Household Study of COVID-19, Influenza and RSV Burden, Transmission Dynamics and Viral Interaction in South Africa

NCT05277298 | Unknown

• 1 other identifier: PHIRST-C
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 2

Brief Summary

The study aims to characterize the community burden (including the clinical features) and transmissibility of SARS-CoV-2 within the context of a functional antibody response. In addition,the study will assess the effect of the interaction of SARS-CoV-2 with influenza virus and RSV on disease severity and transmission dynamics. A household-level prospective cohort study will be conducted in one rural and one urban community located in Mpumalanga Province and North West Province, respectively. The study will be conducted for 12 months of intensive follow up (July 2020 to August 2021) with a post-intensive follow-up continuing for a further 16 months (until December 2022). Two hundred households; 1,000 study participants of all ages; will be randomly selected from a list of 327 hoseholds that participated and successfully completed a 10-months follow-up period in a study similar to that currently proposed, but directed at community burden and transmission dynamics of influenza, respiratory syncytial virus and other respiratory pathogens. Each household and household member will be enumerated and the HIV infection status and the level of immunosuppression of HIV-infected individuals will be assessed. Each household member will be followed twice per week during the intense follow-up period (12 months) of the study. During this period upper respiratory tract samples will be collected irrespective of presence of symptoms and data on key symptoms, healthcare seeking, hospitalization and death will be captured at each follow up visit. Respiratory samples will be tested by reverse transcriptase real-time polymerase chain reaction (rRT-PCR) for SARS-CoV-2, influenza and RSV, and selected samples will be cultured and sequenced. An infection risk questionnaire will be administered to all study participants at enrollment and every month thereafter. Sera will be collected at enrollment and every 2 months during the 12-month intense follow-up period from all participants. In addition, sera will be collected every 2 months for a further 6 months following the 12-month intense follow-up period from study participants that tested positive for SARS-CoV-2 by rRT-PCR on respiratory specimens at 14, 16 and 18 months and from all study participants at 18 months. Sera will be tested for the presence of SARS-CoV-2, influenza and RSV antibodies. Wearable proximity sensors will be deployed for 8-12 days in each household over the 6-month intense follow-up period.

Conditions

SARS-CoV-2 Infection; Influenza; Respiratory Syncytial Virus (RSV)

Keywords

SARS-CoV-2; influenza; RSV; household transmission; COVID-19

Outcome Measures

Primary Outcomes (6)

• Describe the symptomatic fraction of SARS-CoV-2 infections among individuals in household cohort in an rural and urban setting, South Africa 2020/2021.

  The proportion of SARS-CoV2 infection that are symptomatic. This will be stratified by age, underlying conditions, HIV infection.

  14 months

• Describe the household secondary infection risk of SARS-CoV-2 infection among individuals in a household cohort in an rural and urban setting, South Africa 2020/2021.

  The number of secondary cases in a household divided by the total number of susceptible gives the secondary attack risk during the 14months of follow-up. This will be explored by underlying conditions, age and HIV status

  14 months

• Describe the serial interval for SARS-CoV-2 in households over 14 months of follow-up in an urban and rural setting, South Africa 2020/2021

  Calculate the time between successive cases in a each household as documented by onset of symptoms and/or PCR positive test.

  14 months

• Describe the duration of shedding of SARS-CoV-2 in a household cohort in an rural and urban setting, South Africa 2020/2021.

  The duration of PCR positive SARS-CoV-2 infection in individual over 14 months of follow-up, including describing the interval by age, HIV status and underlying conditions.

  14 month

• Describe the incidence of infection by PCR and serology in a household cohort in a rural and urban setting, South Africa 2020/21

  The number of new cases of symptomatic illness recorded by symptoms reported cohort over the 14 months of follow-up. Including estimating a person time to follow-up incident rate

  14 months

• Describe the incidence illness by PCR and/or serology in a household cohort in a rural and urban setting, South Africa 2020/21

  Describe the incidence of infection by PCR and serology in a household cohort over 14 months of follow-up, in a rural and urban setting, South Africa 2020/21

  14 months

Eligibility Criteria

• Age: 0 Days - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Mpumalanga Province site The population is approximately 120,000 people living in 20,000 households While HIV prevalence is high, life expectancy is improving with marked epidemiological transition leading to rising prevalence of non-communicable disease including cardio-metabolic conditions and stroke. North West Province Site Klerksdorp is located in the local municipality of Matlosana in North West Province and has a population of over 385,000 people and is 115 km2. The townships are organized into extensions that include mostly single-family houses and shacks. Prevalence of HIV in Klerksdorp is approximately 12%.

You may qualify if:

• Households/individuals that consent to participate to the study; and that are planning to reside in the selected community for the duration of the study.
• Provide at least one serum sample in the intensive follow up period, for individuals five years and older and
• Households should have at least 3 or more.

You may not qualify if:

• Households that:

Sponsors & Collaborators

• National Institute for Communicable Diseases, South Africa: lead
• Perinatal HIV Research Unit of the University of the Witswatersrand: collaborator
• University of Witwatersrand, South Africa: collaborator
• Centers for Disease Control and Prevention: collaborator
• Institute for Scientific Interchange, Torino, Italy: collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (2)

MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), Bushbuckridge, South Africa

Agincourt, Mpumalanga, 1256, South Africa

Location

Perinatal HIV Research

Klerksdorp, North West, 4538, South Africa

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Respiratory samples (nasal swab), serological samples

MeSH Terms

Conditions

COVID-19; Influenza, Human

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Study Officials

• Kathleen Kahn, MD, PhD

  MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), Bushbuckridge, South Africa

  PRINCIPAL INVESTIGATOR

• Neil Martinson, MD, PhD

  Perinatal HIV Research Unit, Johannesburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: March 14, 2022
• Study Start: July 1, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 31, 2022
• Last Updated: March 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Protocol informed consent will be uploaded to PHIRST-C webpage by by 31/1/2021.
• Access Criteria: open access, will be added once available

Locations

ZA (2)