COVID-19Core-NBNCT05268380
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
An observational study of COVID-19 and HIV Seropositivity, run by University of Namibia at 1 site in Namibia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19, HIV Seropositivity, Tuberculosis, Pulmonary
- What is being tested?
- Covid-19, TB and HIV diagnosis
- How many people
- 1,750 participants
- Where
- 1 siteNamibia
- Study dates
- 1 Aug 2022to 29 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Household contact study: all household members of Covid-19 index cases in selected areas
- Healthcare facility study: all attendees of selected primary healthcare facilities
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Namibia1 site
University of Namibia
Windhoek
About this study
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.
- Being tested
- Covid-19, TB and HIV diagnosis
- Medical subject headings
- COVID-19, HIV Seropositivity, Tuberculosis, Pulmonary, Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covid-19, TB and HIV diagnosisDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Household contact study | Investigation of Covid-19 index cases' households for TB infection and disease, HIV seropositivity, Covid-19 active infection and previous infection. Receives: 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. Receives: Diagnostic Test: Covid-19, TB and HIV diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Covid-19 active infection in households
To determine Covid-19 active infection amongst household members of Covid-19 index cases
Measured: 6 months
Covid-19 active infection in healthcare facilities
To determine Covid-19 active infection amongst healthcare facility attendees
Measured: 6 months
Secondary outcomes (4)
TB infection and disease in households
To determine TB infection and disease amongst household members of Covid-19 index cases
Measured: 6 months
TB infection and disease in healthcare facilities
To determine TB infection and disease amongst healthcare facility attendees
Measured: 6 months
HIV seropositivity in households
To determine HIV seropositivity amongst household members of Covid-19 index cases
Measured: 6 months
HIV seropositivity in healthcare facilities
To determine HIV seropositivity amongst healthcare facility attendees
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start1 Aug 2022
- Primary completion30 Sep 2023
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 1,750 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Namibia
- Sponsor type
- University, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP), Research Center Borstel, Victus Global Botswana Organization
- Responsible party
- Principal investigator, Mareli Claassens, University of Namibia
- Investigators
- Stefan Niemann, PhD, Principal investigator, Research Center Borstel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268380
- Sponsor's protocol ID
- RIA2020EF-2963
- Acronym
- Core-NB
- Status last verified
- Feb 2023
- First submitted
- 2 Mar 2022
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05268380
- Acronym / sponsor ID
- Core-NB / RIA2020EF-2963
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,750 participants (actual)
- Lead sponsor
- University of NamibiaUniversity, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP), Research Center Borstel, Victus Global Botswana Organization
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Household contact study | – | Diagnostic Test: Covid-19, TB and HIV diagnosisInvestigation of Covid-19 index cases' households for TB infection and disease, HIV seropositivity, Covid-19 active infection and previous infection. |
| Primary healthcare facility study | – | Diagnostic Test: Covid-19, TB and HIV diagnosisInvestigation of primary healthcare facility attendees for TB infection and disease, HIV seropositivity, Covid-19 active infection and previous infection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Household contact study: all household members of Covid-19 index cases in selected areas
- Healthcare facility study: all attendees of selected primary healthcare facilities
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Covid-19, TB and HIV diagnosisGeneXpert (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. | Diagnostic test | Household contact study, Primary healthcare facility study |
Primary outcome
Covid-19 active infection in households
Time frame: 6 months
To determine Covid-19 active infection amongst household members of Covid-19 index cases
Covid-19 active infection in healthcare facilities
Time frame: 6 months
To determine Covid-19 active infection amongst healthcare facility attendees
4 secondary outcomes
TB infection and disease in households
Time frame: 6 months
TB infection and disease in healthcare facilities
Time frame: 6 months
HIV seropositivity in households
Time frame: 6 months
HIV seropositivity in healthcare facilities
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Niemann, PhD principal investigator
Research Center Borstel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and HIV Seropositivity, run by University of Namibia at 1 site in Namibia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Namibia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Covid-19 active infection in households (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.