartment number on that floor.

HOUSEHOLD VISITS

The survey organizers have worked with County and State officials to notify the selected areas about the survey using their recommended communication networks and routes, as well as through locally relevant social media networks such as NextDoor and Facebook Neighborhood. In some areas they may also have provided flyers or informational leaflets to households, please check what pre-survey communications with the selected communities have been completed with the survey leads during the training session.

Overview of Approaching, Enrolling, and Departing from a household

Please wear your ID badge (and survey T-shirt, if provided) and identify yourself as coming from the CDC. Make sure your ID badge is clearly visible as people may choose not to answer the door if they cannot see you are associated with CDC. Otherwise, please dress in business casual, and remain polite and congenial during all interactions.

Once you have selected a house, you need to have your PPE and forms ready and be prepared to introduce the survey to the household. Make sure the official letter from CDC, State and County Health Departments is to hand in case the household request to see it. As you will potentially be completing paper forms in and outside households, we recommend that you always wear gloves when handling them. At each household, we recommend that you follow the procedures outlined below:

• Approach the residence wearing a surgical facemask, knock or ring bell, then move back 6 feet

  • If household refuses to participate, is vacant, or does not respond, assign a household ID and fill in the household ID and household status on the cluster tracking sheet

  • If a household needs to be revisited, please note the address on the cluster tracking sheet

• If someone answers the door, ask for an adult member of the household, introduce yourself and briefly explain the purpose of the survey and what would be involved for the household (Appendix A – Introduction and consent script).

• If they agree that this is something they are interested in, explain the PPE procedures (included in introduction and consent script).

  • For a household to be enrolled, at least one person in the household must consent to provide a venous blood sample. Please make sure this is made clear to the household.

• Don N95 mask, gown, disposable face shields, and gloves BEFORE entering household

• Ask if anyone in the household is currently experiencing the following symptoms: fever, cough, and/or shortness of breath. If yes, explain the following procedure to the household.

  • If any household member is symptomatic or is self-isolating because they suspect they have or have confirmed COVID-19, they should be interviewed and have their blood collected after other household members.

    • Symptomatic household members should wait in a different room while the team is interviewing and collecting blood from other household members.

    • Symptomatic household members should have a surgical facemask on when entering a room with other people, including the CDC team. If they do not have facemasks, the CDC team should provide the symptomatic household member with a surgical facemask

    • For individuals that are self-isolating from the rest of their household members, these individuals should be consented, interviewed and have their blood drawn in the room where they are isolating themselves.

• Describe who would be considered eligible to participate and identify all eligible household members

  • An eligible household member is an individual who spends an average of ≥2 nights per week in the home.

• Ask the household member to gather all non-symptomatic eligible household members, then explain the survey and consent them all together (complete consent forms, one per person).

  • Use a new pen for each household to complete the forms and leave the pen with the household

• Identify an adult household member and complete the household questionnaire.

  • In households where there are multiple adults, select the adult with the next birthday to complete the household questionnaire

  • During this time, ask where would be appropriate to set up the blood draw station and have the phlebotomist set it up.

• Next start completing the individual questionnaire for each household member.

• Once an individual has completed the questionnaire, give them a copy of their consent form and the blood tube labels to take to the phlebotomist for the blood draw.

• The phlebotomist will explain what the procedure will entail, label the blood tube, and then collect the participant’s blood.

  • Blood collection procedures should follow national guidelines.

    • For children, if necessary, have the parent hold the child on their lap. You may also want to ask the parents how to best approach drawing the blood from their children I.e. do the children first, or have the children wait in a separate room so they don’t watch their parents’ blood being drawn etc.

  • The phlebotomist should change gloves between each participant. Discarded gloves should be placed in the biohazard bag.

  • If any of the phlebotomists PPE becomes contaminated with blood, that piece of PPE should be replaced, and the contaminated piece placed in the biohazard bag.

• Once non-symptomatic household members have been processed, complete the interview and blood collection for symptomatic and/or self-isolating household members.

• Complete the individual questionnaire for and collect a blood sample from all household members that provide consent.

  • Indicate consent and participation status of all household members on the cluster tracking sheet.

  • The phlebotomist will keep all blood samples in a blood tube rack/zip-lock bag to take out to the team car.

• Once a household has been completed:

  • The phlebotomist should clean and disinfect the area used for the blood collection station

  • Update the cluster tracking sheet for that household

    • If some household members are away at the time of the visit, but will likely be back that evening or within the data collection period, arrange a follow up visit to collect information and blood from this person (record follow-up visit time and date on the cluster tracking sheet).

      • Leave the household informational letter with a contact number and ask for that person’s cell phone number so that you can double check they are available before the arranged follow-up visit.

      • If these missing household members are not available at all, they will be documented in the household questionnaire and cluster tracking sheet and classified as missing.

  • Thank the household members for their participation and:

    • check that all forms are complete prior to leaving – cluster tracking sheet (participation status of each household member is complete), consent forms signed, questionnaires completed.

    • Ask if you can leave a closed trash bag with used PPE in their outdoor trash can (if at a home with household trash cans).

• Once outside of the household, doff all PPE after the door has been closed and dispose of the PPE into the trash bag. Seal the trash bag with a tie, then place inside that household’s outdoor trash can or in the team vehicle if a trash can is not available. Clean hands with alcohol-based hand sanitizer once all PPE has been removed.

  • Use a new trash bag for each household

  • The same sharps container can be used for the whole day, but wipe down with disinfectant wipes between household visits

  • The phlebotomist should don a new pair of gloves to take the blood samples to the cool box in the car

• Take the collected blood samples to the car and store in a blood tube rack/zip-lock bag in the cool box in the team car.

  • Ensure the serum tube labels for the blood tubes are in a separate zip-lock bag placed with the blood tubes in the cool box.

  • The phlebotomist should wipe down the rack being used within each household once the blood samples have been transferred to the cool box (if using a rack).

  • Remove gloves and place in biohazard bag, then clean hands again with alcohol-based hand sanitizer

• Proceed to next household

Consenting household members

Work through the consent script with the consent form to obtain each household members approval to participate. There are 2 different consent forms: 1) for adults and 2) for minors <18 years olds. As part of the consent process, you will need to explain the purpose and components of the survey and the potential benefits and harms of participating to the individual and provide an opportunity for them to ask any questions.

Questionnaires

• Two standardized questionnaires will be administered: a household questionnaire and an individual questionnaire.

• Household questionnaire:

  • One respondent in each household (an adult who knows all residents of the household) will provide responses for the household questionnaire.

  • The household questionnaire will capture information on household characteristics and document all household members whether they are present at the time of the visit or not.

  • We estimate the household questionnaire will take 15 minutes.

• Individual questionnaire:

  • Each household member will provide responses for the individual questionnaire.

  • The individual questionnaire will capture information on age, sex, race, ethnicity, exposures, underlying medical conditions, and symptoms consistent with COVID-19 since January 2020 for each available and consenting household member.

  • For children or adults with memory issues, a parent or caregiver may answer for them.

  • We estimate the individual questionnaire will take 15–30 minutes.

• The team surveyor will conduct the questionnaires and capture the responses electronically on CDC-issued cell phones or tablets through RedCap (Appendix X – Instructions for using RedCap).

  • If there are any issues with the electronic data collection, surveyors should capture the information on the back-up paper questionnaires.

ASSIGNING HOUSEHOLD AND HOUSEHOLD MEMBER IDENTIFICATION NUMBERS

• Each visited household must be assigned an ID on the cluster tracking sheet to enable us to track participation. Within a cluster, start assigning numbers sequentially (1–XX) to account for all households visited. We will link this number to the cluster ID to ensure each household has a unique ID.

  • Start the count from ‘1’ for each new cluster you visit.

• If the household refuses, is vacant, or does not respond, write the household ID number and the household status on the cluster tracking sheet.

• If a household has agreed to participate:

  • Enter the household ID, household status, and number of household members on the cluster tracking sheet

  • Each team will be provided with a roll of labels with unique identification numbers (CSIDs) for each participant. There are 8 labels (2 rows) for each person and the purpose of each label is indicated on the label (Figure 2).

  • Take the first set of labels for the first person you consent to participate and ensure the CSID is the same across the 8 labels:

    • Apply the label called ‘Tracking’ to the household member 1 column in the cluster tracking sheet

    • Apply the labels called ‘Consent_CDC’ and ‘Consent_HHM’ (HHM-household member) to the appropriate copy of the consent form.

    • Apply the label called ‘Ind Qst Frm’ to the first page of the paper questionnaire (if used).

    • Next separate the 2 rows of labels for this individual from the rest of the roll and hand the labels to the participant to take to the phlebotomist.

    • The phlebotomist will attach the ‘Blood Tube’ label to the blood tube and place the rest of the labels in a zip lock bag to keep with the specimens to hand to the laboratory at the end of the day.

    • All forms and blood tubes for this individual should have the same CSID.

  • Repeat the process for each enrolled household member ensuring the CSID is the same across all 8 labels

• All household members should be accounted for on the cluster tracking sheet and household questionnaire regardless of whether they consent to participate or not or if they are absent at the time of the visit.

Figure 2: A label set for an individual household member

END OF DAY PROCEDURES

• If collecting data electronically, ensure all completed questionnaires have been uploaded to the server.

• Drop off blood samples, in-use sharp boxes, used biohazard waste bags, and cool/ice packs to the laboratory.

  • Ensure blood samples are stored appropriately at 4°C if not processed immediately

  • Ensure cool/ice packs are returned to the fridge/freezer so that they will be ready for pick up the next morning

• Provide summary update to survey coordinating team through pre-defined communication route e.g. WhatsApp, phone call, email etc.

  • Include:

1. Team number

2. Cluster ID

3. Number of households enrolled

4. If any revisits or mop-up are needed

5. Number of households requiring a follow up visit

6. Whether cluster is complete or not

It would also be helpful to share any challenges faced and how they were addressed.

MEDIA

You may receive media requests from local or state newspapers or television reporters. Teams should NOT be conducting interviews during the survey. Please forward all media requests to Holly Biggs (Appendix X – contact information).

END OF DATA COLLECTION PERIOD PROCEDURES

• Ensure all completed questionnaires have been uploaded to the server

• Return all leftover supplies and completed or unused forms to the survey coordinating team at the location and time specified during the training

• Return government vehicle, if used

• Follow usual procedures for claiming mileage reimbursement if using POV or overtime

TEAM ROLES AND RESPONSIBILITIES

Surveyor:

1. Pick up supplies at CDC at the start of each day

2. Be responsible for all supplies and own use of PPE

3. Determine starting point in cluster and route through cluster

4. Performing systematic random household selection

5. Enrolling and consenting household

6. Assigning labels with unique household and participant IDs to forms and blood collection tube

7. Answering any questions about the survey and COVID-19

8. Conducting questionnaires, and entering data into RedCap App

9. Scheduling follow up visits where needed

10. Tracking household visits on cluster tracking sheet

11. Reviewing all forms at the end of the day for completion and accuracy

12. Providing daily progress update via WhatsApp to Central Planning Team

13. Return all completed forms, blood, ice/cool packs to CDC at the end of the day

Phlebotomist:

1. Check sufficient PPE for day and follow guidelines for PPE use, responsible for own use of PPE

2. Check sufficient blood collection supplies for day and appropriate waste management supplies

3. Collect venous blood sample, verify sample labelled correctly

4. Ensure correct handling of sharps and biohazard waste

5. Responsible for managing blood samples in the field

6. Complete specimen tracking form

Finally, teams should be flexible – there may be occasions when we ask teams to move locations to help speed the data collection process.

DATA SECURITY

RedCap should be maintained on EOC or CDC-issued secure cell phones ONLY. DO NOT email documents with personally identifying information (PII). All documents with PII such as names need to be secured in a locked space when not in use or being transported.

APPENDICES

Appendix A: Introduction and Consent script

Appendix B: FAQs and talking points

Appendix C: Instructions for entering data into RedCap App and uploading data to server

Appendix D: PPE guidelines and PPE and blood collection supplies

Appendix E: Instructions for using Google Earth App to visualize clusters

Appendix F: Contact information