Characterising Transmission of SARS-CoV-2 in a Peri-urban Population in Mozambique

NCT ID: NCT04442165

Last Updated: 2025-03-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6049 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-15

Study Completion Date

2022-03-29

Brief Summary

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A population-based COVID19 surveillance in a household cohort will be set-up using an existing Household demographic surveillance system (HDSS). From any individual in this population with any respiratory symptom or loss of smell or taste, with or without fever, investigators will collect a respiratory specimen and test these for SARS-CoV-2 virus, during 12 months. Demographic, epidemiological and clinical data of possible cases and of the source population will be recorded at baseline.

An age-stratified serial sero-survey will be conducted at baseline in a subset of the population in the population-based COVID19 surveillance, and at 3, 6 and 12 months, after confirmation of community transmission.

Detailed Description

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The investigators will use the established HDSS to set up population-based COVID19 surveillance in a household cohort. From any individual in this population with any respiratory symptom or loss of smell or taste, with or without fever, investigators will collect a respiratory specimen and test these for SARS-CoV-2 virus by PCR, during 12 months. These cases will be identified through bi-weekly household visits, through an alert system involving community leaders and HDSS interviewers, or when presenting with symptoms at healthcare centres or the referral hospital. Demographic, epidemiological and clinical data (comorbidities, medication, obesity, HIV, TB, smoking) of possible cases and of the source population will be recorded at baseline; recent illness, potential risk exposure of each household member (including duration and type) to SARS-CoV-2 positive individuals, uptake of measures to reduce exposure/transmission, and barriers to the uptake of such measures, will be recorded/updated during every household visit.

An age-stratified serial sero-survey will be conducted at baseline in a subset of the population in the population-based COVID19 surveillance, and at 3, 6 and 12 months, after confirmation of community transmission.

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Any individual enrolled in the Polana Caniço-HDSS: All members residing in the household for at least 3 months (infants, children, adults, elderly), regardless of age, underlying conditions, medical history, infection or disease status or history
* Able and willing to provide written informed consent: by the household head for the surveillance; by each selected participant for the sero-survey.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

Sponsor Role collaborator

Instituto Nacional de Saúde, Mozambique

OTHER_GOV

Sponsor Role collaborator

Institut de Recherche pour le Developpement

OTHER_GOV

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role collaborator

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc-Alain Widdowson, Dr

Role: PRINCIPAL_INVESTIGATOR

Institute of Tropical Medicine

Locations

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INS

Maputo, , Mozambique

Site Status

Countries

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Mozambique

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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AfriCoVER

Identifier Type: -

Identifier Source: org_study_id

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