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

NCT05268380 | Completed

• 1 other identifier: RIA2020EF-2963
• Study Type: observational
• Target: 1,750
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; HIV Seropositivity; Tuberculosis, Pulmonary; Tuberculosis Infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• TB infection and disease in households

  6 months

• TB infection and disease in healthcare facilities

  6 months

• HIV seropositivity in households

  6 months

• HIV seropositivity in healthcare facilities

  6 months

Study Arms (2)

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

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

Interventions

Covid-19, TB and HIV diagnosis DIAGNOSTIC_TEST

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.

Household contact study; Primary healthcare facility study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of Namibia

Windhoek, Namibia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sputum, blood and nasopharyngeal swabs.

MeSH Terms

Conditions

COVID-19; HIV Seropositivity; Tuberculosis, Pulmonary; Latent Tuberculosis

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; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Latent Infection

Study Officials

• Stefan Niemann, PhD

  Research Center Borstel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate research professor

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 7, 2022
• Study Start: August 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: February 29, 2024
• Last Updated: October 24, 2024

Record last verified: 2023-02

Locations

NA (1)