Prospective COVID-19 Cohort Study, Dominican Republic

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04898738

Collaborator

Centers for Disease Control and Prevention (U.S. Fed), London School of Hygiene and Tropical Medicine, UK (Other), The University of Queensland (Other), Yale University (Other), Broad Institute (Other), Ministerio de Salud Publica y Asistencia Social, Republica Dominicana (Other)

2,000

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2 Infection Covid19	Other: Alcohol based hand sanitizer	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Hand hygiene practices [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 Outcome Measures

Acceptability of hand hygiene technology [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.
SARS-Cov-2 seroconversion [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

Principal Investigator: Eric J Nilles, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eric J. Nilles, M.D.,M.S.C., Principal Investigator, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT04898738

Other Study ID Numbers:

2021p001294

First Posted:

May 24, 2021

Last Update Posted:

May 24, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Hand Sanitizers

Study Results

No Results Posted as of May 24, 2021