bluuebunny/crossref_metadata_2025 huggingface dataset:
PO 8470 FIRST INDEPENDENT ASSESSMENT OF PHARMACEUTICAL COMPANY ACTION ON AMR
Authors: Kisakye Jacqueline , Knoeff Josefien , Ruiz Adrian , Calcada Dulce , Iyer Jayasree , Gabrielle Breugelmans J
Published: April 2019

Background

Antimicrobial resistance (AMR) is one of the most significant threats to public health globally. It will worsen without concerted efforts to spur the development of new antibiotics and ensure access and stewardship of existing ones. Pharmaceutical companies have a critical role to play in these efforts. The Access to Medicine Foundation developed the AMR Benchmark to measure how pharmaceutical companies are responding to AMR and to share and push best practices within the industry.

Methods

The AMR Benchmark assessed the AMR activities of 30 pharmaceuticalcompanies in 106 low- and middle-income countries. Survey data on company activities were collected across three research areas: research and development (R&D); manufacturing and production; and access and stewardship. For each research area, specific metrics were developed to evaluate company performance. These metrics were defined through consultation with experts working across the AMR field and represent a broad consensus on where companies can and should be taking action to limit AMR.

Results

The Benchmark found that there are good practices in all research areas. Out of 276 R&D projects targeting infectious diseases, 175 target pathogens identified as priority by WHO/CDC. Of these, 88 are in preclinical stage, 87 are in clinical stage, and 54 target gram-negative bacteria. Out of 28 antibiotics in late clinical stage, only two have access and stewardship plans in place. Nearly half of companies evaluated are involved in AMR surveillance and eight companies set limits on antibiotic wastewater discharge. Lastly, four companies separate sales agent bonuses from antibiotics sales volumes to reduce overuse of antibiotics.

Conclusion

The Benchmark identified the good ideas being implemented by companies to limit AMR and mapped opportunities to amplify current efforts. Although companies are taking some action, the R&D pipeline needs to be further strengthened and candidates reaching late clinical stage must be supported by concrete plans to ensure access and stewardship.
PO 8472 EACCR-2 INSTITUTIONAL CLINICAL RESEARCH CAPACITY ASSESSMENT: CASE STUDY OF SIAYA COUNTY REFERRAL HOSPITAL, WESTERN KENYA
Authors: Oduor Patience , Wambura Mary , Mwai Geoffrey , Wandiga Steve
Published: April 2019

Background

Infrastructural inadequacies and lack of research management expertise impede optimal research participation by Ministries of Health in Africa. The East African Consortium for Clinical Research (EACCR-2) network champions research strengthening through capacity building and partnership with local institutions to improve research output in the region. The Siaya County Referral Hospital was evaluated for research needs in preparation for a future clinical trial.

Methods

In April 1018, we interviewed departmental in-charges or designees for administrative, financial and clinical data management, laboratory records and information technology (IT). Standardised assessment questionnaires were used.

Results

Five of the seven respondents interviewed were males. Patient populations such as children, adolescents and pregnant mothers were identified as having unique characteristics. They are to be considered for future inpatient and outpatient clinical trials. There is little research exposure among clinical, data and laboratory staff despite some of them receiving GCP and GCLP training.

An Institutional Review Board (IRB) is in place and it reviews both academic research proposals and large multicentre clinical trials before studies are carried out. However, the members lack appropriate training in bioethics.

Acute staff shortage, reagent stock-outs, space constraints, and faulty equipment limit the laboratory’s capacity. Insufficient IT support and internet access cause delays in data entry. A lack of expertise in monitoring, data analysis and statistics, of financial management systems and library services were also identified.

Conclusion

The hospital’s capacity to conduct clinical research is low. Assessment findings highlighted funding constraints faced at the referral hospital in a country burdened by disease. North-South partnership through EDCTP will contribute towards addressing part of these gaps.
PO 8473 IMPACT OF EBOLA ON SLEEPING SICKNESS IN COASTAL GUINEA: A RETROSPECTIVE ANALYSIS (2012–2017) FROM THE GUINEAN NATIONAL CONTROL PROGRAMME
Authors: Camara Oumou , Ilboudo Hamidou , Camara Mariame , Ouattara Eric , Duvignaud Alexandre , Leno Amadou , Solano Philippe , Malvy Denis , Bucheton Bruno , Camara Mamadou
Published: April 2019

Background

Coastal Guinea harbours the most active human African trypanosomiasis (HAT) foci in West Africa. The Guinean government and its partners are conducting HAT control activities to reduce the burden of this neglected tropical disease and, as set-up by WHO, to eliminate it as a public health problem by 2020. Unfortunately, control efforts were deeply impaired during the Ebola outbreak that struck the country in 2014–2015. The aim of the study was to evaluate the impact of this unprecedented outbreak on HAT screening and care activities and more generally onT. brucei gambiensetransmission.

Methods

A retrospective analysis of the data collected by the HAT-NCP between 2012 and 2013 (pre-Ebola period) and 2014–2015 (Ebola outbreak) has shown an interruption of active HAT screening activities and a rapid decrease of passive HAT screening activities as the Ebola outbreak was spreading. During the Ebola epidemic, HAT patients were also diagnosed in a later stage of the disease and attendance to post-treatment control visits was also severely affected.

Results

Only 59 HAT patients were diagnosed and treated during the Ebola outbreak (January 2014–October 2015) as compared to 154 before the outbreak (February 2012–December 2013). This potentially large undiagnosed human reservoir of trypanosomes may have contributed to increased transmission levels. After Guinea was declared free of Ebola virus disease, screening activities (both passive and active) were progressively resumed. In 2016 and 2017, Guinea reported 107 and 140 HAT cases, respectively (almost twice as much as during the pre-Ebola period) and became the second most affected country after the Democratic Republic of the Congo.

Conclusion

A major lesson taken from the Ebola outbreak is that disruption of medical care may lead to a quick HAT burst in areas of high transmission. Current HAT control measures combining screening and tsetse control interventions will help to stay on course for the elimination goal.
PO 8475 ENHANCING THE CAPACITY OF THE LIBERIA MEDICINES AND HEALTH PRODUCTS REGULATORY AUTHORITY IN POST-MARKETING SURVEILLANCE OFIN VITRODIAGNOSTICS
Authors: George Alexander E , Somwarbi Joseph N , Sumo David , Pérez Guillermo Martínez , Mayor Alfredo
Published: April 2019

Background

The Quality Control Laboratory (QCL) of the Liberia Medicines and Health Products Regulatory Authority (LMHRA) lacks capacity to assess the quality ofin vitrodiagnostics (IVDs). The LMHRA needs be strengthened to develop post-market surveillance (PostMS) regulations in order to fulfil its supervisory role for IVDs used in research and healthcare settings. IGORCADIA, an EDCTP-funded project of LMHRA and the Barcelona Institute for Global Health (ISGlobal) started in December 2017 with the aim of building LMHRA diagnostics assessment capacity.

Methods

Project activities targeting the QCL include: the constitution of an in-house Technical Working Group and a Diagnostic Steering Committee involving national stakeholders to develop PostMS regulation; a Training Programme in Diagnostics Research (TPDxR) including a malaria diagnostics performance study as its post-TPDxR exercise.

Results

The QCL is developing with its new knowledge and networks improved mechanisms to enact its supervisory mandate. QCL staff contributed to the development of guidance for Post-MS. Private sector and government stakeholders helped the LMHRA identify unlicensed premises where IVDs of presumably poor accuracy are available over the counter. Following the TPDxR, the QCL planned quality assurance to oversee the quality assessments on suspected substandard IVDs. Quality control tools, staff training requirements, standard inspection procedures, and PostMS registers and reports were re-designed in accordance with Good Laboratory Practice and guidance from the TPDxR.

Conclusion

The LMHRA is strengthening its regulatory, inspection and PostMS capacities thanks to a partnership with a European research institution with expertise in malaria diagnostics development. To ensure that the Liberian population has access to safe quality diagnostics in routine healthcare provision and in future infectious diseases outbreaks, it is of utmost importance that the LMHRA has capacity to assess the accuracy of the non-WHO prequalified IVDs that are currently available outside the healthcare system, and is well-equipped to recall those IVDs identified as substandard.
PO 8476 USER EXPERIENCE OF SMS REMINDERS TO TAKE MEDICATION AMONG PREGNANT AND BREASTFEEDING WOMEN LIVING WITH HIV IN KILIMANJARO, TANZANIA
Authors: Ngowi Kennedy M , Maro Eusibious , Nieuwkerk Pythia T , Aarnoutse Rob E , Mmbaga Blandina T , Marion Sumari-De Boer I
Published: April 2019

Background

Pregnant women living with HIV have difficulties in reaching adequate levels of treatment adherence. One way to intervene is sending reminder cues using short message service (SMS) texts. We conducted a pilot study on the use of SMS among pregnant and breastfeeding women living with HIV in Kilimanjaro, Tanzania. One objective was to investigate user experiences of SMS reminders.

Methods

We enrolled adult (age 18–45) pregnant or breastfeeding women living with HIV from Kilimanjaro region, Tanzania. Women received a reminder SMS 30 min before usual time of intake. One hour after usual time of intake, they received an SMS asking whether medication was taken. SMSes were sent less-than-daily and randomly distributed over the week. During consultation we listened to their feedback on the system. After six-months, we interviewed women using a semi-structured exit interview.

Results

Twenty-five women were enrolled. Two women were lost to follow-up. We received feedback from 18 women. Sixteen (89%) said they were content about the SMS reminding. One said she had problems with privacy issues (6%), but 5 specifically mentioned no privacy issues (28%). Preliminary results of 18 exit interviews show that 16 women (89%) had a good experience with the SMS. Fourteen women (78%) found the content of SMS good; 2 women (11%) said it was not good at all due to risk of unwanted disclosure. Three women (17%) experienced stigma. Eleven women (61%) told they were always able to reply to the SMS and 16 (89%) believed it really improves adherence.

Conclusion

We believe most women were satisfied with the SMS system. A few women had trouble with risks or fear of unwanted disclosure. One way to solve that, may be to send more neutral language messages. The results can be used for clinical trial design to investigate the effect on adherence.
PO 8483 ASSOCIATIONS BETWEEN HIV AND OTHER STIS AMONG GAY, BISEXUAL MEN AND TRANSGENDER WOMEN IN NAIROBI, KENYA
Authors: Wanjiru Rodah , Kimani Joshua , Smith Adrian
Published: April 2019

Background

Men who have sex with men (MSM) are a key target population for HIV prevention and control in Kenya. Although male sex workers remain the focus of research in Nairobi, HIV/STI prevalence has not been assessed among the wider MSM population since 2010. This study set out to reassess prevalence and associations of HIV and other STIs.

Methods

Respondent-driven sampling recruited 618 MSM. Eligibility criteria were age 18+, male (birth or currently), Nairobi residence and consensual oral or anal intercourse with a man in the last year. Consenting participants completed an online survey including current experience of STI symptoms. Participants tested for HIV [Determine, First Response [2ndgen] and GeneXpert HIV-Qual [4thgen]], syphilis [RPR/TPHA], hepatitis B and C [HBsAg and HCV ELISA], urine and rectal chlamydia and gonorrhea [GeneXpert CTNG]. Associations with prevalent HIV were assessed using multivariate logistic regression.

Results

HIV prevalence was 26.4% [22.6–30.6] including 0.5% [0.2–1.5] detected solely on 4th gen testing. Prevalent HIV was independently associated with age, lower education, Kenyan birth, transgender identity and exclusive sex with men in the past 3 months but dependently associated with STI symptoms. Prevalence of syphilis was 0.8% [0.3–1.9]; hepatitis B 4.4% [3.4–6.9]; hepatitis C 0.5% [0.2–1.5]. Current symptoms consistent with urethritis were reported by 6.4% [4.5–9.0] of participants. Prevalence of urethral GC and CT were 4.4% [2.9–6.7] and 7.3% [5.2–10.3] respectively. Symptoms consistent with proctitis were reported by 8.6% [6.3–11.6] of participants. The prevalence of rectal GC and CT were 13.3% [10.4–16.8] and 8.7% [6.7–11.2] respectively. Overall, only 17.7% [9.2–31.2] of participants with urethral CT/NG and 17.8% [10.7–28.0] rectal CT/NG were symptomatic.

Conclusion

The burden of HIV among gay, bisexual and other MSM (GBMSM) remains considerably higher than other men in Nairobi, whilst the prevalence of syphilis and hepatitis C are relatively low. Chlamydia and gonorrhoea infections, particularly rectal, are common and frequently asymptomatic. Capacity of GBMSM-friendly and community-based providers to offer CT/NG screening should be prioritised.
PO 8485 INTERFERON GAMMA RESPONSE KINETICS IN TUBERCULOSIS PATIENTS AND HOUSEHOLD CONTACTS IN THE GAMBIA
Authors: Mbayo Georgetta , Garand Mathieu , Donkor Simon , Wathuo Miriam , Ottenhoff Tom , Owolabi Olumuyiwa , Sutherland Jayne
Published: April 2019

Background

Methods which useMycobacterium tuberculosis(Mtb)-specific antigens to measure IFN-γ responses (IFN-γ release assays (IGRA)) have been useful in detecting Mtb infection in exposed individuals. We assessed infections in TB cases and their exposed household contacts (HHC) using an in-house optimised IGRA, the QuantiFERON-TB Gold in Tube (QFT-GIT) and QFT-Plus (QFT+).

Methods

For the in-house IGRA, we analysed 266 active TB patients and 759 HHC (256 tuberculin skin test-positive and 503 test-negative, TST+ and TST- respectively) at baseline and 6 months. In a separate study we assessed QFT-GIT and QFT-plus responses using samples from 72 TB cases and 69 HHC at baseline. QFT-GIT has 3 Mtb-specific antigens: ESAT6, CFP10 and TB7.7 while QFT-plus has long and short peptides of ESAT-6 and CFP-10, designed to induce CD4+ and CD8+T cell responses respectively.

Results

IFN-γ responses were lowest in TST- compared to both TST+ and TB patients at baseline (p<0.0001 for both), with 32% IGRA-positive compared to 76% and 73%, respectively using in-house IGRA. HHC sleeping in the same room with TB patient had a significantly higher IGRA conversion rate by 6 months compared to those sleeping further away (p=0.0004). We also observed a significant decline in IGRA IFN-γ levels by 6 months of TB treatment (p<0.0001). Among QFT-positive TB patients, smear-positive was 57% and culture-positive was 62%. The IFN-γ concentration between TB1 and TB 2 was similar, while, QFT-GIT had a significantly higher response than TB 1 and TB 2 for both TB patients (p=0.003) and HHC (p=0.0005).

Conclusion

Our findings show that IGRA conversion is significantly increased in HHC with highest exposure but that IGRA -positive cannot predict risk of progression to active TB. We also found that QFT-GIT was quantifiably better than QTF-plus in our setting, limiting the ‘grey zone’ of indeterminate results.
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

Background

Accurate 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.

Methods

Our 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.

Results

A 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.

Conclusion

There 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

Background

Poverty, 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.

Methods

Three 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.

Results

One PCR protocol using a nested approach was positive in two of the samples. Sequencing analysis confirmedLeishmaniasp. DNA.

Conclusion

This 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

Background

The 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.

Methods

In 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.

Results

In 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.

Conclusion

Improved 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

Background

Despite 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.

Methods

To 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.

Results

Promoting 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.

Conclusion

Developing 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

Background

Acute 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.

Methods

From 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.

Results

The 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%).

Conclusion

This 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

Background

Early-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.

Methods

PEAA 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.

Results

Asymptomatic 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).

Conclusion

Asymptomatic 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

Background

The 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).

Methods

We 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.

Results

Preliminary results were presented at the meeting.

Conclusion

Our 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

Background

Bespoke 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.

Methods

We 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.

Results

We 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.

Conclusion

Our 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

Background

Many 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.

Methods

PWOAE 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.

Results

93 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).

Conclusion

Ivermectin 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

Background

The 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.

Methods

This 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.

Results

Interviews 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.

Conclusion

I 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.
PO 8581 ZOONOTIC VIRAL ANTIGENS SURVEILLANCE IN HEALTHY POPULATIONS LIVING IN LAMBARÉNÉ, GABON
Authors: Bache Emmanuel , Loembe Marguerite M , Agnandji Selidji T
Published: April 2019

Background

Worldwide, viral zoonotic infections such as filoviruses, flaviviruses, nairoviruses and arenaviruses cause self-limiting to severe diseases. They are endemic in sub-Saharan Africa, causing sporadic outbreaks warranting the development of sustainable surveillance systems. In Gabon, Ebola outbreaks occurred from 1994 to 2002 causing 214 human cases and 150 deaths, while Dengue, Zika and Chikungunya virus outbreaks occurred between 2007 and 2010. Beyond these outbreaks, little is known about the epidemiology. Recently, in collaboration with the Japanese government, the Research and Health Ministries of Gabon supported the implementation of a biosecurity level-3 (BSL-3) laboratory at CERMEL in Lambaréné as a zoonotic disease surveillance unit. Start-off involved antigen detection and characterisation of circulating antibodies to targeted viral antigens in healthy populations. This study reports data from healthy participants (18–50 years) in a phase I rVSV-ZEBOV-GP Ebola vaccine trial.

Methods

Hundred-six (106) baseline samples were screened for Ebola, Dengue (serotypes) 1–4 and Chikungunya viral RNA by RT-PCR on serum. IgG ELISA on plasma was used to identify antibodies against: Zaire-Ebola-(EBOV-GP and EBOV-VP40), Marburg-(MARV-GP and MARV-VP40), Crimean Congo Haemorrhagic Fever-(CCHFV-GP), Lasa-(LASV-GPC and LASV-NP), Yellow Fever-(YFV-NS1), West-Nile-(WNV-NS1), Zika virus-(ZIKV-NS1), Chikungunya-(CHIKV-VLP) and Dengue-(DENV1-NS1,DENV2-NS1,DENV3-NS1,DENV4-NS1) virus antigens.

Results

No viral RNA was isolated by RT-PCR in 106 samples. About 9% (10/106), 3% (3/106), 6% (6/106), 24% (25/106), 51% (54/106), 38% (40/106) and 36% (38/106) participants were seropositive for antibodies specific to EBOV-GP, MARV-GP, CCHFV-GP, YFV-NS1, WNV-NS1, ZIKV-NS1 and CHIKV-VLP, respectively. Twelve percent (12%; 13/106) of participants possessed antibodies specific to Zika, Chikungunya and Dengue 1–4 antigens. Six percent (6%; 6/106) of participants were seropositive for EBOV-GP and CCHFV-GP.

Conclusion

We found antibodies to viral zoonotic infections among our healthy volunteers. Further assays, including neutralisation assays are being performed to ascertain the specificity of the antibodies. These findings, once confirmed, will provide insights into disease surveillance, vaccine trial designs, evaluation of post-vaccine immune responses, variability in adverse events and overall disease transmission patterns.
PO 8585 HIV, HBV AND HCV PREVALENCE, CO-INFECTIONS, RISK FACTORS AND AWARENESS AMONG STUDENTS IN A NIGERIAN UNIVERSITY
Authors: Japhet Margaret , Adewumi Moses , Olufisayo Adesina
Published: April 2019

Background

HIV, Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) are life threatening viral infections. Co-infections are possible since they share routes of transmission through exchange of blood/body fluids. Youths are the most vulnerable to HIV infection due to unsafe practices. There is no free counselling and testing for HBV/HCV in Nigeria, hence many may not be aware of their HBV/HCV status. This study assessed prevalence, knowledge and risk factors of transmission among University students in order to provide preventive intervention.

Methods

Previously counselled/consenting university students (total=903, M=502, F=428; age range 16–40 years; mean age 19 years) were enrolled. Relevant information was collected through questionnaire. About 5 ml of blood was collected from each student and serum recovered was analysed for detectable HIV antigens/antibodies using specific ELISA kit. HIV antigen/antibody-positives were analysed for detectable hepatitis B surface antigen and anti-HCV. The HIV and HBV-positives were compared in terms of gender, age group, and risk factors by use of chi-square and Fischer exact tests, with two-tailed significance using SPSS version 20.0.1 for Windows.

Result

Of the 930 students examined, 630 (67.7%) were sexually active and 104 (16.5%) had multiple sex partners. Knowledge of HIV, HBV and HCV status was 55%, 36.3% and 4.2% respectively. Overall, 13 (1.40%) students had detectable HIV antigens and/or antibodies, 5 (38.5%) of whom were HBV-positive, none had HCV infection. All HBV-positive students were ignorant of their HBV status. HIV and HBV-positive students fall within age range 15–24 years with higher HIV/HBV prevalence in females than males. Statistical significance exists between HIV, HBV prevalence and a) gender, b) number of sex partners, and c) sharing sharps with people of unknown HIV/HBV status (p=0.005; 0.002 and 0.005, respectively).

Conclusion

Knowledge about HBV and HCV is generally low among the students. Awareness campaigns specifically tailored towards educating young adults on HIV, HBV and HCV prevention/control should be encouraged.
PO 8592 WHY, WHEN AND WHERE DO NEWBORNS NOT ONLY GET SICK BUT ALSO DIE IN SÃO TOMÉ AND PRÍNCIPE? A CASE-CONTROL STUDY
Authors: Vasconcelos Alexandra , Sousa Swasilanne , Bandeira Nelson , Baptista João L , Machado Maria Do Céu , Pereira Filomena
Published: April 2019

Background

Neonatal deaths in São Tomé and Príncipe account for about 43% of all under-5 deaths, but there are major gaps in understanding this. The objective of this study was to identify ante-, intra-, and post-partum risk factors and to analyse characteristics of neonatal morbimortality.

Methods

Stillbirths and sick newborns (NB) with ≥32 week´s gestation or ≥1500 g were eligible cases, while controls were healthy newborns≥28 days. The study is still underway, and more data will become available. Results presented here are from a questionnaire applied by the investigator, and from medical records of mothers and newborns. Point-of-care tests were used to screen for syphilis, HIV and Hepatitis B. The SPSS 23 statistical programme was used for data analysis. Informed consent was obtained from every mother included in the study.

Results

Out of 675 mothers, 132 were enrolled corresponding to 134 newborns (2 twins), while 35 cases and 41 newborn controles were followed up. Pregnant women’s medium age was 26 years, 23% being adolescents and 23% without antenatal care. Primary education was attended by 57%, secondary by 63%, 7% never attended school. Syphilis – 1/96 reactive test; HIV or malaria not detected; 3 infected with HBV. Newborn morbimortality: 10 preterm, 12 birth asphyxia, 30 with risk of neonatal and 8 with invasive infections, 8 foetal growth restriction, 5 microcephaly, 4 minor congenital anomalies and 1 death in the first 24 hours of life (congenital lung anomaly). Low birth weight (<2500 g), meconium and caesarean section were statistically significant with respect to morbidity (p<0.05). No deaths were verified in the 76 babies followed up.

Conclusion

In this study, newborn morbidity was high (59%). More conclusions will be drawn when a higher number of participants is included and analysed. As a result, at the completion of this study, we hope to be able to design an intervention algorithm in order to achieve peri-neonatal morbimortality reduction.
OC 8453 SCALING-UP MASS TESTING AND TREATMENT EFFECTIVELY REDUCED MALARIA ASYMPTOMATIC PARASITAEMIA IN CHILDREN UNDER 15 YEARS OF AGE IN GHANA
Authors: Ndong Ignatius Cheng , Ahorlu Collins Stephan , Okyere Daniel , Nyarko Alexander A , Amambua-Ngwa Alfred , Koram Kwakwo A
Published: April 2019

Background

Global efforts to scale up malaria control interventions that work, are gaining momentum. These include the use of long-lasting insecticide nets, intermittent preventive treatment and test, treat and track using artemisinin-based combination therapies. Mass testing, treatment and tracking (MTTT) of the entire populations complemented by home-based management (HBM) using volunteers could be an effective approach at lower cost. MTTT of children in Ghana has demonstrated a parasite load reduction of 90%. However, unanswered questions include – Could this be scaled-up? What proportion of the community could be covered? What do we need? Can MTTT reduce asymptomatic parasitaemia levels in under-15 children?

Methods

The target population for this study was 5000 asymptomatic individuals in seven communities in the Pakro subdistrict in Ghana. A community register was developed following a census. Community volunteers conducted quarterly house-to-house testing (using RDTs) and treating positive cases with ACTs. Between interventions HBM was conducted.

Results

In those tested, asymptomatic malaria parasitaemia reduced from 1795 (36.3%) in July 2017 to 942 (23.1%) in March 2018. In eight months, parasitaemia declined by 43.5% and 37.3% in children under 15 and under 5, respectively. Coverage was 98.8% in July 2017 and 81.4% in March 2018. One of the challenges that surfaced was the fact that decrease in hospital attendance had a negative effect on money generated by the health facility. The district and subdistrict services, though appreciating the work, indicated that the negative effect on the health system may be serious and that measures need to be taken to address alternative financing for the health system.

Conclusion

This study has demonstrated that combining MTTT and home-based management of malaria could reduce prevalence in under-15 children and that using community volunteers could ensure effective coverage at lower cost. There is need to start looking at financing of the health system without malaria.