Collision of Three Global Pandemics: the Effect of Tuberculosis and HIV on the Epidemiological, Clinical, Virological and Immunological Trajectory of COVID-19 in Botswana and Namibia (Core-NB)

COVID-19 has emerged as global pandemic during the past few months, with an unprecedented impact on public health, and society more generally. Virus epidemiology is poorly understood, as are factors influencing the diverse clinical picture. To date most cases have been seen in high income countries and consequently COVID-19 diagnostics and research have mainly been set-up in these settings. Outstanding questions include an understanding of how the virus spreads and how it causes pathology. A particular gap in current knowledge is the effect of HIV and tuberculosis (TB) on the outcomes of COVID-19 disease as these two conditions impair the host immune response to other infectious disease. Understanding how these three pandemics interact is crucial. We have developed a proposal that will answer critical questions concerning COVID-19 disease epidemiology in the context of low resource countries with high burden of poverty, and in the presence of high rates of TB and HIV, namely, Namibia and Botswana. Given that there are currently few cases of COVID-19 diagnosed in both countries, the project will document how the virus spreads within susceptible populations. The development of this proposal is highly collaborative and interdisciplinary, with investigators from Namibia and Botswana working closely with colleagues in Europe. We will also work with an NGO in Namibia, Health Poverty Action, to support rapid implementation.

The project includes two studies that will be conducted sequentially. The first study will follow the WHO protocol for household transmission investigations in the context of COVID-19. It will explore transmission frequency and describe the clinical spectrum of disease. Samples collected will also serve as basis for COVID-19 molecular epidemiology and host immunological response. The second study will evaluate the presentation, diagnosis and clinical characteristics of individuals presenting to sentinel health facilities in both countries. The project will have a strong laboratory strengthening component which will enhance COVID-19 laboratory and research capacity. This will include the development of skills and knowledge for diagnostic testing and COVID-19 sequencing and will build scientific and research capacity.

The findings from this project will provide robust data to assist in guiding national responses to COVID-19 in both countries as well as assisting with our understanding of the pathogenesis of the virus in the context of TB and HIV, in turn providing vital information on how to deliver clinical care and how to design therapeutics and vaccines.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; HIV Seropositivity; Tuberculosis, Pulmonary; Tuberculosis Infection
• Intervention / Treatment: Diagnostic test: Covid-19, TB and HIV diagnosis

• Study Type: Observational
• Enrollment (Anticipated): 2100

Contacts and Locations

Study Locations

• Namibia
  • Windhoek, Namibia
    • Recruiting
    • University of Namibia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Household contact study: household members of Covid-19 index cases in one urban and one rural region of Namibia and Botswana, respectively.

Healthcare facility study: facility attendees at one urban and one rural primary healthcare facility in Namibian and Botswana, respectively.

Description

Inclusion Criteria:

• Household contact study: all household members of Covid-19 index cases in selected areas
• Healthcare facility study: all attendees of selected primary healthcare facilities

Exclusion Criteria:

• Household contact study: non-household members of Covid-19 index cases in selected areas; individuals not giving consent
• Healthcare facility study: individuals not giving consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Household contact study; Investigation of Covid-19 index cases' households for TB infection and disease, HIV seropositivity, Covid-19 active infection and previous infection.	Diagnostic test: Covid-19, TB and HIV diagnosis; GeneXpert (sputum) will be used to diagnose active TB disease, IGRA will be used to diagnose latent TB infection, PCR will be used to diagnose Covid-19 active infection, HIV rapid test will be used to diagnose HIV seropositivity.
Primary healthcare facility study; Investigation of primary healthcare facility attendees for TB infection and disease, HIV seropositivity, Covid-19 active infection and previous infection.	Diagnostic test: Covid-19, TB and HIV diagnosis; GeneXpert (sputum) will be used to diagnose active TB disease, IGRA will be used to diagnose latent TB infection, PCR will be used to diagnose Covid-19 active infection, HIV rapid test will be used to diagnose HIV seropositivity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Covid-19 active infection in households	To determine Covid-19 active infection amongst household members of Covid-19 index cases	6 months
Covid-19 active infection in healthcare facilities	To determine Covid-19 active infection amongst healthcare facility attendees	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TB infection and disease in households	To determine TB infection and disease amongst household members of Covid-19 index cases	6 months
TB infection and disease in healthcare facilities	To determine TB infection and disease amongst healthcare facility attendees	6 months
HIV seropositivity in households	To determine HIV seropositivity amongst household members of Covid-19 index cases	6 months
HIV seropositivity in healthcare facilities	To determine HIV seropositivity amongst healthcare facility attendees	6 months

Collaborators and Investigators

• Sponsor: University of Namibia
• Collaborators: European and Developing Countries Clinical Trials Partnership (EDCTP); Research Center Borstel; Victus Global Botswana Organization

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Latent Infection; HIV Infections; COVID-19; Tuberculosis; Latent Tuberculosis; HIV Seropositivity; Tuberculosis, Pulmonary
• Other Study ID Numbers: RIA2020EF-2963

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No