Clinical trial NCT04442165: Characterising Transmission of SARS-CoV-2 in a Peri-urban Population in Mozambique
Official title: Characterising Transmission of SARS-CoV-2 in a Peri-urban Population in Mozambique Using Population-based (Sero)Surveillance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: European and Developing Countries Clinical Trials Partnership (EDCTP)
name: Instituto Nacional de Saúde, Mozambique
name: Institut de Recherche pour le Developpement
name: UMC Utrecht
First posted: 2020-06-22
Enrollment: 6049
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Polana Caniço-HDSS (Health- and Demographic Surveillance System) has been established since 2017. In total, 2108 households (defined as residents of the same building, sharing a cooking area) have been enrolled in the HDSS. All members residing in the household for at least 3 months (infants, children, adults, elderly) are enrolled in the HDSS.

All households in the HDSS (2108 during the last round, in 2019) consenting to participate in the study will be visited biweekly by a trained HDSS interviewer, following the same procedures as in routine HDSS rounds, specified in the HDSS protocol (Instituto Nacional de Saude, 2016). We assume the same number of households will consent to participate as in other HDSS rounds.

Brief summary: 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: 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.

Eligibility criteria: 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.

No Exclusion Criteria

Primary outcomes:
measure: COVID-19 Disease Incidence Rate (Symptomatic Infections Per Month)
timeFrame: 12 months
measure: COVID-19 Related Hospitalization Rate Due to SARS-CoV-2
timeFrame: 12 months
measure: Case (Disease) Fatality Risk (Percent) Due to SARS-CoV-2
timeFrame: 12 months
measure: Percentage Asymptomatic Infections
timeFrame: 12 months
measure: Percentagge of Participants With SARS-CoV-2 Infection Annually
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Maputo
country: Mozambique
facility: INS
Study officials:
affiliation: Institute of Tropical Medicine
name: Marc-Alain Widdowson, Dr
role: PRINCIPAL_INVESTIGATOR
References: