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Impact of Introducing Hepatitis B Birth Dose Vaccines into the Infant Immunization Program in Burkina Faso: Study Protocol for a Stepped Wedge Cluster Randomized Trial (NeoVac Study).

ABSTRACT: To achieve global hepatitis elimination by 2030, it is critical to prevent the mother-to-child transmission (MTCT) of hepatitis B virus (HBV). Since 2009, the WHO has recommended administering hepatitis B vaccine to all neonates within 24 h of birth to prevent MTCT. However, many countries in sub-Saharan Africa only provide hepatitis B immunization at the age of 6, 10, and 14 weeks or 8, 12, and 16 weeks using a combined vaccine. To accelerate the introduction of the hepatitis B birth dose vaccine (HepB-BD) into sub-Saharan Africa, it is critical to establish to what extent the addition of HepB-BD can further reduce HBV transmission in areas where three-dose infant vaccination has been implemented. We therefore designed a study to evaluate the impact, acceptability, and cost-effectiveness of incorporating the HepB-BD into the routine immunization program in a real-life field condition in Burkina Faso, where the hepatitis B vaccination is currently scheduled at 8-12-16 weeks. Through a multidisciplinary approach combining epidemiology, anthropology, and health economics, the Neonatal Vaccination against Hepatitis B in Africa (NéoVac) study conducts a pragmatic stepped wedge cluster randomized controlled trial in rural areas of the Hauts-Bassins Region. The study was registered in ClinicalTrials.gov (identifier: NCT04029454). A health center is designated as a cluster, and the introduction of HepB-BD will be rolled out sequentially in 24 centers. Following an initial period in which no health center administers HepB-BD, one center will be randomly allocated to incorporate HepB-BD. Then, at a regular interval, another center will be randomized to cross from the control to the intervention period, until all 24 centers integrate HepB-BD. Pregnant women attending antenatal care will be systematically invited to participate. Infants born during the control period will follow the conventional immunization schedule (8-12-16 weeks), while those born in the interventional period will receive HepB-BD in addition to the routine vaccines (0-8-12-16 weeks). The primary outcome, the proportion of hepatitis B surface antigen (HBsAg) positivity in infants aged at 9 months, will be compared between children born before and after HepB-BD introduction. The study will generate data that may assist governments and stakeholders in sub-Saharan Africa to make evidence-based decisions about whether to add HepB-BD into the national immunization programs.

SUBMITTER: Tall H

PROVIDER: S-EPMC8227098 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature

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Impact of Introducing Hepatitis B Birth Dose Vaccines into the Infant Immunization Program in Burkina Faso: Study Protocol for a Stepped Wedge Cluster Randomized Trial (NéoVac Study).

Tall Haoua H Adam Pierrick P Tiendrebeogo Abdoul Salam Eric ASE Vincent Jeanne Perpétue JP Schaeffer Laura L von Platen Cassandre C Fernandes-Pellerin Sandrine S Sawadogo François F Bokoum Alkadri A Bouda Ghislain G Ouattara Seydou S Ouédraogo Issa I Herrant Magali M Boucheron Pauline P Sawadogo Appolinaire A Betsem Edouard E Essoh Alima A Kabore Lassané L Ouattara Amariane A Méda Nicolas N Hien Hervé H Gosset Andréa A Giles-Vernick Tamara T Boyer Sylvie S Kania Dramane D Vray Muriel M Shimakawa Yusuke Y

Vaccines 20210601 6

To achieve global hepatitis elimination by 2030, it is critical to prevent the mother-to-child transmission (MTCT) of hepatitis B virus (HBV). Since 2009, the WHO has recommended administering hepatitis B vaccine to all neonates within 24 h of birth to prevent MTCT. However, many countries in sub-Saharan Africa only provide hepatitis B immunization at the age of 6, 10, and 14 weeks or 8, 12, and 16 weeks using a combined vaccine. To accelerate the introduction of the hepatitis B birth dose vacci ...[more]

PMID: 34206058

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Project description:BackgroundThe global recognition of vaccination is strongly related to the fact that it has proved in the past able to dramatically reduce the incidence of certain diseases. Nevertheless, reactions regarding the practice of vaccination still vary among communities, affecting the worldwide vaccination coverage. Numerous studies, conducted from varying perspectives, have focused on explaining this active refusal or resistance to vaccination. Although in some cases low immunization coverage has been well explained by active refusal or resistance to vaccination, little is known about the reasons for low coverage where those reactions are absent or play a minor role, especially outside an epidemic context. This study attempts to explain this situation, which is found in the health district of Nouna in Burkina Faso.MethodsAn in-depth ethnographic study was undertaken in the health district of Nouna in an effort to understand, from an anthropological point of view, the logic behind the parental decision-making process regarding the vaccination or non-vaccination of children, in a context where rejection of, and reservations concerning vaccination are not major obstacles.ResultsThree elements emerged from the analysis: the empirical conceptions of childhood diseases, the perceived efficacy of vaccine and the knowledge of appropriate age for vaccination uptake; the gap between the decision-making process and the actual achievement of vaccination; and the vaccination procedure leading to vaccination uptake in the particular context of the health district of Nouna.ConclusionThe procedures parents must follow in order to obtain vaccination for their children appear complex and constraining, and on certain points discord with the traditional systems of meaning and idioms of distress related to pregnancy, the prevention of childhood diseases and with the cultural matrix shaping decision-making and behaviour. Attention needs to be directed at certain promotional, logistical and structural elements, and at the procedure that must currently be followed to obtain vaccination for a child during routine vaccination sessions, which are currently limiting the active demand for vaccination. ABSTRACT IN FRENCH : See the full article online for a translation of this abstract in French.

Project description:BackgroundThe Integrated eDiagnosis Approach (IeDA), centred on an electronic Clinical Decision Support System (eCDSS) developed in line with national Integrated Management of Childhood Illness (IMCI) guidelines, was implemented in primary health facilities of two regions of Burkina Faso. An evaluation was performed using a stepped-wedge cluster randomised design with the aim of determining whether the IeDA intervention increased Health Care Workers' (HCW) adherence to the IMCI guidelines.MethodsTen randomly selected facilities per district were visited at each step by two trained nurses: One observed under-five consultations and the second conducted a repeat consultation. The primary outcomes were: overall adherence to clinical assessment tasks; overall correct classification ignoring the severity of the classifications; and overall correct prescription according to HCWs' classifications. Statistical comparisons between trial arms were performed on cluster/step-level summaries.ResultsOn average, 54 and 79% of clinical assessment tasks were observed to be completed by HCWs in the control and intervention districts respectively (cluster-level mean difference = 29.9%; P-value = 0.002). The proportion of children for whom the validation nurses and the HCWs recorded the same classifications (ignoring the severity) was 73 and 79% in the control and intervention districts respectively (cluster-level mean difference = 10.1%; P-value = 0.004). The proportion of children who received correct prescriptions in accordance with HCWs' classifications were similar across arms, 78% in the control arm and 77% in the intervention arm (cluster-level mean difference = - 1.1%; P-value = 0.788).ConclusionThe IeDA intervention improved substantially HCWs' adherence to IMCI's clinical assessment tasks, leading to some overall increase in correct classifications but to no overall improvement in correct prescriptions. The largest improvements tended to be observed for less common conditions. For more common conditions, HCWs in the control districts performed relatively well, thus limiting the scope to detect an overall impact.Trial registrationClinicalTrials.gov NCT02341469 ; First submitted August 272,014, posted January 19, 2015.

Project description:BackgroundDespite rapid and tangible progress in vaccine coverage and in premature mortality rates registered in sub-Saharan Africa, inequities to access remain firmly entrenched, large pockets of low vaccination coverage persist, and coverage often varies considerably across regions, districts, and health facilities' areas of responsibility. This paper focuses on system-related factors that can explain disparities in immunization coverage among districts in Burkina Faso.MethodsA multiple-case study was conducted of six districts representative of different immunization trends and overall performance. A participative process that involved local experts and key actors led to a focus on key factors that could possibly determine the efficiency and efficacy of district vaccination services: occurrence of disease outbreaks and immunization days, overall district management performance, resources available for vaccination services, and institutional elements. The methodology, geared toward reconstructing the evolution of vaccine services performance from 2000 to 2006, is based on data from documents and from individual and group interviews in each of the six health districts. The process of interpreting results brought together the field personnel and the research team.ResultsThe districts that perform best are those that assemble a set of favourable conditions. However, the leadership of the district medical officer (DMO) appears to be the main conduit and the rallying point for these conditions. Typically, strong leadership that is recognized by the field teams ensures smooth operation of the vaccination services, promotes the emergence of new initiatives and offers some protection against risks related to outbreaks of epidemics or supplementary activities that can hinder routine functioning. The same is true for the ability of nurse managers and their teams to cope with new situations (epidemics, shortages of certain stocks).ConclusionThe discourse on factors that determine the performance or breakdown of local health care systems in lower and middle income countries remains largely concentrated on technocratic and financial considerations, targeting institutional reforms, availability of resources, or accessibility of health services. The leadership role of those responsible for the district, and more broadly, of those we label "the human factor", in the performance of local health care systems is mentioned only marginally. This study shows that strong and committed leadership promotes an effective mobilization of teams and creates the conditions for good performance in districts, even when they have only limited access to supports provided by external partners. ABSTRACT IN FRENCH: See the full article online for a translation of this abstract in French.

Project description:BackgroundThe greatest challenge facing expanded programs on immunization in general, and in Burkina Faso in particular, lies in their capacity to achieve and sustain levels of immunization coverage that will ensure effective protection of children. This article aims to demonstrate that full immunization coverage of children, which is the primary indicator for monitoring national immunization programs, is sufficient neither to evaluate their performance adequately, nor to help identify the broad strategies that must be implemented to improve their performance. Other dimensions of performance, notably adherence to the vaccination schedule and the efficacy of the approaches used to reach all the children (targeting) must also be considered.MethodsThe study was carried out using data from surveys carried out in Burkina Faso: the 1993, 1998 and 2003 Demographic and Health Surveys and the 2003 national Survey of Immunization Coverage. Essentially, we described levels of immunization coverage and their trends according to the indicators considered. Performance differences are illustrated by amplitudes and maximum/minimum ratios.ResultsThe health regions' performances vary according to whether they are evaluated on the basis of full immunization coverage or vaccination status of children who have not completed their vaccinations. The health regions encompass a variety of realities, and efforts of substantially different intensity would be required to reach all the target populations.ConclusionDecision-making can be improved by integrating a tripartite view of performance that includes full immunization coverage, adherence to the vaccination schedule (timely coverage), and the status of children who are not fully vaccinated. With such an approach, interventions can be better targeted. It provides information on the quality and timeliness of vaccination and identifies the efforts required to meet the objectives of full immunization coverage. ABSTRACT IN FRENCH: See the full article online for a translation of this abstract in French.

Project description:IntroductionAdequate nutrition during pregnancy is crucial to both mother and child. Maternal malnutrition can be the cause of stillbirth or lead to poor birth outcomes such as preterm delivery and small-for-gestational-age newborns. There is a probable positive effect of providing pregnant women a balanced energy-protein (BEP) food supplement, but more evidence is needed. The MIcronutriments pour la SAnté de la Mère et de l'Enfant (MISAME) III project aims to improve birth outcomes and infant growth by testing a BEP supplement during pregnancy and lactation in rural Burkina Faso. This paper describes the study protocol.Methods and analysisMISAME-III is a four-arm individually randomised efficacy trial implemented in six rural health centre catchments areas in the district of Houndé. Eligible pregnant women, aged between 15 and 40 years old and living in the study areas, will be enrolled. Women will be randomly assigned to one of the four study groups: (1) prenatal intervention only, (2) postnatal intervention only, (3) prenatal and postnatal intervention or (4) no prenatal or postnatal intervention. The intervention group will receive the BEP supplement and iron/folic acid (IFA) tablets, while the control group will only receive the IFA tablets following the national health protocol. Consumption will be supervised by trained village women on a daily basis by means of home visits. The primary outcomes are small-for-gestational age at birth and length-for-age z-score at 6 months of age. Secondary outcomes will be measured at birth and during the first 6 months of the infants' life. Women will be enrolled from October 2019 until the total sample size is reached.Ethics and disseminationMISAME-III has been reviewed and approved by the University Hospital of Ghent and the ethics committee of Centre Muraz, Burkina Faso. Informed consent will be obtained. Results will be published in relevant journals and shared with other researchers and public health institutions.Trial registration numberNCT03533712.

Project description:BACKGROUND:Infants are thought to be protected against malaria during the first months of life mainly due to passage of maternal antibodies. However, in high transmission settings, malaria in early infancy is not uncommon and susceptibility to the infections varies between individuals. This study aimed to determine malaria morbidity and infection during early childhood in rural Burkina Faso. METHODS:Malariometric indices were determined over 1-year follow-up in a birth cohort of 734 infants living in Nanoro health district. Clinical malaria episodes were determined by passive case detection at peripheral health centres while asymptomatic malaria infections were identified during 4 cross-sectional surveys at 3, 6, 9 and 12 months of age. Plasmodium falciparum infections were detected by rapid diagnostic test and/or light microscopy (LM) and quantitative PCR (qPCR). RESULTS:In total, 717 clinical episodes were diagnosed by qPCR over 8335.18 person-months at risk. The overall malaria incidence was 1.03 per child-year and increased from 0.27 per child-year at 0-3 months of age to 1.92 per child-year at 9-12 months of age. Some 59% of children experienced at least one clinical episode with a median survival time estimated at 9.9 months, while 20% of infants experienced the first episode before 6 months of age. The majority of the clinical episodes were attributable to microscopic parasitaemia (84.2%), and there was a positive correlation between parasite density and age (Spearman's rho = 0.30; P < 0.0001). Prevalence of asymptomatic infections was similar at 3, 6 and 9 months of age (17.7-20.1%) and nearly 1.6 times higher at 12 months (31.3%). Importantly, gametocyte prevalence among the LM-positive study population was 6.7%, but increased to 10% among asymptomatic infections. In addition, 46% of asymptomatic infections were only detected by qPCR suggesting that infants below 1 year are a potential reservoir for sustaining malaria transmission. Both symptomatic and asymptomatic infections showed marked seasonal distribution with the highest transmission period (July to December) accounting for about 89 and 77% of those infections, respectively. CONCLUSIONS:These findings indicate high and marked age and seasonal-dependency of malaria infections and disease during the first year of life in Nanoro, calling for intensified efforts to control malaria in rural Burkina Faso.

Project description:BackgroundOperative vaginal birth is a common procedure used to expedite birth after full cervical dilatation where there is a clinical need to do so (15% of births in the UK in 2016). The acquisition of skills for operative vaginal birth is dependent on the exposure of junior obstetricians to situations in which they can undertake directly supervised learning from senior accouchers. The Royal College of Obstetricians and Gynaecologists has recently introduced the first structured course in operative vaginal birth. To date, there have been no attempts to determine the clinical impact of a structured training package for operative vaginal birth.MethodsThe STROBE study is a quasi-experimental before-after interrupted time-series study of the effect of simulation training in operative vaginal birth for obstetricians on clinical outcomes of women and babies following operative vaginal birth. Similar to a stepped-wedge design, the intervention will be gradually implemented in all participating units but at different time periods. The primary outcome is failed operative vaginal birth with the first intended instrument. Secondary maternal outcomes are; use of second instrument to achieve operative vaginal birth, caesarean section, episiotomy, perineal trauma (1st, 2nd, 3rd, 4th degree tear), cervical tear requiring suturing, general anaesthesia and estimated blood loss. Secondary neonatal outcomes are; Apgar score at one, five, and ten minutes, Umbilical artery pH, shoulder dystocia, admission to Neonatal Intensive Care Unit and death within 28 days of birth. The analysis will be intention-to-treat (per unit) on the primary and secondary outcomes. The STROBE study received approval from the Health Research Authority and is sponsored by North Bristol NHS Trust. Results will be published in an open-access peer-reviewed medical journal within one year of completion of data gathering.DiscussionThe STROBE study will help establish our understanding of the effectiveness of locally-delivered simulation training for operative vaginal birth. Robust evidence supporting the effectiveness of such an approach would add weight to the argument supporting regular, local training for junior obstetricians in operative vaginal birth.Trial registrationISRCTN11760611 05/03/2018 (retrospectively registered).

Dataset Information

Impact of Introducing Hepatitis B Birth Dose Vaccines into the Infant Immunization Program in Burkina Faso: Study Protocol for a Stepped Wedge Cluster Randomized Trial (NeoVac Study).

Publications

Impact of Introducing Hepatitis B Birth Dose Vaccines into the Infant Immunization Program in Burkina Faso: Study Protocol for a Stepped Wedge Cluster Randomized Trial (NéoVac Study).

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