bluuebunny/crossref_metadata_2025_split huggingface dataset:
OC 8715 GOING FURTHER TOGETHER: THE ROLE OF THE EU IN SUPPORTING REGULATORY HARMONISATION OF HEALTH TOOLS IN AFRICA
Authors: Martin Lasanta Agustin 
Published: April 2019

BackgroundOn May 20, 2018, African governments adopted the Treaty for the establishment of the African Medicines Agency (AMA) as a stepping stone in the strengthening and harmonising of medical products regulation on the continent. Many countries in Africa lack robust and comprehensive regulatory systems supporting the research and registration of health products, hampering the translation of health research and innovation into public health impacts. The AMA could substantially improve the access to quality-assured, safe andeffective health solutions and technologies in Africa and around the world. As the main trade partner and donor to Africa, the European Union (EU) has a key role to play in supporting this effort.MethodDesk research and case-study analyses of key initiatives to strengthen medicinesregulation in Africa were conducted. Specifically, the EDCTP, the African Vaccine Regulatory Forum (AVAREF), the African Medicines Regulatory Harmonisation Programme (AMRH) and the Zazibona Process; to assess the gaps, needs and opportunities for EU collaboration using actual and reconfigured EU-Africa funding and policy cooperation mechanisms.Results and conclusionsThis presentation will explore initiatives aimed at regulatory strengthening and harmonisation in Africa and propose policy recommendations on how to improve EU efforts in order to support these initiatives in a more systematic and synergetic manner. The recommendations fall into four categories: EU-Africa priority-setting, coordination, funding and capacity-building actions. Recommendations explore, for instance, advancing the national implementation of the African Union Model Law on Medical Products Regulation by all African countries, enlarging the scope of EDCTP regulatory strengthening actions to include Africa’s Regional Centres of Regulatory Excellence (RCOREs) or improving the attractiveness and incentive system of the EMA’s article 58 procedure for African governments, researchers and manufacturers.
PO 7167 IMPROVING USE OF LONG-LASTING INSECTICIDAL NETS IN KAYANGE COMMUNITY OF NORTH-WESTERN BURUNDI: A QUALITY IMPROVEMENT STUDY
Authors: Habonimana Desire , Ndayisaba Gabriel , Nimako Gideon 
Published: April 2019

BackgroundThe use of long-lasting insecticidal nets (LLINs) for malaria prevention is a cost-effective intervention. WHO recommends universal coverage and use of LLINs. In lower- and middle-income countries, LLINs are provided free of charge but are either not used or misused. Our study sought to improve LLIN use in Kayange community of north-western Burundi by using a model for improvement (MFI).MethodsA one-group, pre/post-test study was conducted. LLIN weekly use was assessed for four weeks before intervention and for another four weeks after intervention. The study was conducted in 96 households. The intervention consisted of testing four different weekly small change actions by using the MFI.ResultsOf the 96 households, 83 households (87%) owned at least one LLIN. However, only 40 households (42%) owned at least one LLIN for every two people. After intervention, the number of LLINs used increased from 32 to 75 per cent (134% increase) and the number of persons (general population) sleeping under LLIN from 35 to 73 per cent (108% increase). The number of children under 5 years old sleeping under LLIN increased from 31 to 76 per cent (145% increase) and the number of pregnant women who slept under LLIN from 43 to 73 per cent (69% increase). Also, the averages of the number of nights in each week that the general population slept under LLIN increased from 2.13 to 5.11 (140% increase), children under 5 years old slept under LLIN from 1.68 to 4.78 (184% increase) and pregnant women slept under LLIN from 1.56 to 4.47 (186% increase).ConclusionOur intervention led to significant increase in all outcome indicators. This increase is the result of a combination of an enabling context and an effective implementation of an evidence-based quality improvement intervention. Small tests of change at the community level have the potential for achieving improved outcomes.
PO 8168 CLINICAL UTILITY OF XPERT MTB/RIF ASSAY FOR THE DIAGNOSIS OF EXTRAPULMONARY TUBERCULOSIS IN ETHIOPIA
Authors: Tadesse Mulualem , Abebe Gemeda , Yilma Danie , Apers Ludwig , Jong Bouke De , Rigouts Leen 
Published: April 2019

BackgroundThe diagnosis of extrapulmonary tuberculosis (EPTB) is often made on clinical suspicion alone, and many people receive the wrong diagnosis leading to unnecessary TB treatment or poor outcomes from untreated EPTB. In this study, we evaluated the clinical utility of the Xpert MTB/RIF assay on routinely collected extra-pulmonary specimens in Ethiopia.MethodsThis study was carried out at Jimma University Specialized Hospital, Southwest Ethiopia from September 2015 to June 2017. Extra-pulmonary specimens were collected from 572 patients clinically suspected of suffering from EPTB. All specimens were tested for TB by smear-microscopy, culture and Xpert MTB/RIF. The diagnostic accuracy of Xpert MTB/RIF was calculated compared to a composite reference standard (CRS), composed of liquid culture and anti-TB treatment response.ResultsIn total, 572 extra-pulmonary specimens (279 lymph node, 159 pleural, 80 peritoneal, 45 cerebrospinal and 9 pericardial fluids) were tested. The pooled sensitivity and specificity of Xpert MTB/RIF were calculated to be 91% and 90.6% respectively when compared to culture. The pooled sensitivity of Xpert MTB/RIF was decreased to 75% and the specificity was improved to 98% when Xpert MTB/RIF was compared to the CRS. The sensitivities among the specimen types differed markedly. The highest sensitivity was documented for lymph node (90%), moderate sensitivity for cerebrospinal (53%), while the sensitivity was lowest for pleural (30%) and peritoneal (32%) fluids. Xpert MTB/RIF, in addition, detected rifampicin resistance in 13 patients in perfect agreement with line probe assay.ConclusionOur study showed that Xpert MTB/RIF is likely to be of greatest utility when testing lymph node specimens. A negative Xpert MTB/RIF result on fluid specimens does not exclude the diagnosis of EPTB and patients with a high clinical probability of EPTB should be started on anti-TB treatment.
PO 8194 OPTIMISED INFORMED CONSENT FOR PARTICIPANTS IN A RANDOMISED CONTROLLED TRIAL IN RURAL UGANDA: A COMPARATIVE PROSPECTIVE COHORT STUDY
Authors: Ditai James , Kanyago Jesca , Nambozo Rachael , Kanyago Nathan , Abeso Julian , Olupot Peter , Carrol Enitan , Gladstone Melissa , Weeks Andrew , Faragher Brian , Medina-Lara Antonietta , Storr Julie 
Published: April 2019

BackgroundPoor participant understanding of research information can be a problem in community interventional studies in rural African women where levels of illiteracy, dependency and compliance are high. We assessed the impact of alternative consent models on participants’ understanding of the clinical trial information and its contribution to the informed consent process in rural Uganda.MethodsThis was a prospective comparative cohort, nested within a pilot study of community distribution of alcohol-based hand rub to prevent neonatal sepsis (BabyGel). As part of the informed consent process, information about the trial was presented using one of three consent methods: standard researcher-read information; a ‘slide show’ using illustrated text on a flip chart; and a video showing the patient information sheet (PIS) being read as if by a newsreader in either English or the local language. In addition, all women received a written PIS in their preferred language. Each information method was used for 1 week of recruitment. Two days after recruitment, women’s understanding of the clinical trial was evaluated.ResultsA total of 30 pregnant women from 13 villages in Mbale participated in this study. Majority 90% (27/30) were assessed for recall of trial information within planned 48 hours. The slide-show was the most popular, with a mean score not less than 4.2 highest [mean (sd) range: 4.8 (0.6) [4–5]] by women who had been recruited using any of the three models. The slide show was preferred by 63% of the women (19/30), compared with 17% (5/30) and 20% (6/30) who preferred the standard and video show message, respectively. Reasons given included the benefits of having pictures to aid understanding, and the logical progression of the information.ConclusionOur results suggest that a slide-show message is an effective and popular alternative way of presenting trial information to women in rural Uganda, many of whom had little or no literacy.
PO 8254 LESSONS LEARNT FROM SCALING UP AN ONLINE SYSTEM FOR REVIEW AND MANAGEMENT OF PROTOCOLS IN SUB-SAHARAN AFRICA
Authors: Ngongo Prince B , Kombe Francis , Kamali Anatoli , IJsselmuiden Carel 
Published: April 2019

BackgroundThe transition from paper-based to online submission of health research protocols using the RHinnOEthics(RE) platform has been shown to improve efficiency and quality of ethics reviews. However, despite these documented benefits, there are only a total of 40 installations in 12 out of the 54 countries in Africa. We analysed facilitators and barriers to adoption of RE by Researc Ethics Committees.MethodsWe used a retrospective analysis to identify determinants of adoption or rejection of RE by grouping feedback from users into key emerging themes identified through three stages of RE adoption: 1) contractual 2) trial 3) full implementation.ResultsA total of 3947 protocols have been managed through RE by March 2018. Of those reached, 25 per cent adopted and continue to use RE. Of those that rejected, 14 per cent rejected after the trial. At the contractual stage, the key determinants of adoption were the guarantee of sustainable funding, pre-existing good IT infrastructure, and the assurance of technical assistance from the providers. The key determinants of rejection were concerns of cyber security, limited control and ownership by Researc Ethics Committees and cost of the annual subscription. At the trial stage, the determinants of continued adoption and use were continued IT support from providers and a proven comparative advantage over the paper-based system. The key determinant of rejection was limited support from organisation leadership. Those who have continued through the implementation stage emphasised financial sustainability and continuous improvement of the RE as key determinants.ConclusionAccelerated adoption of RE will require increased adaptability of the platform, decrease in cost of annual subscription, improved confidence in security and ownership of data. Developers, Research Ethics Committees and sponsors of RE need to develop a cost-effective funding strategy to increase efficiency, economies of scale and benefits related to harmonised and standardised digital platforms.
PO 8264 QUALITY CARE CRITERIA IN A CLINICAL TRIAL CONTEXT: PATIENT AND DAFRA AND NANORO CMA HEALTH WORKER PERCEPTIONS IN BURKINA FASO
Authors: Nourou Barry , Toe Léa Pare , Toe Patrice 
Published: April 2019

BackgroundParticipants in clinical trials as well as researchers conducting them, establish a close link between clinical trial and quality care. However, what understanding do they have of the concept of quality of care? This study aimed to answer this question by presenting the criteria which define for them quality care in the context of clinical research.MethodsThe data were collected from the participants involved in these clinical trials as well as from the health workers (research teams and other health workers) using a qualitative approach with 70 in-depth interviews. Direct observations of the participants partaking in care activities were also made in both health districts. The data were recorded, transcribed and then analysed on the thematic content basis.ResultsFor the health workers interviewed, the clinical trials are conducted in optimal conditions which highly contribute to ensure a good quality of care. To them, quality of care in the process of the trial implementation is evident from some availability of qualified human resources, quality medico-technical equipment, as well as good clinical practice strictly adhered to by the researchers.As for the participants, the quality of care in clinical trials meets specific criteria. To them, quality care delivered by the research team became tangible through laboratory tests before any treatment proposal, the promptness in taking care of any discomfort, as well as the regular and permanent follow-up of the patient until recovery of his health. Blood sampling for laboratory examinations was highly appreciated and mentioned by our respondents as the main indicator of the quality of care provided by the research teams.ConclusionThe quality of care according to the criteria the participants and the health workers assigned to it, is intrinsically linked to clinical trials.
PO 8290 INFLUENCE OF THE SICKLE CELL TRAIT ONPLASMODIUM FALCIPARUMTRANSMISSION IN ASYMPTOMATIC CHILDREN
Authors: Maffo Christelle Ngou , Berry Antoine , Morlais Isabelle , B Feufack Donfack Lionnel , Bayibeki Ngano Albert , E Nsango Sandrine , Milo Sarah-Matio Elangwe , Ayong Lawrence 
Published: April 2019

BackgroundThe sickle cell trait is associated with protection against severe malaria. Recently, it has been shown that the genetic protection conferred by the sickle cell trait has no effect on the transmission ofPlasmodiumspecies from humans to vectors. Our study aimed to investigate the putative association between the sickle cell trait AS and the susceptibility to malaria infection of both the human host and the insect vector.MethodsThe study was conducted from June to November 2017 among asymptomatic children living in Cameroon. The samples were collected on microscopy slides, Whatman FTA and grade 17 paper for the selection of gametocyte carriers by microscopy, the molecular diagnosis ofPlasmodiumspecies, and sickle cell trait (PCR- RFLP), respectively. Infectivity of the mosquito was measured by experimental infections on gametocyte-containing blood from naturally infected carrier. Genetic diversity was measured using microsatellite markers.ResultsA total of 1557 children were recruited; the prevalence ofPlasmodiuminfection among this group was 58% and the AS sickle cell trait 20%. No significant difference in the prevalence ofP. falciparuminfection was observed according to the sickle cell trait carriage and this irrespective of the parasite stage (p>0.05). The level of infectivity of the mosquito was higher when feedings were performed on blood from HbAS genotypes compared to HbAA genotype blood, and the difference was even more significant when the blood pellet was resuspended with non-immune AB plasma (p<0.0001). No significant difference was observed in the infection complexity between HbAS and HbAA genotypes (p>0.05).ConclusionPlasmodiuminfection is not influenced by HbAS genotype regardless of parasite stage; the risk of anopheles infection is higher with blood from gametocyte carriers with sickle cell trait (HbAS). The sickle cell trait does not affect the multiplicity of infection.
PO 8300 REGIONAL CENTER FOR REGULATORY EXCELLENCE IN CLINICAL TRIAL OVERSIGHT – TRAINING 2017
Authors: Darko Delese , Adu-Boahen Yvonne 
Published: April 2019

BackgroundThe competencies of the various national medicines regulatory agencies (NMRAs) in Africa vary which leads to generally porous regulatory systems for clinical trial oversight. Consequently, many trials have been conducted under unacceptable conditions compromising participants’ safety and data credibility and resulted in questionable outcomes that are used for making scientific judgement in addressing issues of public health in Africa.To improve the safety and quality of health technologies in Africa, the New Partnership for African Development (NEPAD) agency launched a programme to designate Regional Centres of Regulatory Excellence (RCOREs) with the specific objective of bridging existing gaps between African NMRAs through strengthening regulatory capacity of African Union member states. The Food and Drugs Authority (FDA), Ghana, was designated as RCORE for Clinical Trials oversight in May 2014.MethodsTo achieve the RCORE objectives, the FDA collaborated with the School of Public Health (SPH), University of Ghana to develop a training manual and piloted a training programme with funds from the International AIDS Vaccine Initiative (IAVI) through NEPAD.The programme, consisting of 4 compulsory modules, was organised from 6–30 November 2017 for 10 participants from Zambia, Sierra Leone, Liberia, Rwanda and Ghana. Interactive training methods in the form of theoretical and practical sessions were employed.ResultsThe pilot RCORE training was successful with expected training objectives achieved. Participants gained hands-on experience through activities like observing Good Clinical Practice inspection and a Technical Advisory Committee Meeting. Participants were given template tools to assist in developing regulatory guidelines and forms in their respective countries.A follow-up questionnaire was circulated to participants to assess the impact of the training on their work. Feedback indicates that regulation of clinical trials has improved in their respective institutions.ConclusionThis pilot fellowship training was successful, leading to the improvement of clinical trial regulation in the participating countries.
PO 8355 HOST GENETIC POLYMORPHISMS AND ASYMPTOMATIC MALARIA IN SOUTHERN GHANA
Authors: Otu Paulina , Lo Aminata Colle , Gyan Ben , Afrane Yaw , Amoah Linda Eva 
Published: April 2019

BackgroundDespite several interventions through malaria control programmes, asymptomatic malaria is a major barrier to control as asymptomatic individuals serve as reservoirs from which others are re-infected. The mechanism by which these individuals remain asymptomatic is not well understood. Much work has been done in relation to human genes and their association to severe, mild and uncomplicated malaria. However, there is limited knowledge regarding host genetic factors and asymptomatic malaria.MethodIn this study, we investigated the association between host genetic polymorphisms of glucose-6-phosphate dehydrogenase gene (G6PD), mannose binding lectin (MBLG54A), tumor necrotic factor alpha (TNF-G308A) and nitric oxide synthase 2 (NOS2-G954C) and the outcome of asymptomaticP. falciparummalaria in 150 healthy individuals in southern Ghana.ResultsWe found a significant association between G6PDd and asymptomatic malaria with a prevalence of 9.6% (p=0.035, by chi-square test). All the individuals who were heterozygous and hemizygote deficient (5.3% and 4.3%) were found to be asymptomatic. Individuals homozygous (GG) for TNF (G308A) were found to be highly asymptomatic (p=0.019, by chi-square test). Regarding MBL (G54A) and NOS (G954C), no significant association was found between these markers and asymptomatic malaria.ConclusionUpon reviewing our data with other data from published work, we conclude that both heterozygous and hemizygous individuals with G6PD A- and homozygous individuals (GG) of TNF (G308A) polymorphisms could be predisposed genetically to asymptomatic malaria.
OC 8378 REQUIREMENTS FOR THE ETHICAL CONDUCT OF CLINICAL RESEARCH IN CAMEROON, SUB-SAHARAN AFRICA: THE IMPORTANCE OF ACTIVE MONITORING
Authors: Ngounoue Marceline Djuidje , Ateudjieu Jerome , Fokunang Charles , Chi Primus Che , Ndje Mireille Ndje , Nolna Sylvie Kwedi , Magne Gisele , Kaptue Lazare 
Published: April 2019

BackgroundPrevious evaluation of the state of ethics regulation in Cameroon revealed: law regulating clinical research is lacking; existing committees lack infrastructure and financial support to sustainably review and effectively monitor approved protocols. The present Cameroon National Ethics Committee (CNEC)-EDCTP project aimed at implementing and evaluating active monitoring of clinical research in Cameroon.MethodsBetween 2011–2013, approved clinical trials and protocols involving transfer of biological materials abroad were consecutively monitored. The monitoring tool, a questionnaire on the conformity of key documents e.g. research protocols, ethical clearance, informed consent documents, investigator’s brochure, with a focus on GCP standards was sent to promoters/investigators ten days prior to the field visit. Teams of two-three monitors, made up of CNEC members and independent consultants, were mobilised per site (hospital/research institute/NGO). Reports with key recommendations were submitted to CNEC for review and approval, to different promoters/investigators, and the Regulatory Authority for action; the monitoring summary was submitted to EDCTP.ResultsUp to 22 site visits were done throughout the country, monitoring about 30 protocols within 11 hospitals, 9 research institutes, a National Programme and a non-governmental organisation. All sites had ethical clearance and administrative authorisation for research. From the registered number of research participants, less than half of the signed consent forms were available. Other issues were the lack of full involvement of local investigators, inexistence of material transfer and data sharing agreements with collaborative studies, non-implication of study communities/participants. As educators-consultants, monitors formulated recommendations to investigators, ethics committees and regulatory authority, insisting on the implication of local PI/collaborators with defined percentages of time to be devoted for research and good participatory practice among research communities/participants.ConclusionActive monitoring shows some formality in the application of ethical/administrative clearance in Cameroon. However, complex issues raised confirm the necessity of continuous monitoring to meet the high standards for clinical research ethics in Cameroon.
PO 8388 THE GLOBAL HEALTH TRAINING CENTRE PROFESSIONAL DEVELOPMENT SCHEME: CAPACITY DEVELOPMENT AND CAREER TRACKING FOR RESEARCHERS
Authors: Rapa Elizabeth 
Published: April 2019

BackgroundHealth researchers need a free, online and reliable mechanism to record their skill set, track their career development, and identify gaps in their knowledge. Research teams also require ways to monitor and report their team’s capacity development over time. The Global Health Network, a trusted and respected digital platform, is now able to provide researchers with these tools (www.globalhealthtrainingcentre.org/pds).MethodsThe Global Health Network compared diverse data types and took into account user feedback to create a professional development scheme (PDS). Together with TDR (The Special Programme for Research and Training in Tropical Diseases), a framework was developed with a list of the core competencies that a research team needs to demonstrate to carry out a study succesfully. A multi-functional dashboard was designed for team coordinators to assess the capacity development of individuals and groups.ResultsThe PDS provides researchers with a step by step process for recording their career and core competencies. The core competency framework can be applied to any research study, regardless of size of the team, place, disease focus or type of research. Team coordinators can quickly and easily produce visual records of the strengths and weaknesses in the competencies of their team and implement plans to address these gaps. Together with supporting tools in the PDS, research teams can plan staffing requirements for a study, carry out appraisals and guide the career development and training programme of research staff.ConclusionThe Global Health Network has created a flexible method and set of tools (PDS) to support researchers and teams to document their professional career and core competencies. It enables individuals and groups to easily identify and track capacity development; an essential requirement for conducting effective health research.