Tuberculosis, Multidrug-ResistantH3TBNCT05022238
Hotspots, Households and Hospitals: Enhanced Drug-resistant Tuberculosis Case Finding in Namibia
An observational study of Tuberculosis, Multidrug-Resistant, run by University of Namibia at 1 site in Namibia.
Trial summary
Poor case management, pharmacokinetic variability and on-going transmission have fostered the drug-resistant tuberculosis (DR-TB) epidemic leading to a global estimated number of >500,000 new multidrug resistant (MDR) TB cases per year, of which roughly 10% are extensively drug resistant (XDR). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tuberculosis, Multidrug-Resistant
- How many people
- 2,100 participants
- Where
- 1 siteNamibia
- Study dates
- 1 Aug 2022to Sep 2026
- 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: For the first outcome, the study population is all DR-TB cases in three regions of Namibia, diagnosed by the National Institute of Pathology (GeneXpert Ultra Rifampicin resistant) over 18 months. For the second outcome, all household contacts of DR-TB cases in the three regions is the study population, as well as DR-TB patients' hospital visitors and community members at transmission hotspots.
Who may be able to join
- All cases diagnosed with drug-resistant TB in Namibia, in three regions of Khomas, Otjozondjupa and Ohangwena will be included for the first outcome. For the second outcome, all household members of DR-TB cases will be included; all hospital visitors to DR-TB cases will be included and community members at transmission hotspots will be included.
Who cannot join
- Anyone who does not give consent to participate.
Trial locations and contacts
1 site in 1 country.
Namibia1 site, 1 recruiting
- Recruiting
University of Namibia
Windhoek
Mareli Claassens, mclaassens@unam.na
About this study
Poor case management, pharmacokinetic variability and on-going transmission have fostered the drug-resistant tuberculosis (DR-TB) epidemic leading to a global estimated number of >500,000 new multidrug resistant (MDR) TB cases per year, of which roughly 10% are extensively drug resistant (XDR). Namibia is a high TB burden country with an incidence rate of 446/100,000 in 2016; about 11,000 new cases per year. 3.9% of new cases and 8.7% of previously treated cases have MDR-TB. Whole genome sequencing (WGS) has recently been applied to interrogate the complete genetic code of Mycobacterium tuberculosis (Mtb) strains. WGS can be used to infer relationships between identified strains as well as determine genomic variations involved in resistance development.
The specific aims of the H3TB study are to: (i) characterise the DR-TB epidemic, in terms of clinical, epidemiological, geospatial, social network and laboratory data, to identify transmission hotspots in three regions of Namibia, (ii) evaluate the feasibility of targeted case finding intervention strategies to improve DR-TB control in highly affected populations and (iii) develop a transmission model to investigate the potential impact of the case finding intervention strategies on DR-TB incidence in Namibia.
Read more
A prospective surveillance study started in January 2020, which includes all DR-TB cases in Namibia, and which will nest H3TB. Data collection tools and other study implementation tools have been designed and implemented. The study team is working in close collaboration with the National Institute of Pathology, where all DR-TB cases from the country are registered, to ensure all possible cases are captured. This is important for the identification of transmission hotspots.
After HREC and MOHSS approval, individuals with GeneXpert® MTB/RIF rifampicin-resistant samples and a positive Mtb culture from three regions in Namibia will be included in a transmission hotspot identification study. Preliminary data have shown that DR-TB clusters exist in these regions. Clinical, epidemiological, geospatial, social network and laboratory data (GeneXpert® MTB/RIF, culture, drug sensitivity tests) will be collected. WGS capacity has been established at the UNAM research laboratory, where WGS will be performed on the samples of H3TB participants; results will be validated at the Research Center Borstel in Germany. These study results in conjunction with a systematic review and meta-analysis will inform the design of case finding interventions which will be evaluated through a mixed-methods feasibility study conducted at high transmission areas (hotspots, households and hospitals). Data from these studies and the TB programme will be used to develop the model which will include a health economics component.
The study will strengthen DR-TB diagnosis, surveillance and control, inform DR-TB case finding policy in Namibia and regionally, inform resource allocation by identifying high transmission areas and create preliminary data to design a large scale DR-TB case finding intervention.
- Conditions
- Tuberculosis, Multidrug-Resistant
- Keywords
- case-finding, Namibia
- Medical subject headings
- Tuberculosis, Multidrug-Resistant
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of drug-resistant tuberculosis transmission hotspots in Namibia
Finding DR-TB transmission hotspots through whole genome sequencing (WGS), social network and shared space analyses, and geospatial analyses. WGS, social network and shared space data, and geospatial data, will be triangulated to identify transmission hotspots.
Measured: 18 months
Feasibility study of three interventions to enhance drug-resistant TB case finding in Namibia, measured with a questionnaire
Evaluating the acceptability, yield and cost of three interventions, viz., finding cases in community transmission hotspots, in drug-resistant tuberculosis hospitals, and in households of drug-resistant tuberculosis patients, in three regions of Namibia
Measured: 24 months
Transmission model
Using programmatic and data from outcomes 1 and 2 to develop and calibrate transmission model to look at the impact of scale-up of interventions
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start1 Aug 2022
- Primary completionSep 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, Multidrug-ResistantStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 2,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Namibia
- Sponsor type
- University, hospital or other
- Collaborators
- UK Medical Research Council (MRC), European and Developing Countries Clinical Trials Partnership (EDCTP), Research Center Borstel, Imperial College London, University of Stellenbosch, National Taiwan University, Namibian National Tuberculosis and Leprosy Programme (NTLP), UK Foreign, Commonwealth & Development Office (FCDO)
- Responsible party
- Principal investigator, Mareli Claassens, University of Namibia
- Investigators
- Mareli Claassens, PhD, Principal investigator, University of Namibia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022238
- Sponsor's protocol ID
- HGC/611/2021
- Acronym
- H3TB
- Status last verified
- May 2024
- First submitted
- 10 Aug 2021
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared after the acceptance for publication of the main findings from the final dataset by researchers' efforts if a data transfer agreement is made between the custodians of the data (the H3TB study team) and other researchers, that: (i) data will be used only for research purposes, (ii) proper technological measures will be used to ensure data security, (iii) no effort will be made to identify study participants, (iv) data will be destroyed after the agreed analyses and (v) the data source will be acknowledged. The sequencing data will be made available on ReSeqTB or a similar platform. The other data will be stored locally at UNAM in a tailored database and made available by researchers' efforts. These data include individual-level information on health status (e.g., TB and HIV infection status) which cannot be made publicly available.
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
- Hotspots, Households and Hospitals: Enhanced Drug-resistant Tuberculosis Case Finding in Namibia
- ClinicalTrials.gov ID
- NCT05022238
- Acronym / sponsor ID
- H3TB / HGC/611/2021
- Conditions
- Tuberculosis, Multidrug-Resistant
- Keywords
- case-finding, Namibia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- University of NamibiaUniversity, hospital or other
- Collaborators
- UK Medical Research Council (MRC), European and Developing Countries Clinical Trials Partnership (EDCTP), Research Center Borstel, Imperial College London, University of Stellenbosch, National Taiwan University, Namibian National Tuberculosis and Leprosy Programme (NTLP), UK Foreign, Commonwealth & Development Office (FCDO)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 26 Aug 2021 (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.
Poor case management, pharmacokinetic variability and on-going transmission have fostered the drug-resistant tuberculosis (DR-TB) epidemic leading to a global estimated number of >500,000 new multidrug resistant (MDR) TB cases per year, of which roughly 10% are extensively drug resistant (XDR). Namibia is a high TB burden country with an incidence rate of 446/100,000 in 2016; about 11,000 new cases per year. 3.9% of new cases and 8.7% of previously treated cases have MDR-TB. Whole genome sequencing (WGS) has recently been applied to interrogate the complete genetic code of Mycobacterium tuberculosis (Mtb) strains. WGS can be used to infer relationships between identified strains as well as determine genomic variations involved in resistance development.
The specific aims of the H3TB study are to: (i) characterise the DR-TB epidemic, in terms of clinical, epidemiological, geospatial, social network and laboratory data, to identify transmission hotspots in three regions of Namibia, (ii) evaluate the feasibility of targeted case finding intervention strategies to improve DR-TB control in highly affected populations and (iii) develop a transmission model to investigate the potential impact of the case finding intervention strategies on DR-TB incidence in Namibia.
A prospective surveillance study started in January 2020, which includes all DR-TB cases in Namibia, and which will nest H3TB. Data collection tools and other study implementation tools have been designed and implemented. The study team is working in close collaboration with the National Institute of Pathology, where all DR-TB cases from the country are registered, to ensure all possible cases are captured. This is important for the identification of transmission hotspots.
After HREC and MOHSS approval, individuals with GeneXpert® MTB/RIF rifampicin-resistant samples and a positive Mtb culture from three regions in Namibia will be included in a transmission hotspot identification study. Preliminary data have shown that DR-TB clusters exist in these regions. Clinical, epidemiological, geospatial, social network and laboratory data (GeneXpert® MTB/RIF, culture, drug sensitivity tests) will be collected. WGS capacity has been established at the UNAM research laboratory, where WGS will be performed on the samples of H3TB participants; results will be validated at the Research Center Borstel in Germany. These study results in conjunction with a systematic review and meta-analysis will inform the design of case finding interventions which will be evaluated through a mixed-methods feasibility study conducted at high transmission areas (hotspots, households and hospitals). Data from these studies and the TB programme will be used to develop the model which will include a health economics component.
The study will strengthen DR-TB diagnosis, surveillance and control, inform DR-TB case finding policy in Namibia and regionally, inform resource allocation by identifying high transmission areas and create preliminary data to design a large scale DR-TB case finding intervention.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- For the first outcome, the study population is all DR-TB cases in three regions of Namibia, diagnosed by the National Institute of Pathology (GeneXpert Ultra Rifampicin resistant) over 18 months. For the second outcome, all household contacts of DR-TB cases in the three regions is the study population, as well as DR-TB patients' hospital visitors and community members at transmission hotspots.
Key inclusion criteria (1 listed)
- All cases diagnosed with drug-resistant TB in Namibia, in three regions of Khomas, Otjozondjupa and Ohangwena will be included for the first outcome. For the second outcome, all household members of DR-TB cases will be included; all hospital visitors to DR-TB cases will be included and community members at transmission hotspots will be included.
Key exclusion criteria (1 listed)
- Anyone who does not give consent to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of drug-resistant tuberculosis transmission hotspots in Namibia
Time frame: 18 months
Finding DR-TB transmission hotspots through whole genome sequencing (WGS), social network and shared space analyses, and geospatial analyses. WGS, social network and shared space data, and geospatial data, will be triangulated to identify transmission hotspots.
Feasibility study of three interventions to enhance drug-resistant TB case finding in Namibia, measured with a questionnaire
Time frame: 24 months
Evaluating the acceptability, yield and cost of three interventions, viz., finding cases in community transmission hotspots, in drug-resistant tuberculosis hospitals, and in households of drug-resistant tuberculosis patients, in three regions of Namibia
Transmission model
Time frame: 12 months
Using programmatic and data from outcomes 1 and 2 to develop and calibrate transmission model to look at the impact of scale-up of interventions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Individual participant dataSharing planned: Yes. Data will be shared after the acceptance for publication of the main findings from the final dataset by researchers' efforts if a data transfer agreement is made between the custodians of the data (the H3TB study team) and other researchers, that: (i) data will be used only for research purposes, (ii) proper technological measures will be used to ensure data security, (iii) no effort will be made to identify study participants, (iv) data will be destroyed after the agreed analyses and (v) the data source will be acknowledged. The sequencing data will be made available on ReSeqTB or a similar platform. The other data will be stored locally at UNAM in a tailored database and made available by researchers' efforts. These data include individual-level information on health status (e.g., TB and HIV infection status) which cannot be made publicly available.
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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.
Mareli Claassens, PhD principal investigator
University of Namibia
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 Tuberculosis, Multidrug-Resistant, 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 1 inclusion and 1 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mareli Claassens, PhD (264814482082, mclaassens@unam.na), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of drug-resistant tuberculosis transmission hotspots in Namibia (time frame: 18 months). The study lists 3 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.