Electronic pillbox-enabled self-administered therapy versus standard directly observed therapy for tuberculosis medication adherence and treatment outcomes in Ethiopia (SELFTB): protocol for a multicenter randomized controlled trial

Manyazewal, Tsegahun; Woldeamanuel, Yimtubezinash; Holland, David; Fekadu, Abebaw; Blumberg, Henry M.; Marconi, Vincent C.

doi:10.1186/s13063-020-04324-z

Cited by 31 publications

(43 citation statements)

References 83 publications

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“…The SELFTB Trial included 10 public health centers with the largest TB client load. The average quarterly cases in the sites [14] have been reduced by two-third in the COVID-19 period.…”

Section: Covid-19 Implications On Tb Carementioning

confidence: 96%

“…We see a similar challenge in Addis Ababa where we have sites for both EXIT-TB study and the SELFTB Trial (Electronic pillbox-enabled self-administered therapy versus standard directly observed therapy for tuberculosis medication adherence and treatment outcomes in Ethiopia: a multicenter randomized controlled trial) [14]. The SELFTB Trial included 10 public health centers with the largest TB client load.…”

Section: Covid-19 Implications On Tb Carementioning

confidence: 99%

“…We are currently implementing the EXIT-TB research project, which is funded by the European and Developing Countries Clinical Trials Partnership (EDCTP2) program under the European Union (CSA2016S-1608). A co-author of this study is implementing a clinical trial on TB with financial support from the U.S. National Institutes of Health (D43TW009127) [14]. COVID-19 has a significant impact on these studies.…”

Section: Covid-19 Implications On Tb Researchmentioning

confidence: 99%

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Containment of COVID-19 in Ethiopia and implications for tuberculosis care and research

et al. 2020

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Background The coronavirus disease 2019 (COVID-19) has emerged as a global health and economic security threat with staggering cumulative incidence worldwide. Given the severity of projections, hospitals across the globe are creating additional critical care surge capacity and limiting patient routine access to care for other diseases like tuberculosis (TB). The outbreak fuels panic in sub-Saharan Africa where the healthcare system is fragile in withstanding the disease. Here, we looked over the COVID-19 containment measures in Ethiopia in context from reliable sources and put forth recommendations that leverage the health system response to COVID-19 and TB. Main text Ethiopia shares a major proportion of the global burden of infectious diseases, while the patterns of COVID-19 are still at an earlier stage of the epidemiology curve. The Ethiopian government exerted tremendous efforts to curb the disease. It limited public gatherings, ordered school closures, directed high-risk civil servants to work from home, and closed borders. It suspended flights to 120 countries and restricted mass transports. It declared a five-month national state of emergency and granted a pardon for 20 402 prisoners. It officially postponed parliamentary and presidential elections. It launched the ‘PM Abiy-Jack Ma initiative’, which supports African countries with COVID-19 diagnostics and infection prevention and control commodities. It expanded its COVID-19 testing capacity to 38 countrywide laboratories. Many institutions are made available to provide clinical care and quarantine. However, the outbreak still has the potential for greater loss of life in Ethiopia if the community is unable to shape the regular behavioral and sociocultural norms that would facilitate the spread of the disease. The government needs to keep cautious that irregular migrants would fuel the disease. A robust testing capacity is needed to figure out the actual status of the disease. The pandemic has reduced TB care and research activities significantly and these need due attention. Conclusions Ethiopia took several steps to detect, manage, and control COVID-19. More efforts are needed to increase testing capacity and bring about behavioral changes in the community. The country needs to put in place alternative options to mitigate interruptions of essential healthcare services and scientific researches of significant impact.

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“…The SELFTB Trial included 10 public health centers with the largest TB client load. The average quarterly cases in the sites [14] have been reduced by two-third in the COVID-19 period.…”

Section: Covid-19 Implications On Tb Carementioning

confidence: 96%

Section: Covid-19 Implications On Tb Carementioning

confidence: 99%

Section: Covid-19 Implications On Tb Researchmentioning

confidence: 99%

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Containment of COVID-19 in Ethiopia and implications for tuberculosis care and research

et al. 2020

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“…Glossary of research terms in the review.Glossary DescriptionBiomarker A measurable characteristic of the organism state during treatment18 Treatment completedTreatment completed as recommended by the national policy8 Predictive biomarkersBiomarkers which allow the prediction of the treatment outcome 10 Bacterial loads A measure of M. tb in original sputum samples and quantified as estimated colony-forming unit in 1 mL of sputum sample (eCFU/mL)18,19 Xpert MTB/RIF Molecular method for diagnosis of TB and can provide resistance strain on rifampicin14,15 TB: tuberculosis.…”

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confidence: 99%

Molecular bacterial load assay versus culture for monitoring treatment response in adults with tuberculosis

et al. 2021

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The lack of rapid, sensitive, and deployable tuberculosis diagnostic tools is hampering the early diagnosis of tuberculosis and early detection of treatment failures. The conventional sputum smear microscopy or Xpert MTB/RIF assay cannot distinguish between alive and dead bacilli and the culture method delays providing results. Tuberculosis molecular bacterial load assay is a reverse transcriptase real-time quantitative polymerase chain reaction that quantifies viable tuberculosis bacillary load as a marker of treatment response for patients on anti-tuberculosis therapy. However, results are not synthesized enough to inform its comparative advantage to tuberculosis culture technique which is yet the gold standard of care. With this review, we searched electronic databases, including PubMed, Embase, and Web of Science, from March 2011 up to February 2021 for clinical trials or prospective cohort studies that compared tuberculosis molecular bacterial load assay with tuberculosis culture in adults. We included eight studies that meet the inclusion criteria. Tuberculosis molecular bacterial load assay surpasses culture in monitoring patients with tuberculosis during the first few weeks of anti-tuberculosis treatment. It is more desirable over culture for its shorter time to results, almost zero rates of contamination, need for less expertise on the method, early rate of decline, lower running cost, and reproducibility. Its rapid and specific tuberculosis treatment monitoring competency benefits patients and healthcare providers to monitor changes of bacillary load among isolates with drug-susceptible or resistance to anti-tuberculosis regimens. Despite of the high installing cost of the tuberculosis molecular bacterial load assay method, molecular expertise, and a well-equipped laboratory, tuberculosis molecular bacterial load assay is a cost-effective method with comparison to culture in operational running. To achieve maximum utility in high tuberculosis burden settings, an intensive initial investment in nucleic acid extraction and polymerase chain reaction equipment, training in procedures, and streamlining laboratory supply procurement systems are crucial. More evidence is needed to demonstrate the potential large-scale and sustainable use of tuberculosis molecular bacterial load assay over culture in resource-constrained settings.

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“…However, compared to other countries, it is still much lower. Africa, in general, shares only 2.4% of clinical trials generated globally and Ethiopia shares only 2.3% of clinical trials generated out of Africa and the trials are limited in number and variety ( 13 – 15 ). This is due to the existence of many challenges for the conduct of clinical trials that would determine the safety and efficacy of new products and interventions in the country.…”

Section: Introductionmentioning

confidence: 99%

Harnessing Clinical Trial Capacity to Mitigate Zoonotic Diseases: The Role of Expert Scientists in Ethiopia

Belay

Giday

Manyazewal

2021

Front. Public Health

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Background: The emergence and resurgence of zoonotic diseases have continued to be a major threat to global health and the economy. Developing countries are particularly vulnerable due to agricultural expansions and domestication of animals with humans. Scientifically sound clinical trials are important to find better ways to prevent, diagnose, and treat zoonotic diseases, while there is a lack of evidence to inform the clinical trials' capacity and practice in countries highly affected with the diseases. This study aimed to investigate expert scientists' perceptions and experiences in conducting clinical trials toward zoonotic diseases in Ethiopia.Methods: This study employed a descriptive, qualitative study design. It included major academic and research institutions in Ethiopia that had active engagements in veterinary and public health researches. It included the National Veterinary Institute, the National Animal Health Diagnostic and Investigation Center, the College of Veterinary Medicine at Addis Ababa University, the Ethiopian Public Health Institute, the Armauer Hansen Research Institute, and the College of Health Sciences at Addis Ababa University. In-depth interviews were conducted with expert scientists. Data were collected from October 2019 to April 2020. Data analysis was undertaken using open code 4.03 for qualitative data analysis.Results: Five major themes, with 18 sub-themes, emerged from the in-depth interviews. These were: challenges in the prevention, control, and treatment of zoonotic diseases; One Health approach to mitigate zoonotic diseases; personal and institutional experiences in conducting clinical trials on zoonotic diseases; barriers in conducting clinical trials toward zoonotic diseases; and strategies that promote conducting clinical trials on zoonotic diseases. Conducting clinical trials on zoonotic diseases in Ethiopia is hampered by a lack of clearly articulated ethics and regulatory frameworks, trial experts, financial resources, and good governance.Conclusion: In Ethiopia, conducting clinical trials on zoonotic diseases deserves due attention. Strengthening institutional and human resources capacity is a pre-condition to harness effective implementation of clinical trials on zoonotic diseases in the country. In Ethiopia where skilled human resource is scarce, One Health approach has the potential to form multidisciplinary teams to systematically improve clinical trials capacity and outcomes in the country.

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Electronic pillbox-enabled self-administered therapy versus standard directly observed therapy for tuberculosis medication adherence and treatment outcomes in Ethiopia (SELFTB): protocol for a multicenter randomized controlled trial

Cited by 31 publications

References 83 publications

Containment of COVID-19 in Ethiopia and implications for tuberculosis care and research

Containment of COVID-19 in Ethiopia and implications for tuberculosis care and research

Molecular bacterial load assay versus culture for monitoring treatment response in adults with tuberculosis

Harnessing Clinical Trial Capacity to Mitigate Zoonotic Diseases: The Role of Expert Scientists in Ethiopia

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