bluuebunny/crossref_metadata_2025_split huggingface dataset:
URGENT NEED TO EDUCATE NIGERIANS ABOUT THE EBOLA VACCINE TRIAL PROGRAM
Authors: Oluremi Adeolu , Opaleye Oluyinka 
Published: February 2017

BackgroundWith the effort of the World Health Organization to start distributing an experimental Ebola vaccine in West Africa, there is need to assess knowledge and willingness to participate in Ebola virus vaccine trials (EBVT) and possible barriers to participation.MethodsFrom June to November 2015, a structured questionnaire was used to measure the participants' knowledge and attitudes about Ebola virus vaccine in Nigeria. Data were analysed with packages within SPSS software and p< 0.05 considered significant.ResultsA total of 5000 participants aged 18–49 years were involved; mean age was 37 years; 3218 (64.4%) were female and 1782 (35.6%) male. Willingness to participate in Ebola virus vaccine trials was found in 803 (16.1%) in this population. It was higher in men than women (p=0.001), increased with education levels (p=0.003), higher among employed than unemployed (p=0.005) and higher among single than married (p=0.01). Those who wanted to participate were primarily youth and reasons for readiness to participate include: free health care, monetary gain, international connection and employment opportunity. Decreased willingness was associated with concerns about: fear of reverting back, side effect, refusal of spouses, physical harm, use of parenteral route for vaccine administration, multiple doses of vaccines and societal stigmatisation.ConclusionsThis study showed reduced willingness to participate in EBVT. It also revealed limited knowledge about EBVT in Nigeria. Therefore, there is a need for proper education on the potential role of preventive Ebola virus vaccines in the control of epidemics and the importance of vaccination among the populace of Nigeria. Incentives for would-be subjects should also be part of the planning to encourage greater participation in these trials.
EFFECT OF ONCHOCERCIASIS TREATMENT ON THE FREQUENCY OF SEIZURES IN PATIENTS WITH EPILEPSY AND ONCHOCERCIASIS
Authors: Michel Mandro 
Published: February 2017

BackgroundA high prevalence of epilepsy is mainly observed inOnchocerca volvulus(OV) hyperendemic areas with no or low ivermectin coverage. There is anecdotal evidence that ivermectin may reduce seizure frequency in patients with onchocerciasis associated epilepsy (OAE).MethodsBetween 2008 and 2012, Rethy in Ituri Province, Democratic Republic of Congo, was a study site for a phase III trial comparing moxidectin versus ivermectin as treatment for subjects infested with OV. Participants received a single oral dose of OV drug and were followed for 18 months. Parasitological efficacy was assessed by skin snip exams. In July 2016, the randomisation code has not been broken yet. In 2015 we traced 7 families of patients with epilepsy who had been enrolled in the trial. We interviewed them and reviewed the trial case report forms.ResultsOf 472 trial participants, 13(2.7%) had a medical history of active convulsive epilepsy. After OV treatment, 6 (80%) of 7 male patients with epilepsy became seizure free during the following 18 months. Seizures continued in this period in only 1 person with a decrease in frequency; in the latter microfilariae remained detectable in the skin. In all subjects who became seizure free, the skin snips too became microfilaria free for at least 6 months. None of the patients received any anti-epileptic drug nor an additional dose of moxidectin or ivermectin during or after the trial. In all subjects the frequency of seizures increased again after the 18 months and 2 patients died in 2015, because of drowning in the river during seizures.ConclusionsThis study suggests that moxidectin and/or ivermectin may be able to decrease the frequency of seizures in OV-infested people with epilepsy. A clinical trial will be needed to support this hypothesis.
ASSESSMENT OF THE ENDEMICITY STATUS OF SCHISTOSOMIASIS AND SOIL-TRANSMITTED HELMINTHIASIS IN THE GAMBIA
Authors: Camara Yaya , Sanneh Bakary 
Published: February 2017

BackgroundThe Ministry of Health and Social Welfare, The Gambia with support from WHO and Task Force for Global Health (TFGH), conducted a national endemicity mapping survey for schistosomiasis (SCH) and soil-transmitted helminths (STH) to establish their endemicity status. The survey was meant to provide baseline information on endemicity in order to plan and implement strategic interventions. This is a critical step towards NTD elimination by 2020.MethodsA cross-section of fifty school-aged children (SAC, 25 boys and 25 girls) per school was sampled in 209 schools countrywide. Eligible SAC of 7 to 14 years old were randomly selected using formula (n/50) where n=total eligible pupils per school. Stool, urine and finger prick samples provided, were examined for SCH and STH using Kato-Katz, urine filtration, dip-stick and CCA techniques.ResultsNational prevalence of schistosomiasis and soil-transmitted helminthiasis were 4.3% and 2.5%, respectively. At district level, Niani had the highest prevalence of SCH, recording 22%. Whereas for STH, Banjul, the capital city, had the highest prevalence, recording 55%, followed by 22% prevalence in Kombo South.Schistosoma haematobiumis the most dominant parasitic infection in The Gambia. Fourteen (38%) districts in the country are co-endemic for both STH and SCH. Generally, male pupils are more infected with urinary schistosomiasis than females.ConclusionsIt was established that 19 (45%) of districts mapped are endemic for schistosomiasis; thus the need for treatment with praziquantel. Twenty (47%) of districts mapped are endemic for soil-transmitted helminthiasis at varying rates. However, only two STH endemic districts, Banjul (55%), and Kombo South (22%), within the high and very high prevalence rates of endemicity, are eligible for treatment with albendazole.
THE INTERNATIONAL GOOD CLINICAL PRACTICES GUIDELINES: TIME FOR A REVISION?
Authors: Ravinetto Raffaella , Tinto Halidou , Diro Ermias , Okebe Joseph , Mahendradhata Yodi , Rijal Suman , Gotuzzo Eduardo , Lutumba Pascal , Nahum Alain , Nys Kateljine De , Casteels Minnes , Boelaert Marleen 
Published: February 2017

BackgroundThe Good Clinical Practices (GCP) codes of the World Health Organization and the International Conference of Harmonization set international standards for clinical research. But critics argue that they were written without considering the challenges faced by clinical researchers in low- and middle-income countries (LMIC).MethodsWe analysed the challenges met when conducting clinical trials in LMIC, including in several locations in sub-Saharan Africa and in EDCTP-funded trials. We compared these challenges to GCP guidance, in order to (a) verify if there are gaps between the international GCP codes and the field reality in LMIC, and (b) formulate recommendations for GCP improvement if needed.ResultsWe identified shortcomings in the GCP guidance concerning three broad domains: ethical, legal and operational. We identified also eleven specific issues: the double ethical review of ‘externally sponsored’ trials; the informed consent in children; the informed consent in illiterate people; the informed consent comprehension; the definition of vulnerability; the post-trial access to communities; the role of communities as key stakeholders in research; the definition of sponsor; the guidance for contractual agreements; the clinical monitoring; the laboratory quality management systems; and the quality assurance of investigational products. For each specific issue, we formulated a recommendation for the improvement of GCP.ConclusionsClinical trials are increasingly conducted in LMICs, thus a comprehensive revision of GCP guidelines is needed, to ensure adequate guidance for researchers operating in these contexts, and to maximise protection of research participants. The revised GCP code should be strongly rooted in ethics, sensitive to different socio-cultural perspectives, and allow consideration of trial- and context-specific challenges. This can be only achieved if researchers, sponsors, regulators and ethical reviewers from LMIC are transparently involved in the revision process, as well as non-commercial researchers and sponsors, and major agencies that fund international collaborative clinical research.
ETHICAL AND SCIENTIFIC CONSIDERATIONS FOR THE DESIGN AND IMPLEMENTATION OF THE PREP DEMONSTRATION PROJECT IN NIGERIA
Authors: Ukpong Morenike , Sagay Atiene , Khamofu Hadiza , Torpey Kwasi , Afiadigwe Evaristus , Anenih James , Ezechi Oliver , Nweneka Chidi , Idoko John 
Published: February 2017

BackgroundThis abstract highlights the ethical and scientific considerations that informed the development and review of the Nigeria PrEP demonstration study protocol.MethodsA desk review was conducted on all the meeting reports that led to the choice of the study design and the decisions made to modify the protocol for the PrEP demonstration project in Nigeria. The study focused on the ethical and scientific rationales for modifying the Partners' PrEP Sero-discordant protocol for this study as well as for the first and second protocol amendments of this study.ResultsThe decision to conduct a PrEP study was based on the outcome of a modelling study that suggested that sero-discordant couples will benefit from access to condom, TasP, and PrEP. Next, the decisions on the target population for the PrEP demonstration study, the models for evaluation at specific project site, and the design of the community engagement programme were reached through a formative research which engaged 611 individuals using multiple media. The study did not exclude study participants based on Hepatitis status and HIV risk profile since Truvada was an effective hepatitis treatment and the prevalence of hepatitis infection is high in Nigeria. Participants' interest in PrEP use was considered enough reason to prescribe PrEP in a country where uptake of ARV is slow and stigma associated with ARV use is high. Also, HIV-negative partners could assess when the viral load of the HIV-positive partner was 400 copies/ml. Since adherence was a challenge for PrEP use, adherence was enhanced through the use of the MEMS Cap.ConclusionsA PrEP demonstration study that mimics real life scenarios for PrEP provision within public health care institutions and is designed on the basis of community consultations, ethical and scientific considerations, will enhance the success of PrEP roll-out in resource-limited settings like Nigeria.
DETERMINING THE ENVIRONMENTAL, SOCIAL AND CULTURAL CONTEXTS OF A PROPOSED SCHISTOSOMIASIS HEALTH EDUCATION INTERVENTION IN EGGUA, YEWA NORTH LOCAL GOVERNMENT AREA, OGUN STATE NIGERIA
Authors: Anumudu Chiaka , Onile Olugbenga , Oladele Victoria , Adebayo Adewale , Awobode Henrietta 
Published: February 2017

BackgroundThe role of health education in the control of schistosomiasis cannot be over-emphasised. Central to its utility is an understanding of the way a community perceives, understands and can explain how schistosomiasis occurs among them.MethodsIn order to study the environmental, social and cultural determinants of continued schistosomiasis prevalence in Eggua, we administered a semi-structured questionnaire to 371 adults and 265 children between November 2012 and December 2015. We asked questions about their occupation, present and previous water contact pattern, knowledge of schistosomiasis, sanitation, smoking and alcohol behaviour and length of residence in the village.ResultsThe respondents ranged in age from 35 to above 60 years; 45% had no schooling and 30% had a least a primary education. Most were farmers (48%) and traders (30%) with a small number (2%) of fisher-folk and had been at this work for more than 15 years. The majority (93%) were Christian, of a denomination in which members spend long periods in the river praying. The rivers are the main source of water for a large number of respondents (63%). Water contact is frequent: 90% go at least daily to the rivers. All the respondents worked at non-itinerant jobs. Despite the research surveys were taking place in Yewa since 2009, 90% of respondents did not know the cause of blood in urine and self-reported haematuria was low (4.6%). Many homes did not have a latrine. Children respondents also didn't have knowledge of the cause of schistosomiasis (60%); those who had heard about it were not well educated on ways to avoid being infected; and 83% did not know they could be re-infected after treatment.ConclusionsFormal health education initiatives for the control of schistosomiasis in Eggua are imperative and these findings should be taken into account in designing them.
FROM LABORATORY RESEARCH TO THE PUBLIC: SCIENCE COMMUNICATION FOR POLICY, RESEARCH COMMUNITY AND PUBLIC
Authors: Kabuye Emily , Lutalo Tom , Kaleebu Pontiano , Mbidde Edward 
Published: February 2017

BackgroundThe Government of Uganda uses empirical evidence for policy formulation. The Uganda Virus Research Institute (UVRI) and the International Association of National Public Health Institutions (IANPHI) trained journalists and scientists to communicate research processes and findings to the public. This improved the capacity to communicate important information during outbreaks and to disseminate research findings as part of policy formulation.MethodsThrough training workshops, 30 research scientists including study coordinators, research officers and principal investigators interacted with 12 health reporters from various media houses. Training covered writing policy briefs and press releases. Attendees were taken through the ‘dos and don'ts’ when being interviewed by television/radio journalist while journalists were trained in basic epidemiology terms and research processes. They analysed research papers to find different story angles. They conducted mock media talk shows for television and radio and these sessions were reviewed by all those in attendance, identifying areas for improvement.ResultsKey findings revealed that journalists do not ably write about research findings because they do not understand the scientific research procedure. Training journalists on health research communication, ethical issues and research procedure enabled them to appreciate the scientific research process. Continued interaction was found to be of help to articulate research findings for health journalist before they are presented in print and audio media for the wider audience/public. This method built capacity of participating scientists to communicate to the lay audiences. It also helped the scientists plan for the media and policy makers during future dissemination of their research findings.ConclusionsMeaningful engagement of journalists and the public by scientists results in proper understanding of the ethical and scientific research procedure. This calls for systematic investment by research organisations and, during proposal development, budgeting for communication and knowledge translation of research findings to benefit policy makers and the wider research community.
PREVALENCE AND CLINICAL SIGNIFICANCE OF SCHISTOSOMIASIS-CHRONIC HEPATITIS B VIRUS CO-INFECTION IN ZAMBIA
Authors: Chisenga Caroline , Sinkala Edford , Chilengi Roma , Chitundu Hellen , Zyambo Zude , Wandeler Gilles , Vinikoor Michael 
Published: February 2017

BackgroundHepatosplenic schistosomiasis (HSS) and hepatitis B virus (HBV) are both endemic in sub-Saharan Africa but the clinical epidemiology of co-infection is not well-characterised. Within a current HIV cohort study, we assessed the prevalence of HSS and its impact on markers of liver fibrosis in HIV-HBV co-infected individuals.MethodsAt two urban HIV care facilities in Zambia's capital Lusaka, we screened for HBV co-infection using a hepatitis B surface antigen (HBsAg) test and for lifetime infection withSchistosoma mansoniusing an IgG enzyme-linked immunoassay (Abcam, Cambridge, UK). Among HIV-HBV patients, we also performed abdominal ultrasonography. We defined HSS as evidence of periportal hepatic fibrosis on ultrasound regardless of IgG result. Patient characteristics, including liver fibrosis markers (ALT and transient elastography) were measured and stratified by HSS. We used Wilcoxon rank sum test for continuous and chi-square test for categorical comparisons between groups.ResultsAmong 895 HIV-infected adults, lifetime exposure toS. mansoniwas observed in 23.3%. Within the cohort 92 HBsAg-positives underwent assessment for HSS. Median age among these was 34.7 years (interquartile range [IQR], 28.9–39.9), 48% were men, CD4 count was 247 cells/mm3 (IQR, 145–335), HBV viral load was 2.87 (IQR, 1.00–5.18) log10 IU/mL, and liver stiffness was 5.5 kilopascals (IQR, 4.7–6.9).On ultrasound, 1 patient had cirrhosis and 36 (39.1%) had evidence of HSS. HBV-HSS patients had a non-significant trend toward higher portal vein diameter (8.5 versus 10.2; p=0.15) compared to those without HSS but ALT (18.5vs20 U/L), and liver stiffness (5.3vs5.0 kPa) were similar between groups (both p >0.05).ConclusionsLifetimeS. mansoniexposure and current HSS were common among HIV-infected patients with HBV co-infection in Zambia. Mild HSS did not appear to alter non-invasive markers of liver fibrosis. Further research on the impact of more advanced HSS on HBV co-infection is needed.
RUBELLA SEROPREVALENCE AMONG HIV-INFECTED AND UNINFECTED ZAMBIAN CHILDREN AND ADOLESCENTS
Authors: Matakala Kalumbu , Sutcliffe Catherine , Searle Kelly , Greenman Michelle , Rainwater-Lovett Kaitlin , Thuma Philip , Moss William 
Published: February 2017

BackgroundCongenital rubella syndrome remains a significant cause of morbidity and mortality among children in sub-Saharan Africa. A safe and effective vaccine is available and many countries, including Zambia, plan to introduce the measles-rubella vaccine by 2020. HIV-infected youths may be an important group to consider as they may remain susceptible to rubella virus due to waning immunity. More information is needed in this age group to guide policy on catch-up rubella vaccination campaigns after introduction.MethodsThis cross-sectional study was nested within ongoing studies of HIV and malaria in Southern Province, Zambia. Dried blood spot cards from children and youths 5–15 years of age enrolled in these studies from 2009–2013 were selected and tested for IgG antibodies to rubella virus. Antibody levels among HIV-uninfected youth, HIV-infected treatment-naïve youth, and HIV-infected youth receiving antiretroviral therapy (ART) were compared.Results617 HIV-uninfected, 144 HIV-infected treatment-naïve, and 128 HIV-infected youth receiving ART were included in the study. The proportion seropositive for rubella virus was significantly higher among HIV-uninfected youth (54.7%) compared to HIV-infected treatment-naïve youth (41.7%) and HIV-infected youth receiving ART (49.6%). The proportion of youth with equivocal results was significantly higher for the two groups of HIV-infected youth (treatment-naïve=11.8%; receiving ART=7.9%) compared to HIV-uninfected youth (1.1%). Within groups, the proportion seropositive increased with age. Other than age, no demographic or clinical characteristics were associated with susceptibility among HIV-infected youth.ConclusionsOur results suggest that HIV-infected youth would benefit from vaccination against rubella virus. Half of all youth in rural Zambia were susceptible to Rubella virus. When rubella vaccine is introduced, failure to target older girls in immunisation campaigns could lead to an increase in congenital rubella cases.
PREVALENCE AND RISK FACTORS OF VIROLOGICAL FAILURE AMONG CHILDREN ON ANTIRETROVIRAL THERAPY
Authors: Owusu Michael , Mensah Eric , Enimil Anthony , Mutocheluh Mohamed 
Published: February 2017

BackgroundAn unprecedented global effort at scaling up universal access to antiretroviral therapy has decreased the progression of HIV. However, due to challenges with supplies and adherence to intermittent antiretroviral therapy (ART) for mothers, infants continue to be infected, some with resistant viruses. Exposure to these resistant strains leads to non-responsiveness to therapy resulting in virological failure. Children are more vulnerable to HIV drug resistance because of their life long treatment, the possible selection of resistant strains as a result of prophylaxis for mothers with HIV enrolled in PMTCT. The objective of the study was to determine the prevalence and risk factors of virological resistance among HIV-1-positive children on antiretroviral therapy.MethodsThis was a longitudinal study that was performed at the HIV paediatric clinic of the Komfo Anokye Teaching Hospital, Kumasi, Ghana. Blood samples of children below the age of 18 years who had been on therapy for at least 3 months were analysed for virological load using real-time COBAS AmpliPrep/COBAS Taqman PCR. The samples were analysed at two consecutive time points when they came for their ART refill. Socio-demographic and clinical information was collected from their folders and also from the mother.ResultsA total of 188 subjects were enrolled into the study from September 2015 to June 2016. The average duration on ART was 36 months (IQR=12–72 months). Of all subjects recruited, 134 (71.3%) were found to be on regular drug ART. Of these, 21 (15.7%) had virological failure and 102 (76.1%) had virological suppression. A regression analysis showed that subjects whose parents were unemployed had 5.4 (1.4–20.9) chances of virological failure compared to those with parents employed.ConclusionsThe risk of virological failure among HIV-positive children is still high. Efforts must be made to further identify the potential causes of virological failure among these children.
VIROLOGICAL RESPONSE TO EARLY COMBINED ANTIRETROVIRAL THERAPY IN HIV-INFECTED INFANTS: EVALUATION AFTER TWO YEARS OF TREATMENT IN THE PEDIACAM STUDY
Authors: Ndongo Francis Ateba , Tejiokem Mathurin Cyrille , Texier Gaetan , Penda Calixte , Ndiang Suzie , Ndongo Jean-Audrey , Guemkam Georgette , Sofeu Casimir Ledoux , Afumbom Kfutwa , Faye Albert , Msellati Philippe , Warszawski Josiane 
Published: February 2017

BackgroundLittle is known about virological responses to early combined antiretroviral therapy (cART) in HIV-infected infants in limited-resource settings. We estimated the probability of achieving viral suppression within two years of cART initiation, and investigated the factors associated with success.MethodsWe analysed all 190 infants from the Cameroon PediaCAM study who began free cART before the age of 12 months. The main outcome measure was viral suppression (<1000 cp/mL) on at least one occasion. The other outcome measures considered were viral suppression (<400 copies/ mL) on at least one occasion and confirmed viral suppression (both thresholds) on two consecutive occasions. We used competing-risks regression for a time-to-event analysis to estimate the cumulative incidence of outcomes, and univariate and multivariate models to identify risk factors.ResultsDuring the first 24 months of cART, 20.0% (38) of the infants died, giving a mortality rate of 11.9 deaths per 100 infant-years [95% CI: 8.1–15.7]. The probability of achieving a viral load below 1000 or 400 copies/mL was 80.0% [69.0–81.0] and 78.0% [66.0–79.0], respectively. The probability of virological suppression (with these two thresholds) on two consecutive occasions was 67.0% [56.0–70.0] and 60.0% [49.0–64.0], respectively. Virological success was associated with not having missed any doses of treatment before the visit, but not with socioeconomic and living conditions.ConclusionsThe long-term daily administration of drugs to babies seems to be difficult. Mortality remained high despite early cART initiation. Future studies should focus on longer-term treatment outcomes in children still alive after two years of treatment.