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

Completed

• Conditions: COVID-19; HIV Seropositivity; Tuberculosis, Pulmonary; Tuberculosis Infection
• Interventions: Diagnostic Test: Covid-19, TB and HIV diagnosis

• Registration Number: NCT05268380
• Lead Sponsor: University of Namibia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-02
• Study First Posted: 2022-03-07
• Study Start: 2022-08-01
• Status Verified: 2023-02
• Primary Completion: 2023-09-30
• Study Completion: 2024-02-29
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1750

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary healthcare facility study	Covid-19, TB and HIV diagnosis	Investigation of primary healthcare facility attendees for TB infection and disease, HIV seropositivity, Covid-19 active infection and previous infection.
Household contact study	Covid-19, TB and HIV diagnosis	Investigation of Covid-19 index cases' households for TB infection and disease, HIV seropositivity, Covid-19 active infection and previous infection.

Primary Outcome Measures

Name	Time	Method
Covid-19 active infection in households	6 months	To determine Covid-19 active infection amongst household members of Covid-19 index cases
Covid-19 active infection in healthcare facilities	6 months	To determine Covid-19 active infection amongst healthcare facility attendees

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Namibia; 🇳🇦 Windhoek, Namibia