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Challenges in preparing and implementing a clinical trial at field level in an Ebola emergency: A case study in Guinea, West Africa.

ABSTRACT: During the large Ebola outbreak that affected West Africa in 2014 and 2015, studies were launched to evaluate potential treatments for the disease. A clinical trial to evaluate the effectiveness of the antiviral drug favipiravir was conducted in Guinea. This paper describes the main challenges of the implementation of the trial in the Ebola treatment center of Guéckédou. Following the principles of the Good Clinical Research Practices, we explored the aspects of the community's communication and engagement, ethical conduct, trial protocol compliance, informed consent of participants, ongoing benefit/risk assessment, record keeping, confidentiality of patients and study data, and roles and responsibilities of the actors involved. We concluded that several challenges have to be addressed to successfully implement a clinical trial during an international medical emergency but that the potential for collaboration between research teams and humanitarian organizations needs to be highlighted.

SUBMITTER: Carazo Perez S

PROVIDER: S-EPMC5480829 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Challenges in preparing and implementing a clinical trial at field level in an Ebola emergency: A case study in Guinea, West Africa.

Carazo Perez Sara S Folkesson Elin E Anglaret Xavier X Beavogui Abdoul-Habib AH Berbain Emmanuel E Camara Alseny-Modet AM Depoortere Evelyn E Lefevre Annabelle A Maes Piet P Malme Kristian Nødtvedt KN Malvy Jean-Marie Denis JD Ombelet Sien S Poelaert Geertrui G Sissoko Daouda D Tounkara Alexis A Trbovic Pierre P Piguet Pascal P Antierens Annick A

PLoS neglected tropical diseases 20170622 6

During the large Ebola outbreak that affected West Africa in 2014 and 2015, studies were launched to evaluate potential treatments for the disease. A clinical trial to evaluate the effectiveness of the antiviral drug favipiravir was conducted in Guinea. This paper describes the main challenges of the implementation of the trial in the Ebola treatment center of Guéckédou. Following the principles of the Good Clinical Research Practices, we explored the aspects of the community's communication and ...[more]

PMID: 28640812

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Project description:BackgroundThe 2013-2014 West African Ebola outbreak highlighted how the world's weakest health systems threaten global health security and heralded huge support for their recovery. All three Ebola-affected countries had large shortfalls and maldistribution in their health workforce before the crisis, which were made worse by the epidemic. This paper analyzes the investment plans in Liberia, Sierra Leone, and Guinea to strengthen their health workforces and assesses their potential contribution to the re-establishment and strengthening of their health systems. The analysis calculates the plans' costs and compares those to likely fiscal space, to assess feasibility.MethodsPublic sector payroll data from 2015 from each country was used for the workforce analysis and does not include the private sector. Data were coded into the major cadres defined by the International Standard Classification of Occupations (ISCO-88). We estimated health worker training numbers and costs to meet international health worker density targets in the future and used sensitivity analysis to model hypothetical alternate estimates of attrition, drop-outs, and employment rates.ResultsHealth worker-to-population density targets per 1000 population for doctors, nurses, and midwives are only specified in Liberia (1.12) and Guinea's (0.78) investment plans and fall far short of the regional average for Africa (1.33) or international benchmarks of 2.5 per 1000 population and 4.45 for universal health coverage. Even these modest targets translate into substantial scaling-up requirements with Liberia having to almost double, Guinea quadruple, and Sierra Leone having to increase its workforce by seven to tenfold to achieve Liberia and Guinea's targets. Costs per capita to meet the 2.5 per 1000 population density targets with 5% attrition, 10% drop-out, and 75% employment rate range from US$4.2 in Guinea to US$7.9 in Liberia in 2029, with projected fiscal space being adequate to accommodate the proposed scaling-up targets in both countries.ConclusionsAchieving even a modest scale-up of health workforce will require a steady growth in health budgets, a long-term horizon and substantial scale-up of current training institution capacity. Increasing value-for-money in health workforce investments will require more efficient geographical distribution of the health workforce and more consideration to the mix of cadres to be scaled-up.

Project description:The handling, capturing, butchering, and transportation of wildmeat can increase the risk of zoonoses, including the Ebola virus disease (EVD). Guinea, West Africa, experienced a catastrophic outbreak of EVD between 2013 and 2016. This study aimed to understand local people's sources of information concerning EVD, their perceptions of potential wildlife carriers of EVD and their meat and fish consumption behavior during this period. A semi-structured questionnaire was administered to 332 participants in two urban centers (N = 209) and three villages (N = 123) between January 3 and March 30, 2015 in the prefecture of Lola in southeastern Guinea. Chi-square analyses revealed that, in rural areas, awareness missions represented the main source of information about EVD (94.3%), whereas in urban settings such missions (36.1%), as well as newspapers (31.6%) and radio (32.3%) were equally mentioned. Bats (30.1% and 79.4%), chimpanzees (16.3% and 48.8%) and monkeys (13.0% and 53.1%) were the most commonly cited potential agents of EVD in both rural and urban areas respectively, while the warthog (2.3% rural and 6.5% urban), crested porcupine (1.7% rural and 10.7% urban), duiker (1.19% rural and 2.6% urban) and the greater cane rat (1.1% rural and 9.5% urban) were also cited but to a lesser extent. However, 66.7% of rural respondents compared to only 17.2% in the urban area did not consider any of these species as potential carriers of the Ebola virus. Nonetheless, a fifth of our respondents reported not consuming any of these species altogether during the EVD outbreak. Among all seven faunal groups mentioned, a significant reduction in reported consumption during the Ebola outbreak was only noted for bats (before: 78.3% and during: 31.9%) and chimpanzees (before: 31.6% and during: 13.5%). Automatic Chi-Square Interaction Detection (CHAID) analysis revealed that the belief that bats or chimpanzees were associated with EVD or not had a significant effect respectively on their non-consumption or continued consumption. However, only 3.9% of respondents reported shifting to alternative protein sources such as domestic meat or fish specifically to avoid EVD. Only 10.8% reported consuming more domestic meat during the EVD outbreak compared with before; affordability and availability were the main reported reasons for why people did not consume more domestic meat and why two thirds reported consuming more fish. While increased domestic meat consumption was linked to the belief that duikers, the most commonly consumed wildmeat before the epidemic, were associated with EVD, increased fish consumption was not predicted by any EVD related factors. Our study revealed deep-rooted false beliefs among rural respondents and constraints when it comes to access to alternative protein sources such as domestic meat. Our findings emphasize the urgent need for greater consideration of the relationship between socio-economic context, food security, and public health.

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Challenges in preparing and implementing a clinical trial at field level in an Ebola emergency: A case study in Guinea, West Africa.

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Challenges in preparing and implementing a clinical trial at field level in an Ebola emergency: A case study in Guinea, West Africa.

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