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Abstract Background The importance of strong and transformative leadership is recognised as essential to the building of resilient and responsive health systems. In this regard, Sustainable Development Goals (SDG) 5 prioritises a current gap, by calling for women’s full and effective participation and equal opportunities for leadership, including in the health system. In South Africa, pre-democracy repressive race-based policies, coupled with strong patriarchy, led to women and especially black women, being ‘left behind’ in terms of career development and progression into senior health leadership positions. Methods Given limited prior inquiry into this subject, we conducted a qualitative exploratory study employing case study design, with the individual managers as the cases, to examine the influence of gender on career progression and leadership perceptions and experiences of senior managers in South Africa in five geographical districts, located in two provinces. We explored this through in-depth interviews, including life histories, career pathway mapping and critical incident analysis. The study sample selection was purposive and included 14 female and 5 male senior-managers in district and provincial health departments. Results Our findings suggest that women considerably lag behind their male counterparts in advancing into management- and senior positions. We also found that race strongly intersected with gender in the lived experiences and career pathways of black female managers and in part for some black male managers. Professional hierarchy further compounded the influence of gender and race for black women managers, as doctors, who were frequently male, advanced more rapidly into management and senior management positions, than their female counterparts. Although not widespread, other minority groups, such as male managers in predominantly female departments, also experienced prejudice and marginalisation. Affirmative employment policies, introduced in the new democratic dispensation, addressed this discriminatory legacy and contributed to a number of women being the ‘first’ to occupy senior management positions. In one of the provinces, these pioneering female managers assumed role-modelling and mentoring roles and built strong networks of support for emerging managers. This was aided by an enabling, value-based, organisational culture. Conclusion This study has implications for institutionalising personal and organisational development that recognise and appropriately advances women managers, paying attention to the intersections of gender, race and professional hierarchy. It is important in the context of national and global goals, in particular SDG 5, that women and in particular black women, are prioritised for training and capacity development and ensuring that transformative health system policies and practices recognise and adapt, supporting the multiple social and work roles that managers, in particular women, play.

Abstract Background Health inequity has mainly been linked to differences in economic status, with the poor facing greater challenges accessing healthcare than the less poor. To extend financial coverage to the poor and vulnerable, Kenya has therefore implemented several pro-poor health policy reforms. However, other social determinants of health such as gender and disability also influence health status and access to care. This study employed an intersectional approach to explore how gender disability and poverty interact to influence how poor women in Kenya benefit from pro-poor financing policies that target them. Methods We applied a qualitative cross-sectional study approach in two purposively selected counties in Kenya. We collected data using in-depth interviews with women with disabilities living in poverty who were beneficiaries of the health insurance subsidy programme and those in the lowest wealth quintiles residing in the health and demographic surveillance system. We analyzed data using a thematic approach drawing from the study’s conceptual framework. Results Women with disabilities living in poverty often opted to forgo seeking free healthcare services because of their roles as the primary household providers and caregivers. Due to limited mobility, they needed someone to accompany them to health facilities, leading to greater transport costs. The absence of someone to accompany them and unaffordability of the high transport costs, for example, made some women forgo seeking antenatal and skilled delivery services despite the existence of a free maternity programme. The layout and equipment at health facilities offering care under pro-poor health financing policies were disability-unfriendly. The latter in addition to negative healthcare worker attitudes towards women with disabilities discouraged them from seeking care. Negative stereotypes against women with disabilities in the society led to their exclusion from public participation forums thereby limiting their awareness about health services. Conclusions Intersections of gender, poverty, and disability influenced the experiences of women with disabilities living in poverty with pro-poor health financing policies in Kenya. Addressing the healthcare access barriers they face could entail ensuring availability of disability-friendly health facilities and public transport systems, building cultural competence in health service delivery, and empowering them to engage in public participation.

Abstract Background Gender is often neglected in health systems, yet health systems are not gender neutral. Within health systems research, gender analysis seeks to understand how gender power relations create inequities in access to resources, the distribution of labour and roles, social norms and values, and decision-making. This paper synthesises findings from nine studies focusing on four health systems domains, namely human resources, service delivery, governance and financing. It provides examples of how a gendered and/or intersectional gender approach can be applied by researchers in a range of low- and middle-income settings (Cambodia, Zimbabwe, Uganda, India, China, Nigeria and Tanzania) to issues across the health system and demonstrates that these types of analysis can uncover new and novel ways of viewing seemingly intractable problems. Methods The research used a combination of mixed, quantitative, qualitative and participatory methods, demonstrating the applicability of diverse research methods for gender and intersectional analysis. Within each study, the researchers adapted and applied a variety of gender and intersectional tools to assist with data collection and analysis, including different gender frameworks. Some researchers used participatory tools, such as photovoice and life histories, to prompt deeper and more personal reflections on gender norms from respondents, whereas others used conventional qualitative methods (in-depth interviews, focus group discussion). Findings from across the studies were reviewed and key themes were extracted and summarised. Results Five core themes that cut across the different projects were identified and are reported in this paper as follows: the intersection of gender with other social stratifiers; the importance of male involvement; the influence of gendered social norms on health system structures and processes; reliance on (often female) unpaid carers within the health system; and the role of gender within policy and practice. These themes indicate the relevance of and need for gender analysis within health systems research. Conclusion The implications of the diverse examples of gender and health systems research highlighted indicate that policy-makers, health practitioners and others interested in enhancing health system research and delivery have solid grounds to advance their enquiry and that one-size-fits-all heath interventions that ignore gender and intersectionality dimensions require caution. It is essential that we build upon these insights in our efforts and commitment to move towards greater equity both locally and globally.

Abstract Background The Nigerian National Health Act proposes a radical shift in health financing in Nigeria through the establishment of a fund – Basic Healthcare Provision Fund, (BHCPF). This Fund is intended to improve the functioning of primary health care in Nigeria. Key stakeholders at national, sub-national and local levels have raised concerns over the management of the BHCPF with respect to the roles of various stakeholders in ensuring accountability for its use, and the readiness of the implementers to manage this fund and achieve its objectives. This study explores the governance and accountability readiness of the different layers of implementation of the Fund; and it contributes to the generation of policy implementation guidelines around governance and accountability for the Fund. Methods National, state and LGA level respondents were interviewed using a semi structured tool. Respondents were purposively selected to reflect the different layers of implementation of primary health care and the levels of accountability. Different accountability layers and key stakeholders expected to implement the BHCPF are the Federal government (Federal Ministry of Health, NPHCDA, NHIS, Federal Ministry of Finance); the State government (State Ministry of Health, SPHCB, State Ministry of Finance, Ministry of Local Government); the Local government (Local Government Health Authorities); Health facilities (Health workers, Health facility committees (HFC) and External actors (Development partners and donors, CSOs, Community members). Results In general, the strategies for accountability encompass planning mechanisms, strong and transparent monitoring and supervision systems, and systematic reporting at different levels of the healthcare system. Non-state actors, particularly communities, must be empowered and engaged as instruments for ensuring external accountability at lower levels of implementation. New accountability strategies such as result-based or performance-based financing could be very valuable. Conclusion The key challenges to accountability identified should be addressed and these included trust, transparency and corruption in the health system, political interference at higher levels of government, poor data management, lack of political commitment from the State in relation to release of funds for health activities, poor motivation, mentorship, monitoring and supervision, weak financial management and accountability systems and weak capacity to implement suggested accountability mechanisms due to political interference with accountability structures.

Background Kenya introduced a free maternity policy in 2013 to address the cost barrier associated with accessing maternal health services. We carried out a mixed methods process evaluation of the policy to examine the extent to which the policy had been implemented according to design, and positive experiences and challenges encountered during implementation. Methods We conducted a mixed methods study in 3 purposely selected counties in Kenya. Data were collected through in-depth interviews (IDIs) with policy-makers at the national level, health managers at the county level, and frontline staff at the health facility level (n = 60), focus group discussions (FGDs) with community representatives (n = 10), facility records, and document reviews. We analysed the data using a framework approach. Results Rapid implementation led to inadequate stakeholder engagement and confusion about the policy. While the policy was meant to cover antenatal visits, deliveries, and post-natal visits, in practice the policy only covered deliveries. While the policy led to a rapid increase in facility deliveries, this was not matched by an increase in health facility capacity and hence compromised quality of care. The policy led to an improvement in the level of revenues for facilities. However, in all three counties, reimbursements were not made on time. The policy did not have a system of verifying health facility reports on utilization of services. Conclusion The Kenyan Ministry of Health (MoH) should develop a formal policy on the free maternity services, and provide clear guidelines on its content and implementation arrangements, engage with and effectively communicate the policy to stakeholders, ensure timeliness of payment disbursement to healthcare facilities, and introduce a mechanism for verifying utilization reports prepared by healthcare providers. User fee removal policies such as free maternity programmes should be accompanied by supply side capacity strengthening

Abstract There has been a welcome emphasis on gender issues in global health in recent years in the discourse around human resources for health. Although it is estimated that up to 75% of health workers are female (World Health Organization, Global strategy on human resources for health: Workforce 2030, 2016), this gender ratio is not reflected in the top levels of leadership in international or national health systems and global health organizations (Global Health 50/50, The Global Health 50/50 report: how gender responsive are the world’s leading global health organizations, 2018; Clark, Lancet, 391:918–20, 2018). This imbalance has led to a deeper exploration of the role of women in leadership and the barriers they face through initiatives such as the WHO Global Strategy on Human Resources for Health: Workforce 2030, the UN High Level Commission on Health Employment and Economic Growth, the Global Health 50/50 Reports, Women in Global Health, and #LancetWomen. These movements focus on advocating for increasing women’s participation in leadership. While efforts to reduce gender imbalance in global health leadership are critical and gaining momentum, it is imperative that we look beyond parity and recognize that women are a heterogeneous group and that the privileges and disadvantages that hinder and enable women’s career progression cannot be reduced to a shared universal experience, explained only by gender. Hence, we must take into account the ways in which gender intersects with other social identities and stratifiers to create unique experiences of marginalization and disadvantage.

Abstract Background A common challenge for health sector planning and budgeting has been the misalignment between policies, technical planning and budgetary allocation; and inadequate community involvement in priority setting. Health system decentralisation has often been promoted to address health sector planning and budgeting challenges through promoting community participation, accountability, and technical efficiency in resource management. In 2010, Kenya passed a new constitution that introduced 47 semi-autonomous devolved county governments, and a substantial transfer of responsibility for healthcare from the central government to these counties. Methods This study analysed the effects of this major political decentralization on health sector planning, budgeting and overall financial management at county level. We used a qualitative, case study design focusing on Kilifi County, and were guided by a conceptual framework which drew on decentralisation and policy analysis theories. Qualitative data were collected through document reviews, key informant interviews, and participant and non-participant observations conducted over an eighteen months’ period. Results We found that the implementation of devolution created an opportunity for local level prioritisation and community involvement in health sector planning and budgeting hence increasing opportunities for equity in local level resource allocation. However, this opportunity was not harnessed due to accelerated transfer of functions to counties before county level capacity had been established to undertake the decentralised functions. We also observed some indication of re-centralisation of financial management from health facility to county level. Conclusion We conclude by arguing that, to enhance the benefits of decentralised health systems, resource allocation, priority setting and financial management functions between central and decentralised units are guided by considerations around decision space, organisational structure and capacity, and accountability. In acknowledging the political nature of decentralisation polices, we recommend that health sector policy actors develop a broad understanding of the countries’ political context when designing and implementing technical strategies for health sector decentralisation.

Abstract Background Decentralisation is argued to promote community participation, accountability, technical efficiency, and equity in the management of resources, and has been a recurring theme in health system reforms for several decades. In 2010, Kenya passed a new constitution that introduced 47 semi-autonomous county governments, with substantial transfer of responsibility for health service delivery from the central government to these counties. Focusing on two key elements of the health system, Human Resources for Health (HRH) and Essential Medicines and Medical Supplies (EMMS) management, we analysed the early implementation experiences of this major governance reform at county level. Methods We employed a qualitative case study design, focusing on Kilifi County, and adapted the decision space framework developed by Bossert et al., to guide our inquiry and analysis. Data were collected through document reviews, key informant interviews, and participant and non-participant observations between December 2012 and December 2014. Results As with other county level functions, HRH and EMMS management functions were rapidly transferred to counties before appropriate county-level structures and adequate capacity to undertake these functions were in place. For HRH, this led to major disruptions in staff salary payments, political interference with HRH management functions and confusion over HRH management roles. There was also lack of clarity over specific roles and responsibilities at county and national government, and of key players at each level. Subsequently health worker strikes and mass resignations were witnessed. With EMMS, significant delays in procurement led to long stock-outs of essential drugs in health facilities. However, when the county finally managed to procure drugs, health facilities reported a better order fill-rate compared to the period prior to devolution. Conclusion The devolved government system in Kenya has significantly increased county level decision-space for HRH and EMMS management functions. However, harnessing the full potential benefits of this increased autonomy requires targeted interventions to clarify the roles and responsibilities of different actors at all levels of the new system, and to build capacity of the counties to undertake certain specific HRH and EMMS management tasks. Capacity considerations should always be central when designing health sector decentralisation policies.

Abstract Background In March 2013, Kenya transitioned from a centralized to a devolved system of governance. Within the health sector, this entailed the transfer of service provision functions to 47 newly formed semi-autonomous counties, while policy and regulatory functions were retained at the national level. The devolution process was rapid rather than progressive. Methods We conducted qualitative research within one county to examine the early experiences of devolution in the health sector. We specifically focused on the experience of change from the perspective of sub-county managers, who form the link between county level managers and health facility managers. We collected data by observing a diverse range of management meetings, support supervision visits and outreach activities involving sub-county managers between May 2013 and June 2015, conducting informal interviews wherever we could. Informal observations and interviews were supplemented by fifteen tape recorded in depth interviews with purposively selected sub-county managers from three sub-counties. Results We found that sub county managers as with many other health system actors were anxious about and ill-prepared for the unexpectedly rapid devolution of health functions to the newly created county government. They experienced loss of autonomy and resources in addition to confused lines of accountability within the health system. However, they harnessed individual, team and stakeholder resources to maintain their jobs, and continued to play a central role in supporting peripheral facility managers to cope with change. Conclusions Our study illustrates the importance in accelerated devolution contexts for: 1) mid-level managers to adopt new ways of working and engagement with higher and lower levels in the system; 2) clear lines of communication during reforms to these actors and 3) anticipating and managing the effect of change on intangible software issues such as trust and motivation. More broadly, we show the value of examining organisational change from the perspective of key actors within the system, and highlight the importance in times of rapid change of drawing upon and working with those already in the system. These actors have valuable tacit knowledge, but tapping into and building on this knowledge to enable positive response in times of health system shocks requires greater attention to sustained software capacity building within the health system.

Introduction: Community engagement is increasingly recognized as a critical aspect of global health. Recent years have seen an expansion of community engagement activities linked to health research, but debates and inconsistencies remain about the aims of different types of engagement, mechanisms underpinning their implementation and impact, and influential contextual factors. Greater commitment to and consistency around community engagement by health research programs, implementers and funders requires a more coherent evidence base. This realist review is designed to improve our understanding of how and why community engagement contributes to intended and unintended outcomes (including research and ethical outcomes) in different contexts. Given the breadth and diversity of the literature on community engagement in health research, the review will initially focus on malaria research in low- and middle-income countries (LMICs) and draw on wider global health literature where needed. Methods and analysis: Community engagement in practice is often a complex set of interventions. We will conduct a realist review – a theory driven approach to evidence synthesis – to provide explanations for how and why community engagement with health research produces the pattern of outcomes observed across different contexts of application. We will consolidate evidence from a range of documents, including qualitative, quantitative and mixed method studies. The review will follow several stages: devising an initial programme theory, searching evidence, selecting appropriate documents, extracting data, synthesizing and refining the programme theory, and reiteration of these steps as needed. Ethics and dissemination: A formal ethics review is not required for this literature review. Findings will be disseminated in a peer reviewed journal, through national and international conferences, and through a set of short briefings tailored for audiences with an interest in community engagement. Outputs and presentations will be informed by and feed into our network of community engagement experts. PROSPERO registration number: CRD42019125687

Introduction: Community engagement is increasingly recognized as a critical aspect of global health. Recent years have seen an expansion of community engagement activities linked to health research, but debates and inconsistencies remain about the aims of different types of engagement, mechanisms underpinning their implementation and impact, and influential contextual factors. Greater commitment to and consistency around community engagement by health research programs, implementers and funders requires a more coherent evidence base. This realist review is designed to improve our understanding of how and why community engagement contributes to intended and unintended outcomes (including research and ethical outcomes) in different contexts. Given the breadth and diversity of the literature on community engagement in health research, the review will initially focus on malaria research in low- and middle-income countries (LMICs) and draw on wider global health literature where needed. Methods and analysis: Community engagement in practice is often a complex set of interventions. We will conduct a realist review – a theory driven approach to evidence synthesis – to provide explanations for how and why community engagement with health research produces the pattern of outcomes observed across different contexts of application. We will consolidate evidence from a range of documents, including qualitative, quantitative and mixed method studies. The review will follow several stages: devising an initial programme theory, searching evidence, selecting appropriate documents, extracting data, synthesizing and refining the programme theory, and reiteration of these steps as needed. Ethics and dissemination: A formal ethics review is not required for this literature review. Findings will be disseminated in a peer reviewed journal, through national and international conferences, and through a set of short briefings tailored for audiences with an interest in community engagement. Outputs and presentations will be informed by and feed into our network of community engagement experts. PROSPERO registration number: CRD42019125687

Facilitating mutually-beneficial educational activities between researchers and school students is an increasingly popular way for research institutes to engage with communities who host health research, but these activities have rarely been formally examined as a community or public engagement approach in health research. The KEMRI-Wellcome Trust Research Programme (KWTRP) in Kilifi, Kenya, through a Participatory Action Research (PAR) approach involving students, teachers, researchers and education stakeholders, has incorporated ‘school engagement’ as a key component into their community engagement (CE) strategy. School engagement activities at KWTRP aim at strengthening the ethical practice of the institution in two ways: through promoting an interest in science and research among school students as a form of benefit-sharing; and through creating forums for dialogue aimed at promoting mutual understanding between researchers and school students. In this article, we provide a background of CE in Kilifi and describe the diverse ways in which health researchers have engaged with communities and schools in different parts of the world. We then describe the way in which the KWTRP school engagement programme (SEP) was developed and scaled-up. We conclude with a discussion about the challenges, benefits and lessons learnt from the SEP implementation and scale-up in Kilifi, which can inform the establishment of SEPs in other settings.

Abstract Background Nutrition plays an important role in child survival and development. Treatment action in the management of child health and nutrition is influenced by perceptions of illness, and gender plays an important role. However, little is known about if and how moderate undernutrition is recognised among lay populations, or how local social norms and intra-household dynamics affect decisions to seek biomedical assistance for nutritional concerns. In this paper we describe how childhood nutritional problems are recognised and understood within rural households. We demonstrate how context influences local constructs of ‘normal’, and suggest the centrality of gender in the management of child health and nutrition in our research context. Methods This qualitative study was undertaken in Kilifi County on the Kenyan Coast. A set of 15 households whose children were engaged in a community-based nutrition intervention were followed up over a period of twelve months. Over a total of 54 household visits, group and individual in-depth interviews were conducted with a range of respondents, supplemented by non-participant observations. Eight in-depth interviews with community representatives were also conducted. Results Local taxonomies of childhood undernutrition were found to overlap with, but differ from, biomedical categories. In particular, moderate undernutrition was generally not recognised as a health problem requiring treatment action, but rather as routine and manageable, typically seasonal, weight-loss. Where symptoms were considered more serious and requiring remedial action, household management strategies were typically based on perceived aetiology of the illness. Additionally, gender emerged as a potentially central theme in childhood nutrition problems and related management. Women reported that they have primary responsibility for ensuring children’s good health and nutritional status, and that they are often held accountable when their children are of sub-optimal health. Conclusion Perceptions of child nutrition and illness and gendered roles within households influence treatment action, and engagement with nutrition interventions. Community-based nutrition interventions must recognise these complex realities.

Background: The range and amount of volunteer infection studies, known as Controlled Human Infection Model (CHMI) studies, in Low-Middle Income Countries (LMICs) is increasing with rapid technological advancement, world-class laboratory facilities and increasing capacity development initiatives. However, the ethical issues these studies present in LMICs have not been empirically studied. We present findings of a descriptive social science study nested within a malaria volunteer infection study, on-going at the time of writing, at the KEMRI-Wellcome Trust Research Programme (KWTRP) on the Kenyan Coast. Methods: The study included non-participant observations, five group discussions with more than half of the CHMI study participants, two in-depth interviews with study team members, and an exit questionnaire administered to the participants. Results: Participants understood the key elements of the study, including that they would be deliberately infected with malaria parasites and may get malaria as a result, there would be regular blood draws, and they would spend up to 24 days in a residence facility away from their homes. The greatest motivation for participation was the monetary compensation of 20 USD per overnight stay given as a lump-sum at the end of their residency stay. Also appreciated were the health screening tests prior to enrolment and the positive relations with the study team. Concerns raised included the amount and regularity of blood draws experienced, and concerns that this type of research may feed into on-going rumours about research generally. Conclusion: With the increasing range and number of CHMI studies being conducted in LMICs, current ethical guidance are inadequate. This study highlights some of the ethical issues that could emerge in these settings, emphasizing the heavy responsibility placed on research review and regulatory systems, researchers and funders, as well as the importance of carefully tailored community engagement and consent processes.

Background: The range and amount of volunteer infection studies, known as Controlled Human Infection Model (CHMI) studies, in Low-Middle Income Countries (LMICs) is increasing with rapid technological advancement, world-class laboratory facilities and increasing capacity development initiatives. However, the ethical issues these studies present in LMICs have not been empirically studied. We present findings of a descriptive social science study nested within a malaria volunteer infection study, on-going at the time of writing, at the KEMRI-Wellcome Trust Research Programme (KWTRP) on the Kenyan Coast. Methods: The study included non-participant observations, five group discussions with more than half of the CHMI study participants, two in-depth interviews with study team members, and an exit questionnaire administered to the participants. Results: Participants understood the key elements of the study, including that they would be deliberately infected with malaria parasites and may get malaria as a result, there would be regular blood draws, and they would spend up to 24 days in a residence facility away from their homes. The greatest motivation for participation was the monetary compensation of 20 USD per overnight stay given as a lump-sum at the end of their residency stay. Also appreciated were the health screening tests prior to enrolment and the positive relations with the study team. Concerns raised included the amount and regularity of blood draws experienced, and concerns that this type of research may feed into on-going rumours about research generally. Conclusion: With the increasing range and number of CHMI studies being conducted in LMICs, current ethical guidance for more than minimal risk studies is inadequate. This study highlights some of the ethical issues that could emerge in these settings, emphasizing the heavy responsibility placed on research review and regulatory systems, researchers and funders, as well as the importance of carefully tailored community engagement and consent processes.

BACKGROUND:Intermittent preventive treatment for malaria in pregnancy (IPTp) is part of a multi-pronged strategy aimed at preventing malaria in pregnancy in areas of moderate to high transmission in sub-Saharan Africa. Despite being formally adopted as a malaria prevention policy over a decade ago, IPTp coverage has remained low. Recent demands for action have incorporated calls to strengthen IPTp monitoring and evaluation systems, including the use of routine data, to measure coverage, track implementation and identify roadblocks to improving uptake. Concerns about the quality of malaria indicators reported through routine information systems are well recognized, but there are few data on the realities of IPTp recording practices in frontline facilities or their entry into District Health Information Software (DHIS2). METHODS:Drawing on fieldwork conducted in two malaria endemic sub-counties in Kenya, we explore how local adaptations and innovations employed by health workers and sub-country managers to cope with a range of health system constraints, shape recording practices and in turn, the measurement of IPTp. Data were collected through observations, interviews, and document reviews. Data analysis and interpretation was guided by thematic analysis approach. RESULTS:Measurement of IPTp was undermined by health system constraints such as stock-out of drugs and human resource shortages. Coping strategies adopted by health workers to address these challenges ensured continuity in service delivery and IPTp data generation but had variable consequences on IPTp data quality. Unclear recording and reporting instructions also led to lack of standardization in IPTp data generation. The use of redundant tools created significant data burdens which undermined service delivery in general. CONCLUSIONS:There is need to integrate monthly reporting forms so as to remove redundancies which exacerbates workload for health workers and disrupts service delivery. Similarly, data collection instructions in registers and reporting forms need to be clarified to standardize IPTp data generation across health facilities. There is also need to address broader contextual factors such as stock-out of commodities and human resource shortages which undermine IPTp data generation process.

Background Priority setting in healthcare is a key determinant of health system performance. However, there is no widely accepted priority setting evaluation framework. We reviewed literature with the aim of developing and proposing a framework for the evaluation of macro and meso level healthcare priority setting practices. Methods We systematically searched Econlit, PubMed, CINAHL, and EBSCOhost databases and supplemented this with searches in Google Scholar, relevant websites and reference lists of relevant papers. A total of 31 papers on evaluation of priority setting were identified. These were supplemented by broader theoretical literature related to evaluation of priority setting. A conceptual review of selected papers was undertaken. Results Based on a synthesis of the selected literature, we propose an evaluative framework that requires that priority setting practices at the macro and meso levels of the health system meet the following conditions: (1) Priority setting decisions should incorporate both efficiency and equity considerations as well as the following outcomes; (a) Stakeholder satisfaction, (b) Stakeholder understanding, (c) Shifted priorities (reallocation of resources), and (d) Implementation of decisions. (2) Priority setting processes should also meet the procedural conditions of (a) Stakeholder engagement, (b) Stakeholder empowerment, (c) Transparency, (d) Use of evidence, (e) Revisions, (f) Enforcement, and (g) Being grounded on community values. Conclusion Available frameworks for the evaluation of priority setting are mostly grounded on procedural requirements, while few have included outcome requirements. There is, however, increasing recognition of the need to incorporate both consequential and procedural considerations in priority setting practices. In this review, we adapt an integrative approach to develop and propose a framework for the evaluation of priority setting practices at the macro and meso levels that draws from these complementary schools of thought.

In 2013, Kenya transitioned into a devolved system of government with a central government and 47 semi-autonomous county governments. In this paper, we report early experiences of devolution in the Kenyan health sector, with a focus on public county hospitals. Specifically, we examine changes in hospital autonomy as a result of devolution, and how these have affected hospital functioning.We used a qualitative case study approach to examine the level of autonomy that hospitals had over key management functions and how this had affected hospital functioning in three county hospitals in coastal Kenya. We collected data by in-depth interviews of county health managers and hospital managers in the case study hospitals (n = 21). We adopted the framework proposed by Chawla et al (1995) to examine the autonomy that hospitals had over five management domains (strategic management, finance, procurement, human resource, and administration), and how these influenced hospital functioning.Devolution had resulted in a substantial reduction in the autonomy of county hospitals over the five key functions examined. This resulted in weakened hospital management and leadership, reduced community participation in hospital affairs, compromised quality of services, reduced motivation among hospital staff, non-alignment of county and hospital priorities, staff insubordination, and compromised quality of care.Increasing the autonomy of county hospitals in Kenya will improve their functioning. County governments should develop legislation that give hospitals greater control over resources and key management functions.

Kenya is a generally homophobic country where homosexuality is criminalised and people who engage in same sex sexuality face stigma and discrimination. In 2013, we developed a 16 min documentary entitled “Facing Our Fears” that aimed at sharing information on how and why men who have sex with men (MSM) are involved in on-going KEMRI HIV prevention research, and associated community engagement. To consider the film’s usefulness as a communication tool, and its perceived security risks in case the film was publicly released, we conducted nine facilitated viewings with 122 individuals representing seven different stakeholder groups. The documentary was seen as a strong visual communication tool with potential to reduce stigma related to homosexuality, and facilitated film viewings were identified as platforms with potential to support open dialogue about HIV research involving MSM. Despite the potential, there were concerns over possible risks to LGBT communities and those working with them following public release. We opted—giving emphasis to the “do no harm” principle—to use the film only in facilitated settings where audience knowledge and attitudes can be carefully considered and discussed. The results highlight the importance of carefully assessing the range of possible impacts when using visuals in community engagement.

Providing benefits and payments to participants in health research, either in cash or in kind, is a common but ethically controversial practice. While much literature has concentrated on appropriate levels of benefits or payments, this paper focuses on less well explored ethical issues around the nature of study benefits, drawing on views of community members living close to an international health research centre in Kenya.The consultation, including 90 residents purposively chosen to reflect diversity, used a two-stage deliberative process. Five half-day workshops were each followed by between two and four small group discussions, within a two week period (total 16 groups). During workshops and small groups, facilitators used participatory methods to share information, and promote reflection and debate on ethical issues around types of benefits, including cash, goods, medical and community benefits. Data from workshop and field notes, and voice recordings of small group discussions, were managed using Nvivo 10 and analysed using a Framework Analysis approach.The methods generated in-depth discussion with high levels of engagement. Particularly for the most-poor, under-compensation of time in research carries risks of serious harm. Cash payments may best support compensation of costs experienced; while highly valued, goods and medical benefits may be more appropriate as an 'appreciation' or incentive for participation. Community benefits were seen as important in supporting but not replacing individual-level benefits, and in building trust in researcher-community relations. Cash payments were seen to have higher risks of undue inducement, commercialising relationships and generating family conflicts than other benefits, particularly where payments are high. Researchers should consider and account for burdens families may experience when children are involved in research. Careful context-specific research planning and skilled and consistent communication about study benefits and payments are important, including in mitigating potential negative effects.

There is increasing recognition of the importance of sharing research data within the international scientific community, but also of the ethical and social challenges this presents, particularly in the context of structural inequities and varied capacity in international research. Public involvement is essential to building locally responsive research policies, including on data sharing, but little research has involved stakeholders from low-to-middle income countries.Between January and June 2014, a qualitative study was conducted in Kenya involving sixty stakeholders with varying experiences of research in a deliberative process to explore views on benefits and challenges in research data sharing. In-depth interviews and extended small group discussions based on information sharing and facilitated debate were used to collect data. Data were analysed using Framework Analysis, and charting flow and dynamics in debates.The findings highlight both the opportunities and challenges of communicating about this complex and relatively novel topic for many stakeholders. For more and less research-experienced stakeholders, ethical research data sharing is likely to rest on the development and implementation of appropriate trust-building processes, linked to local perceptions of benefits and challenges. The central nature of trust is underpinned by uncertainties around who might request what data, for what purpose and when. Key benefits perceived in this consultation were concerned with the promotion of public health through science, with legitimate beneficiaries defined differently by different groups. Important challenges were risks to the interests of study participants, communities and originating researchers through stigmatisation, loss of privacy, impacting autonomy and unfair competition, including through forms of intentional and unintentional 'misuse' of data. Risks were also seen for science.Given background structural inequities in much international research, building trust in this low-to-middle income setting includes ensuring that the interests of study participants, primary communities and originating researchers will be promoted as far as possible, as well as protected. Important ways of building trust in data sharing include involving the public in policy development and implementation, promoting scientific collaborations around data sharing and building close partnerships between researchers and government health authorities to provide checks and balances on data sharing, and promote near and long-term translational benefits.

Clinical trials conducted in Africa often require substantial investments to support trial centres and public health facilities. Trial resources could potentially generate benefits for routine health service delivery but may have unintended consequences. Strengthening ethical practice requires understanding the potential effects of trial inputs on the perceptions and practices of routine health care providers. This study explores the influence of malaria vaccine trials on health service delivery in Ghana, Kenya and Burkina Faso.We conducted: audits of trial inputs in 10 trial facilities and among 144 health workers; individual interviews with frontline providers (n=99) and health managers (n=14); and group discussions with fieldworkers (n=9 discussions). Descriptive summaries were generated from audit data. Qualitative data were analysed using a framework approach.Facilities involved in trials benefited from infrastructure and equipment upgrades, support with essential drugs, access to trial vehicles, and placement of additional qualified trial staff. Qualified trial staff in facilities were often seen as role models by their colleagues; assisting with supportive supervision and reducing facility workload. Some facility staff in place before the trial also received formal training and salary top-ups from the trials. However, differential access to support caused dissatisfaction, and some interviewees expressed concerns about what would happen at the end of the trial once financial and supervisory support was removed.Clinical trials function as short-term complex health service delivery interventions in the facilities in which they are based. They have the potential to both benefit facilities, staff and communities through providing the supportive environment required for improvements in routine care, but they can also generate dissatisfaction, relationship challenges and demoralisation among staff. Minimising trial related harm and maximising benefits requires careful planning and engagement of key actors at the outset of trials, throughout the trial and on its' completion.

BACKGROUND:Public primary health care (PHC) facilities are for many individuals the first point of contact with the formal health care system. These facilities are managed by professional nurses or clinical officers who are recognised to play a key role in implementing health sector reforms and facilitating initiatives aimed at strengthening community involvement. Little in-depth research exists about the dimensions and challenges of these managers' jobs, or on the impact of decentralisation on their roles and responsibilities. In this paper, we describe the roles and responsibilities of PHC managers-or 'in-charges' in Kenya, and their challenges and coping strategies, under accelerated devolution. METHODS:The data presented in this paper is part of a wider set of activities aimed at understanding governance changes under devolution in Kenya, under the umbrella of a 'learning site'. A learning site is a long term process of collaboration between health managers and researchers deciding together on key health system questions and interventions. Data were collected through seven formal in depth interviews and observations at four PHC facilities as well as eight in depth interviews and informal interactions with sub-county managers from June 2013 to July 2014. Drawing on the Aragon framework of organisation capacity we discuss the multiple accountabilities, daily routines, challenges and coping strategies among PHC facility managers. RESULTS:PHC in-charges perform complex and diverse roles in a difficult environment with relatively little formal preparation. Their key concerns are lack of job clarity and preparedness, the difficulty of balancing multidirectional accountability responsibilities amidst significant resource shortages, and remuneration anxieties. We show that day-to-day management in an environment of resource constraints and uncertainty requires PHC in-charges who are resilient, reflective, and continuously able to learn and adapt. We highlight the importance of leadership development including the building of critical soft skills such as relationship building.

Planning study benefits and payments for participants in international health research in low- income settings can be a difficult and controversial process, with particular challenges in balancing risks of undue inducement and exploitation and understanding how researchers should take account of background inequities. At an international health research programme in Kenya, this study aimed to map local residents' informed and reasoned views on the effects of different levels of study benefits and payments to inform local policy and wider debates in international research.Using a relatively novel two-stage process community consultation approach, five participatory workshops involving 90 local residents from diverse constituencies were followed by 15 small group discussions, with components of information-sharing, deliberation and reflection to situate normative reasoning within debates. Framework Analysis drew inductively and deductively on voice-recorded discussions and field notes supported by Nvivo 10 software, and the international research ethics literature. Community members' views on study benefits and payments were diverse, with complex contextual influences and interplay between risks of giving 'too many' and 'too few' benefits, including the role of cash. While recognising important risks for free choice, research relationships and community values in giving 'too many', the greatest concerns were risks of unfairness in giving 'too few' benefits, given difficulties in assessing indirect costs of participation and the serious consequences for families of underestimation, related to perceptions of researchers' responsibilities.Providing benefits and payments to participants in international research in low-income settings is an essential means by which researchers meet individual-level and structural forms of ethical responsibilities, but understanding how this can be achieved requires a careful account of social realities and local judgment. Concerns about undue inducement in low-income communities may often be misplaced; we argue that greater attention should be placed on avoiding unfairness, particularly for the most-poor.

To document and explore the views and experiences of key stakeholders regarding the consent procedures of an emergency research clinical trial examining immediate fluid resuscitation strategies, and to discuss the implications for similar trials in future.A social science sub-study of the FEAST (Fluid Expansion As Supportive Therapy) trial. Interviews were held with trial team members (n = 30), health workers (n = 15) and parents (n = 51) from two purposively selected hospitals in Soroti, Uganda, and Kilifi, Kenya.Overall, deferred consent with prior assent was seen by staff and parents as having the potential to protect the interests of both patients and researchers, and to avoid delays in starting treatment. An important challenge is that the validity of verbal assent is undermined when inadequate initial information is poorly understood. This concern needs to be balanced against the possibility that full prior consent on admission potentially causes harm through introducing delays. Full prior consent also potentially imposes worries on parents that clinicians are uncertain about how to proceed and that clinicians want to absolve themselves of any responsibility for the child's outcome (some parents' interpretation of the need for signed consent). Voluntariness is clearly compromised for both verbal assent and full prior consent in a context of such vulnerability and stress. Further challenges in obtaining verbal assent were: what to do in the absence of the household decision-maker (often the father); and how medical staff handle parents not giving a clear agreement or refusal.While the challenges identified are faced in all research in low-income settings, they are magnified for emergency trials by the urgency of decision making and treatment needs. Consent options will need to be tailored to particular studies and settings, and might best be informed by consultation with staff members and community representatives using a deliberative approach.