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
About this trial
This is an interventional prevention trial for SARS-CoV-2 Infection
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
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
NCT ID
NCT04898738
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
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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