Network-Targeted Strategies for Efficient Community SARS-CoV-2 (COVID-19) Sampling (Snowball)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04437706|
Recruitment Status : Enrolling by invitation
First Posted : June 18, 2020
Last Update Posted : December 23, 2020
|Condition or disease|
|COVID-19 SARS-CoV 2|
Purpose and objective: The purpose of this study is to use community sampling to detect active, undiagnosed COVID-19 cases and/or determine the spread or distribution of active infection. The objective is to use a network targeted sampling design to direct testing to yield a higher proportion of results which indicate active infection and possibly differentiating between venues or communities where transmission is active and undiagnosed.
Study activities: A person who tests positive for COVID-19 will be given a set of "tokens" to give to contacts that will entitle these contacts to make an appointment to receive a test for COVID-19.
Population groups: The population group will include people with index cases of COVID-19 and their contacts for the past 14 days. As these contacts are tested and receive positive results, they will be given tokens to hand out to their contacts over the past 14 days. The network of positive cases will "blossom" to reveal community transmission and asymptomatic cases, thus giving researchers an indication of disease prevalence.
Data analysis: At the completion of each epoch and at the end of the study, we will scale the social networks up and conduct network analysis using SAS and the igraph package in R. These analyses will be applied in an ongoing manner to guide selection of seeds in subsequent epochs to ensure representativeness and to guide selection of alters to encourage longer referral chain lengths.
Risk/safety issues: The primary risks include discomfort from the nasal swab and risks from the venous blood draw used in testing and the potential loss of confidentiality. All efforts will be made to securely manage the data to ensure participant confidentiality.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||Network-Targeted Strategies for Efficient Community SARS-CoV-2 (COVID-19) Sampling|
|Actual Study Start Date :||December 11, 2020|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
Participants completing COVID-19 testing
- Number of Participants with Active Infection [ Time Frame: 12 months ]Number of participants with active COVID-19 infection
- Number of Participants with Antibodies Indicating Past Exposure [ Time Frame: 12 months ]Number of participants with antibodies indicating past exposure to SARS-CoV-2
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04437706
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Erich Huang, MD, PhD||Duke University|