There are about 7 clinical studies being (or have been) conducted in Namibia. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
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.
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.
The specific aim of this study is to evaluate whether RockTape has similar efficacy to Elastikon in the treatment of foot blisters in ultramarathon runners. Elastikon with paper tape and spray adhesive is a well-accepted means of blister treatment and has been used by medical staff at over 50 multi-stage ultramarathons around the world. RockTape is another commercially available product that has also been used by runners successfully to treat foot blisters. RockTape's adhesive qualities have a potential advantage over Elastikon, in that it does not require an additional adhesive substituting a level of complexity, weight, and cost for foot care. There have been no studies examining the efficacy of either agent for blister treatment. This randomized controlled trial will compare the traditional method of treating blisters with a multi-step approach of percutaneous drainage, paper tape, spray adhesive and then Elastikon to percutaneous drainage, paper tape and RockTape.