Prospective COVID-19 Cohort Study, Dominican Republic

Covid19 Clinical Trial

Official title:

Prospective COVID-19 Cohort Study to Assess the Epidemiology, Transmission and Control of SARS-CoV-2 in the Dominican Republic

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04898738
• Other study ID #: 2021p001294
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2021
• Est. completion date: September 2022

Study information

• Verified date: May 2021
• Source: Brigham and Women's Hospital
• Contact: Eric J Nilles, MD
• Phone: 7819957077
• Email: enilles[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project will build on an existing CDC funded cooperative agreement in the Dominican Republic with the Brigham and Women's Hospital (2018-2023) that includes (i) prospective COVID-19 and AFI surveillance at two health facilities and (ii) a nationally representative cross-sectional community-based serological survey of approximately 7,000 healthy adults and children targeting SARS-CoV-2 and other AFI pathogens to be conducted between April and June 2021. This linked study will establish a nested cohort of 2,000 participants enrolled in the national serological survey and prospectively monitor them for COVID-19 symptoms, conduct serial serological testing, implement molecular surveillance for SARS-CoV-2 and sequencing for variants of concern, implement and evaluate WASH mitigation measures, and monitor uptake and perceptions of COVID-19 vaccines.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• Previously enrolled in a linked national community-based seroepidemiological study in the Dominican Republic

• Agreed and consented to be recontacted to participate in additional research studies at the time of enrollment in #1

• =2 years of age

• Agree to participate

Exclusion Criteria:

• Ward of the State

Related Conditions & MeSH terms

• Covid19
• SARS-CoV-2 Infection

Intervention

Other:
• Alcohol based hand sanitizer
Provision of ABHS to randomly selected households

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Broad Institute, Centers for Disease Control and Prevention, London School of Hygiene and Tropical Medicine, UK, Ministry of Public Health and Social Assistance, Dominican Republic, The University of Queensland, Yale University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hand hygiene practices	The average daily frequency of study participant hand hygiene events over the previous seven days will be assessed using standardized survey questionnaires at 0-, 3-, 6-, 9-, and 12-months.	1 year
Secondary	Acceptability of hand hygiene technology	Study participants preference for different hand hygiene technology (e.g. soap and water, ABHR) as measured using a five-point Likert Scale at 0-, 3-, 6-, 9-, and 12-months.	1 year
Secondary	SARS-Cov-2 seroconversion	Number of study participants that seroconvert from SARS-CoV-2 seronegative to seropositive at time points 0-, 6-, and 12-months as assessed by presence of anti-nucleocapsid immunoglobulin	1 year