Prospective COVID-19 Cohort Study, Dominican Republic

NCT04898738 | Completed

• 1 other identifier: 2021p001294
• Study Type: interventional
• Target: 1,043
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2 Infection; Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Acceptability of hand hygiene technology

  1 year

• SARS-Cov-2 seroconversion

  1 year

Study Arms (2)

Alcohol-based hand sanitizer

ACTIVE COMPARATOR

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

Other: Alcohol based hand sanitizer

No Alcohol-based hand sanitizer

NO INTERVENTION

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

Interventions

Alcohol based hand sanitizer OTHER

Provision of ABHS to randomly selected households

Alcohol-based hand sanitizer

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Ward of the State

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Centers for Disease Control and Prevention: collaborator
• London School of Hygiene and Tropical Medicine: collaborator
• The University of Queensland: collaborator
• Yale University: collaborator
• Broad Institute of MIT and Harvard: collaborator
• Ministerio de Salud Publica y Asistencia Social, Republica Dominicana: collaborator

Study Sites (1)

Community study

Santo Domingo, Dominican Republic

Location

MeSH Terms

Conditions

COVID-19

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Eric J Nilles, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a prospective cohort study that aims to prospectively monitor 2,000 community-based study participants with serial serological screening for SARS-CoV-2 and enhanced molecular surveillance for active infection. Nested within this cohort is a randomized trial that will allocate study participants into two arms: thoe that receive versus do not receive alcohol-based hand sanitizer (ABHS) through the course of the study.

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 24, 2021
• Study Start: August 18, 2021
• Primary Completion: November 22, 2022
• Study Completion: February 10, 2023
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

DO (1)