"Arming half-baked people with weapons!" Information enclaving among professionals and the need for a care-centred model for antibiotic use information in Uganda, Tanzania and Malawi.

BACKGROUND: The overuse of antimicrobial medicines is a global health concern, including as a major driver of antimicrobial resistance. In many low- and middle-income countries, a substantial proportion of antibiotics are purchased over-the-counter without a prescription. But while antibiotics are widely available, information on when and how to use them is not. OBJECTIVE: We aimed to understand the acceptability among experts and professionals of sharing information on antibiotic use with end users - patients, carers and farmers - in Uganda, Tanzania and Malawi. METHODS: Building on extended periods of fieldwork amongst end-users and antibiotic providers in the three countries, we conducted two workshops in each, with a total of 44 medical and veterinary professionals, policy makers and drug regulators, in December 2021. We carried out extensive documentary and literature reviews to characterise antibiotic information systems in each setting. RESULTS: Participants reported that the general public had been provided information on medicine use in all three countries by national drug authorities, health care providers and in package inserts. Participants expressed concern over the danger of sharing detailed information on antibiotic use, particularly that end-users are not equipped to determine appropriate use of medicines. Sharing of general instructions to encourage professionally-prescribed practices was preferred. CONCLUSIONS: Without good access to prescribers, the tension between enclaving and sharing of knowledge presents an equity issue. Transitioning to a client care-centred model that begins with the needs of the patient, carer or farmer will require sharing unbiased antibiotic information at the point of care.

House modifications as a malaria control tool: how does local context shape participants' experience and interpretation in Uganda?

BACKGROUND: Evidence that house design can provide protection from malaria is growing. Housing modifications such as screening windows, doors, and ceilings, and attaching insecticide-impregnated materials to the eaves (the gap between the top of the wall and bottom of the roof), can protect against malaria. To be effective at scale, however, these modifications must be adopted by household residents. There is evidence that housing modifications can be acceptable, but in-depth knowledge on the experiences and interpretation of modifications is lacking. This qualitative study was carried out to provide a holistic account of the relationship between experiences and interpretations of four types of piloted housing modifications and the local context in Jinja, Uganda. METHODS: Qualitative research was conducted between January to June 2021, before and during the installation of four types of housing modifications. The methods included nine weeks of participant observations in two study villages, nine focus group discussions with primary caregivers and heads of households (11-12 participants each), and nine key informant interviews with stakeholders and study team members. RESULTS: Most residents supported the modifications. Experiences and interpretation of the housing modifications were shaped by the different types of housing in the area and the processes through which residents finished their houses, local forms of land and property ownership, and cultural and spiritual beliefs about houses. CONCLUSIONS: To maximize the uptake and benefit of housing modifications against malaria, programme development needs to take local context into account. Forms of local land and house ownership, preferences, the social significance of housing types, and religious and spiritual ideas shape the responses to housing modifications in Jinja. These factors may be important in other setting. Trial registration Trial registration number is NCT04622241. The first draft was posted on November 9th 2020.

Pharmaceuticalised livelihoods: antibiotics and the rise of 'Quick Farming' in peri-urban Uganda.

The 'livestock revolution' has seen the lives and livelihoods of peri-urban peoples increasingly intertwine with pigs and poultry across Africa in response to a rising demand for meat protein. This 'revolution' heralds the potential to address both poverty and nutritional needs. However, the intensification of farming has sparked concern, including for antibiotic misuse and its consequences for antimicrobial resistance (AMR). These changes reflect a micro-biopolitical conundrum where the agendas of microbes, farmers, publics, authorities and transnational agencies are in tension. To understand this requires close attention to the practices, principles and potentials held between these actors. Ethnographic research took place in a peri-urban district, Wakiso, in Uganda between May 2018 and March 2021. This included a medicine survey at 115 small- and medium-scale pig and poultry farms, 18 weeks of participant observation at six farms, 34 in-depth interviews with farmers and others in the local livestock sector, four group discussions with 38 farmers and 7 veterinary officers, and analysis of archival, media and policy documents. Wide-scale adoption of quick farming was found, an entrepreneurial phenomenon that sees Ugandans raising 'exotic' livestock with imported methods and measures for production, including antibiotics for immediate therapy, prevention of infections and to promote production and protection of livelihoods. This assemblage - a promissory assemblage of the peri-urban - reinforced precarity against which antibiotics formed a potential layer of protection. The paper argues that to address antibiotic use as a driver of AMR is to address precarity as a driver of antibiotic use. Reduced reliance on antibiotics required a level of biosecurity and economies of scale in purchasing insurance that appeared affordable only by larger-scale commercial producers. This study illustrates the risks - to finances, development and health - of expanding an entrepreneurial model of protein production in populations vulnerable to climate, infection and market dynamics.

Taking Opportunities, Taking Medicines: Antibiotic Use in Rural Eastern Uganda.

The ways in which dimensions of health and healthcare intersect with economics and politics in particular contexts requires close attention. In this article we connect concerns about antibiotic overuse in Uganda to the social milieu created through policies that follow President Museveni's vision for a population who kulembeka, "tap wealth." Ethnographic fieldwork in rural Eastern Uganda illustrates how taking medicines in rural households reflects a wider landscape of everyday imperatives to "tap" opportunities in a context of acute precarity. We argue for a closer connection between medical and economic anthropology to push forward understanding of health, medicines and wellbeing in Africa.

Reconciling imperatives: Clinical guidelines, antibiotic prescribing and the enactment of good care in lower-level health facilities in Tororo, Uganda.

Faced with the threat of antimicrobial resistance, health workers are urged to reduce unnecessary prescription of antimicrobials. Clinical guidelines are expected to form the basis of prescribing decisions in practice. Emerging through evaluations of best practice - bundling clinical, technological and economic dimensions - guidelines also create benchmarks through which practice can be assessed with metrics. To understand the relationships between guidelines and practice in the prescribing and dispensing of antibiotics, ethnographic fieldwork was undertaken in lower-level health care facilities in rural Eastern Uganda for 10 months between January and October 2020, involving direct observations during and outside of clinics and interviews with staff. In a context of scarcity, where 'care' is characterised by delivery of medicines, and is constituted beyond algorithmic outputs, we observed that clinical practice was shaped by availability of resources, and professional and patient expectations, as much as by the clinical guidelines. For stewardship to care for patients as well as for medicines, a better understanding of clinical practice and expectations of care is required in relation to and beyond clinical guidelines.

Antibiotic stories: a mixed-methods, multi-country analysis of household antibiotic use in Malawi, Uganda and Zimbabwe.

BACKGROUND: As concerns about the prevalence of infections that are resistant to available antibiotics increase, attention has turned toward the use of these medicines both within and outside of formal healthcare settings. Much of what is known about use beyond formal settings is informed by survey-based research. Few studies to date have used comparative, mixed-methods approaches to render visible patterns of use within and between settings as well as wider points of context shaping these patterns. DESIGN: This article analyses findings from mixed-methods anthropological studies of antibiotic use in a range of rural and urban settings in Zimbabwe, Malawi and Uganda between 2018 and 2020. All used a 'drug bag' survey tool to capture the frequency and types of antibiotics used among 1811 households. We then undertook observations and interviews in residential settings, with health providers and key stakeholders to better understand the stories behind the most-used antibiotics. RESULTS: The most self-reported 'frequently used' antibiotics across settings were amoxicillin, cotrimoxazole and metronidazole. The stories behind their use varied between settings, reflecting differences in the configuration of health systems and antibiotic supplies. At the same time, these stories reveal cross-cutting features and omissions of contemporary global health programming that shape the contours of antibiotic (over)use at national and local levels. CONCLUSIONS: Our findings challenge the predominant focus of stewardship frameworks on the practices of antibiotic end users. We suggest future interventions could consider systems-rather than individuals-as stewards of antibiotics, reducing the need to rely on these medicines to fix other issues of inequity, productivity and security.

Marked reduction in antibiotic usage following intensive malaria control in a cohort of Ugandan children.

BACKGROUND: Intensive malaria control may have additional benefits beyond reducing the incidence of symptomatic malaria. We compared antibiotic treatment of children before and after the implementation of highly effective malaria control interventions in Tororo, a historically high transmission area of Uganda. METHODS: Two successive cohorts of children, aged 0.5 to 10 years, were followed from September 2011 to October 2019 in a dedicated study clinic. Universal distribution of long-lasting insecticidal nets was conducted in 2013 and 2017. Sustained indoor residual spraying of insecticide (IRS) was initiated in December 2014. Generalized linear mixed-effects models were used to compare the incidence of antimalarial and antibiotic treatments before and after vector control measures were implemented. RESULTS: Comparing the period prior to the implementation of IRS to the period after IRS had been sustained for 4-5 years, the adjusted incidence of malaria treatments decreased from 2.68 to 0.05 per person-year (incidence rate ratio [IRR] = 0.02, 95% CI 0.01-0.03, p < 0.001), and the adjusted incidence of antibiotic treatments decreased from 4.14 to 1.26 per person-year (IRR = 0.30, 95% CI 0.27-0.34, p < 0.001). The reduction in antibiotic usage was primarily associated with fewer episodes of symptomatic malaria and fewer episodes of fever with sub-microscopic parasitemia, both of which were frequently treated with antibiotics. CONCLUSIONS: In a historically high transmission setting, the implementation of highly effective vector control interventions was followed by a marked reduction in antibiotic treatment of children. This added benefit of malaria control could have important implications for antibiotic prescribing practices, efforts to curtail antimicrobial resistance, and health system costs.

Opening the 'black box' of collaborative improvement: a qualitative evaluation of a pilot intervention to improve quality of malaria surveillance data in public health centres in Uganda.

BACKGROUND: Demand for high-quality surveillance data for malaria, and other diseases, is greater than ever before. In Uganda, the primary source of malaria surveillance data is the Health Management Information System (HMIS). However, HMIS data may be incomplete, inaccurate or delayed. Collaborative improvement (CI) is a quality improvement intervention developed in high-income countries, which has been advocated for low-resource settings. In Kayunga, Uganda, a pilot study of CI was conducted in five public health centres, documenting a positive effect on the quality of HMIS and malaria surveillance data. A qualitative evaluation was conducted concurrently to investigate the mechanisms of effect and unintended consequences of the intervention, aiming to inform future implementation of CI. METHODS: The study intervention targeted health workers, including brief in-service training, plus CI with 'plan-do-study-act' (PDSA) cycles emphasizing self-reflection and group action, periodic learning sessions, and coaching from a CI mentor. Health workers collected data on standard HMIS out-patient registers. The qualitative evaluation (July 2015 to September 2016) included ethnographic observations at each health centre (over 12-14 weeks), in-depth interviews with health workers and stakeholders (n = 20), and focus group discussions with health workers (n = 6). RESULTS: The results suggest that the intervention did facilitate improvement in data quality, but through unexpected mechanisms. The CI intervention was implemented as planned, but the PDSA cycles were driven largely by the CI mentor, not the health workers. In this context, characterized by a rigid hierarchy within the health system of limited culture of self-reflection and inadequate training and supervision, CI became an effective form of high-quality training with frequent supervisory visits. Health workers appeared motivated to improve data collection habits by their loyalty to the CI mentor and the potential for economic benefits, rather than a desire for self-improvement. CONCLUSIONS: CI is a promising method of quality improvement and could have a positive impact on malaria surveillance data. However, successful scale-up of CI in similar settings may require deployment of highly skilled mentors. Further research, focusing on the effectiveness of 'real world' mentors using robust study designs, will be required to determine whether CI can be translated effectively and sustainably to low-resource settings.

Setting the standard: multidisciplinary hallmarks for structural, equitable and tracked antibiotic policy.

There is increasing concern globally about the enormity of the threats posed by antimicrobial resistance (AMR) to human, animal, plant and environmental health. A proliferation of international, national and institutional reports on the problems posed by AMR and the need for antibiotic stewardship have galvanised attention on the global stage. However, the AMR community increasingly laments a lack of action, often identified as an 'implementation gap'. At a policy level, the design of internationally salient solutions that are able to address AMR's interconnected biological and social (historical, political, economic and cultural) dimensions is not straightforward. This multidisciplinary paper responds by asking two basic questions: (A) Is a universal approach to AMR policy and antibiotic stewardship possible? (B) If yes, what hallmarks characterise 'good' antibiotic policy? Our multistage analysis revealed four central challenges facing current international antibiotic policy: metrics, prioritisation, implementation and inequality. In response to this diagnosis, we propose three hallmarks that can support robust international antibiotic policy. Emerging hallmarks for good antibiotic policies are: Structural, Equitable and Tracked. We describe these hallmarks and propose their consideration should aid the design and evaluation of international antibiotic policies with maximal benefit at both local and international scales.

Use of antibiotics to treat humans and animals in Uganda: a cross-sectional survey of households and farmers in rural, urban and peri-urban settings.

BACKGROUND: Use of antibiotics to treat humans and animals is increasing worldwide, but evidence from low- and middle-income countries (LMICs) is limited. We conducted cross-sectional surveys in households and farms in Uganda to assess patterns of antibiotic use among humans and animals. METHODS: Between May and December 2018, a convenience sample of 100 households in Nagongera (rural), 174 households in Namuwongo (urban) and 115 poultry and piggery farms in Wakiso (peri-urban) were selected and enrolled. Using the 'drug bag' method, participants identified antibiotics they used frequently and the sources of these medicines. Prevalence outcomes were compared between different sites using prevalence ratios (PRs) and chi-squared tests. RESULTS: Nearly all respondents in Nagongera and Namuwongo reported using antibiotics to treat household members, most within the past month (74.7% Nagongera versus 68.8% Namuwongo, P = 0.33). Use of metronidazole was significantly more common in Namuwongo than in Nagongera (73.6% versus 40.0%, PR 0.54, 95% CI: 0.42-0.70, P < 0.001), while the opposite was true for amoxicillin (33.3% versus 58.0%, PR 1.74, 95% CI: 1.33-2.28, P < 0.001).Veterinary use of antibiotics within the past month was much higher in Wakiso than in Nagongera (71.3% versus 15.0%, P < 0.001). At both sites, oxytetracycline hydrochloride was the most frequently used veterinary antibiotic, but it was used more commonly in Wakiso than in Nagongera (76.5% versus 31.0%, PR 0.41, 95% CI: 0.30-0.55, P < 0.001). CONCLUSIONS: Antibiotics are used differently across Uganda. Further research is needed to understand why antibiotics are relied upon in different ways in different contexts. Efforts to optimize antibiotic use should be tailored to specific settings.

The 'Drug Bag' method: lessons from anthropological studies of antibiotic use in Africa and South-East Asia.

Understanding the prevalence and types of antibiotics used in a given human and/or animal population is important for informing stewardship strategies. Methods used to capture such data often rely on verbal elicitation of reported use that tend to assume shared medical terminology. Studies have shown the category 'antibiotic' does not translate well linguistically or conceptually, which limits the accuracy of these reports. This article presents a 'Drug Bag' method to study antibiotic use (ABU) in households and on farms, which involves using physical samples of all the antibiotics available within a given study site. We present the conceptual underpinnings of the method, and our experiences of using this method to produce data about antibiotic recognition, use and accessibility in the context of anthropological research in Africa and South-East Asia. We illustrate the kinds of qualitative and quantitative data the method can produce, comparing and contrasting our experiences in different settings. The Drug Bag method produce accurate antibiotic use data as well as provide a talking point for participants to discuss antibiotic experiences. We propose it can help improve our understanding of antibiotic use in peoples' everyday lives across different contexts, and our reflections add to a growing conversation around methods to study ABU beyond prescriber settings, where data gaps are currently substantial.

Understanding the context of delays in seeking appropriate care for children with symptoms of severe malaria in Uganda.

INTRODUCTION: A large proportion of children with uncomplicated malaria receive appropriate treatment late, contributing to progression of illness to severe disease. We explored contexts of caregiver delays in seeking appropriate care for children with severe malaria. METHODS: This qualitative study was conducted at the Children's Ward of Jinja Hospital, where children with severe malaria were hospitalized. A total of 22in-depth interviews were conducted with caregivers of children hospitalized with severe malaria. Issues explored were formulated based on the Partners for Applied Social Sciences (PASS) model, focusing on facilitators and barriersto caregivers'promptseeking and accessing ofappropriate care. The data were coded deductively using ATLAS.ti (version 7.5). Codes were then grouped into families based on emerging themes. RESULTS: Caregivers' rating of initial symptoms as mild illness lead to delays in response. Use of home initiated interventions with presumably ineffective herbs or medicines was common, leading to further delay. When care was sought outside the home, drug shops were preferred over public health facilities for reasons of convenience. Drug shops often provided sub-optimal care, and thus contributed to delays in access to appropriate care. Public facilities were often a last resort when illness was perceived to be progressing to severe disease. Further delays occurred at health facilities due to inadequate referral systems. CONCLUSION: Communities living in endemic areas need to be sensitized about the significance of fever, even if mild, as an indicator of malaria. Additionally, amidst ongoing efforts at bringing antimalarial treatment services closer to communities, the value of drug shops as providers ofrationalantimalarialtreatment needs to be reviewed.

Data value and care value in the practice of health systems: A case study in Uganda.

In anthropology, interest in how values are created, maintained and changed has been reinvigorated. In this case study, we draw on this literature to interrogate concerns about the relationship between data collection and the delivery of patient care within global health. We followed a pilot study conducted in Kayunga, Uganda that aimed to improve the collection of health systems data in five public health centres. We undertook ethnographic research from July 2015 to September 2016 in health centres, at project workshops, meetings and training sessions. This included three months of observations by three fieldworkers; in-depth interviews with health workers (n = 15) and stakeholders (n = 5); and six focus group discussions with health workers. We observed that measurement, calculation and narrative practices could be assigned care-value or data-value and that the attempt to improve data collection within health facilities transferred 'data-value' into health centres with little consideration among project staff for its impact on care. We document acts of acquiescence and resistance to data-value by health workers. We also describe the rare moments when senior health workers reconciled these two forms of value, and care-value and data-value were enacted simultaneously. In contrast to many anthropological accounts, our analysis suggests that data-value and care-value are not necessarily conflicting. Actors seeking to make changes in health systems must, however, take into account local forms of value and devise health systems interventions that reinforce and enrich existing ethically driven practice.

The impact of an intervention to introduce malaria rapid diagnostic tests on fever case management in a high transmission setting in Uganda: A mixed-methods cluster-randomized trial (PRIME).

BACKGROUND: Rapid diagnostic tests for malaria (mRDTs) have been scaled-up widely across Africa. The PRIME study evaluated an intervention aiming to improve fever case management using mRDTs at public health centers in Uganda. METHODS: A cluster-randomized trial was conducted from 2010-13 in Tororo, a high malaria transmission setting. Twenty public health centers were randomized in a 1:1 ratio to intervention or control. The intervention included training in health center management, fever case management with mRDTs, and patient-centered services; plus provision of mRDTs and artemether-lumefantrine (AL) when stocks ran low. Three rounds of Interviews were conducted with caregivers of children under five years of age as they exited health centers (N = 1400); reference mRDTs were done in children with fever (N = 1336). Health worker perspectives on mRDTs were elicited through semi-structured questionnaires (N = 49) and in-depth interviews (N = 10). The primary outcome was inappropriate treatment of malaria, defined as the proportion of febrile children who were not treated according to guidelines based on the reference mRDT. FINDINGS: There was no difference in inappropriate treatment of malaria between the intervention and control arms (24.0% versus 29.7%, adjusted risk ratio 0.81 [95% CI: 0.56, 1.17] p = 0.24). Most children (76.0%) tested positive by reference mRDT, but many were not prescribed AL (22.5% intervention versus 25.9% control, p = 0.53). Inappropriate treatment of children testing negative by reference mRDT with AL was also common (31.3% invention vs 42.4% control, p = 0.29). Health workers appreciated mRDTs but felt that integrating testing into practice was challenging given constraints on time and infrastructure. CONCLUSIONS: The PRIME intervention did not have the desired impact on inappropriate treatment of malaria for children under five. In this high transmission setting, use of mRDTs did not lead to the reductions in antimalarial prescribing seen elsewhere. Broader investment in health systems, including infrastructure and staffing, will be required to improve fever case management.

Behind the scenes of the PRIME intervention: designing a complex intervention to improve malaria care at public health centres in Uganda.

BACKGROUND: In Uganda, health system challenges limit access to good quality healthcare and contribute to slow progress on malaria control. We developed a complex intervention (PRIME), which was designed to improve quality of care for malaria at public health centres. OBJECTIVE: Responding to calls for increased transparency, we describe the PRIME intervention's design process, rationale, and final content and reflect on the choices and challenges encountered during the design of this complex intervention. DESIGN: To develop the intervention, we followed a multistep approach, including the following: 1) formative research to identify intervention target areas and objectives; 2) prioritization of intervention components; 3) review of relevant evidence; 4) development of intervention components; 5) piloting and refinement of workshop modules; and 6) consolidation of the PRIME intervention theories of change to articulate why and how the intervention was hypothesized to produce desired outcomes. We aimed to develop an intervention that was evidence-based, grounded in theory, and appropriate for the study context; could be evaluated within a randomized controlled trial; and had the potential to be scaled up sustainably. RESULTS: The process of developing the PRIME intervention package was lengthy and dynamic. The final intervention package consisted of four components: 1) training in fever case management and use of rapid diagnostic tests for malaria (mRDTs); 2) workshops in health centre management; 3) workshops in patient-centred services; and 4) provision of mRDTs and antimalarials when stocks ran low. CONCLUSIONS: The slow and iterative process of intervention design contrasted with the continually shifting study context. We highlight the considerations and choices made at each design stage, discussing elements we included and why, as well as those that were ultimately excluded. Reflection on and reporting of 'behind the scenes' accounts of intervention design may improve the design, assessment, and generalizability of complex interventions and their evaluations.

Challenging logics of complex intervention trials: community perspectives of a health care improvement intervention in rural Uganda.

Health systems in many African countries are failing to provide populations with access to good quality health care. Morbidity and mortality from curable diseases such as malaria remain high. The PRIME trial in Tororo, rural Uganda, designed and tested an intervention to improve care at health centres, with the aim of reducing ill-health due to malaria in surrounding communities. This paper presents the impact and context of this trial from the perspective of community members in the study area. Fieldwork was carried out for a year from the start of the intervention in June 2011, and involved informal observation and discussions as well as 13 focus group discussions with community members, 10 in-depth interviews with local stakeholders, and 162 context descriptions recorded through quarterly interviews with community members, health workers and district officials. Community members observed a small improvement in quality of care at most, but not all, intervention health centres. However, this was diluted by other shortfalls in health services beyond the scope of the intervention. Patients continued to seek care at health centres they considered inadequate as well as positioning themselves and their children to access care through other sources such as research and nongovernmental organization (NGO) projects. These findings point to challenges of designing and delivering interventions within a paradigm that requires factorial (reduced to predictable factors) problem definition with easily actionable and evaluable solutions by small-scale projects. Such requirements mean that interventions often work on the periphery of a health system rather than tackling the murky political and economic realities that shape access to care but are harder to change or evaluate with randomized controlled trials. Highly projectified settings further reduce the ability to genuinely 'control' for different health care access scenarios. We argue for a raised consciousness of how evaluation paradigms impact on intervention choices.

Strengthening patient-centred communication in rural Ugandan health centres: A theory-driven evaluation within a cluster randomized trial.

This article describes a theory-driven evaluation of one component of an intervention to improve the quality of health care at Ugandan public health centres. Patient-centred services have been advocated widely, but such approaches have received little attention in Africa. A cluster randomized trial is evaluating population-level outcomes of an intervention with multiple components, including 'patient-centred services.' A process evaluation was designed within this trial to articulate and evaluate the implementation and programme theories of the intervention. This article evaluates one hypothesized mechanism of change within the programme theory: the impact of the Patient Centred Services component on health-worker communication. The theory-driven approach extended to evaluation of the outcome measures. The study found that the proximal outcome of patient-centred communication was rated 10 percent higher (p < 0.008) by care seekers consulting with the health workers who were at the intervention health centres compared with those at control health centres. This finding will strengthen interpretation of more distal trial outcomes.

The PROCESS study: a protocol to evaluate the implementation, mechanisms of effect and context of an intervention to enhance public health centres in Tororo, Uganda.

BACKGROUND: Despite significant investments into health improvement programmes in Uganda, health indicators and access to healthcare remain poor across the country. The PRIME trial aims to evaluate the impact of a complex intervention delivered in public health centres on health outcomes of children and management of malaria in rural Uganda. The intervention consists of four components: Health Centre Management; Fever Case Management; Patient- Centered Services; and support for supplies of malaria diagnostics and antimalarial drugs. METHODS: The PROCESS study will use mixed methods to evaluate the processes, mechanisms of change, and context of the PRIME intervention by addressing five objectives. First, to develop a comprehensive logic model of the intervention, articulating the project's hypothesised pathways to trial outcomes. Second, to evaluate the implementation of the intervention, including health worker training, health centre management tools, and the supply of artemether-lumefantrine (AL) and rapid diagnostic tests (RDTs) for malaria. Third, to understand mechanisms of change of the intervention components, including testing hypotheses and interpreting realities of the intervention, including resistance, in context. Fourth, to develop a contextual record over time of factors that may have affected implementation of the intervention, mechanisms of change, and trial outcomes, including factors at population, health centre and district levels. Fifth, to capture broader expected and unexpected impacts of the intervention and trial activities among community members, health centre workers, and private providers. Methods will include intervention logic mapping, questionnaires, recorded consultations, in-depth interviews, focus group discussions, and contextual data documentation. DISCUSSION: The findings of this PROCESS study will be interpreted alongside the PRIME trial results. This will enable a greater ability to generalise the findings of the main trial. The investigators will attempt to assess which methods are most informative in such evaluations of complex interventions in low-resource settings. TRIAL REGISTRATION: Clinicaltrials.gov, NCT01024426.

Pharmacovigilance of antimalarial treatment in Uganda: community perceptions and suggestions for reporting adverse events.

OBJECTIVES: The deployment of new antimalarials in Africa provides an important opportunity to develop systems for pharmacovigilance. To inform strategies for reporting adverse events in Uganda, we investigated local perceptions and experiences with antimalarial treatment, and evaluated existing and potential systems for pharmacovigilance. METHODS: Focus group discussions (FGD) were conducted with community members and health workers from urban and rural Uganda exploring knowledge of fever/malaria, perceptions and expectations of treatment, understanding of adverse effects, and experiences with adverse events. Sessions were recorded, transcribed into English, and analysed using a coding scheme developed from pre-defined topics together with themes emerging from the data. RESULTS: Between April and July 2006, we conducted 25 FGDs; 16 with community members and nine with health workers. All respondents had extensive experience with malaria and its treatment. Community members commonly recognized adverse effects of antimalarial therapy. However, events were uncommonly reported, and certain events were often interpreted as signs of successful treatment. Community members often felt that the costs of reporting or seeking additional care outweighed the potential benefits. Health workers were unfamiliar with formal pathways for reporting, and were deterred by the additional work of reporting and fear of incrimination. Respondents provided suggestions for incentives and methods of reporting, emphasizing that pharmacovigilance should ideally encompass the public and private sector, and the community. CONCLUSIONS: To be successful, pharmacovigilance relying on voluntary reporting will require active participation of patients and health workers. Addressing the costs and benefits of reporting, and providing sensitization, training and feedback will be important.