During the 2014 Ebola Virus Disease (EVD) epidemic, the Ebola-Tx trial evaluated the use of convalescent plasma (CP) in Guinea. The effectiveness of plasmapheresis trials depends on the recruitment of plasma donors. This paper describes what motivated or deterred EVD survivors to donate CP, providing insights for future plasmapheresis trials and epidemic preparedness. This qualitative study, part of Ebola-Tx, researched and addressed emergent trial difficulties through interviewing, participant observation and focus group discussions. Sampling was theoretical and retroductive analysis was done in NVivo 10. Willingness or hesitance to participate in plasma donation depended on factors at the interface of pre-existing social dynamics; the impact of the disease and the consequent emergency response including the trial set-up. For volunteers, motivation to donate was mainly related to the feeling of social responsibility inspired by having survived EVD and to positive perceptions of plasmapheresis technology despite still unknown trial outcomes. Conversely, confidentiality concerns when volunteering due to stigmatization of survivors and perceived decrease in vital strength and in antibodies when donating, leading to fears of loss in protection against EVD, were main deterrents. The dynamic (dis) trust in Ebola Response Actors and in other survivors further determined willingness to participate and lead to the emergence/decline of rumours related to blood stealing and treatment effectiveness. Historic inter-ethnic relations in the health care setting further defined volunteering along socio-economic and ethnic lines. Finally, lack of follow-up and of dedicated care further impacted on motivation to volunteer. Ebola-Tx was the first trial to solicit and evaluate blood-product donation as an experimental treatment on a large scale in Sub-Saharan Africa. An effective donation system requires directly engaging with emergent social barriers and providing an effective ethical response, including improved and transparent communication, effective follow-up after donation, assuring confidentiality and determining ethical incentives.
The urgency to contain the 2013–2016 West-African Ebola virus disease (EVD) epidemic led to the World Health Organization’s prioritization of the clinical evaluation of convalescent plasma (CP) or whole blood in September 2014 [1–4] as a potential cure, resulting in fast-tracked non-randomized clinical trials in Sierra Leone, Guinea and Liberia [5]. The Ebola-Tx trial in Guinea aimed to determine whether the administration of EVD antibodies from the blood plasma of EVD survivors could increase EVD patients’ survival rate compared to a historical control group receiving only supportive care at the same site. Although the treatment was found to be safe, receiving two consecutive units of 200-250ml CP did not significantly improve the overall survival rate [6]. The effective implementation of such trials depends on the recruitment of EVD survivors as volunteers for plasma donation. Throughout sub-Saharan Africa, even the sampling of small amounts of blood has been associated with considerable fears of ‘blood stealing’ or ‘blood selling’, documented since colonial times [7,8], leading to reticence for participation in clinical research [8–13]. Reports from Guinea, Sierra Leone and Liberia suggested similar concerns as blood-related rumors were frequently reported during the EVD outbreak [14–17], an example of which being the local suspicion that burial teams of EVD victims “filled their tanks” with the blood of the deceased in exchange for international aid [18]. There were further concerns that the stigmatization of EVD survivors [19,20] could hinder efforts to recruit survivors to donate plasma [21,22]. This stigmatization was often related to suspicions of Ebola Treatment Centre workers and survivors having killed patients through mystical means to ensure their own survival in addition to fears of survivors still being infectious. Due to these complexities, scientists were concerned that collection of CP from EVD survivors during the outbreak might not be feasible. Nevertheless, the Ebola-Tx trial recruited 98 survivors, sufficient to provide experimental treatment to all trial patients [23]. This anthropological study was part of the Ebola-Tx trial “Emergency evaluation of convalescent plasma for Ebola Virus Disease (EVD) in Guinea” (NCT02342171) and aimed to provide insights into what motivated or deterred EVD survivors to donate convalescent plasma, in order to contribute to the effectiveness of future plasmapheresis trials and outbreak preparedness.
The qualitative research was carried out in both Ebola-Tx trial sites in Guinea– (i) the National Blood Transfusion Centre (NBTC), and (ii) the Médecins Sans Frontières (MSF) run Donka Ebola Treatment Centre–as well as in surrounding areas in Conakry and the three peripheral prefectures of Coyah, Kindia and Dubréka. Sampling for the study was theoretical (i. e. based on emerging results) [28] (Table 1). Participants were selected based on characteristics such as involvement in the trial, social ties with survivors, professional background, socio-economic status, gender, age, and urban or rural residence. Data collection was intermittently carried out between January and September 2015 by two European anthropologists from ITM, in some cases accompanied by an EVD survivor/gatekeeper. This period coincided with phases E and F of the Guinean epidemic [29,30], right after the highest peak of October-December 2014, characterized by a decrease in cases and a movement of the epidemic to the Lower Guinean region (including the capital). The position of the researchers and gatekeepers, especially within the context of this epidemic, initially proved challenging in gaining trust of different types of informants. This was gradually overcome through regular visits and constant rapport building. The anthropological team often reflected on and discussed their role in the trial and thus navigated the tension between their critical independence with regards to the trial on the one hand, and, on the other hand, their direct involvement in strategies and activities to improve the effectiveness of the trial. Semi-structured in-depth interviews were carried out using continuously evolving question guides addressing personal experiences with EVD, power relations and social dynamics within the SA, perception and experience of the trial, recommendations for improvement, plasma versus blood perceptions, internal work dynamics, recommendations for further steps of the trial, suggestions for improvement, and rumors pertaining to the trial itself as well as to the Ebola outbreak more generally. Participant observation was used at different stages and places linked to trial preparation and implementation, allowing insights into the trial dynamics. Focus Group Discussions aimed at eliciting contrasting opinions. Separate group discussions were organized for survivors, donors, trial staff (including doctors) and patients. Analysis was retroductive and concurrent to data collection. Preliminary data were intermittently analyzed in the field. Temporary results were further confirmed or refuted through constant validity checks until saturation was reached and the data was theoretically supported. Thematic analysis was carried out with NVivo Qualitative Data Analysis software (QSR International Pty Ltd. Cardigan UK). Oral informed consent was obtained from all adult participants. Considering the sensitive nature of this qualitative research, oral rather than written consent was preferred for a number of reasons: (i) to avoid the high illiteracy in the study population challenging the practical obtaining of written consent; (ii) written consent might seem a breach of confidentiality by the participants; (iii) written consent, requiring a signature and therefore introducing formality in the procedure, affects trust between respondents and researchers and consequently willingness to participate in the study, as conversations usually do not require formal procedures. In addition, this formality introduces bias and hence reduces data quality. Informed consent was documented in written by the person who obtained the consent and, if present, by a witness. The study, including the use of oral consent, was reviewed and approved by the Institutional Review Board of the ITM (IRB/AB/ac/092 Ref: 1098/16) and the Guinean National Ethics Committee for Research in Health–CNERS (131/CNERS/16). Ethical reviews and approval for the Ebola-Tx trial are described in [6].
Blood was considered sacred and a vital element associated with health. A decrease in volume of blood was perceived to weaken the body and cause (potentially irreversible) sickness, limiting people’s willingness to participate in the trial. Despite the use of plasma instead of blood, and the trial team’s explicit explanation of the difference (e. g. in color, time for recovery, quantities required), participants still perceived the procedure to be “blood” donation. The absence of a word for plasma in the Susu language, leading to the use of the word ‘blood’ (‘wouly’), contributed to this ambiguity. Donating plasma was thus associated with blood donation, leading to common fears such as the fear of the “unknown” for first-time donors, fear of knowing one’s serological status, fear of the pain, needles, and physical weakening, especially when survivors felt they had not completely recovered from EVD or when they felt they were affected by poor nutrition. Some donors reported needing considerable time to recover. For donors who, conversely, were positively surprised by their smooth recovery, this was mostly linked to their perceptions of the technology being cutting-edge. In addition, the Plasma Mobile and its high-quality equipment was welcomed by survivors as an acknowledgement of previous hardship. Survivors, especially those with a medical background, perceived the loss of immunity and the increased risk of reinfection and relapse due to the transference of antibodies when donating to be a health risk, as illustrated by the following quote: “You know it’s the antibodies that helped us recover. If you want to weaken our antibodies even more, what am I going to do? Won’t I become sick again? ” (EVD survivor, IDI) One of the main factors influencing decision-making was trust, or the absence of it, in the organizations and people involved. Due to the stigmatization of EVD survivors by neighbors, relatives and more broadly in social and professional networks, the difficulty of dealing with anonymity was decisive for non-participation as it could expose donors as survivors. While some survivors required to be contacted by peers in a confidential way, others demanded openness from peer educators and requested them to sensitize their families, prior to taking the decision to participate. The perception of contributing to patients’ survival and indirect motives such as a sense of patriotism, the feeling of being part of a historic fight against a lethal disease and the feeling of being ‘in debt’ because they survived while others did not, leading to a moral obligation to do something in return, motivated potential donors to participate in the trial.
Time limitations, security measures, initial people’s distrust and financial and political incentives for respondents as part of the response to the epidemic did not always allow for the researchers’ immersion in the study setting as is usual with ethnographic research methods. This limited access to sensitive information and informants, which limited the scope and depth of the collected data.
Actively engaging with, responding to and following up participants, especially when concerning vulnerable populations such as EVD survivors enrolled as plasma donors, should be integral to the trial design. Effective and ethical donation systems, emergency trials, and even trials in low-resource settings more broadly, require directly engaging with emergent factors that occur at the interface between pre-existing social dynamics, the impact of the disease, and the consequent (emergency) response including the trial set-up. We advocate for the integration of methodologies to face emergent factors into trial designs from the start.
During the 2014 West-African Ebola Virus Disease epidemic, the Ebola-Tx clinical trial in Guinea aimed to determine whether the administration of Ebola antibodies from the blood plasma of Ebola survivors could increase Ebola patients’ survival rate. Ebola-Tx was the first trial to solicit and evaluate blood-product donation as an experimental treatment on a large scale in Sub-Saharan Africa. In this qualitative study, part of the Ebola-Tx study, we report on factors of motivation and demotivation influencing Ebola survivors to donate their plasma. Understanding these factors is essential as the successful recruitment of this specific subgroup, providing the therapy itself, directly impacts the effectiveness of such a trial. We show that organizing an effective and ethical donation system requires directly engaging with emerging social barriers at the interface between pre-existing social dynamics, the impact of the disease, and the consequent emergency response including the trial set-up. These results provide insights that can be useful for future plasma trials but also for emergency clinical trials as part of general epidemic preparedness.
guinea
medicine and health sciences
clinical laboratory sciences
body fluids
pathology and laboratory medicine
education
pathogens
sociology
geographical locations
tropical diseases
social sciences
ebola hemorrhagic fever
microbiology
viruses
research design
filoviruses
rna viruses
neglected tropical diseases
transfusion medicine
africa
research and analysis methods
medical education
viral hemorrhagic fevers
infectious diseases
medical microbiology
microbial pathogens
qualitative studies
blood plasma
hematology
people and places
diagnostic medicine
blood
anatomy
medical humanities
ebola virus
physiology
viral pathogens
biology and life sciences
viral diseases
blood transfusion
hemorrhagic fever viruses
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What motivates Ebola survivors to donate plasma during an emergency clinical trial? The case of Ebola-Tx in Guinea