COVID-19 Surveillance in Rural Mozambique for Prompt and Effective Response (MozCOVID)

Coronavirus Disease 2019 Surveillance in Manhiça District Southern Mozambique for a Prompt and Effective Response Against the Epidemic

Extraordinary times require extraordinary measures. The current COVID-19 pandemic is the paradigmatic example of how infectious diseases may menace the world's health and economy, and particularly contribute to enhancing current inequities in health-related to wealth. The main goal of the proposed study is to understand the epidemiology and natural history of COVID-19 in a rural area in Southern Mozambique

Study Overview

• Status: Completed
• Conditions: COVID-19

Detailed Description

Although Mozambique has so far had few confirmed cases of COVID19, it is unknown if low testing rates and other factors such as the warm climatic conditions may explain the apparently low spread of the virus. The present proposal aims to rapidly gain an understanding of the epidemic curve and natural history of SARS-CoV-2 in a rural area in southern Mozambique through a series of epidemiological indicators obtained at both the health facility and community levels, so as to provide evidence-based recommendations for managing and mitigating the COVID19 epidemic. Age-specific incidence of severe COVID-19 obtained at health facilities during a period of 15 months together with seroprevalence data obtained from the community will be used to determine SARS-CoV-2 reproduction number and effects of interventions through mathematical modeling. Viral, serological, and clinical progression will be assessed in a longitudinal cohort of symptomatic SARS-CoV-2 infected individuals. Community awareness of COVID-19 and of project aims will be fostered through engagement activities among community leaders and members. COVID-19 surveillance capacities in Mozambique will be strengthened by developing SARS-CoV-2 diagnostic approaches (molecular testing and an innovative immunoassay to detect antibodies against the virus), as well as SARS-CoV-2 genome sequencing approaches to identify transmission chains. Finally, the project will pursue the creation of a bank of serum, virus materials, and data which will be open for immediate public health purposes, including the development of point-of-care diagnostic tests. This project will be coordinated by the Manhiça Health Research Centre (Mozambique) in conjunction with the Barcelona Institute for Global Health (Spain), which will lead the transfer of molecular and immunological tools to the Mozambican research center. Imperial College will provide the modeling expertise to derive metrics of transmission, and INS the expertise to conduct quality control of laboratory determinations as well as dissemination and networking with the Ministry of Health in Mozambique. Four WPs will comprise the main research tasks, including COVID-19 surveillance (WP1), Laboratory determinations (WP2), Contact tracing and community awareness (WP3), Modelling (WP4), as well as two cross-cutting WPs related to Capacity-building (WP5) and Scientific coordination, management, networking & dissemination (WP6). We expect this 21-month project will increase the level of preparedness, alertness, and response in Mozambique

• Study Type: Observational
• Enrollment (Actual): 6494

Contacts and Locations

Study Locations

• Mozambique
  • Manhica, Mozambique
    • Centro de Investigaçao em Saúde de Manhiça

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Manhiça district has a total population of 204,357 and 47.061 households and 27.560 children under five years. Each person living within the DSS study area is issued a unique Permanent Identification number that describes the geographic localization of his/her household. Some demographic indicators in 2015 are: a birth cohort of 3,946, life expectancy at birth 51 years, neonatal, infant, and under-five mortalities are 22.5/1,000 live births, 55.8 and 99.0, respectively. Children under the age of five represent 18% (29,700) of the total population.

Description

Inclusion Criteria The study has five components and therefore the inclusion criteria may vary from one component to another.

1. COVID-19 morbidity surveillance

   • Individuals of any age admitted to MDH or pregnant attending the Maragra health center meet the COVID-19 case definition as defined above after the project start date.
   • Resident of Manhiça DSS area
   • Written informed consent from a parent or guardian if a child, and from participant if an adult prior recruitment.

2. COVID-19 mortality surveillance • All deaths in children under the age of 5 (including stillbirths), occurring at the health facility or at the community; • In hospital adult deaths occurring at the MDH;

   • Resident of Manhiça DSS area;

   • Written informed consent from the relative of the dead person.

3. COVID-19 population-based serosurveys • Individuals of all age groups residing in Manhiça DSS surveillance area • Signed informed parental permission from a parent or guardian if a child and from participant if an adult.

4. Natural history of SARS-CoV-2 infection

   • Participants who fulfill eligibility criteria for activity a) and with laboratory-confirmed SARS-CoV-2 infection.

5. Clinical presentation and factors associated with SARS-CoV-2 • Participants who fulfill eligibility criteria for activities a) and c).

Exclusion Criteria

• Participation in an interventional clinical trial at the time of enrollment.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age-specific positivity rate of SARS-CoV-2 infection	Positivity rate by age-group (0-9, 10-19, 20-29, 30-39, 40-49, 50-59, 60-69, >=70 years) of SARS-CoV-2 infection among acute respiratory syndrome individuals during 15 months	15 months
Age-specific Incidence of SARS-CoV-2 infection	Incidence by age-group (0-9. 10-19, 20-29, 30-39, 40-49, 50-59, 60-69, >=70 years) of SARS-CoV-2 infection among acute respiratory syndrome individuals during 15 months	15 months
Community Age-specific seroprevalence	Seroprevalence by age-group (0-19, 20-39, 40-59, >=60 years) of IgM and IgG against SARS-CoV-2 at baseline andd after 15 months	month 5
Community Age-specific seroprevalence	Seroprevalence by age-group (0-19, 20-39, 40-59, >=60 years) of IgM and IgG against SARS-CoV-2 at baseline andd after 15 months	month 11
Community Age-specific seroprevalence	Seroprevalence by age-group (0-19, 20-39, 40-59, >=60 years) of IgM and IgG against SARS-CoV-2 at baseline andd after 15 months	month 14
COVID-19 associated mortality	Factors associated with acute COVID-19, sero-positivity and COVID-19 associated mortality	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCR and antibody-negativization	Median time (weeks or months) to PCR and antibody-negativization in symptomatic PCR-confirmed acute COVID-19 individuals	up to 12 months
Relatedness of SARS-CoV-2 genome	Monophyletic groups of closely related SARS-CoV-2 genome	15 months

Collaborators and Investigators

• Sponsor: Centro de Investigação em Saúde de Manhiça
• Collaborators: Imperial College London; World Health Organization; Barcelona Institute for Global Health; Instituto Nacional de Saúde, Mozambique; Instituto de Biomedina de Valencia, IBV

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Epidemiology; Diagnostic; Surveillance; SARS-CoV-2 infection; Serosurvey
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 80/CNBS/20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No