Project Summary:

COLLABORATING INSTITUTIONS

 

1. SACIDS Foundation for One Health, Tanzania (Muhimbili University of Health and Allied Sciences, Sokoine University of Agriculture, National Institute for Medical Research, Tanzania Veterinary Laboratory Agency
2. London School of Hygiene and Tropical Medicine, United Kindom
3. Chatham House Centre for Global Health

 

INVESTIGATORS

 

Principal Investigator

1. Mecky Matee, Muhimbili University of Health and Allied Sciences, Tanzania

 

CO- Investigators (Tanzania)

1. Leonard E.G. Mboera, SACIDS-Foundation for One Health, Sokoine University of Agriculture, P.O. Box 3297, Chuo Kikuu, Morogoro, Tanzania
2. Mark Rweyemamu, SACIDS Foundation for One Health, Sokoine University of Agriculture, Tanzania
3. Stephen E. Mshana, Catholic University of Health and Allied Sciences, Tanzania
4. Gasto Frumence, Muhimbili University of Health and Allied Sciences, Tanzania
5. Henry Budodi Magwisha, Tanzania Veterinary Laboratory Agency, Tanzania
6. Shardhuli I. Kimera, Sokoine University of Agriculture, Tanzania
7. Rogers Azabo, Sokoine University of Agriculture, Tanzania
8. Calvin Sindato, National Institute for Medical Research
9. Bugwesa Zablon, Tanzania Wildlife Research Institute, Tanzania

 

Co-Investigators (United Kingdom)

1. Mishal Khan, London School of Hygiene and Tropical Medicine
2. Helena Legido_Quigley, London School of Hygiene and Tropical Medicine
3. Taane Clark, London School of Hygiene and Tropical Medicine
4. Osman Dar, Chatham House Centre on Global Security

 

BACKGROUND

 

In recent years, Antimicrobial resistance (AMR) has emerged as among the major global threat to public health systems. The misuse and abuse of antimicrobials in agriculture, veterinary and human medicine practices have been described to be the major contributing factors. In clinical settings in Tanzania, the prevalence of multidrug resistant bacteria ranges from 25% to 50% (Mshana et al.,2009, 2013; Moremi et al. 2012; Moyo et al. 2014). More recently about two-thirds of isolates from wounds infections at Muhimbili National Hospital were found to be resistant to at least three classes of antibiotics (Manyahi et al. 2014). Human activities have been shown to contribute to the evolution and spread of AMR in the environment (Pruden et al. 2012). These activities include misuse and overuse of antimicrobials of variable quality and efficacy in humans and animals, improper storage and disposal of antimicrobials and preservatives for food and antibacterial agents in household products.

 

In low-and middle-income countries, AMR problem is compounded by the following factors (i) lack of access to appropriate antimicrobial therapy; (ii) weak of regulation in use of antibiotics for human and animal; (iii) weak surveillance of antibiotic use and resistance levels; (iv) lack of updated antibiotic use and treatment guidelines; (v) lack of continuing medical/veterinary education on antibiotic use for prescribers (Mtenga et al 2011); (vi) a weak regulatory framework for the use of antibiotics in animal production and aquaculture combined with a tendency for animal owners to stock drugs in their houses and engaging unskilled people such as farmers/peasants themselves  in treating animals (Karimuribo et al 2005); and (vii) high degree of drugs abuse by livestock keepers through failure in observing the recommended therapeutic doses, use of wrong routes of administration, arbitrary drug combinations and non-observance of withdraw periods  (Mmbando 2004). Others include (i) lack of basic knowledge on the concept of antibiotic resistance among livestock keepers (Katakweba et al., 2012); (ii) unregulated disposal of industrial waste; and (iii) unregulated disposal of waste in dumps; as well as self-medication using antimicrobials (Kajeguka & Moses, 2017). AMR is been seen at the time when there has been diminishing number of novel antibiotics, risking rise of untreatable infections and inevitable loss of life (Parsonage et al 2017) especially in resource limited countries with limited treatment options.

 

AIM AND OBJECTIVES

 

To attain a holistic understanding of AMR, this proposal aims to uncover the covert and overt drivers of AMR within Tanzania’s public health and animal health system using a triangulation of qualitative methods and interdisciplinary, “One Health” research approach.

The specific objectives are:

• Conduct a needs assessment to identify the gaps that currently exist in the areas of surveillance, access to, and stewardship of antimicrobials at all levels of the human and animal health systems.
• Review existing policies, programmes and structures in place that address antimicrobial use (AMU) and AMR in humans and animals.
• Conduct a stakeholder analysis of the AMR environment to examine the motivations, social constructs, contextual drivers and power relations of policy actors that influence behaviours and decision-making processes in developing policies for AMR, specifically in relation to the appropriate AMU.
• Based on the policy analysis, needs assessment and stakeholder analysis, identify and prioritise potential interventions in the public and animal healthcare sectors that can be tested using appropriate epidemiological designs and incorporating suitable evaluation methods to measure their impact.
• Develop strategies and tools for working with policy makers to effectively implement policies for responsible AMU in human and pig populations.

 

THEORETICAL FRAMEWORK

 

Health Systems, Policy and Behavioural Sciences Research: Health systems research is an interdisciplinary field that brings together diverse disciplines to better understand how societies organize themselves to achieve collective health goals. Such research provides insight into how health systems both shape and are shaped by policies and other social determinants of health. Health systems research is intertwined with health policy research as policymaking and decision-making processes are directly and indirectly affected by the processes and dynamics driving health systems. In the context of AMR, health system strengthening at the global, regional and national level is called for in addressing the multifaceted drivers of AMR with the One Health approach as the cornerstone for policies addressing AMR.

 

The One Health Approach: Tackling AMR is quintessentially a One Health issue that requires a holistic and multidisciplinary approach as it has a clear link that intersects with all three domains of human health, animal health, and the wider environment. Further, globalization has brought on an unprecedented increase in cross-border movements of people, animals and food commodities, which precipitates the global spread of resistant organisms. Against this backdrop, this initiative will seek to generate local and international evidence to facilitate policy recommendations and directions within the framework of the One Health approach focused on the mitigation and management of AMR. Most of the investigators in this project already collaborate in a One Health partners, primarily SACIDS Foundation for One Health which is a One Health Virtual Centre that links medical and veterinary, academic and research institutions in Southern and Eastern Africa with the London School of Hygiene and Tropical Medicine (LSHTM) with Chatham House in the area of One Health, including AMR. We will also build on the Tanzania National Action Plan for Antimicrobial Resistance (URT-WHO, 2017) that has been developed and an inter-sectorial collaboration between Ministries responsible for Public Health and Animal Health, under the coordination of the National One Health Platform in the Office of the Prime Minister.

 

Multisectoral Approach to AMR: Relevant stakeholders may be included from public and private sectors, as well as civil societies and academic institutions in important sectors including public health, veterinary health, agriculture, food safety, and environmental health. This research project will serve as a platform to integrate research between these various disciplines and push forward academic and policy discourse among the multiple stakeholders involved in tackling AMR.

 

Integrated Governance for AMR-related actions: Integrated governance is defined as the ‘systems, processes and behaviours by which health care organizations lead, direct and control their functions in order to achieve organisational objectives, safety and quality of services, and in which they relate to patients and carers, the wider community and partner organizations’ (National Health Service 2016). Research has shown that effective governance plays a crucial role in determining antibiotic resistance in a country (Collignon et al. 2015). Good governance in the mitigation and management of AMR is therefore essential to facilitate collaborations between human and animal health sectors, and in establishing national policies, strategies and activities that are not only in line with international guidelines, but also aligned across the various sectors.

 

METHODOLOGY

 

Approach

This study will be carried out in Tanzania. Research participants will include policy/decision makers, regulatory authorities, medical and veterinary practitioners, pharmacists, pharmaceutical industries, animal feed industries, farmers, members of the community and drug vendors. The districts to be involved are Ilala, Kilosa and Kibaha. The selection of the districts are based on the following criteria. Ilala is characterised by  an urban area, densely populated, occupied by multiple activities ranging from informal housing, transport infrastructure, dump sites, agriculture, industrial commercial activities, fishing and sand mining. It is highly polluted by effluents from Msimbazi rive tributaries originating from different sources, leakage of effluent from waste dumps, abattoirs and domestic wastewater from septic tanks and pit latrines that are used by about 85% of the city population. The area is very ideal for the study because of three reasons: 1) high interaction of people with varieties of activities, 2) environmental contamination by effluents and other wastes from different sources and 3) apart from the high level of contamination reported in different studies no study conducted on antimicrobial resistant. Kibaha is characterised by large and small scale poultry farming and fish farming that are likely to be using antimicrobial in their production activities. Kilosa district has a large population of pastoralists keeping cattle and known to practice self-animal treatment, with frequent use of antibiotics.

 

First, we will conduct a needs assessment to identify the gaps that currently exist in the areas of surveillance, access to, and stewardship of antimicrobials at all levels of the human and animal health systems. Second, we will conduct a stakeholder analysis which will involve comprehensively mapping out the range of actors involved in policy processes relating to appropriate use of antimicrobials, across the One Health spectrum including formal and informal sector actors (e.g. government (human and animal) bodies, pharmaceutical and livestock production industry, trade department, civil society groups) and their networks. Using the list of policy actors generated by the mapping exercise, we will purposively select policy actors for in-depth interviews which will follow a three-part process: a) capturing existing knowledge and perceptions about AMU and AMR; b) questions about the role of the actor, exploring political, cultural, economic and institutions interests/values related to AMU and AMR; and c) the ranking and ‘thinking aloud’ exercise. Drawing on the Social Construction Framework, qualitative methods will be used by a multidisciplinary research team to identify how motivation, social constructions, power relations and contextual factors shape policy-making behaviours.  Third, based on the needs assessment and stakeholders’ analysis, researchers together with key stakeholders will identify and prioritize potential interventions in the healthcare and veterinary health systems that can be tested using appropriate epidemiological designs and incorporating suitable evaluation methods to measure their impact.

 

To attain a holistic understanding of AMR, this project aspires to uncover the covert and overt drivers of AMR within Tanzania using a multi-method and multidisciplinary research approach. Study aims will be guided by research gaps and lessons learnt identified from existing systematic reviews on AMR. This proposal will provide an avenue for research focused on analysing the policy environment for AMR in Tanzania by evaluating policy options and initiatives, developing evidence-based policy implementation strategies and measuring the impact of policy decisions relating to AMR.

 

Methodology

To achieve the overall goal of the project, an inception workshop is planned at the commencement of the project. This workshop will bring together key stakeholders including key actors identified above. During the workshop, the project objectives and approach will be shared and discussed. The priority areas will be identified in consensus approach. The engagement of the community/public and policy makers in this research project is envisaged to raise awareness and agree on the priority areas. It will also provide opportunities to members of the public and policy makers to act as informed actors of the project. With this approach, we expect that researchers shall be encouraged to identify and actively engage relevant users and stakeholders of research findings at appropriate stages as well articulate a clear understanding of the context and needs of public and policy makers and consider ways for the proposed research to provide impact on health and socio-economy of the Tanzanian populations.

 

A use of triangulation of qualitative methods (In-depth interviews, discussions with key stakeholders through workshops/forums and review of policy documents) will be adopted to conduct the needs assessment across the public health and animal health sectors of Tanzania.  The methodology will involve: mapping of policy actors and their connections (policy networks), by applying a political science based network analysis methodology (Lewis, 2006; Wonodi et al., 2012; Shearer et al., 2014). We will identify actors from government, human and animal health bodies (national and sub-national), pharmaceutical industry, animal feed industry, trade department and civil society groups through invited advisory committee members. These actors will be asked to nominate people or institutions that they view as playing an important role in driving use of antimicrobials in Tanzania. We will then contact all the nominated actors and carry on the snowballing process until saturation is reached, capturing the full set of stakeholders nominated and the networks and connections between them. We expect the initial list of identified stakeholders to be large and exhaustive.

 

Mapping of stakeholders’ influence will be done at a stakeholders’ workshop. To define stakeholders’ influence a timeframe to assess influence will be defined. The timeframe will be defined as pre-time e.g. pre-joint external evaluation (JEE) which will be the policy forming era, present time which is post-JEE and adoption of a national action plan for AMR and the future time which is the National Action Plan implementation stage. Stakeholders influence will be prioritized by ranking through expertise, willingness to engage and value. The stakeholders ranking will narrow the number to 40 for in in-depth interviews.

 

In-depth interviews and ranking exercises: At least 40 policy actors purposively selected from the mapping exercise for in-depth interviews will be asked to rank five locally adapted appropriate use policies and AMR interventions identified in the Lancet Review (Dar, 2016), while talking through their rationale using a ‘thinking aloud’ methodological approach (Someren et al., 1994). In-depth-interviews will follow a three-part process: (i) capturing existing knowledge and perceptions about AMR; (ii) questions about the role of the actor, exploring political, cultural, economic and institutions interests/values related to antimicrobial use; (iii) the ranking and ‘thinking aloud’ exercise.

 

The specific methodology for the chosen intervention will be detailed once the stakeholder and needs assessment has been conducted. But it is expected that research objectives and questions will be explored through a series of innovative research methods including a stakeholder analysis, a ranking and a thinking aloud exercises, in-depth psychosocial and behavioural studies, mapping of the supply of antimicrobials for healthcare and livestock sectors, microbiological and epidemiological investigation of AMR patterns and risk factors in human and livestock populations.

 

Capacity building

The proposal builds on pre-existing partnership between United Kingdom (UK) and Tanzania institutions, from inception of idea the research proposal has been jointly designed.  During implementation smart partnership relationship will be adopted. In design and implementation we have adopted the community of practice approach by which UK and Tanzania investigators interact regularly. This practice of exchanging ideas aims at strengthening Tanzanian institutions in good research practices. The project includes one Tanzania Post-Doc, this will strengthen health system analytical capability in Tanzania. In addition, separately funded post-doc and 3 PhD students working on AMR who will benefit by being part of wide expertise and therefore benefiting from research environment created by this project. This will have impact on the quality of the research of Post-doc and PhD students and be able to publish in high impact Journals and attend in international conferences.

 

EXPECTED OUTCOMES

 

The overall expected outcome will be an evidence based policy relevant in human and animal health systems in Tanzania that could be adoptable by policy makers to minimize AMR problem and serve as model for resource limited countries. Synthesised evidence based information on the role of health and veterinary systems in the contribution and persistence of AMR will be generated. This information will be used in strengthening the systems in relation to antimicrobial distribution and uses using evidence based practices in developing countries. New policy options for optimal intervention strategies based on a One Health approach for effective risk management of AMR will be suggested for implementation taking into account the contextual factors relevant to Tanzania. This will be summarised in a Policy Advisory Briefing document. This project expects to: (i) identify the factors affecting the enforcement of the policy and regulations on management and use of antimicrobials; and (ii) consolidate our knowledge on practices on the use of antimicrobials

 

IMPACT

 

AMR has recently emerged as among the major threat to public health systems in low-and middle-income countries like Tanzania. The misuse and abuse of antimicrobials in veterinary and human medicine practices have been described to be the major contributing factors. This study intends to attain a holistic understanding of AMR through uncovering the covert and overt drivers of AMR within Tanzania. The overall expected outcome will be a cost effective, evidence based policy relevant in health and agricultural systems in Tanzania that will be adoptable by policy makers to minimize AMR problem and serve as model for resource limited countries

 

Our pathways to impact will be through stakeholders’ engagement, knowledge translations, sensitization and policy dialogues. This will be done at the start and throughout the implementation of the project.   A number of stakeholders are expected to adopt, influenced by and benefit from the proposed research. They include government ministries (policy and decision makers) from the health, veterinary, agriculture and environment sectors, non-governmental organizations, private/business sector, and the general public. Government ministries, which will directly benefit from this research are ministries responsible for human health, animal health, agriculture, environment and industries and trade.  Under the Ministry of Health, key stakeholders are Directorate of Pharmaceutical services, Directorate of Curative Services, Tanzania Food and Drug Authority, Medical Store Department, Directorate of Quality Assurance and Directorate of Policy and Planning. Others are the National Institute for Medical Research and Tanzania Food and Nutrition Centre. President’s Office, Regional Administration and Local Government, which own most of the public health facilities is also a key stakeholder. In addition, country representative of the World Health Organization and Food and Agriculture Organization will be among the key stakeholders to be involved in the inception, implementation and conclusion of the project.

 

Within the Ministry of Livestock and Fisheries key actors are from Directorate of Veterinary Services, Tanzania Veterinary Laboratory Agency, Veterinary Council of Tanzania, Tanzania Livestock Research Institute, Livestock Training Agency and Fisheries Education Training Agency. Other key government stakeholders are the One Health Desk of the Prime Minister’s Office, Division of Environment of the Vice President’s Office and Crop Protection department of the Ministry of Agriculture. Non-governmental and faith-based organizations include Pharm Access, Christian Social Services, and Moslem Association of Tanzania (BAKWATA). Private firms including Association of Private Health Facility of Tanzania, Tanzania Farmers Association, Farmer Centre, Bajuta International and Pharmaceutical Society of Tanzania, and Professional Associations such as Medical Association of Tanzania, Tanzania Veterinary Association, Medical Laboratory Scientist Association and Tanzania Paraveterinary Association are also key stakeholders and beneficiaries of this project.

 

This project is envisaged to have both cultural, economic and health, environment and social impact to the society. The evidences to be generated are likely to influence public policy and practice as well as behavioural change in the general public. The most significant benefit will be improving human health and livestock productivity through better regulations and appropriate use of antimicrobials. The engagement of policy/decision makers will increase awareness on AMU and AMR; enhance interaction among one health actors, and ultimately, improved better use of antimicrobials as well as improved quality of life. On one hand, the policy makers, managers and implementers of AMR strategies and interventions will benefit from adopting the proposed interventions that aims at reducing AMR problems in the community. On the other hand, long term impact of reduction of prevalence of multi-drug resistance, will directly benefit the communities by increasing the effectiveness of antimicrobials through policy design and implementation.

 

A two-way engagement with publics and stakeholders approach will be adopted to provide continuous feedback that will be used to monitor the achievements of the project. The project will establish an advisory panel with representatives from key actors to provide advices during the implementation. The project plan will be shared with key stakeholders.

 

DISSEMINATION AND KNOWLEDGE TRANSLATION

 

The findings of this project will be shared with policy makers and key actors through various forums including policy dialogues and evidence-based policy briefs. Several events will be held to share the information on AMU and AMR will include public lecturers, public debates, exhibitions, public open days, conferences, seminars and workshops. Others will include press activity such as interaction with mass media, press briefing, press releases/ conferences, radio/television appearance. The research findings will be translated in an accessible and tailored format for user communities i.e. policy briefings, articles within professional newsletters, journals and magazine, promotional flyers for professional conferences and events. A web-page dedicated for the project activities will be created by the collaborating institutions. One health approach will be employed to bring together different actors from health, animal and environmental sectors to enhance the application and co-production of knowledge. Learning opportunities are expected to facilitate the societal impact of the research. There will be regular communications and feedback between project and the key stakeholders, and facilitated learning within projects. Publication products will be shared widely with all key stakeholders and the general public through the website.

 

Sharing findings along the way will be encouraged throughout the project life-span. This will enable the project to foster the inclusive involvement of as wide a range of stakeholders as possible from the project inception, implementation and knowledge translation. The project will encourage researchers to get early drafts of findings out to potential users for feedback from early on to build a learning culture and to encourage open-mindedness.

 

ETHICAL ASPECTS

 

Ethical approval to will be sought from the Medical Research Coordinating Committee of the National Institute for Medical Research in Tanzania. Upon approval, then the study will be carried out adhering to the approved protocol. The study and its objectives will be introduced to relevant authorities at all levels. During data collection, the study objectives and procedures will be explained to each stud participant, and they will be made aware that participation in the study is on voluntary basis. A written informed consent will be obtained from participants.  Participants will be free to respond or refuse to respond to any question and will be free to stop their participation in the study at any time without any penalty on such a decision. Confidentiality and anonymity of the study participants will be emphasized and maintained throughout the study.

 

DATA MANAGEMENT AND ANALYSIS

 

A database will be developed for quantitative and qualitative data. Qualitative data will be entered in EpiData v.3.1 by qualified data clerks. Descriptive statistics will be conducted by calculating necessary summary statistical measures including frequency distribution, percentages, tabulation and so forth. Graphical displays such as charts, bars, will be employed to relevant variables. Statistical analysis will be performed using Epi-Info (Atlanta, GA), SAS (Cary, NC) software or any other suitable statistical package.

 

Type of study   

This research aims to understand covert and overt drivers of antimicrobial resistance (AMR) within the human and animal health systems in Tanzania. The study will take a mixed methods multidisciplinary approach in analysing research and surveillance gaps, existing regulatory environment for AMR in Tanzania by evaluating policy options and initiatives in order to develop evidence-based policy implementation.

 

Types of data

Qualitative and quantitative data will be collected through structured and semi-structured questionnaires as well as in-depth interviews (IDI) with key stakeholders. The interviews will be conducted in the local language Kiswahili. Data output from the IDIs will be in the form of audio recordings and written transcripts. The quantitative data, will include information on AMU, surveillance indicators surveillance indicators, mapping on stakeholders/players and available guiding documents e.g. policies in AMR in animal and human health will be collected using a digital application (AfyaData). Workshop and meeting proceedings from stakeholders’ engagement forums will be documented. Raw data will be collected and analysed, expressed in the form of tables, graphs, maps, reports and publications. The captured data will be exported to the excel spread sheet for subsequent descriptive analysis using Stata software. The generated data and output of analysis will be projected onto the ArcGIS to produce antimicrobial risk profile maps.

 

• Format and scale of the data

The needs assessment will be done through in-depth interviews with key informants and stakeholder meetings at inception. Data will be entered directly through a mobile apps (AfyaData) and submitted directly to the SACIDS server. Other types of data that will be collected/generated include: Scanned or electronic copies of publicly available guidelines, documents, Technical reports and publications

 

DATA MANAGEMENT PLAN

 

Project staff and data collectors will be adequately trained before start of study. Quality checks will be performed by the PI at key stages to ensure accuracy. All data collection tools will be piloted before use and revised where needed. The data will be collected at a central server in a secure location at the SACIDS Foundation for One Health at Sokoine University of Agriculture in Morogoro. The data will be back up to an external hard drive on a daily basis.  Data will be accessed by members of the study team only by authorized personnel using user defined access code.  All collected data (tapes, electronic and paper) relating to the study will be archived at SACIDS at the end of the study. The archived data will be kept for a period of five years from date of completion of the study. Once agreed destruction of collected data will be done through shredding of paper, electronic data will be deleted, external hard drives re-formatted and tapes will be erased and physically destroyed.

 

There is a risk that unauthorized users may gain access to data containing personal information. To reduce the likelihood, user authentication will be applied throughout. Laptops used in data collection will be password protected using user authentication. Data will be transferred in an encrypted form.

Project Members: