Core-NB: 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

Sponsor
University of Namibia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05268380
Collaborator
European and Developing Countries Clinical Trials Partnership (EDCTP) (Other), Research Center Borstel (Other), Victus Global Botswana Organization (Other)
2,100
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Covid-19, TB and HIV diagnosis

Study Design

Study Type:
Observational
Anticipated Enrollment :
2100 participants
Observational Model:
Family-Based
Time Perspective:
Cross-Sectional
Official Title:
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
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Covid-19 active infection in households [6 months]

    To determine Covid-19 active infection amongst household members of Covid-19 index cases

  2. Covid-19 active infection in healthcare facilities [6 months]

    To determine Covid-19 active infection amongst healthcare facility attendees

Secondary Outcome Measures

  1. TB infection and disease in households [6 months]

    To determine TB infection and disease amongst household members of Covid-19 index cases

  2. TB infection and disease in healthcare facilities [6 months]

    To determine TB infection and disease amongst healthcare facility attendees

  3. HIV seropositivity in households [6 months]

    To determine HIV seropositivity amongst household members of Covid-19 index cases

  4. HIV seropositivity in healthcare facilities [6 months]

    To determine HIV seropositivity amongst healthcare facility attendees

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Stefan Niemann, PhD, Research Center Borstel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mareli Claassens, Associate research professor, University of Namibia
ClinicalTrials.gov Identifier:
NCT05268380
Other Study ID Numbers:
  • RIA2020EF-2963
First Posted:
Mar 7, 2022
Last Update Posted:
Mar 7, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 7, 2022