Periodic Reporting for period 1 - NeuroSolve (Implementation of superior treatment regimen and improved patient pathway for neurocysticercosis in Sub-Saharan Africa)
Période du rapport: 2023-05-01 au 2024-10-31
Neurocysticercosis (NCC) is a potentially fatal zoonotic disease following ingestion of eggs of the pork tapeworm, Taenia solium. The eggs develop into larval forms (cysticerci) in various tissues, including the central nervous system, leading to NCC, mainly characterized by epileptic seizures. NCC is one of the leading preventable causes of epilepsy worldwide, affecting 2.56–8.30 millions of people. NCC management guidelines have been published by the WHO, however, their uptake in national policies is very limited.
The pork tapeworm (Taenia solium) is responsible for approximately 212 human deaths per year in Tanzania and is responsible for almost 60% of epilepsy in endemic areas.
In NeuroSolve, we are demonstrating and promoting a methodological approach for conducting health research that leads to the adoption of improved approaches into policy and clinical practice. The proposed approach includes (1) strengthening of clinical and research capacity through training and mentoring of early career researchers, clinicians and frontline healthcare workers as well as upgrading infrastructure for surveillance and control, (2) demonstrating the improved pragmatic effectiveness of the combined treatment on quality of life through a hospital-based, randomized, open-label study for the treatment of neurocysticercosis in Tanzania and Zambia, (3) evaluating the potential impact of serological testing on the patient outcomes and the wider health system through a simulation study, (4) demonstrating the cost-effectiveness and cost-benefit of the proposed health technologies, (5) developing and validating an implementation strategy addressing identified barriers for uptake using the robust implementation frameworks and (6) enhance research results uptake into national and international guidelines and health policy through engagement of relevant policy/decision-makers throughout the project period and beyond.
The pork tapeworm (Taenia solium) is responsible for approximately 212 human deaths per year in Tanzania and is responsible for almost 60% of epilepsy in endemic areas.
In NeuroSolve, we are demonstrating and promoting a methodological approach for conducting health research that leads to the adoption of improved approaches into policy and clinical practice. The proposed approach includes (1) strengthening of clinical and research capacity through training and mentoring of early career researchers, clinicians and frontline healthcare workers as well as upgrading infrastructure for surveillance and control, (2) demonstrating the improved pragmatic effectiveness of the combined treatment on quality of life through a hospital-based, randomized, open-label study for the treatment of neurocysticercosis in Tanzania and Zambia, (3) evaluating the potential impact of serological testing on the patient outcomes and the wider health system through a simulation study, (4) demonstrating the cost-effectiveness and cost-benefit of the proposed health technologies, (5) developing and validating an implementation strategy addressing identified barriers for uptake using the robust implementation frameworks and (6) enhance research results uptake into national and international guidelines and health policy through engagement of relevant policy/decision-makers throughout the project period and beyond.
Since the commencement of the project, all important activities needed for the start of the project, have been conducted. A total of 11 Postgraduate students were recruited in both countries (8 PhDs and 3 MScs). Each student has a specific topic from the clinical trial to implementation sciences. A systematic review of the available serological tests for the diagnosis of NCC has been conducted. Results from the systematic review on serological techniques highlight the importance of transparent and unambiguous data reporting. With promising immunological tests in development, the challenge before usage in targeted settings will be to perform large-scale evaluations whilst holding into account both optimized test performance and ease of use. Accessibility to validated tests and feasibility of implementation should also be considered. Based on the review and expert opinion serological tests were selected to be used in the clinical trial.
The protocols for the various studies to achieve the project objectives were developed through workshops. The developed protocols were submitted for ethical and regulatory approvals. Ethical approvals for the studies have been obtained in both Tanzania and Zambia. A stakeholders’ workshop was held in Lusaka, Zambia, at which the project was launched by the Permanent Secretary from the Zambia Ministry of Health. Study sites were identified and visits made to introduce the project. A detailed stakeholder mapping was conducted in the different settings, including the hospital based setting, community household based setting, and health education setting. Local health and veterinary authorities including hospitals were visited. These visits included hospitals to be used for the treatment trial to ensure the hospitals were equipped with the necessary requirements for admission of study participants. On the level of the implementation research, these visits enabled identification of important stakeholders and the development of a data collection plan (which tool to use for which stakeholders and their selection). The field missions were successful as the project was well received by the health authorities and the hospitals had the necessary facilities for the project purposes. Trainings in GCP and GLP practice have been conducted in both Tanzania and Zambia to prepare the staff and students for the studies. These trainings were also open to other members of staff at the respective institutions in both countries as part of capacity building. SOPs and all necessary documents required for the various studies especially the clinical trial have been developed and finalised in readiness for the recruitment of study participants. The students have also been trained in the data collection tool to be used by the project. Field trial staff has been trained on the recruitment and management of study participants at the study sites. Data collection tools for the implementation research components have been developed, were pre-tested, and have been entered in the RedCap data collection system. Consortium members have presented the project and its objectives have been presented at both local and international conference and meetings.
The protocols for the various studies to achieve the project objectives were developed through workshops. The developed protocols were submitted for ethical and regulatory approvals. Ethical approvals for the studies have been obtained in both Tanzania and Zambia. A stakeholders’ workshop was held in Lusaka, Zambia, at which the project was launched by the Permanent Secretary from the Zambia Ministry of Health. Study sites were identified and visits made to introduce the project. A detailed stakeholder mapping was conducted in the different settings, including the hospital based setting, community household based setting, and health education setting. Local health and veterinary authorities including hospitals were visited. These visits included hospitals to be used for the treatment trial to ensure the hospitals were equipped with the necessary requirements for admission of study participants. On the level of the implementation research, these visits enabled identification of important stakeholders and the development of a data collection plan (which tool to use for which stakeholders and their selection). The field missions were successful as the project was well received by the health authorities and the hospitals had the necessary facilities for the project purposes. Trainings in GCP and GLP practice have been conducted in both Tanzania and Zambia to prepare the staff and students for the studies. These trainings were also open to other members of staff at the respective institutions in both countries as part of capacity building. SOPs and all necessary documents required for the various studies especially the clinical trial have been developed and finalised in readiness for the recruitment of study participants. The students have also been trained in the data collection tool to be used by the project. Field trial staff has been trained on the recruitment and management of study participants at the study sites. Data collection tools for the implementation research components have been developed, were pre-tested, and have been entered in the RedCap data collection system. Consortium members have presented the project and its objectives have been presented at both local and international conference and meetings.
The present study will bring about several groundbreaking advancements. The use of implementation research joined to the biomedical assessment of the added value of serology and the combined treatment, ensures a guaranteed uptake of the project results after the end of the project, as bottlenecks for sustained implementation of the new tools will be identified and solutions proposed, based on bottom up and top down inputs. Moreover, this includes developing and validating comprehensive One Health strategies that integrate human, animal, and environmental health interventions, setting new standards for NTD control programmes. Additionally, creating culturally tailored intervention strategies that achieve high levels of community acceptance and participation will lead to sustained behaviour change. Generating robust evidence to inform and influence national policies can result in systemic changes and increased funding for NTD control. Utilising behavioural science to design interventions will lead to sustained behaviour changes, and innovative training programmes will enhance the skills and capacity of local health workers, ensuring long-term sustainability of interventions.