Incorporating a quiz into informed consent processes: Qualitative study of participants' reactions

<p>Abstract</p> <p>Background</p> <p>Formal checks of participant understanding are now widely recommended to improve informed consent processes. However, the views of the participants these assessments are designed to protect are rarely considered. In this paper the findings of a qualitative study aimed at documenting community reactions to a semi-structured questionnaire ('quiz') are reported. The quiz was administered to 189 mothers after consenting for their children to participate in a malaria vaccine trial on the Kenyan Coast.</p> <p>Methods</p> <p>Once the malaria vaccine trial was underway, focus group discussions were held with some of these mothers (nine groups; 103 mothers), and with community-based field staff attached to the malaria vaccine trial (two groups of five workers). Individual interviews with other trial staff were also held.</p> <p>Results</p> <p>The quiz prompted community members to voice concerns about blood sampling and vaccine side-effects, thereby encouraging additional discussions and interactions between the research team and potential study participants. However, it also caused significant upset and concern. Some of the quiz questions, or the way in which they were asked, appeared to fuel misconceptions and fears, with potentially negative consequences for both the study and community members.</p> <p>Conclusion</p> <p>Formal approaches to checking study understanding should be employed with sensitivity and caution. They are influenced by and impact upon complex social relationships between and among researchers and community members. Adequate consideration of these contexts in assessments of understanding, and in responding to the issues raised, requires strong social science capacity.</p

Application of Marxist analysis: Basis for accounting for ethno-regional inequalities in education and consequent opportunities in Kenya

Introduction: Addressing inequalities in education has been a necessary condition for equal opportunities to be achieved. Accordingly, providing equal opportunities in education has also been a step toward maintaining social equality. An inhibited educational opportunity within some ethno-regions and social groups is the main source of this occurrence. Purpose: To investigate persistent ethno-regional inequalities in education in Kenya using Marxist ideology. Methodology: This philosophical study has employed ideas or viewpoints from the philosophy of Karl Marx and related ideology to probe the persistence of inequality in education. Marxist analysis has involved studying, and evaluating educational reports with a view to find out if equality in education in Kenya is a reality or an ideology (illusion). Results: The Kenyan education system has inbuilt inequalities within it. These have included: stratification in form of classification of schools as public or private, national, extra-county, county and sub-county. The hierarchical organization of schools has always contributed to the hierarchical aspect of Kenyan society. The majority of rich families enroll their children in private schools, giving them access to a system that is selective in terms of work and household income. Therefore, education in Kenya has not improved equality as intended. In reality, it has been imitating the current societal structure. The illusion of scholastic achievement has been upheld by the affluent, who have used it to justify their position while blaming the inferior status of the poor to their own failure. They have defended the presence of those with various statuses through philosophy. Recommendations: The study recommended that Kenya should adopt instreamed comprehensive schooling instead of different types of schools, and that no privatization or private control of educational institutions

Critique of strategies the Kenyan government is using to address ethno-regional inequalities in education

Introduction: Equal opportunities cannot be achieved without addressing inequalities in education. Consequently, the provision of equal opportunities in education is a step toward social equality. A constrained educational opportunity among the disadvantaged ethno-regions is cited as the root cause of this phenomenon. Purpose: To investigate strategies employed by the Kenyan government in addressing ethno-regional inequalities in education in Kenya. Methodology: This philosophical investigation utilized critique as a philosophical method of inquiry which is the intellectual disciplined process of actively and skillfully conceptualizing, applying, analyzing, synthesizing, and or evaluating information gathered from, or generated by, observation, experience, reflection, reasoning, or communication, as a guide to belief and action. Results: The government has attempted to address ethno-regional inequalities in education through the constitution (2010), however, the culture of tokenism, which considers empowerment of marginalized groups and ethno-regions as one of the goodies to be dished to them as a favour still persists in Kenya. Most counties are inhabited by either one ethnic group or by dominant ethnic groups. This has, however, created a new problem of ethnic minorities within several counties. The government has also introduced FPE and FDSE, delocalization policy, the equalization fund, HELB however they have gaps that need filling to make them fully operational as tools of levelling down ethno-regional inequality. Regions where ruling elites come from have received more educational resources as compared to other areas. Recommendations: Free Primary Education, Free Day Secondary Education and Higher Education Loans Board funds should be distributed equitably to address inequality, equalization fund should be made operational and managed by county governments

A Phase 2b Randomised Trial of the Candidate Malaria Vaccines FP9 ME-TRAP and MVA ME-TRAP among Children in Kenya

OBJECTIVE: The objective was to measure the efficacy of the vaccination regimen FFM ME-TRAP in preventing episodes of clinical malaria among children in a malaria endemic area. FFM ME-TRAP is sequential immunisation with two attenuated poxvirus vectors (FP9 and modified vaccinia virus Ankara), which both deliver the pre-erythrocytic malaria antigen construct multiple epitope–thrombospondin-related adhesion protein (ME-TRAP). DESIGN: The trial was randomised and double-blinded. SETTING: The setting was a rural, malaria-endemic area of coastal Kenya. PARTICIPANTS: We vaccinated 405 healthy 1- to 6-year-old children. INTERVENTIONS: Participants were randomised to vaccination with either FFM ME-TRAP or control (rabies vaccine). OUTCOME MEASURES: Following antimalarial drug treatment children were seen weekly and whenever they were unwell during nine months of monitoring. The axillary temperature was measured, and blood films taken when febrile. The primary analysis was time to a parasitaemia of over 2,500 parasites/μl. RESULTS: The regime was moderately immunogenic, but the magnitude of T cell responses was lower than in previous studies. In intention to treat (ITT) analysis, time to first episode was shorter in the FFM ME-TRAP group. The cumulative incidence of febrile malaria was 52/190 (27%) for FFM ME-TRAP and 40/197 (20%) among controls (hazard ratio = 1.52). This was not statistically significant (95% confidence interval [CI] 1.0–2.3; p = 0.14 by log-rank). A group of 346 children were vaccinated according to protocol (ATP). Among these children, the hazard ratio was 1.3 (95% CI 0.8–2.1; p = 0.55 by log-rank). When multiple malaria episodes were included in the analyses, the incidence rate ratios were 1.6 (95% CI 1.1–2.3); p = 0.017 for ITT, and 1.4 (95% CI 0.9–2.1); p = 0.16 for ATP. Haemoglobin and parasitaemia in cross-sectional surveys at 3 and 9 mo did not differ by treatment group. Among children vaccinated with FFM ME-TRAP, there was no correlation between immunogenicity and malaria incidence. CONCLUSIONS: No protection was induced against febrile malaria by this vaccine regimen. Future field studies will require vaccinations with stronger immunogenicity in children living in malarious areas

Local perceptions of intermittent screening and treatment for malaria in school children on the south coast of Kenya.

BACKGROUND: The intermittent screening and treatment (IST) of school children for malaria is one possible intervention strategy that could help reduce the burden of malaria among school children. Future implementation of IST will not only depend on its efficacy and cost-effectiveness but also on its acceptability to parents of the children who receive IST, as well as those responsible for its delivery. This study was conducted alongside a cluster-randomized trial to investigate local perceptions of school-based IST among parents and other stakeholders on the Kenyan south coast. METHODS: Six out of the 51 schools receiving the IST intervention were purposively sampled, based on the prevalence of Plasmodium infection, to participate in the qualitative study. Twenty-two focus group discussions and 17 in-depth interviews were conducted with parents and other key stakeholders involved in the implementation of school health programmes in the district. Data analysis was guided by the framework analysis method. RESULTS: High knowledge of the burden of clinical malaria on school children, the perceived benefits of preventing clinical disease through IST and previous positive experiences and interactions with other school health programmes facilitated the acceptability of IST. However, lack of understanding of the consequences of asymptomatic parasitaemia for apparently healthy school children could potentially contribute to non-adherence to treatment, and use of alternative anti-malarial drugs with simpler regimens was generally preferred. The general consensus of stakeholders was that health workers were best placed to undertake the screening and provide treatment, and although teachers' involvement in the programme is critical, most participants were opposed to teachers taking finger-prick blood samples from children. There was also a strong demand for the distribution of mosquito nets to augment IST. CONCLUSION: School-based malaria control through IST was acceptable to most parents and other stakeholders, but careful consideration of the various roles of teachers, community health workers, and health workers, and the use of anti-malarial drugs with simpler regimens are critical to its future implementation

Beginning community engagement at a busy biomedical research programme: Experiences from the KEMRI CGMRC-Wellcome Trust Research Programme, Kilifi, Kenya

There is wide acknowledgement of the need for community engagement in biomedical research, particularly in international settings. Recent debates have described theoretical approaches to identifying situations where this is most critical and potential mechanisms to achieve it. However, there is relatively little published experience of community engagement in practice. A major component of the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme is centred on Kilifi District General Hospital and surrounding community of 240,000 local residents. Documented community perceptions of the research centre are generally positive, but many indicate a low understanding of research and therapeutic misconceptions of its activities. As in other settings, these misunderstandings have contributed to concerns and rumours, and potentially undermine ethical aspects of research and local trust in the institution. Through a series of consultative activities, a community engagement strategy has been developed in Kilifi to strengthen mutual understanding between community members and the Centre. One important component is the establishment of a representative local resident network in different geographic locations commonly involved in research, to supplement existing communication channels. Early implementation of the strategy has provided new and diverse opportunities for dialogue, interaction and partnership building. Through the complex social interactions inherent in the community engagement strategy, the centre aims to build context specific ethical relations with local residents and to strengthen understanding of how ethical principles can be applied in practice. Evaluations over time will assess the effectiveness and sustainability of these strategies, provide generalisable information for similar research settings, and contribute to debates on the universality of ethical principles for research. This paper aims to summarise the rationale for community engagement in research, drawing on published literature and local findings, to outline the process of community engagement in Kilifi and to describe issues emerging from its development and early implementation

Taking social relationships seriously: Lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast

Individual informed consent is a key ethical obligation for clinical studies, but empirical studies show that key requirements are often not met. Common recommendations to strengthen consent in low income settings include seeking permission from community members through existing structures before approaching individuals, considering informed consent as a process rather than a single event, and assessing participant understanding using questionnaires. In this paper, we report on a qualitative study exploring community understanding and perceptions of a malaria vaccine trial (MVT) conducted in a rural setting on the Kenyan Coast. The MVT incorporated all of the above recommendations into its information-giving processes. The findings support the importance of community level information-giving and of giving information on several different occasions before seeking final individual consent. However, an emerging issue was that inter-personal interactions and relationships between researchers and community members, and within the community, play a critical role in participants' perceptions of a study, their decisions to consent or withdraw, and their advice to researchers on study practicalities and information to feedback at the end of the trial. These relationships are based on and continually tested by information-giving processes, and by context specific concerns and interests that can be difficult to predict and are well beyond the timescale and reach of single research activities. On the basis of these findings, we suggest that the current move towards increasingly ambitious and stringent formal standards for information-giving to individuals be counter-balanced with greater attention to the diverse social relationships that are essential to the successful application of these procedures. This may be assisted by emphasising respecting communities as well as persons, and by recognising that current guidelines and regulations may be an inadequate response to the complex, often unpredictable and ever shifting ethical dilemmas facing research teams working ‘in the field’