bluuebunny/crossref_metadata_2025_split huggingface dataset:
PO 8490 PROMOTING GOOD DATA MANAGEMENT PRACTICES IN CLINICAL RESEARCH IN RESOURCE-POOR SETTINGS
Authors: Loen Harry Van , Arango Diana , Landuyt Hanne , Burm Christophe , Herrewege Yven Van 
Published: April 2019

BackgroundAccurate and timely data management (DM) is of key importance in clinical research to generate high-quality and GCP-compliant data for analysis and/or sharing. Our objective is to strengthen the capacity for DM in clinical research in resource-poor settings by organising several teaching initiatives.MethodsOur teaching initiatives have a twofold approach. First, a generic and comprehensive approach with capacity building on various thematical modules. These include a research component (overviewing the research data management procedures) and a technological component (introducing databases and software). In addition, a component on legislation, guidelines and standards specific towards DM is discussed, as well as a project management component on how to organise DM efficiently and timely. Second, we apply a more focused and study-specific approach which details roles and responsibilities in data management, milestones and documentation practices. Both approaches are based upon successful implementation in EDCTP-funded clinical trials, such as the 4ABC, PREGACT and Microbicide Safety Biomarkers studies, as well as the FP7 sponsored NIDIAG project. The target audience comprises various study stakeholders such as data managers, IT administrators, clinicians, laboratory researchers and statisticians, coming from sub-Saharan Africa, South-East Asia and Latin America.ResultsA teaching model for promoting Good Data Management Practices has been developed with theory- and practice-based modules. This model is used at face-to-face workshops in remote settings and has been re-used by colleagues and implemented by other research institutions to promote further capacity building and sustainable development in the South. In addition, it has led to mutual learning and enhanced institutional and personal North-South collaborations.ConclusionThere is a clear case for promoting DM and providing guidelines for Good Data Management Practices. Our twofold approach has enabled the successful conduct of GCP compliant non-commercial clinical trials in the South.
PO 8505 LEISHMANIASIS IN ANGOLA – AN EMERGING DISEASE?
Authors: Cortes Sofia , Pereira André , Vasconcelos Jocelyne , Paixão Joana P , Quivinja Joltim , Afonso Joana De Morais , Cristóvão José M , Campino Lenea 
Published: April 2019

BackgroundPoverty, lack of resources, inadequate treatments and control programmes exacerbate the impact of infectious diseases in the developing world. Leishmaniasis is a vector-borne disease that is among the ten major neglected tropical diseases. Although endemic in more than 90 countries, the ones most affected, representing over 90% of new cases, are Bangladesh, Brazil, Ethiopia, India, Kenya, Nepal, and Sudan. In Africa south of the equator, the impact of leishmaniasis is much lower. In several countries, like Angola, little is known about this infectious neglected disease. In the 1970s, a group of Portuguese researchers described three cases of cutaneous leishmaniasis in children from Huambo district and in the 1990s visceral leishmaniasis was diagnosed in an African patient. More recently a canine survey in Luanda revealed twoLeishmania-infected dogs.After some suspected cases of human cutaneous leishmaniasis in Huambo region in 2017, the Angola health authorities and the Instituto de Higiene e Medicina Tropical (IHMT), Lisbon, Portugal, established a collaboration to analyse samples from some suspected cases.MethodsThree paraffin-embedded human skin samples from dermatological lesions were sent to IHMT for molecular analysis. After DNA extraction, PCR was performed by using four protocols with different molecular markers.ResultsOne PCR protocol using a nested approach was positive in two of the samples. Sequencing analysis confirmedLeishmaniasp. DNA.ConclusionThis was the first time that suspected human cutaneous samples were screened for leishmaniasis by molecular methods with detection ofLeishmaniasp. DNA. These preliminary studies highlight the need for higher awareness of health professionals for leishmaniasis clinical forms, to recognise risk factors and the epidemiological features of leishmaniasis in the Huambo province. It would be relevant to perform further epidemiological studies to confirm if this vector-borne disease could be emergent in this country.
PO 8515 CAPACITY BUILDING IN PREPARATION FOR AN HIV VACCINE TRIAL: THE GLOBALLY RELEVANT AIDS VACCINE EUROPE-AFRICA TRIALS PARTNERSHIP (GREAT)
Authors: Kilembe William , Okech Brenda , Nielsen Leslie , Muturi-Kioi Vincent , Jaoko Walter , Mutua Gaudensia , Sanders Eduard , Mpendo Juliet , Gumbe Anne , Chinyenzi Kundai , Bont Jan De , Kuipers Hester , Crook Alison , King Deborah , Kaleebu Pontiano , Fast Patricia , Hanke Tomáš 
Published: April 2019

BackgroundThe Globally Relevant AIDS Vaccine Europe-Africa Trials (GREAT) partnership is an EDCTP-funded project that aims to foster collaboration between institutions in Europe and sub-Saharan Africa to build capacity among African clinical research centres (CRCs) for the design and conduct of HIV-1 vaccine efficacy trials.MethodsIn January 2017, the University of Oxford (UOXF) and five CRCs in Kenya, Uganda and Zambia were awarded a 5 year grant for capacity building and to support conduct of an HIV-1 vaccine trial in different high-risk populations across Africa using cross-clade (conserved protein regions) T-cell vaccines. UOXF and CRCs embarked on activities to strengthen capacity of the CRCs for future efficacy trials. This included training, community engagement, cohort preparation and infrastructure upgrade.ResultsIn the first year, the African investigators at the CRCs collaborated on the development of a protocol aimed at assessing the safety and immunogenicity of the tHIVconsvX vaccines. In preparation for the planned vaccine trial, infrastructure upgrades were prioritised at all partner sites and this included building laboratory space and procurement of appropriate laboratory equipment. Planned infrastructure upgrades will also ensure that high-risk populations can be safely and confidentially included in HIV prevention clinical trials. Systematic community engagement was implemented at all sites, training in GCP/GCLP was provided and training is planned for nominated CRC staff to lead community engagement efforts.ConclusionImproved infrastructure and the provision of targeted training will enhance future trials and increase the capacities of CRCs and staff to conduct quality trials in previously hard-to-reach populations. Early collaboration between investigators from European and sub-Saharan African institutions, with equal responsibilities in the protocol development process, established a meaningful partnership. EDCTP funding also offers a unique opportunity for capacity building.
PO 8522 ESTABLISHING AN EQUITABLE GOVERNANCE FRAMEWORK FOR AN EBOLA DATA-SHARING PLATFORM
Authors: Cherif Mahmoud Sama , Craig Elaine , Strudwick Samantha , Hawryszkiewycz Alice , Merson Laura 
Published: April 2019

BackgroundDespite the potential public health gains of enabling access to patient-level data on emerging infections, the launch of a centralised, international platform to deliver on this has not been achieved to date. Barriers include: concerns over retention of national data ownership; patient privacy; appropriate consent; loss of academic recognition; criticism or exploitation of the data generators; perceived data misuse; and the challenges of sharing benefits with communities where data is generated.MethodsTo determine the best approach to these issues in the context of Ebola, we have assembled a collaboration of partners including governments of Ebola-affected countries, non-government organisations, academic institutions, funders and public health authorities to form the Steering Committee of the Ebola Data Platform. Following stakeholder consultation, research and debate, the committee has developed a governance framework to enable access to emerging infections data, beginning with the data from the West African Ebola outbreak.ResultsPromoting fair and equitable sharing of benefits that arise from the use of data is a key element of the framework. Strategies to secure this principle include integration of platform data management activities with the national health institutions in Ebola-affected countries and collaboration with research communities in these countries to determine research priorities and plan analyses. Public health benefit in affected countries is further supported via training and strengthening of research capacity and infrastructure.ConclusionDeveloping a governance framework centered on the principle of equity has focused activities of the Ebola Data Platform on the affected health and research communities where they can have the most impact on patient outcomes, public health preparedness and future outbreak response.
PO 8524 MOLECULAR CHARACTERISATION OF THE NOROVIRUS STRAINS RESPONSIBLE FOR ACUTE DIARRHOEA IN CHILDREN UNDER FIVE YEARS OLD HOSPITALISED IN BRAZZAVILLE
Authors: E Mikounou Louya Vivaldie , Koukouikila-Koussounda Félix , Vouvoungui Christevy , Ch. Kobawila Simon , Ntoumi Francine 
Published: April 2019

BackgroundAcute gastroenteritis is a leading cause of morbidity and mortality among children under five years old worldwide. Viruses are the most common responsible agent and norovirus is second after rotavirus. There is no published data on the occurrence of this agent in Brazzaville. This study aimed to determine the prevalence of norovirus infection andto evaluate the risk factors in hospitalised children in Brazzaville, Congo.MethodsFrom June 2012 to June 2013, stool samples were collected from children under five years old hospitalised with acute gastroenteritis at Makelekele hospital. Rotavirus and adenovirus infections were already characterised in this population. A total of 545 samples were tested for GI and GII norovirus infections using nested duplex reverse-transcription–polymerase chain reaction with specific primers. The positive samples will be sequenced and analysed to determine the corresponding genotype.ResultsThe GI and GII norovirus infection were found in 148 samples (27, 14%) in this study. Males (28, 85%) were more infected than females (25%) but the difference was not significant. Norovirus infection was detected only in children under 24 months with a higher prevalence in the age group of 7–12 months (p value=0,048). The norovirus infection was detected throughout the year, but it peaked during the dry season (August-September). Dual infection of rotavirus and norovirus was detected in 65 cases (11, 9%), rotavirus-adenovirus in 8 cases (1, 5%), norovirus-adenovirus in 4 cases (0, 73%). Triple infection was detected in 3 cases (0, 55%).ConclusionThis study suggests that norovirus infection is the second cause of gastroenteritis after rotavirus in the study area. However, further surveillance investigations need to be pursued in other sentinel sites of the country.
PO 8542 CLINICAL ILLNESS AND OUTCOMES IN NIGERIAN CHILDREN WITH PERSISTENT EARLY-APPEARING ANAEMIA FOLLOWING ARTEMISININ-BASED COMBINATION TREATMENTS OF UNCOMPLICATEDPLASMODIUM FALCIPARUMMALARIA
Authors: Akano Kazeem , Fatunmbi Bayo , Ntadom Godwin , Alebiosu Omobolaji T , Akpoborie Odafe , Okafor Chukwuebuka , Sowunmi Akintunde 
Published: April 2019

BackgroundEarly-appearing anaemia (EAA) is not uncommon in malarious children following artemisinin-based combination treatments (ACTs) of uncomplicated infections and it may become persistent (PEAA). There is little evaluation of the factors contributing to and the kinetics of the resolution of haemoglobin deficit characteristic of ACT-related PEAA.MethodsPEAA was defined as haemoglobin concentration <10 g/dL for at least 1 week after treatment initiation with artemether-lumefantrine (AL), artesunate-amodiaquine (ASAQ) or dihydroartemisinin-piperaquine (DP) in malarious children with haemoglobin ≥10 g/dL pre-treatment. Drug-attributable fall in haemoglobin (DAFHb) was defined as the difference between pre-treatment and the lowest recorded haemoglobin value in the first week after treatment initiation. Stepwise multiple logistic regression model was used to evaluate independent predictors of PEAA. Time course of deficits in haemoglobin from baseline was used to estimate the disposition kinetics of haemoglobin deficits using a one compartment model.ResultsAsymptomatic PEAA occurred in 46 of 540 children. A duration of illness ≤3 days before presentation, haemoglobin <11.7 g/dL pre-treatment and 8.3 g/dL 1 day after treatment initiation. DAFHb ≥2 g/dL and treatment with DP independently predicted PEAA. Time to 90% reduction in haemoglobin deficit was significantly longer in AL-treated children compared with other treatments. Declines in haemoglobin deficits were monoexponential with the following overall estimated parameters: Cmax 2.6 g/dL (95% CI 2.3–2.9), Tmax 3.2 days (95% CI 2.2–4.1), AUC 31.9 g.dL-1.day (95% CI 25–38.8), Kel0.3 day-1(95% CI 0.3–0,4), t1/23.9 days (95% CI 2.6–5.1), CLp 0.6L.day-1(95% CI 0.5–0.7), and Vd 2.4L (95% CI 1.7–3). Overall, mean anaemia recovery time of 17.9 days (95% CI 15.5–20.2, n=39) was equivalent to 5 multiples of half-time of haemoglobin deficit on Bland-Altman analysis. Eight children, after recovery from PEAA progressed to asymptomatic late-appearing anaemia (LAA).ConclusionAsymptomatic PEAA, which may progress to LAA, is not uncommon in young children following ACTs. Its occurrence, and progression to LAA, may have implications for case management and control efforts for ACT-related anaemia in sub-Saharan Africa.
PO 8559 ASSESSMENT OF THE EFFECT OF RVSV REPLICATION ON NON-EBOLA CIRCULATING ANTIBODIES IN RVSV-ZEBOV-GP-VACCINATED INDIVIDUALS IN LAMBARÉNÉ, GABON
Authors: V Ndong Mbouna Armel , T Agnandji Selidji 
Published: April 2019

BackgroundThe West Africa Ebola virus disease (EVD) outbreak between 2015 and 2016 accelerated the need for safe and effective vaccines. Among candidate vaccines in clinical development, the recombinant Vesicular stomatitis virus (VSV) vectored with the Ebola virus (EBOV) glycoprotein (rVSV-ZEBOV-GP) vaccine showed acceptable safety and promising immunogenicity results across diverse settings.Baseline screening data from the phase I trial of this vaccine in Lambaréné, Gabon, established that prior to vaccination about 21% (33/155) and 8% (12/155) of adults had naturally acquired antibodies to infectious ZEBOV particle and ZEBOV-GP, respectively. In participants with prior ZEBOV(-GP) antibodies, post-vaccination antibodies titres were significantly higher 56 days following vaccination with doses of 3×103, 3×104, and 3×106 PFU compared to those without.Our study seeks to investigate rVSV vector non-specific boosting of naturally acquired antibodies to other viral infections (dengue virus 1–4, and yellow fever virus).MethodsWe measured antibodies titres to Dengue (serotypes 1–4) and yellow fever infection at baseline, 28 and 56 days after injection in a total of 155 serum samples from vaccinees receiving various doses of rVSV-ZEBOV-GP using ELISA technique.ResultsPreliminary results were presented at the meeting.ConclusionOur results confirm rVSV vector non-specific replication on non ZEBOV-GP circulating antibodies in Lambaréné vaccinees and potential boosting action on naturally acquired dengue virus (serotypes 1–4) and yellow fever virus antibodies.
PO 8574 LESSONS FROM ENGAGING AND TRAINING PRIVATE AND FAITH-BASED HEALTH FACILITIES FOR THE USE OF MALARIA RAPID DIAGNOSTIC TESTS IN CAMEROON
Authors: Netongo Palmer Masumbe , Domkam Irénée , Kamdem Séverin D , Maloba Franklin , Nji Akindeh , Tchoupe Eric , Bidias Amel , Namboh Becky , Kwedi-Nolna Sylvie , Athogo-Tiedeu Barbara , Dacombe Russell , Mbacham Wilfred 
Published: April 2019

BackgroundBespoke community engagement is critical for success of any intervention. Lessons learned from engaging and training private and faith-based health facility professionals (grouped as informal health professionals [IHPs]) in Cameroon could streamline training and community engagement activities of networks like ALERRT and PANDORA. With the aim of establishing a system for monitoring malaria RDT accuracy in Cameroon, and supported by a WHO/TDR Impact grant, we tested the hypothesis that training IHPs to use follow-up visits and telephone/online support will improve their ability to perform RDT by 80%. This will also improve access to accurate malaria diagnosis and treatment in the communities served by the IHPs.MethodsWe conducted a baseline survey to map target informal health facilities (GPS location, staffing, training on RDT) and challenges through focus group discussions and group questionnaires. We then organised rotation classroom for a three-day enhanced training on early diagnosis and prompt, effective treatment of malaria.ResultsWe found that though informal health facilities constitute approximately 30% of the country’s health system capacity, IHPs were seldom included in regional RDTs training by the National Malaria Control Programme. Also, some IHPs had limited training to deliver health care services and were not registered with the Ministry of Health. Started as common initiative groups, IHFs constitute major access points for health care within communities and could be major players for community engagement within Cameroon as a sizeable population relies on them for accessible care.ConclusionOur method is a feasible and cost-effective health worker-based approach for training and community engagement, which can help ALERRT to anticipate community preparedness for outbreaks in Cameroon and beyond.
PO 8576 EFFECT OF IVERMECTIN TREATMENT ON THE FREQUENCY OF SEIZURES IN PERSONS WITH ONCHOCERCIASIS-ASSOCIATED EPILEPSY: PRELIMINARY RESULTS OF A RANDOMISED CLINICAL TRIAL
Authors: Ndahura Mandro , Mukendi Deby , Nyisi Françoise , Rossy Deogracias , Siewe Joseph , Abhafule Germain , Nakato Swabra , Suykerbuyk Patrick , Siewe Joseph , Hotterbeekx An , Colebunders Robert , Menon Sonia 
Published: April 2019

BackgroundMany studies reported an association between epilepsy and onchocerciasis. Moreover, anecdotal evidence suggests that ivermectin may reduce seizure frequency in persons with onchocerciasis-associated epilepsy (PWOAE). Therefore, we performed a randomised clinical trial among ivermectin-naïve persons with epilepsy in onchocerciasis-endemic villages in the Ituri province, Democratic Republic of the Congo.MethodsPWOAE were randomised in an arm receiving immediate (arm A) or delayed (4 months later) ivermectin treatment (arm B). All participants were receiving anti-epileptic drugs. Inclusion criteria were: age >5 years, signed informed consent, normal neurological development until onset of epilepsy between 5–18 years of age, seizure frequency of ≥2 seizures/month, presence of microfilaria in skin snip and/or antibodies against the Ov16 antigen. Primary study outcome: seizure freedom at month 4; secondary outcome:>50% reduction in seizure frequency at month 4 compared to reported seizure frequency at randomisation. The proposed sample size was 110 PWOAE.Results93 PWOAE, 57 males and 36 females, (mean age 22), were enrolled between October and November 2017. On March 2018, 90 (97%) participant completed their 4th-month evaluation. One serious adverse event was observed during the trial (Steven Johnson reaction caused by phenobarbital). Considering all participants there was no significant difference in outcome between the 2 arms. However, considering participants with presence of microfilariae at enrollment, at month 4, 26/39 (66.6%) in arm A and 20/44 (45.5%) in arm B were seizure free (p=0.05) and a 50% reduction of the number of seizures was observed in 9/39 (23.1% ) in arm A and 7/43 (16.3%) in arm B. (p=0.4).ConclusionIvermectin may have an added value in reducing the frequency of seizures in PWOAE treated with anti-epileptic drugs. However, a larger study is needed to confirm this.
PO 8578 THE ROLE OF CLINICAL RESEARCH IN EDUCATING THE HEALTH WORKFORCE IN GUINEA-BISSAU
Authors: Silva Isaquel B 
Published: April 2019

BackgroundThe World Health Organisation estimates a global deficit of approximately 4.3 million health workers, particularly doctors, nurses and midwives. Guinea-Bissau is among the 36 countries that suffer from a critical need for human resources (less than 23 health professionals per 10.000 inhabitants). The present research investigates the impact of clinical trials on health worker’s capacity and training.MethodsThis is a qualitative study. I interviewed health professionals who assisted in clinical trials during the past five years and obtained assistance to attend health-related courses. The interviews collected data about the professional’s technical capacity, clinical practices, work conditions, their qualification for their work and socio-economic variables. Additionally, documents about clinical trials conducted in Guinea-Bissau through North-South cooperation, were analysed.ResultsInterviews were held with 35 health professionals (21 female, 14 male) who participated in clinical trials with the Bandim Health Project (Guinea-Bissau) as research assistants and who received subsidies to realise undergraduate or graduate degrees. Among those interviewed, 28 (80%) received support to realise an undergraduate degree in nursing, 4 (11%) a laboratory course, and 3 (9%) a postgraduate course. Twenty-four (24; 69%) stated that they experienced significant improvements in their working conditions within the institutions where they worked after their clinical trials; 7 (20%) declared that they have progressed in their career after being placed in a health center or a hospital; 29 (83%) stated that the participation in clinical trials significantly strengthened their technical capacity and had a positive impact on their careers.ConclusionI observed a positive impact of the involvement in clinical research on the development of health professionals’ capacity. However, the quantity of clinical research in Guinea-Bissau is insufficient to train all health practitioners in this area.