Dr
Primus Chi
Project Title
Social, Ethical and Regulatory implications of conducting a malaria Vaccine Efficacy trial in a human infection study in Kenya
EDCTP Project
TMA2019CDF-2751
EDCTP Program
EDCTP2
EDCTP Project Call
Career Development Fellowship (CDF)
Host Organisation
| Department | Institution | Country |
|---|---|---|
| African Research Collaboration for Health Limited (ARCH) | Kenya |
Current Organisation
KEMRI-Wellcome Trust Research Programme
Current Job Title
Mid-Level Social Scientist
Biography
Publications
Background
Global health research partnerships have been scrutinised for how they operate and criticised for perpetuating inequities. Guidance to inform fair partnership practice has proliferated and the movement to decolonise global health has added momentum for change. In light of this evolving context, we sought in this study to document contemporary experiences of partnership from the perspective of stakeholders in four sub-Saharan African research institutions.
Methods
We conducted qualitative interviews with 20 stakeholders at research institutions in four countries in anglophone eastern and southern Africa. Interview questions were informed by published guidance on equitable research partnerships. Data was analysed through an iterative process of inductive and deductive coding, supported by NVivo software.
Results
Early-career, mid-career and senior researchers and research administrators from four sub-Saharan African research institutions described wide-ranging experiences of partnership with high-income country collaborators. Existing guidelines for partnership provided good coverage of issues that participants described as being the key determinants of a healthy partnership, including mutual respect, role clarity and early involvement of all partners. However, there was almost no mention of guidelines being used to inform partnership practice. Participants considered the key benefits of partnership to be capacity strengthening and access to research funding. Meanwhile, participants continued to experience a range of well-documented inequities, including exclusion from agenda setting, study design, data analysis and authorship; and relationships that were exploitative and dominated by high-income country partners' interests. Participants also reported emerging issues where their institution had been the prime recipient of funds. These included high-income country partners being unwilling to accept a subordinate role and failing to comply with reporting requirements.
Conclusions
Insights from stakeholders in four sub-Saharan African research institutions suggest that contemporary global health research partnerships generate considerable benefits but continue to exhibit longstanding inequities and reveal emerging tensions. Our findings suggest that long-term support targeted towards institutions and national research systems remains essential to fulfil the potential of research led from sub-Saharan Africa. High-income country stakeholders need to find new roles in partnerships and stakeholders from sub-Saharan Africa must continue to tackle challenges presented by the resource-constrained contexts in which they commonly operate.
Introduction:Maternal mortality rates can be adversely affected by armed conflict, implying a greater level of vulnerability among women, and is often linked to the lack of or limited access to maternal healthcare during conflict. Previous research in Uganda has shown that armed conflict negatively impacts women's utilization of maternal healthcare services for a multitude of reasons at the individual, health-system and political levels. Methods:This study compared aggregated Demographic and Health Surveys data from 13 districts in Northern Uganda, a conflict-affected region, with data from the rest of the country, for the use of maternal healthcare services for the years 1988, 1995, 2000, 2006 and 2011, using statistical analyses and logistic regression. Specific indicators for maternal healthcare utilization included contraceptive use, antenatal care, skilled assistance at birth and institutional delivery. Results:Use of contraception and institutional deliveries among women in Northern Uganda was significantly lower compared to the rest of the country. However, skilled assistance at birth among women in Northern Uganda was significantly higher. Conclusions:The findings in this study show that armed conflict can have a negative impact on aspects of maternal healthcare such as contraceptive use and institutional deliveries; however, other indicators such as skilled assistance at birth were seen to be better among conflict-affected populations. This reiterates the complex nature of armed conflict and the interplay of different factors such as conflict intensity, existing health systems and services, and humanitarian interventions that could influence maternal healthcare utilization. Key words:Armed conflict, maternal health utilization, Northern Uganda, contraception, skilled assistance at birth, antenatal care, institutional delivery.
The third Human Challenge Trial Meeting brought together a broad range of international stakeholders, including academia, regulators, funders and industry, with a considerable delegation from Low- and Middle-Income Countries. Controlled human infection models (CHIMs) can be helpful to study pathogenesis and for the development of vaccines. As challenge agents are used to infect healthy volunteers, ethical considerations include that the challenge studies need to be safe and results should be meaningful. The meeting provided a state-of-the-art overview on a wide range of CHIMs, including viral, bacterial and parasitic challenge agents. Recommendations included globally aligned guidance documents for CHIM studies; further definition of a CHIM, based on the challenge agent used; standardization of methodology and study endpoints; capacity building in Low- and Middle-Income Countries, in performance as well as regulation of CHIM studies; guidance on compensation for participation in CHIM studies; and preparation of CHIM studies, with strong engagement with stakeholders.
Armed conflict potentially poses serious challenges to access and quality of maternal and reproductive health (MRH) services, resulting in increased maternal morbidity and mortality. The effects of armed conflict may vary from one setting to another, including the mechanisms/channels through which the conflict may lead to poor access to and quality of health services. This study aims to explore the effects of armed conflict on MRH in Burundi and Northern Uganda.This is a descriptive qualitative study that used in-depth interviews (IDIs) and focus group discussions (FGDs) with women, health providers and staff of NGOs for data collection. Issues discussed include the effects of armed conflict on access and quality of MRH services and outcomes, and the mechanisms through which armed conflict leads to poor access and quality of MRH services. A total of 63 IDIs and 8 FGDs were conducted involving 115 participants.The main themes that emerged from the study were: armed conflict as a cause of limited access to and poor quality of MRH services; armed conflict as a cause of poor MRH outcomes; and armed conflict as a route to improved access to health care. The main mechanisms through which the conflict led to poor access and quality of MRH services varied across the sites: attacks on health facilities and looting of medical supplies in both sites; targeted killing of health personnel and favouritism in the provision of healthcare in Burundi; and abduction of health providers in Northern Uganda. The perceived effects of the conflict on MRH outcomes included: increased maternal and newborn morbidity and mortality; high prevalence of HIV/AIDS and SGBV; increased levels of prostitution, teenage pregnancy and clandestine abortion; and high fertility levels. Relocation to government recognised IDP camps was perceived to improve access to health services.The effects of armed conflict on MRH services and outcomes are substantial. The mechanisms through which armed conflict leads to poor access and quality of MRH services vary from one setting to another. All these issues need to be considered in the design and implementation of interventions to improve MRH in these settings.
Human infection studies (HIS) involve deliberately infecting healthy volunteers with disease-causing pathogens under controlled conditions. These studies are "controlled" by way of using specific types of pathogens, including dose, and the availability of emergency medical facilities to research volunteers. Most HIS involve diseases whose treatment is known and are done to accelerate the development of novel therapeutics such as vaccines, to address emerging and existing infectious diseases. Traditionally, HIS have been conducted primarily in high-income countries (HICs) but are now increasingly being conducted in low-and-middle income countries (LMICs). In LMICs settings, HIS are likely to raise concerns among various stakeholders including participating populations and regulatory bodies, that are unfamiliar with this type of research. Deliberately infecting a healthy individual with a disease-causing pathogen seems to go against the normal practice of medicine of "do no harm". Such types of studies can give rise to increased rumors and jeopardize research participation in study activities, including non-HIS research. Community engagement can be one approach to address particular issues that HIS studies raise through meaningfully engaging with communities, where views and voices inform the conduct of HIS studies. In addition, engagement can inform the ethical conduct and acceptability of HIS studies in LMICs settings and provide opportunities for sharing information, listening to, and responding to concerns and views from potential participants, and the larger community in which the study would be conducted. Despite community engagement being an important aspect to consider, very few published and gray literature cover the types of approaches that have been used, and lessons learnt in engagement for HIS. This article outlinesthe community engagement approaches that were used to engage stakeholders and communities for malaria HIS-controlled human malaria infection (CHMI), undertaken in Kilifi, Kenya. It outlines the engagement activities across the research cycle, from activities conducted during protocol development, to planning, and implementation of the study. We discuss the challenges experienced, lessons learnt, and provide some recommendations for engagement around HIS.
Although the world has experienced remarkable progress in health care since the last half of the 20th century, global health inequalities still persist. In some poor countries life expectancy is between 37-40 years lower than in rich countries; furthermore, maternal and infant mortality is high and there is lack of access to basic preventive and life-saving medicines, as well a high prevalence of neglected diseases, HIV/AIDS, tuberculosis, and malaria. Moreover, globalization has made the world more connected than before such that health challenges today are no longer limited within national or regional boundaries, making all persons equally vulnerable. Because of this, diseases in the most affluent countries are closely connected with diseases in the poorest countries. In this paper, we argue that, because of global health inequalities, in a situation of equal vulnerability, there is need for global solidarity not only as a means of reducing health inequalities, but also as a way of putting up a united force against global health challenges. We argue for an African approach to solidarity in which the humanity of a person is not determined by his/her being human or rational capacity, but by his/her capacity to live a virtuous life. According to this view of solidarity, because no one is self-sufficient, no individual can survive alone. If we are to collectively flourish in a world where no individual, nation or region has all the health resources or protection needed for survival, we must engage in solidarity where we remain compassionate and available to one another at all times.
Background
Teenage pregnancy is a serious public health and social problem, with 95% occurring in developing countries. The aim of the study was to investigate the behavioural, familial and social factors associated with teenage pregnancy among girls aged 13-19 years in Lira District, Uganda.
Methods
Primary data from a case-control study of teenage girls (aged 13-19 years) in Lira District, Uganda was analysed. A Structured questionnaire was administered using face-to-face interviews to collect data on 495 participants, identified through simple random sampling from 32 villages in two counties in Lira District. Data analyses were done using SPSS Statistics 23 for descriptive, bivariate (i.e. Chi-square tests) and multivariable analyses (i.e. logistics regression) used for determining independent associations.
Results
A total of 495 teenage girls participated in the study, however, final analyses were undertaken for 480 respondents. At bivariable analysis, all variables except alcohol consumption were significantly associated with teenage pregnancy. Among the behavioural factors assessed, multivariable analyses showed that having multiple sexual partners, frequent sex and irregular contraceptive use increased the likelihood of teenage pregnancy. Among familial factors, being married was found to increase the likelihood of teenage pregnancy. Peer pressure, sexual abuse and lack of control over sex was observed to increase the likelihood of teenage pregnancy.
Conclusions
Demographic, behavioural, familial and social factors are important predictors of teenage pregnancy in Lira District. Interventions focussing on: retaining pregnant and married girls at school, information on sexual and reproductive health of teenage girls, improving access to and information about contraceptive use among teenage girls, improving socio-economic status of households, and law enforcement on sexual abuse among girls may come a long way to improving adolescent sexual and health services in the low-income settings.
BACKGROUND: Universities in Cameroon are playing an active part in HIV/AIDS research and much of this research is carried out by students, usually for the purpose of a dissertation/thesis. Student theses/dissertations present research findings in a much more comprehensive manner and have been described as the stepping-stone of a budding scientist's potential in becoming an independent researcher. It is therefore important to verify how students handle issues of research ethics. METHOD: Theses/dissertations on HIV/AIDS that described research studies involving the use of human research participants were screened to verify if research ethics approval and informed consent were obtained and documented. The contents of the consent forms were also qualitatively analyzed. RESULTS: Of 174 theses/dissertations on HIV, ethics approval was documented in 17 (9.77%) and informed consent in 77 (47.83%). Research ethics approval was first mentioned at all in 2002 and highly reported in the year 2007. Evidence of ethics approval was found for the first time in 2005 and informed consent first observed and evidenced in 1997. Ethics approval was mostly reported by students studying for an MD (14.01%) and was not reported in any Bachelors' degree dissertation. Informed consent was also highly reported in MD theses (64.58%) followed by undergraduate theses (31.58%). Voluntary participation and potential benefits of the study were some of the common aspects dealt with in most of the consent forms. The right to discontinue participation in the study and management of residual samples were scarcely ever mentioned. CONCLUSIONS: Overall, and given the current state of the art of research ethics around the world, student-scientists in Cameroon would seem to be merely kidding with research ethics. It is thus essential that training in health research ethics (HRE) be incorporated in the curriculum of universities in Cameroon in order that the next generation of scientists may be better equipped with thorough knowledge and practice of HRE. This, we believe, would be one way of fighting the occurrence of research scandals, which have not yet abated significantly, especially those arising from negligence or inexcusable ignorance.
Objectives:Many conflict-affected countries are faced with an acute shortage of health care providers, including skilled birth attendants. As such, during conflicts traditional birth attendants have become the first point of call for many pregnant women, assisting them during pregnancy, labour and birth, and in the postpartum period. This study seeks to explore how the role of traditional birth attendants in maternal health, especially childbirth, has evolved in two post-conflict settings in sub-Saharan Africa (Burundi and northern Uganda) spanning the period of active warfare to the post-conflict era. Methods:A total of 63 individual semi-structured in-depth interviews and 8 focus group discussions were held with women of reproductive age, local health care providers and staff of non-governmental organisations working in the domain of maternal health who experienced the conflict, across urban, semi-urban and rural settings in Burundi and northern Uganda. Discussions focused on the role played by traditional birth attendants in maternal health, especially childbirth during the conflict and how the role has evolved in the post-conflict era. Transcripts from the interviews and focus group discussions were analysed by thematic analysis (framework approach). Results:Traditional birth attendants played a major role in childbirth-related activities in both Burundi and northern Uganda during the conflict, with some receiving training and delivery kits from the local health systems and non-governmental organisations to undertake deliveries. Following the end of the conflict, traditional birth attendants have been prohibited by the government from undertaking deliveries in both Burundi and northern Uganda. In Burundi, the traditional birth attendants have been integrated within the primary health care system, especially in rural areas, and re-assigned the role of 'birth companions'. In this capacity they undertake maternal health promotion activities within their communities. In northern Uganda, on the other hand, traditional birth attendants have not been integrated within the local health system and still appear to undertake clandestine deliveries in some rural areas. Conclusion:The prominent role of traditional birth attendants in childbirth during the conflicts in Burundi and northern Uganda has been dwindling in the post-conflict era. Traditional birth attendants can still play an important role in facilitating facility and skilled attended births if appropriately integrated with the local health system.
Controlled human malaria infection (CHMI) studies involve the deliberate infection of healthy volunteers with malaria parasites under controlled conditions to study immune responses and/or test drug or vaccine efficacy. An empirical ethics study was embedded in a CHMI study at a Kenyan research programme to explore stakeholders' perceptions and experiences of deliberate infection and moral implications of these. Data for this qualitative study were collected through focus group discussions, in-depth interviews and non-participant observation. Sixty-nine participants were involved, including CHMI study volunteers, community representatives and research staff. Data were managed using QSR Nvivo 10 and analysed using an inductive-deductive approach, guided by ethics literature. CHMI volunteers had reasonable understanding of the study procedures. Decisions to join were influenced by study incentives, trust in the research institution, their assessment of associated burdens and motivation to support malaria vaccine development. However, deliberate malaria infection was a highly unusual research strategy for volunteers, community representatives and some study staff. Volunteers' experiences of physical, emotional and social burdens or harms were often greater than anticipated initially, and fluctuated over time, related to specific procedures and events. Although unlikely to deter volunteers' participation in similar studies in furture, we argue that the dissonance between level of understanding of the burdens involved and actual experiences are morally relevant in relation to community engagement, informed consent processes, and ongoing support for volunteers and research staff. We further argue that ethics oversight of CHMI studies should take account of these issues in deciding whether consent, engagement and the balance of benefits and harms are reasonable in a given context.
The Sustainable Development Goals have spurred a growing interest in and focus on equitable development. In theory, donors can play an important role in promoting equity within a country by providing services, influencing government policies and incorporating equity into decision-making. However, we know little about whether this actually happens on the ground. We conduct what we believe is the first study to explore the extent to which equity is prioritised in the allocation and distribution of aid, based on in-depth interviews with government officials, bilateral and international donors, and implementing partners operating in Northern Uganda. We find that a broad category of people are perceived to be marginalised/vulnerable, with a substantial segment largely untargeted by major donor programmes. Various stakeholders employ a wide range of strategies to identify the most vulnerable individuals and groups, including the use of available data and statistics, consultation and engagement with relevant stakeholders, and undertaking primary data collection. The strategies used to incorporate equity in aid allocation and distribution include: targeting the regions of Northern Uganda and Karamoja in particular, targeting both refugees and host populations in refugee-hosting districts, prioritising the critically vulnerable in any aid distribution process, and using specific tools and consultants to ensure that major equity issues are addressed in proposals. Challenges undermining the process include poor understanding of the concept of equity among some implementing partners, lack of comprehensively disaggregated data, corruption, and political interference in choice of aid location from government officials and donors.
Armed conflict has been described as an important contributor to the social determinants of health and a driver of health inequity, including maternal health. These conflicts may severely reduce access to maternal health services and, as a consequence, lead to poor maternal health outcomes for a period extending beyond the conflict itself. As such, understanding how maternal health-seeking behaviour and utilisation of maternal health services can be improved in post-conflict societies is of crucial importance. This study aims to explore the determinants (barriers and facilitators) of women's uptake of maternal, sexual and reproductive health services (MSRHS) in two post-conflict settings in sub-Saharan Africa; Burundi and Northern Uganda, and how uptake is affected by exposure to armed conflict.This is a qualitative study that utilised in-depth interviews and focus group discussions (FGDs) for data collection. One hundred and fifteen participants took part in the interviews and FGDs across the two study settings. Participants were women of reproductive age, local health providers and staff of non-governmental organizations. Issues explored included the factors affecting women's utilisation of a range of MSRHS vis-à-vis conflict exposure. The framework method, making use of both inductive and deductive approaches, was used for analyzing the data.A complex and inter-related set of factors affect women's utilisation of MSRHS in post-conflict settings. Exposure to armed conflict affects women's utilisation of these services mainly through impeding women's health seeking behaviour and community perception of health services. The factors identified cut across the individual, socio-cultural, and political and health system spheres, and the main determinants include women's fear of developing pregnancy-related complications, status of women empowerment and support at the household and community levels, removal of user-fees, proximity to the health facility, and attitude of health providers.Improving women's uptake of MSRHS in post-conflict settings requires health system strengthening initiatives that address the barriers across the individual, socio-cultural, and political and health system spheres. While addressing financial barriers to access is crucial, attention should be paid to non-financial barriers as well. The goal should be to develop an equitable and sustainable health system.
Maternal and neonatal mortality and morbidity rates are particularly grim in conflict, post-conflict and other crisis settings, a situation partly blamed on non-availability and/or poor quality of emergency obstetric and neonatal care (EmONC) services. The aim of this study was to explore the barriers to effective delivery of EmONC services in post-conflict Burundi and Northern Uganda, in order to provide policy makers and other relevant stakeholders context-relevant data on improving the delivery of these lifesaving services.This was a qualitative comparative case study that used 42 face-to-face semi-structured in-depth interviews and 4 focus group discussions for data collection. Participants were 32 local health providers and 37 staff of NGOs working in the area of maternal health. Data was analysed using the framework approach.The availability, quality and distribution of EmONC services were major challenges across the sites. The barriers in the delivery of quality EmONC services were categorised into two major themes; human resources-related challenges, and systemic and institutional failures. While some of the barriers were similar, others were unique to specific sites. The common barriers included shortage of qualified staff; lack of essential installations, supplies and medications; increasing workload, burn-out and turnover; and poor data collection and monitoring systems. Barriers unique to Northern Uganda were demoralised personnel and lack of recognition; poor referral system; inefficient drug supply system; staff absenteeism in rural areas; and poor coordination among key personnel. In Burundi, weak curriculum; poor harmonisation and coordination of training; and inefficient allocation of resources were the unique challenges. To improve the situation across the sites, efforts are ongoing to improve the training and recruitment of more staff; harmonise and strengthen the curriculum and training; increase the number of EmONC facilities; and improve staff supervision, monitoring and support.Post-conflict health systems face different challenges in the delivery of EmONC services and as such require context-specific interventions to improve the delivery of these services.
Human Infection Studies (HIS) have emerged as an important research approach with the potential to fast track the global development of vaccines and treatments for infectious diseases, including in low resource settings. Given the high level of burdens involved in many HIS, particularly prolonged residency and biological sampling requirements, it can be challenging to identify levels of study payments that provide adequate compensation but avoid 'undue' levels of inducement to participate. Through this embedded ethics study, involving 97 healthy volunteers and other research stakeholders in a malaria HIS programme in Kenya, and using in-depth interviews, focus group discussions and observations during and after a malaria HIS, we give a grounded account of ethical issues emerging in relation to study payments in this setting. While careful community, national, international scientific and ethics review processes meant that risks of serious harm were highly unlikely, the levels of motivation to join HIS seen could raise concerns about study payments being too high. Particular value was placed on the reliability, rather than level, of study payment in this setting, where subsistence livelihoods are common. Study volunteers were generally clear about the study aims at the point of recruitment, and this knowledge was retained over a year later, although most reported experiencing more burdens than anticipated at enrolment. Strict study screening procedures, regular clinical and laboratory monitoring of volunteers, with prompt treatment with antimalarial at predetermined endpoints suggested that the risks of serious harm were highly unlikely. Ethical concerns emerged in relation to volunteers' attempts to conceal symptoms, hoping to prolong residency periods and increase study payments; and volunteers making decisions that compromised important family relationships and personal values. Our findings support an interpretation that, although study volunteers were keen to join the study to access cash payments, they also paid attention to other features of the study and the general clinical research landscape, including levels of risk associated with study participation. Overall, our analysis shows that the ethical concerns emerging from the study payments can be addressed through practical measures, hinged on reducing burdens and strengthening communication, raising important issues for research policy and planning.
A study was carried out with 425 children aged 0-14 yr residing in Bolifamba, Cameroon, to investigate the effect of Plasmodium falciparum malaria and intestinal helminth coinfection on anemia and to identify significant predictors of anemia in the community. Blood was collected by finger prick to determine malaria parasitemia and packed cell volume (PCV). The Kato-Katz technique was used to assess the prevalence and egg load of intestinal helminths. The prevalence of P. falciparum malaria, intestinal helminth infections, and coinfection was 64.2%, 38.3%, and 24.7%, respectively. Coinfections in which heavy helminth loads were detected had corresponding high mean P. falciparum parasite loads >5,000/microl compared with coinfections involving light helminth burden. The overall prevalence of anemia was 30.8%. Anemia prevalence increased significantly with P. falciparum parasite load >5,000/microl compared with lower densities (chi2 = 6.734, P = 0.034). Anemia prevalence was significantly higher in febrile children compared with nonfebrile children (chi2 = 6.041, P = 0.014). Children infected exclusively with P. falciparum recorded the highest prevalence of anemia compared with uninfected children, those with coinfections, and those harboring only helminths. This difference in prevalence was significant (chi2 = 6.734, P = 0.031). Multiple regression analysis exposed fever (P > 0.001) and age (P = 0.004) as significant predictors of anemia.