CoVPN 5002

The COMPASS Study – Community Prevalence of SARS-CoV-2 Study (CoVPN 5002) will estimate the percentage of people affected by SARS-CoV-2, the virus that causes COVID-19, in selected communities in the United States.

This study will

• Evaluate the extent of COVID-19 in these communities
• Assess knowledge, attitudes and behaviors related to SARS-CoV-2 and COVID-19
• Model the potential impact of different prevention interventions
• Guide future SARS-CoV-2 prevention studies and COVID-19 treatment studies in these communities
• The study will also provide valuable samples for important laboratory assessments related to the acquisition of SARS-CoV-2 and impact of the COVID-19 pandemic.

About the Study

The COMPASS Study – Community Prevalence of SARS-CoV-2 Study (CoVPN 5002) will estimate the percentage of people affected by SARS-CoV-2 in selected communities in the United States. SARS-CoV-2 is the name of the virus that causes the coronavirus disease, called COVID-19. The COMPASS Study will evaluate the extent of COVID-19 in these communities; assess knowledge, attitudes and behaviors related to SARS-CoV-2 and COVID-19; model the potential impact of different prevention interventions; and guide future SARS-CoV-2 prevention studies and COVID-19 treatment studies in these communities. It will also provide valuable samples for important laboratory assessments related to the acquisition of SARS-CoV-2 and impact of the COVID-19 pandemic.

The study enrolled approximately 26,000 people and results are expected towards the end of 2021. CoVPN 5002 enrolled participants from communities close to research sites that have experience conducting clinical trials. All individuals provided informed consent before they joined the study. In addition to community recruitment, the survey included adults recruited from outpatient medical clinics and nursing and assisted living facilities. The goal of the recruitment strategy was to include children and adults who would provide a representative snapshot of the community. 

What is CoVPN?

The COMPASS Study is being implemented by the COVID-19 Prevention Network (CoVPN). The CoVPN was formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the U.S. National Institutes of Health to respond to the global pandemic. The CoVPN consists of:

• The HIV Vaccine Trials Network (HVTN) at the Fred Hutch Cancer Research Center in Seattle, Washington
• The HIV Prevention Trials Network (HPTN) at FHI 360 in Durham, NC
• The Infectious Diseases Clinical Research Consortium (IDCRC) at Emory University in Atlanta
• The AIDS Clinical Trials Group (ACTG) at Brigham and Women’s Hospital (BWH) in Boston

The HVTN is overseeing the vaccine trials and the HPTN is overseeing the monoclonal antibody (mAb) trials in the CoVPN. The COMPASS Study is an observational study, overseen by the HPTN, and will not assess any vaccines or treatments for COVID.  

For more information on the COVID-19 Prevention Network, please visit www.PreventCOVID.org

FAQ

1. What is The COMPASS Study (CoVPN 5002)?

The COMPASS Study – Community Prevalence of SARS-CoV-2 Study – is a study to estimate the number of people who currently have or have previously had SARS-CoV-2 infection in select communities in the United States. SARS-CoV-2 is the virus that causes COVID-19.

2. When and where will the COMPASS Study be done?

The COMPASS Study is taking place in Atlanta, Aurora, Baltimore, Chicago, Cincinnati, Houston, Miami, New Orleans, New York, Newark, Philadelphia, Pittsburgh, and Ponce (PR). See sites here.

3. Why is the COMPASS Study being done?

The COVID-19 pandemic continues to impact different regions and diverse populations differently across the United States. The impact of COVID-19 has generally had a greater impact on Black/African American, Latinx, and American Indian/Alaska Native communities. These communities have experienced more severe disease and deaths compared to any other racial or ethnic groups in the United States.

The COMPASS Study will provide information on communities impacted by COVID-19, including:

• The number of people (at least 2 months old) who have SARS-CoV-2 or had a prior SARS-CoV-2 infection
• How children may or may not impact the spread of SARS-CoV-2
• The impact of other medical conditions on people who have SARS-CoV-2
• Demographic (characteristics about groups of people) and social risk factors (housing instability, food insecurity, etc.) associated with SARS-CoV-2 infection
• Knowledge about, attitudes and practices on COVID-19 and public health measures to deal with COVID-19 in the community
• Racial and ethnic health disparities including access to testing and other public health resources

4. How many people will be in the study and who can join?

The study enrolled approximately 26,000 people. Participants were recruited from assisted living and skilled nursing facilities, outpatient health care facilities, and neighborhoods close to the selected community. The majority of participants were recruited at random from specific locations in each community, such as near a grocery store, using a technique called time-location sampling (TLS). The goal of this method, which is sometimes called venue-based sampling, was to enroll children and adults who, as a group, were very similar to the population of the community.

5. Why did the COMPASS Study Include Children?

While fewer children have been sick with COVID-19 compared to adults, children can:

• contract the virus that causes COVID-19
• get sick from COVID-19
• have no symptoms and unknowingly spread the virus that causes COVID-19 to others

Most children with COVID-19 have mild symptoms or have no symptoms at all. However, some children can get severely ill from COVID-19. They may require hospitalization, intensive care, or a ventilator to help them breathe.

Children with the following medical conditions may be at increased risk of severe illness compared to other children:

• Asthma
• Diabetes
• Sickle cell disease
• Heart disease
• Weakened immune system
• Multiple chronic conditions
• Obesity
• Children under one year old may be more likely to have a severe illness from COVID-19.

Increased transmissions of SARS-CoV-2 in daycares and schools may lead to poor health outcomes for students, staff, and teachers.

6. What happened during the COMPASS Study?

Participants who consented to join the COMPASS Study answered some questions, provided a small amount of blood (about 2 teaspoons) for antibody testing, and could choose to collect their own mid-nasal swab or have a study staff member collect the swab for SARS-CoV-2 diagnostic testing. The blood test (antibody) results were returned but participants were told how to obtain their nasal swab diagnostic test results. Participants in the COMPASS Study were compensated for their time.

Study procedures included:

• Parental/Guardian Consent and the assent of the child if they were older than 17
• Questionnaire: A guardian had to fill out the study questionnaire if the child was nine years old or younger
• Nasal Swab: Nasal swabs were self-collected for older children. Study staff or parents assisted for younger children
• Blood Draw: Children ages two months to two years old received a heel stick. Children older than two received a small intravenous (traditional) blood draw – approximately 6mL (~1 teaspoon) for children ages two to six and about 10mL (~2 teaspoons) for children older than six years old

7. What happened to participants with a positive nasal swab test result for SARS-CoV-2?

Participants with a positive SARS CoV-2 nasal swab test result received counseling about isolation and referral to care if needed. They were also reminded of any regulatory requirements to inform local health authorities for follow-up and contact tracing.

8. When did the COMPASS Study begin enrolling people and when will results be available?

The COMPASS Study started enrolling participants in October 2020. Results are expected late-2021.

9. What organizations are involved in the COMPASS Study?

The COMPASS Study is being implemented by the COVID-19 Prevention Network (CoVPN). The CoVPN was formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the U.S. National Institutes of Health to respond to the global pandemic. Using the infectious disease expertise of their existing research networks and global partners, NIAID has directed the networks to address the pressing need for vaccines and monoclonal antibodies (mAbs) against SARS-CoV-2. The CoVPN is comprised of the HIV Vaccine Trials Network (HVTN), the HIV Prevention Trials Network (HPTN), the Infectious Diseases Clinical Research Consortium (IDCRC), and the AIDS Clinical Trials Group (ACTG). The HVTN is overseeing the vaccine trials and the HPTN is overseeing the monoclonal antibody (mAb) trials in the CoVPN. The COMPASS Study is an observational study, overseen by the HPTN, and will not assess any vaccines or treatments for COVID.  

For more information on the COVID-19 Prevention Network, please visit www.PreventCOVID.org