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The COVID-19 pandemic has caused widespread disruptions to health, economic and social lives globally. This qualitative study explores frontline healthcare workers’ (HCWs) experiences delivering routine care in Kenya’s informal settlements during the early phases of the pandemic, amidst stringent COVID-19 mitigation measures. Thirteen telephone interviews were conducted with facility and community-based HCWs serving three informal settlements in Nairobi and Mombasa. Data were analyzed using the framework approach. Results indicate there were widespread fears and anxieties surrounding COVID-19 and its management. Secondly, access to facility-based care at the onset of the pandemic was reported to decline, with service availability hampered by the imposed curfew hours and guidance on the maximum allowable number of clients. HCWs experienced heightened risk of COVID-19 infection due to poor working conditions including inadequate personal protective equipment (PPE) and unavailable isolation areas for COVID-19 positive patients. HCWs also experienced stigma associated with contact with persons suspected of having COVID-19 infection, thereby causing a strain on their mental health and wellbeing. The study recommends the need for interventions to support and protect HCWs’ physical and mental health, alongside health system preparedness. Additionally, it is vital to identify ways of taking health services closer to the community to address access barriers in health emergency contexts.

"This paper investigates the impact of community home-based care (CHBC) on self-management outcomes for chronically ill patients in rural Malawi. A pre- and post-evaluation survey was administered among 140 chronically ill patients with HIV and non-communicable diseases, newly enrolled in four CHBC programmes. We translated, adapted and administered scales from the Stanford Chronic Disease Self-Management Programme to evaluate patient's self-management outcomes (health status and self-efficacy), at four time points over a 12-month period, between April 2016 and May 2017. The patient's drop-out rate was approximately 8%. Data analysis included descriptive statistics, tests of associations, correlations and pairwise comparison of outcome variables between time points, and multivariate regression analysis to explore factors associated with changes in self-efficacy following CHBC interventions. The results indicate a reduction in patient-reported pain, fatigue and illness intrusiveness, while improvements in general health status and quality of life were not statistically significant. At baseline, the self-efficacy mean was 5.91, which dropped to 5.1 after 12\xC2\xA0months. Factors associated with this change included marital status, education, employment and were condition-related; whereby self-efficacy for non-HIV and multimorbid patients was much lower. The odds for self-efficacy improvement were lower for patients with diagnosed conditions of longer duration. CHBC programme support, regularity of contact and proximal location to other services influenced self-efficacy. Programmes maintaining regular home visits had higher patient satisfaction levels. Our findings suggest that there were differential changes in self-management outcomes following CHBC interventions. While self-management support through CHBC programmes was evident, CHBC providers require continuous training, supervision and sustainable funding to strengthen their contribution. Furthermore, sociodemographic and condition-related factors should inform the design of future interventions to optimise outcomes. This study provides a systematic evaluation of self-management outcomes for a heterogeneous chronically ill patient population and highlights the potential and relevant contribution of CHBC programmes in improving chronic care within sub-Saharan Africa."

The emergence of COVID-19 has profoundly affected mental health, especially among highly vulnerable populations. This study describes mental health issues among caregivers of young children and pregnant women in three urban informal settlements in Kenya during the first pandemic year, and factors associated with poor mental health. A cross-sectional telephone survey was administered to 845 participants. Survey instruments included the Patient Health Questionnaire-9, General Anxiety Disorder-7 scale, COVID-19 Anxiety Scale, and questions on the perceived COVID-19 effects on caregiver wellbeing and livelihood. Data were analyzed using descriptive statistics, and univariate and multivariate analysis. Caregivers perceived COVID-19 as a threatening condition (94.54%), affecting employment and income activities (&gt, 80%). Caregivers experienced discrimination (15.27%) and violence (12.6%) during the pandemic. Levels of depression (34%), general anxiety (20%), and COVID-19 related anxiety (14%) were highly prevalent. There were significant associations between mental health outcomes and economic and socio-demographic factors, violence and discrimination experiences, residency, and perceptions of COVID-19 as a threatening condition. Caregivers high burden of mental health problems highlights the urgent need to provide accessible mental health support. Innovative and multi-sectoral approaches will be required to maximize reach to underserved communities in informal settlements and tackle the root causes of mental health problems in this population.

Objective: Sexual risk behavior during adolescence is an important public health problem. Self-esteem and hopefulness are potentially important psychological factors that may play a role in the behavioral regulation mechanisms of adolescents. These factors are inadequately explored in sub-Saharan Africa. This study aimed at exploring patterns and associated factors for sexual risk behavior (SRB), self-esteem, and hopefulness among adolescents from a resource-poor setting in Kenya.Method: A cross-sectional study conducted in 2019 among 296 adolescents (12–17 years old) from rural Kilifi (n = 133) and urban informal settings of Nairobi (n = 163) in Kenya. Participants completed the Kilifi Health Risk Behavior Questionnaire, Rosenberg self-esteem questionnaire, and Hope scale administered via computerized tablets. A binary outcome variable based on the experience of adolescents of at least one of the five forms of SRB: transactional sex, sexual violence, intergenerational sex, early sexual debut, and condom non-use was generated. Bi-variate analysis was conducted to summarize various social-demographic and psychosocial factors. A multivariable logistic regression model was fitted to investigate factors associated with the occurrence of SRB, self-esteem, and hopefulness among adolescents.Results: About 13% of the participants had experienced a form of SRB, and among these, 36% reported co-occurrence of multiple forms of SRB. Adolescent SRB was largely characterized by having experienced sexual violence, as well as intergenerational and transactional sex. Higher scores of hopefulness were reported among adolescents who never experienced SRB (P = 0.03) at bivariate analysis level. However, both self-esteem and hopefulness were not significantly associated with the occurrence of SRB in the adjusted logistic regression analysis. Having depressive symptoms (Adj. OR = 3.8, 95% CI: 1.39–10.4), feeling unsafe in the neighborhood (Adj. OR = 3.4, 95% CI: 1.6–7.2), and being in higher compared with lower primary education level (Adj. OR = 0.3, 95% CI: 0.1–0.8) were statistically significantly associated with the occurrence of SRB.Conclusion: Targeted reproductive health interventions, designed with the cognizance of structural and social drivers of adolescent SRB, are needed to concurrently tackle multiple forms of SRB. It is important to integrate mental health promotion within these interventions. More research is needed to understand the mechanisms and implications of self-esteem and hopefulness for adolescent sexual and reproductive health.

BackgroundCommunity engagement is crucial for the design and implementation of community-based early childhood development (ECD) programmes. This paper aims to share key components and learnings of a community engagement process for an integrated ECD intervention. The lessons shared are drawn from a case study of urban informal settlement with embedded refugees in Nairobi, Kenya.MethodsWe conducted three stakeholder meetings with representatives from the Ministry of Health at County and Sub-County, actors in the ECD sector, and United Nations agency in refugee management, a transect walk across five villages (Ngando, Muslim, Congo, Riruta and Kivumbini); and, six debrief meetings by staff from the implementing organization. The specific steps and key activities undertaken, the challenges faced and benefits accrued from the community engagement process are highlighted drawing from the implementation team’s perspective.ResultsContext relevant, well-planned community engagement approaches can be integrated into the five broad components of stakeholder engagement, formative research, identification of local resources, integration into local lives, and shared control/leadership with the local community. These can yield meaningful stakeholder buy-in, community support and trust, which are crucial for enabling ECD programme sustainability.ConclusionOur experiences underscore that intervention research on ECD programmes in urban informal settlements requires a well-planned and custom-tailored community engagement model that is sensitive to the needs of each sub-group within the community to avoid unintentionally leaving anyone out.

Children in urban informal settlements experience high risks for poor health and development. Understanding health seeking behaviors and childcare patterns of caregivers in urban informal settlements is important for devising effective interventions. This study describes household characteristics and aspects of nurturing care among caregivers of children aged 0–2 years in Dagoretti informal settlement, Nairobi-Kenya. In this cross sectional study, data were collected on household socio-demographic characteristics, antenatal care and child delivery practices, infant and young child feeding practices, activities that promote play, learning and school readiness, and on childcare and protection practices. Descriptive statistics of proportions and means were used to summarize the data. The study covers a total of 458 Kenyan and 118 immigrant households. Caregivers from immigrant households, with low education and from the younger age-group (less than 20 years) were vulnerable to sub-optimal caregiving and health seeking practices, including relatively lower rates of age-appropriate breastfeeding and poor dietary diversity. Seventy-five percent of expectant mothers attended less than four antenatal care visits. Households surveyed had limited possession of children’s books (2% with three or more books), limited access to play materials (43% had two or more play materials), and low paternal involvement in child stimulation and early learning activities (14%). One-third and half of the children were left with inadequate care and disciplined using both violent and non-violent methods, respectively. Our findings highlight the urgent need for contextually appropriate and integrated interventions anchored in the WHO’s nurturing care framework. These interventions can benefit from extensive involvement of caregivers, facility and community-based healthcare workers, policy makers, and other relevant stakeholders.

Background With the increasing double burden of communicable and non-communicable diseases (NCDs) in sub-Saharan Africa, health systems require new approaches to organise and deliver services for patients requiring long-term care. There is increasing recognition of the need to integrate health services, with evidence supporting integration of HIV and NCD services through the reorganisation of health system inputs, across system levels. This study investigates current practices of delivering and implementing integrated care for chronically-ill patients in rural Malawi, focusing on the primary level. Methods A qualitative study on chronic care in Phalombe district conducted between April 2016 and May 2017, with a sub-analysis performed on the data following a document analysis to understand the policy context and how integration is conceptualised in Malawi; structured observations in five of the 15 district health facilities, selected purposively to represent different levels of care (primary and secondary), and ownership (private and public). Fifteen interviews with healthcare providers and managers, purposively selected from the above facilities. Meetings with five non-governmental organisations to study their projects and support towards chronic care in Phalombe. Data were analysed using a thematic approach and managed in NVivo. Results Our study found that, while policies supported integration of various disease-specific programmes at point of care, integration efforts on the ground were severely hampered by human and health resource challenges e.g. inadequate consultation rooms, erratic supplies especially for NCDs, and an overstretched health workforce. There were notable achievements, though most prominent at the secondary level e.g. the establishment of a combined NCD clinic, initiating NCD screening within HIV services, and initiatives for integrated information systems. Conclusion In rural Malawi, major impediments to integrated care provision for chronically-ill patients include the frail state of primary healthcare services and sub-optimal NCD care at the lowest healthcare level. In pursuit of integrative strategies, opportunities lie in utilising and expanding community-based outreach strategies offering multi-disease screening and care with strong referral linkages; careful task delegation and role realignment among care teams supported with proper training and incentive mechanisms; and collaborative partnership between public and private sector actors to expand the resource-base and promoting cross-programme initiatives.

To explore how provision of self-management support to chronically-ill patients in resource-limited settings contributes to patient empowerment in chronic care.Concurrent descriptive mixed methods research.A survey of 140 patients with chronic conditions administered at four time-points in 12 months. We conducted 14 interviews and four focus-group discussions with patients (N = 31); 13 healthcare provider interviews; and observations of four patient-support group meetings. Data were collected between April 2016 - May 2017 in rural Malawi. Qualitative data were analysed using a thematic approach and descriptive statistical analysis performed on survey data.Healthcare professionals facilitated patient empowerment through health education, although literacy levels and environmental factors affected self-management guidance. Information exchanged during patient-provider interactions varied and discussions centred around medical aspects and health promoting behaviour. Less than 40% of survey patients prepared questions prior to clinic consultations. Health education was often unstructured and delegated to non-physician providers, mostly untrained in chronic care. Patients accessed psychosocial support from volunteer-led community home-based care programmes. HIV support-groups regularly interacted with peers and practical skills exchanged in a supportive environment, reinforcing patient's self-mangement competence and proactiveness in health care.For optimal self-management, reforms at inter-personal and organizational level are needed including; mutual patient-provider collaboration, diversifying access to self-management support resources and restructuring patient support-groups to cater to diverse chronic conditions.Our study provides insights and framing of self-management support and empowerment for patients in long-term care in sub-Saharan Africa. Lessons drawn could feed into designing and delivering responsive chronic care interventions.目的: 索在资源有限的情况下给慢性病患者提供自我管理互助如何有助于慢性病人护理授权。 设计行描述性混合方法研究。 方法: 12个月内分四个时间点进行的一项对140名慢性疾病患者的调查。我们进行了14次采访、与病人的四次小组讨论(N = 31);13次医疗服务人员采访;和四次病人互助会议的观察。搜集了马拉维农村地区2016年四月至2017年五月之间的数据。采用了主题法对定量数据进行分析并对调查数据进行描述性统计分析。 结果: 医疗专家通过健康教育促进患者赋权,尽管文化水平和环境因素影响了自我管理指导。医患交流中的信息互换多变且讨论以医学和健康促进行为为中心。不到40%接受调查的病人在门诊会诊之前准备了问题。健康教育通常是未经组织的,往往被委托给不是医生的人,大多数并未接受过长期护理训练。病人们从以志愿者为主的社区家庭护理项目处获得心理帮助。艾滋互助小组定期与同伴互动,并在支持性环境中交换实用技能,增强患者的自我管理能力和保健主动性。 结论: 为了实现最佳的自我管理,个人和组织层面的改革应当包括:医患共同合作、使得实现自我管理互助资源的途径多样化以及重组病人互助小组来应对多个长期护理的情况。 影响: 我们的研究为自我管理互助提供了见解与框架,并为撒哈拉沙漠以南非洲地区的病人的长期护理提供了授权。从中学习的经验可用来设计和进行响应性的长期护理干预。.

Background: The high burden of chronic communicable diseases such as HIV/AIDS, and an escalating rise of non-communicable diseases (NCDs) in Malawi and other African countries, calls for a shift in how healthcare services are designed and delivered. Patient-centred care and patient self-management are critical elements in chronic care, and advocated as global strategies. Further evidence is needed around patient self-management practices, and how to best support patients with chronic conditions in the African context. Our study explored self-management practices of patients with different chronic conditions, and their strategies to overcome care challenges in a resource constrained setting in Malawi. To further unpack self-management mechanisms and patient adjustment processes, we make use of Bandura’s social cognitive theory. Methods: We conducted a mixed methods study, involving patients with different chronic conditions from a rural district in Malawi. Data included a longitudinal survey with 129 patients, 14 in-depth interviews, and four focus-group discussions with patients. We used a framework approach for qualitative data analysis and survey data analysed using descriptive statistics. Results: Patients demonstrated ability to self-manage their conditions, though this varied between conditions, and was influenced by individual and environmental factors. Factors included: ability to acquire appropriate disease-specific knowledge; poverty level; the presence of support from family caregivers and community-based support initiatives; the nature of one's social relations; and the ability to deal with stressors and stigma. NCD and HIV comorbid patients were more disadvantaged in their access to healthcare, as they experienced frequent drug stock-outs and incurred additional out of pocket costs when referred. These barriers contributed to delayed care, poorer treatment adherence and likelihood of poorer treatment outcomes. Patients proved resourceful and made adjustments in the face of (multiple) care challenges. Discussion and conclusion: We found that patient adaptiveness is an individualised process and relies on how well a patient is able to cope with circumstances in their environment. Bandura’s social cognitive theory further elaborates adaptation as a process where patients develop different mechanisms. For instance, patients create internal models based on successful management of past experiences/events to deal with current challenges (symbolising); or choose to avoid situations that cause distress (self-regulation); or observe and learn complex skills from others such as peers in support groups (vicarious learning). We found evidence of the development of such mechanisms, but it proved difficult to delineate them from the broader patient environment, which was characterised by a heavy reliance on family support and restricted access to resources in their external environment. These in turn influenced patient experiences and strategies for self-management. As Malawi strives towards attaining universal healthcare, affordability and access to NCD services through the public sector presents a formidable challenge, particularly for the rural parts of the country. We recommend introducing peer-patient and support group initiatives for patients with NCDs, and further investments in the decentralisation of integrated health services. Limitation: Our research focused on one rural district in Malawi, hence transferability of our findings to contexts with different characteristics, such as urban setting(s), should be taken into consideration.

Providing long-term care for people living with chronic conditions is a key component of universal health coverage (UHC). To achieve UHC and address social determinants of health, the Malawian government launched the second health sector strategic plan (HSSPII) in 2017. Achieving its targets would require an understanding of contextual factors and mechanisms influencing HSSPII implementation. We explore health stakeholders’ experiences of planning and delivering chronic care services for rural trans-border communities in Malawi.We conducted 15 semi-structured interviews with health stakeholders in Phalombe district, Malawi near the Mozambique border. Respondents were selected through snowballing and purposively to ensure diversity of responses. We applied a thematic approach to data analysis.Respondents reported mixed experiences with implementing the strategy on ‘paper’, with operational difficulties reflecting on-the-ground realities. A key concern for respondents from public facilities was high influx of migrant patients from border communities in Mozambique, due to user-fees charged in their healthcare system. This resulted to acute shortage of medical supplies and continuous pressure on health personnel in healthcare provision, which hindered the effective implementation of UHC. Respondents reported high patient-workload compromised quality of care provided and served as demotivating factors, which posed as major obstacles to UHC attainment. Health providers also experienced difficulties screening and assessing patient eligibility for free healthcare, given the integration of bordering communities. This was attributed to a lack of national identification system, which has severe financial and logistical implications for UHC implementation. While the HSSPII and UHC goals aim to increase coverage and make healthcare services geographical accessible, patient access was crippled by transportation and medication costs in paying health facilities.Health policy makers and planners need to utilise a sector-wide approach that takes into account the operational realities on the ground in implementing UHC, to design innovative interventions that target these findings.

Community engagement is increasingly emphasized in biomedical research, as a right in itself, and to strengthen ethical practice. We draw on interviews and observations to consider the practical and ethical implications of involving Community Health Workers (CHWs) as part of a community engagement strategy for a vaccine trial on the Kenyan Coast. CHWs were initially engaged as an important network to be informed about the trial. However over time, and in response to community advice, they became involved in trial information sharing and identifying potential participants; thereby taking on roles that overlapped with those of employed fieldworkers (FWs). While CHWs involvement was generally perceived as positive and appreciated, there were challenges in their relations with FWs and other community members, partly related to levels and forms of remuneration. Specifically, payment of CHWs was not as high as for FWs and was based on ‘performance’. This extrinsic motivation had the potential to crowd out CHWs intrinsic motivation to perform their pre-existing community roles. CHWs remuneration potentially also contributed to CHWs distorting trial information to encourage community members to participate; and to researchers encouraging CHWs to utilize their social connections and status to increase the numbers of people who attended information giving sessions. Individual consent processes were protected in this trial through final information sharing and consent being conducted by trained clinical staff who were not embedded in study communities. However, our experiences suggest that roles and remuneration of all front line staff and volunteers involved in trials need careful consideration from the outset, and monitoring and discussion over time.

Public accountability has re-emerged as a top priority for health systems all over the world, and particularly in developing countries where governments have often failed to provide adequate public sector services for their citizens. One approach to strengthening public accountability is through direct involvement of clients, users or the general public in health delivery, here termed 'community accountability'. The potential benefits of community accountability, both as an end in itself and as a means of improving health services, have led to significant resources being invested by governments and non-governmental organizations. Data are now needed on the implementation and impact of these initiatives on the ground. A search of PubMed using a systematic approach, supplemented by a hand search of key websites, identified 21 papers from low- or middle-income countries describing at least one measure to enhance community accountability that was linked with peripheral facilities. Mechanisms covered included committees and groups (n = 19), public report cards (n = 1) and patients' rights charters (n = 1). In this paper we summarize the data presented in these papers, including impact, and factors influencing impact, and conclude by commenting on the methods used, and the issues they raise. We highlight that the international interest in community accountability mechanisms linked to peripheral facilities has not been matched by empirical data, and present a conceptual framework and a set of ideas that might contribute to future studies.

Since the Alma Ata Declaration in 1978, community health volunteers (CHVs) have been at the forefront, providing health services, especially to underserved communities, in low-income countries. However, consolidation of CHVs position within formal health systems has proved to be complex and continues to challenge countries, as they devise strategies to strengthen primary healthcare. Malawi’s community health strategy, launched in 2017, is a novel attempt to harmonise the multiple health service structures at the community level and strengthen service delivery through a team-based approach. The core community health team (CHT) consists of health surveillance assistants (HSAs), clinicians, environmental health officers and CHVs. This paper reviews Malawi’s strategy, with particular focus on the interface between HSAs, volunteers in community-based programmes and the community health team. Our analysis identified key challenges that may impede the strategy’s implementation: (1) inadequate training, imbalance of skill sets within CHTs and unclear job descriptions for CHVs; (2) proposed community-level interventions require expansion of preexisting roles for most CHT members; and (3) district authorities may face challenges meeting financial obligations and filling community-level positions. For effective implementation, attention and further deliberation is needed on the appropriate forms of CHV support, CHT composition with possibilities of co-opting trained CHVs from existing volunteer programmes into CHTs, review of CHT competencies and workload, strengthening coordination and communication across all community actors, and financing mechanisms. Policy support through the development of an addendum to the strategy, outlining opportunities for task-shifting between CHT members, CHVs’ expected duties and interactions with paid CHT personnel is recommended.

This issue of Developing World Bioethics includes a collection of papers on intermediary staff and volunteers working at the interface between research institutions and researchers, and the communities from which research participants are recruited. ‘Field worker’ – a short hand commonly used in many research settings – refers here to those whose main role is face-to-face engagement with participants, who usually speak the participants’ first language, who are from or live in the study areas, and whose work entails moving around the study areas or health facilities. Field workers can be differentiated from medical or scientific staff for whom only part of their duties entail direct interaction with participants, and who are primarily based in the research institution or the clinic. In international research settings field workers are variously called research assistants, community interviewers, data collectors, fieldworkers, field assistants, assessors, follow up staff or defaulter tracers. Although some may hold first degrees or certificates, many are secondary school leavers without higher education opportunity; overall they are formally less qualified than clinical and research staff. Instead, field workers often have extensive informal training and experience from earlier volunteering and jobs in research centres or the NGO sector, which often require similar tasks and expertise.1 Their roles may include communicating about studies and mobilisation and follow-up of participants, conducting interviews, and carrying out relatively simple biomedical data-collection procedures such as taking temperatures and collecting finger prick blood samples.

Background Community engagement (CE) is increasingly promoted for biomedical research conducted in resource poor settings for both intrinsic and instrumental purposes. Given the potential importance of CE, but also complexities and possibilities of unexpected negative outcomes, there is need for more documentation of CE processes in practice. We share experiences of formal CE for a paediatric randomized controlled malaria vaccine trial conducted in three sites within Kilifi County, Kenya. Methods Social scientists independent of the trial held in-depth individual interviews with trial researchers (n = 5), community leaders (n = 8) and parents (15 with enrolled children and 4 without); and group discussions with fieldworkers (n = 6) and facility staff (n = 2). We conducted a survey of participating households (n = 200) and observed over 150 CE activities. Results The overall CE plan was similar across the three study sites. The majority of respondents felt that CE activities helped to clear pre-existing concerns and misconceptions, and increase familiarity with and trust in trial staff. Challenges included: some community leaders attempting to exert pressure on people to enrol; local wording in information sheets and consent forms feeding into serious anxieties about the trial; and concerns about reduced CE over time. Negative effects of these challenges were mitigated through changes to on-going CE activities, and final information sharing and consent being conducted individually by trained clinical staff. One year after enrolment, 31% (n = 62) of participants’ parents reported malaria prevention as the main aim of the activities their children were involved in, and 93% wanted their children to remain involved. Conclusion The trial teams’ goals for CE were relatively clear from the outset. Other actors’ hopes and expectations (like higher allowances and future employment) were not openly discussed, but emerged over the course of engagements. Encouraging open discussion of all actors’ intentions and goals from the outset takes time, risks raising expectations that cannot be met, and is complex. However, doing so in future similar trials may allow successes here to be built upon, and some challenges to be minimized or avoided. Trial registration ClinicalTrials.gov NCT00866619 (registration 19-Mar-2009).

Community engagement is increasingly emphasized in biomedical research, as a right in itself, and to strengthen ethical practice. We draw on interviews and observations to consider the practical and ethical implications of involving Community Health Workers (CHWs) as part of a community engagement strategy for a vaccine trial on the Kenyan Coast. CHWs were initially engaged as an important network to be informed about the trial. However over time, and in response to community advice, they became involved in trial information sharing and identifying potential participants; thereby taking on roles that overlapped with those of employed fieldworkers (FWs). While CHWs involvement was generally perceived as positive and appreciated, there were challenges in their relations with FWs and other community members, partly related to levels and forms of remuneration. Specifically, payment of CHWs was not as high as for FWs and was based on ‘performance’. This extrinsic motivation had the potential to crowd out CHWs intrinsic motivation to perform their pre-existing community roles. CHWs remuneration potentially also contributed to CHWs distorting trial information to encourage community members to participate; and to researchers encouraging CHWs to utilize their social connections and status to increase the numbers of people who attended information giving sessions. Individual consent processes were protected in this trial through final information sharing and consent being conducted by trained clinical staff who were not embedded in study communities. However, our experiences suggest that roles and remuneration of all front line staff and volunteers involved in trials need careful consideration from the outset, and monitoring and discussion over time.

BACKGROUND: 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.METHODS: 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.RESULTS: 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.CONCLUSION: 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.