Prospective COVID-19 Cohort Study, Dominican Republic

Not Applicable

• Conditions: Covid19; SARS-CoV-2 Infection
• Interventions: Other: Alcohol based hand sanitizer

• Registration Number: NCT04898738
• Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-05-20
• Last Update Submitted: 2021-05-20
• Study First Posted: 2021-05-24
• Last Update Posted: 2021-05-24
• Study Start: 2021-08
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alcohol-based hand sanitizer	Alcohol based hand sanitizer	Half the study households with receive ABHS through the course of the study

Primary Outcome Measures

Name	Time	Method
Hand hygiene practices	1 year	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.

Secondary Outcome Measures

Name	Time	Method
SARS-Cov-2 seroconversion	1 year	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
Acceptability of hand hygiene technology	1 year	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.