Prospective COVID-19 Cohort Study, Dominican Republic

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Covid19; SARS-CoV-2 Infection
• Intervention / Treatment: Other: Alcohol based hand sanitizer

• Study Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric J Nilles, MD; Phone Number: 7819957077; Email: enilles@bwh.harvard.edu
• Study Contact Backup: Name: Devan Dumas, MPH; Phone Number: 4103749690; Email: ddumas@bwh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Alcohol-based hand sanitizer; Half the study households with receive ABHS through the course of the study	Other: Alcohol based hand sanitizer; Provision of ABHS to randomly selected households
No Intervention: No Alcohol-based hand sanitizer; Half the study households with not receive ABHS through the course of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: London School of Hygiene and Tropical Medicine; Yale University; Centers for Disease Control and Prevention; The University of Queensland; Broad Institute; Ministerio de Salud Publica y Asistencia Social, Republica Dominicana
• Investigators: Principal Investigator: Eric J Nilles, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): May 24, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Hand Sanitizers
• Other Study ID Numbers: 2021p001294

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data for epidemiological analyses and modelling (including demographic data, clinical data, and survey questionnaire survey) will be shared with the following collaborators: Adam Kucharski (LSHTM), Colleen Lau (University of Queensland), Marietta Vasquez (Yale University), Matt Lozier (US CDC), Pardis Sabeti (Broad Institute), and staff at the Health Ministry Division of Epidemiology. Non-identifiable data shared with listed collaborators will be performed with secure file transfer.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No