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What motivates Ebola survivors to donate plasma during an emergency clinical trial? The case of Ebola-Tx in Guinea.

ABSTRACT: INTRODUCTION: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. METHODS: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. RESULTS: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. CONCLUSIONS: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.

SUBMITTER: Ronse M

PROVIDER: S-EPMC6219816 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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What motivates Ebola survivors to donate plasma during an emergency clinical trial? The case of Ebola-Tx in Guinea.

Ronse Maya M Marí Sáez Almudena A Gryseels Charlotte C Bannister-Tyrrell Melanie M Delamou Alexandre A Guillard Alain A Briki Mustapha M Bigey Frédéric F Haba Nyankoye N van Griensven Johan J Peeters Grietens Koen K

PLoS neglected tropical diseases 20181017 10

<h4>Introduction</h4>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.<h4>Methods</h4>This qualitative study, part of Ebola-Tx, researched and addressed emergent trial difficultie ...[more]

PMID: 30332421

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Project description:BackgroundIn the wake of the recent outbreak of Ebola virus disease (EVD) in several African countries, the World Health Organization prioritized the evaluation of treatment with convalescent plasma derived from patients who have recovered from the disease. We evaluated the safety and efficacy of convalescent plasma for the treatment of EVD in Guinea.MethodsIn this nonrandomized, comparative study, 99 patients of various ages (including pregnant women) with confirmed EVD received two consecutive transfusions of 200 to 250 ml of ABO-compatible convalescent plasma, with each unit of plasma obtained from a separate convalescent donor. The transfusions were initiated on the day of diagnosis or up to 2 days later. The level of neutralizing antibodies against Ebola virus in the plasma was unknown at the time of administration. The control group was 418 patients who had been treated at the same center during the previous 5 months. The primary outcome was the risk of death during the period from 3 to 16 days after diagnosis with adjustments for age and the baseline cycle-threshold value on polymerase-chain-reaction assay; patients who had died before day 3 were excluded. The clinically important difference was defined as an absolute reduction in mortality of 20 percentage points in the convalescent-plasma group as compared with the control group.ResultsA total of 84 patients who were treated with plasma were included in the primary analysis. At baseline, the convalescent-plasma group had slightly higher cycle-threshold values and a shorter duration of symptoms than did the control group, along with a higher frequency of eye redness and difficulty in swallowing. From day 3 to day 16 after diagnosis, the risk of death was 31% in the convalescent-plasma group and 38% in the control group (risk difference, -7 percentage points; 95% confidence interval [CI], -18 to 4). The difference was reduced after adjustment for age and cycle-threshold value (adjusted risk difference, -3 percentage points; 95% CI, -13 to 8). No serious adverse reactions associated with the use of convalescent plasma were observed.ConclusionsThe transfusion of up to 500 ml of convalescent plasma with unknown levels of neutralizing antibodies in 84 patients with confirmed EVD was not associated with a significant improvement in survival. (Funded by the European Union's Horizon 2020 Research and Innovation Program and others; ClinicalTrials.gov number, NCT02342171.).

Project description:OBJECTIVES:To describe the prevalence and correlates of depression and anxiety among adult Ebola virus disease (EVD) survivors in Liberia, Sierra Leone and Guinea. DESIGN:Cross-sectional. SETTING:One-on-one surveys were conducted in EVD-affected communities in Liberia, Sierra Leone and Guinea in early 2018. PARTICIPANTS:1495 adult EVD survivors (726 male, 769 female). PRIMARY AND SECONDARY OUTCOME MEASURES:Patient Health Questionnaire-9 (PHQ-9) depression scores and Generalised Anxiety Disorder-7 (GAD-7) scores. RESULTS:Prevalence and severity of depression and anxiety varied across the three countries. Sierra Leone had the highest prevalence of depression, with 22.0% of participants meeting the criteria for a tentative diagnosis of depression, compared with 20.2% in Liberia and 13.0% in Guinea. Sierra Leone also showed the highest prevalence of anxiety, with 10.7% of participants meeting criteria for generalized anxiety disorder (GAD-7 score ?10), compared with 9.9% in Liberia and 4.2% in Guinea. Between one-third and one-half of respondents reported little interest or pleasure in doing things in the previous 2?weeks (range: 47.0% in Liberia to 37.6% in Sierra Leone), and more than 1 in 10 respondents reported ideation of self-harm or suicide (range: 19.4% in Sierra Leone to 10.4% in Guinea). Higher depression and anxiety scores were statistically significantly associated with each other and with experiences of health facility-based stigma in all three countries. Other associations between mental health scores and respondent characteristics varied across countries. CONCLUSIONS:Our results indicate that both depression and anxiety are common among EVD survivors in Liberia, Sierra Leone and Guinea, but that there is country-level heterogeneity in prevalence, severity and correlates of these conditions. All three countries should work to make mental health services available for survivors, and governments and organisations should consider the intersection between EVD-related stigma and mental health when designing programmes and training healthcare providers.

Project description:BackgroundThe 2013-2016 West African Ebola outbreak infected 28,616 people and caused 11,310 deaths by 11 May 2016, across six countries. The outbreak has also resulted in the largest number of EVD survivors in history-over 17,000. Guinea was declared Ebola-free on 1 June 2016. Reports from the outbreak documented 3814 cases resulting in 2544 deaths and 1270 survivors. EVD survivors face various neuropsychological and psycho-affective alterations that have not been fully identified yet. This study aims to document the depressive symptoms among adult survivors in Guinea.MethodsDepressive symptoms were investigated using the French version of the Center for Epidemiologic Studies-Depression Scale (CES-D) administered to all adult survivors (≥ 20 years) participating in the PostEboGui study and receiving care in Conakry. The study was combined with a clinical consultation by a psychiatrist at the Donka National Hospital in Conakry that ensured adapted care was provided when needed.ResultsOverall, 256 adult participants receiving care in Conakry participated in this study: 55% were women, median age 31 years [IQR: 26-40]. The median time since the Ebola Treatment Center (ETC) discharge was 8.1 months [IQR: 4.1-11.7]. 15% had a score above the threshold values indicating psychological suffering (15% for men and 14% for women). 33 people (16 women and 17 men) met with the psychiatrist, which resulted in the diagnosis of 3 cases of post-traumatic stress disorder (PTSD), 3 cases of mild depression, 13 cases of moderate depression, and 11 cases of severe depression, including 1 with kinesthetic hallucinations and another with visual hallucinations, and 1 with suicidal ideation and 3 with attempted suicide. Severe depression was diagnosed between 1 and 19 months after ETC discharge. The various identified forms of depression responded favorably to conventional drug therapies and cognitive behavioral therapy.ConclusionLong-term follow-up for EVD survivors will be necessary to understand the evolution of these pathologies. In the current post-epidemic context, these cases underscore the need to strengthen mental health diagnostic systems and treatment on a national scale.

Project description:Ebola virus (EBOV) transmission is currently poorly characterized and is thought to occur primarily by direct contact with infectious material; however transmission from swine to nonhuman primates via the respiratory tract has been documented. To establish an EBOV transmission model for performing studies with statistical significance, groups of six guinea pigs (gps) were challenged intranasally (i.n.) or intraperitoneally (i.p.) with 10,000 times the 50% lethal dose (LD50) of gp-adapted EBOV, and naive gps were then introduced as cage mates for contact exposure at 1 day postinfection (p.i.). The animals were monitored for survival and clinical signs of disease and quantitated for virus shedding postexposure. Changes in the duration of contact of naive gps with infected animals were evaluated for their impact on transmission efficiency. Transmission was more efficient from i.n.- than from i.p.-challenged gps, with 17% versus 83% of naive gps surviving exposure, respectively. Virus shedding was detected beginning at 3 days p.i. from both i.n.- and i.p.-challenged animals. Contact duration positively correlated with transmission efficiency, and the abrogation of direct contact between infected and naive animals through the erection of a steel mesh was effective at stopping virus spread, provided that infectious animal bedding was absent from the cages. Histopathological and immunohistochemical findings show that i.n.-infected gps display enhanced lung pathology and EBOV antigen in the trachea, which supports increased virus transmission from these animals. The results suggest that i.n.-challenged gps are more infectious to naive animals than their systemically infected counterparts and that transmission occurs through direct contact with infectious materials, including those transported through air movement over short distances.Ebola is generally thought to be spread between humans though infectious bodily fluids. However, a study has shown that Ebola can be spread from pigs to monkeys without direct contact. Further studies have been hampered, because an economical animal model for Ebola transmission is not available. To address this, we established a transmission model in guinea pigs and determined the mechanisms behind virus spread. The survival data, in addition to microscopic examination of lung and trachea sections, show that mucosal infection of guinea pigs is an efficient model for Ebola transmission. Virus spread is increased with longer contact times with an infected animal and is possible without direct contact between an infected and a naive host but can be stopped if infectious materials are absent. These results warrant consideration for the development of future strategies against Ebola transmission and for a better understanding of the parameters involved in virus spread.

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What motivates Ebola survivors to donate plasma during an emergency clinical trial? The case of Ebola-Tx in Guinea.

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What motivates Ebola survivors to donate plasma during an emergency clinical trial? The case of Ebola-Tx in Guinea.

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