Covid19, SARS-CoV-2 Infection
Conditions
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.
Interventions
OTHERAlcohol based hand sanitizer
Provision of ABHS to randomly selected households
Sponsors
Centers for Disease Control and Prevention
London School of Hygiene and Tropical Medicine
The University of Queensland
Yale University
Broad Institute of MIT and Harvard
Ministerio de Salud Publica y Asistencia Social, Republica Dominicana
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Dominican Republic
Outcome results
None listed