Prospective COVID-19 Cohort Study, Dominican Republic

Mass General Brigham

Status: Completed

Conditions: SARS-CoV-2 Infection; Covid19

Treatments: Other: Alcohol based hand sanitizer

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04898738

2021p001294

Details and patient eligibility

About

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.

Enrollment: 1,043 patients

Sex: All

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,043 participants in 2 patient groups

Alcohol-based hand sanitizer

Active Comparator group

Description:

Half the study households with receive ABHS through the course of the study

Treatment:

Other: Alcohol based hand sanitizer

No Alcohol-based hand sanitizer

No Intervention group

Description:

Half the study households with not receive ABHS through the course of the study