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Completed

NCT Number: NCT04898738

Prospective COVID-19 Cohort Study, 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.

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Key information

Conditions

Sars-CoV-2 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community study

Santo Domingo, Dominican Republic

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alcohol based hand sanitizer

Other

Provision of ABHS to randomly selected households

Primary outcomes

  1. Hand hygiene practices

    Time frame: 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 outcomes

  1. Acceptability of hand hygiene technology

    Time frame: 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.

  2. SARS-Cov-2 seroconversion

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Broad Institute of MIT and Harvard
  • Centers for Disease Control and Prevention
  • London School of Hygiene and Tropical Medicine
  • Ministerio de Salud Publica y Asistencia Social, Republica Dominicana
  • The University of Queensland
  • Yale University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
May 24, 2021
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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