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Prospective COVID-19 Cohort Study, Dominican Republic

Primary Purpose

SARS-CoV-2 Infection, Covid19

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Alcohol based hand sanitizer
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for SARS-CoV-2 Infection

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Alcohol-based hand sanitizer

    No Alcohol-based hand sanitizer

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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

    Full Information

    First Posted
    May 19, 2021
    Last Updated
    May 20, 2021
    Sponsor
    Brigham and Women's Hospital
    Collaborators
    Centers for Disease Control and Prevention, London School of Hygiene and Tropical Medicine, The University of Queensland, Yale University, Broad Institute, Ministerio de Salud Publica y Asistencia Social, Republica Dominicana
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04898738
    Brief Title
    Prospective COVID-19 Cohort Study, Dominican Republic
    Official Title
    Prospective COVID-19 Cohort Study to Assess the Epidemiology, Transmission and Control of SARS-CoV-2 in the Dominican Republic
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2021 (Anticipated)
    Primary Completion Date
    September 2022 (Anticipated)
    Study Completion Date
    September 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brigham and Women's Hospital
    Collaborators
    Centers for Disease Control and Prevention, London School of Hygiene and Tropical Medicine, The University of Queensland, Yale University, Broad Institute, Ministerio de Salud Publica y Asistencia Social, Republica Dominicana

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    SARS-CoV-2 Infection, Covid19

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    2000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Alcohol-based hand sanitizer
    Arm Type
    Active Comparator
    Arm Description
    Half the study households with receive ABHS through the course of the study
    Arm Title
    No Alcohol-based hand sanitizer
    Arm Type
    No Intervention
    Arm Description
    Half the study households with not receive ABHS through the course of the study
    Intervention Type
    Other
    Intervention Name(s)
    Alcohol based hand sanitizer
    Intervention Description
    Provision of ABHS to randomly selected households
    Primary Outcome Measure Information:
    Title
    Hand hygiene practices
    Description
    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.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Acceptability of hand hygiene technology
    Description
    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.
    Time Frame
    1 year
    Title
    SARS-Cov-2 seroconversion
    Description
    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
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eric J Nilles, MD
    Phone
    7819957077
    Email
    enilles@bwh.harvard.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Devan Dumas, MPH
    Phone
    4103749690
    Email
    ddumas@bwh.harvard.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eric J Nilles, MD
    Organizational Affiliation
    Brigham and Women's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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.

    Learn more about this trial

    Prospective COVID-19 Cohort Study, Dominican Republic

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