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BACKGROUND: To guide antibiotic stewardship interventions, understanding for what indications antibiotics are used is essential. METHODS: In rural Burkina Faso, we measured antibiotic dispensing across all healthcare providers. From October 2021 to February 2022, we surveyed patients in Nanoro district, Burkina Faso, following visits to health centres (3), pharmacies (2), informal medicine vendors (5) and inpatients in health centres. We estimated prevalence of antibiotic use and the proportion of Watch group antibiotics by provider type and by clinical presentation, assessing compliance with WHO's AWaRe Antibiotic Book. We estimated per capita antibiotic use by multiplying prevalence of antibiotic use, mean DDD per adult treatment course, and the rate of healthcare visits per 1000 inhabitants per day, estimated from a prior household survey. RESULTS: Outpatient antibiotic use was more frequent after health centre visits (54.8%, of which 16.5% Watch, nâ=â1249) than after visits to pharmacies (26.2%, 16.3% Watch, nâ=â328) and informal medicine vendors (26.9%, 50.0% Watch, nâ=â349). The frequency of antibiotic use was highest for bronchitis (79.9% antibiotic use, of which 12.6% Watch), malaria (31.9%, 23.1% Watch), gastroenteritis (76.0%, 31.7% Watch), rhinopharyngitis (40.4%, 8.3% Watch) and undifferentiated fever (77.0%, 44.8% Watch). Compliance with WHO AWaRe guidance could have averted at least 68.4% of all Watch antibiotic use in outpatients at health centres. Community-wide, 2.9 DDD (95% CI 1.9-3.9) were used per 1000 adult inhabitants per day. CONCLUSIONS: Most Watch antibiotic use at community level or primary care deviated from WHO guidance. Antibiotic stewardship should focus on key clinical presentations and include primary care and self-medication.
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BACKGROUND: This study explores the factors influencing patients and caregivers' adherence to prescription of healthcare workers (HCWs). METHODS: The study was conducted in Temnaore and Pella, in the Nanoro health district in Burkina Faso. HCWs and community members were purposively recruited from 4 communities seeking care at the selected primary healthcare facilities for the clinical trial to attend in-depth interviews and focus group discussions on the factors influencing adherence to prescription. The Behaviour Change Wheel incorporating the Capability, Opportunity, and Motivation Behaviour approach was used. RESULTS: Factors influencing the ability of patients to obtain the prescribed medicine include the availability of medicines and money and the perception of consequences for not getting the medicine. Regarding compliance with the intake of medicines, communication was considered a key factor whose effectiveness depends on the performance of HCWs and on the attention of patients. It is followed by other factors such as adequate management of patients, social influences, the patient's beliefs regarding treatment, and memory. CONCLUSIONS: This research highlights factors influencing adherence to HCWs' prescription from the perspective of the community members and HCWs and therefore provides contextual enablers and barriers, which allows for the development of an intervention to support the clinical trial.
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Personal de Salud , Cooperación del Paciente , Humanos , Burkina Faso , Grupos Focales , Atención Primaria de Salud , Investigación CualitativaRESUMEN
In this Viewpoint, the authors explore the determinants of patients' prescription adherence behaviors as part of FIND's Advancing Access to Diagnostic Innovation essential for Universal Health Coverage and AMR Prevention (ADIP) trials (ClinicalTrials.gov identifier: NCT04081051). Research findings from Burkina Faso, Ghana, and Uganda show that basic knowledge and understanding of prescription instructions are essential for adherence and can be improved through better communication. However, there are a range of other factors that influence adherence, some of which can be influenced through tailored communication messages from healthcare workers. These messages may contribute to changes in adherence behavior but may require other reinforcing interventions to be effective. Finally, there are some drivers of nonadherence centered around costs and time pressure that require other forms of intervention.
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Antibacterianos , Farmacorresistencia Bacteriana , Humanos , Antibacterianos/uso terapéutico , Comunicación , Prescripciones , Investigación CualitativaRESUMEN
BACKGROUND: Low- and middle-income countries face significant challenges in differentiating bacterial from viral causes of febrile illnesses, leading to inappropriate use of antibiotics. This trial aimed to evaluate the impact of an intervention package comprising diagnostic tests, a diagnostic algorithm, and a training-and-communication package on antibiotic prescriptions and clinical outcomes. METHODS: Patients aged 6 months to 18 years with fever or history of fever within the past 7 days with no focus, or a suspected respiratory tract infection, arriving at 2 health facilities were randomized to either the intervention package or standard practice. The primary outcomes were the proportions of patients who recovered at day 7 (D7) and patients prescribed antibiotics at day 0. RESULTS: Of 1718 patients randomized, 1681 (97.8%; intervention: 844; control: 837) completed follow-up: 99.5% recovered at D7 in the intervention arm versus 100% in standard practice (P = .135). Antibiotics were prescribed to 40.6% of patients in the intervention group versus 57.5% in the control arm (risk ratio: 29.3%; 95% CI: 21.8-36.0%; risk difference [RD]: -16.8%; 95% CI: -21.7% to -12.0%; P < .001), which translates to 1 additional antibiotic prescription saved every 6 (95% CI: 5-8) consultations. This reduction was significant regardless of test results for malaria, but was greater in patients without malaria (RD: -46.0%; -54.7% to -37.4%; P < .001), those with a respiratory diagnosis (RD: -38.2%; -43.8% to -32.6%; P < .001), and in children 6-59 months old (RD: -20.4%; -26.0% to -14.9%; P < .001). Except for the period July-September, the reduction was consistent across the other quarters (P < .001). CONCLUSIONS: The implementation of the package can reduce inappropriate antibiotic prescription without compromising clinical outcomes. CLINICAL TRIALS REGISTRATION: clinicaltrials.gov; NCT04081051.
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Antibacterianos , Malaria , Humanos , Niño , Adolescente , Lactante , Preescolar , Burkina Faso , Antibacterianos/uso terapéutico , Prescripciones , Malaria/tratamiento farmacológico , Instituciones de Salud , AlgoritmosRESUMEN
OBJECTIVE: To collect context-specific insights into maternal and child health and nutrition issues, and to explore potential solutions in Nanoro, Burkina Faso. DESIGN: Eleven focus groups with men and women from eleven communities, facilitated by local researchers. SETTING: The study took place in the Nanoro Health district, in the West-Central part of Burkina Faso. PARTICIPANTS: Eighty-six men (18-55 years) and women by age group: 18-25; 26-34 and 35-55 years, participated in the group discussions. RESULTS: Participants described barriers to optimal nutrition of mothers and children related to a range of community factors, with gender inequality as central. Major themes in the discussions are related to poverty and challenges generated by socially and culturally determined gender roles. Sub-themes are women lacking access to food whilst pregnant and having limited access to health care and opportunities to generate income. Although communities believe that food donations should be implemented to overcome this, they also pointed out the need for enhancing their own food production, requiring improved agricultural technologies. Given the important role that women could play in reducing malnutrition, these communities felt they needed to be empowered to do so and supported by men. They also felt that this had to be carried out in the context of an enhanced health care system. CONCLUSIONS: Findings reported here highlight the importance of nutrition-sensitive interventions and women's empowerment in improving maternal and child nutrition. There is a need to integrate a sustainable multi-sectorial approach which goes beyond food support.
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Fenómenos Fisiológicos Nutricionales Infantiles , Estado Nutricional , Burkina Faso , Niño , Empoderamiento , Femenino , Humanos , Masculino , Madres , EmbarazoRESUMEN
OBJECTIVE: To explore community perceptions on maternal and child nutrition issues in Sub-Saharan Africa. DESIGN: Thirty focus groups with men and women from three communities facilitated by local researchers. SETTING: One urban (Soweto, South Africa) and two rural settings (Navrongo, Ghana and Nanoro, Burkina Faso) at different stages of economic transition. PARTICIPANTS: Two hundred thirty-seven men and women aged 18-55 years, mostly subsistence farmers in Navrongo and Nanoro and low income in Soweto. RESULTS: Differences in community concerns about maternal and child health and nutrition reflected the transitional stage of the country. Community priorities revolved around poor nutrition and hunger caused by poverty, lack of economic opportunity and traditional gender roles. Men and women felt they had limited control over food and other resources. Women wanted men to take more responsibility for domestic chores, including food provision, while men wanted more involvement in their families but felt unable to provide for them. Solutions suggested focusing on ways of increasing control over economic production, family life and domestic food supplies. Rural communities sought agricultural support, while the urban community wanted regulation of the food environment. CONCLUSIONS: To be acceptable and effective, interventions to improve maternal and child nutrition need to take account of communities' perceptions of their needs and address wider determinants of nutritional status and differences in access to food reflecting the stage of the country's economic transition. Findings suggest that education and knowledge are necessary but not sufficient to support improvements in women's and children's nutritional status.
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Salud Infantil , Estado Nutricional , Niño , Familia , Femenino , Humanos , Masculino , Población Rural , SudáfricaRESUMEN
BACKGROUND: The global poverty profile shows that Africa and Asia bear the highest burden of multidimensional child poverty. Child survival and development therefore depend on socioeconomic and environmental factors that surround a child.The aim of this paper is to measure multidimensional child poverty and underpin what drives it among children aged 5 to 18 years in a resource poor region of Burkina Faso. METHODS: Using primary data collected from a cross sectional study of 722 households in the Mouhoun region of Burkina Faso, the Alkire-Foster methodology was applied to estimate and decompose child poverty among children aged 5-18 years. Seven broad dimensions guided by the child poverty literature, data availability and the country's SDGs were used. A binary logistic regression model was applied to identify drivers of multidimensional child poverty in the region. RESULTS: The highest prevalence of deprivations were recorded in water and sanitation (91%), information and leisure (89%) followed by education (83%). Interestingly, at k = 3 (the sum of weighted indicators that a child must be deprived to be considered multidimensionally poor), about 97% of children are deprived in at least three of the seven dimensions. At k = 4 to k = 6, between 88.7 and 30.9% of children were equally classified as suffering from multidimensional poverty. The odds of multidimensional poverty were reduced in children who belonged to households with a formally educated mother (OR = 0.49) or stable sources of income (OR = 0.31, OR = 0.33). The results equally revealed that being an adolescent (OR = 0.67), residing in the urban area of Boromo (OR = 0.13) and rural area of Safané (OR = 0.61) reduced the odds of child poverty. On the other hand, child poverty was highest among children from the rural area of Yé (OR = 2.74), polygamous households (OR = 1.47, OR = 5.57 and OR = 1.96), households with an adult head suffering from a longstanding illness (OR = 1.61), households with debts (OR = 1.01) and households with above five number of children/woman (OR = 1.49). CONCLUSION: Child poverty is best determined by using a multidimensional approach that involves an interplay of indicators and dimensions, bearing in mind its causation.
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Pobreza/estadística & datos numéricos , Adolescente , Burkina Faso , Niño , Preescolar , Estudios Transversales , Composición Familiar , Femenino , Humanos , Masculino , Factores de RiesgoRESUMEN
BACKGROUND: A multi-country, community-based trial on scheduled screening and treatment for malaria in pregnancy was conducted in Benin, The Gambia and Burkina Faso. Despite standardized procedures and outcomes, the study became subject to rumours and accusations of placenta being sold for mystical and financial gain by trial staff, leading to drop-out rates of 30% and the consequent halting of placental biopsy sampling in Benin. This paper explores the role of socio-cultural beliefs related to placenta and identified additional factors contributing these rumours. METHODS: A qualitative comparative emergent-theory design was used to assess social factors related to trial implementation and uptake in the three countries. Data from participant observation, informal conversations, group discussions and interviews were triangulated and analysed with NVivo Qualitative Analysis software. RESULTS: Despite similar sociocultural beliefs about the sacred nature of the placenta in all three study countries, these beliefs did not affect participation rates in Burkina Faso and The Gambia and placenta-related rumours only emerged in Benin. Therefore, the presence of beliefs is not a sufficient condition to have generated placenta-selling fears. The rumours in Benin reflected the confluence of placenta-related beliefs and factors related to the implementation of the trial (including a catalysing adverse event and miscommunication during the informed consent procedure). Furthermore, distinct socio-political factors contributed to the emergence of rumours, including the historical distrust in governmental organizations and the tense relationship between some of the actors involved in the trial. CONCLUSION: Transdisciplinary social science research designs should accompany the implementation of the trial. The integration of multiple stakeholders' knowledge and involvement is required to define and solve upcoming barriers.
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Biopsia/psicología , Miedo , Malaria/psicología , Placenta , Complicaciones Parasitarias del Embarazo/psicología , Benin , Biopsia/economía , Femenino , Humanos , Consentimiento Informado , Malaria/parasitología , Embarazo , Complicaciones Parasitarias del Embarazo/parasitologíaRESUMEN
BACKGROUND: Iron deficiency remains a prevalent adolescent health problem in low income countries. Iron supplementation is recommended but improvement of iron status requires good adherence. OBJECTIVES: We explored factors affecting adolescent adherence to weekly iron and/or folic acid supplements in a setting of low secondary school attendance. METHODS: Taped in-depth interviews were conducted with participants in a randomised, controlled, periconceptional iron supplementation trial for young nulliparous women living in a rural, malaria endemic region of Burkina Faso. Participants with good, medium or poor adherence were selected. Interviews were transcribed and analysed thematically. RESULTS: Thirty-nine interviews were conducted. The community initially thought supplements were contraceptives. The potential benefits of giving iron supplementation to unmarried "girls" ahead of pregnancy were not recognised. Trial participation, which required parental consent, remained high but was not openly admitted because iron supplements were thought to be contraceptives. Unmarried non-school attenders, being mobile, were often sent to provide domestic labour in varied locations. This interrupted adherence - as did movement of school girls during vacations and at marriage. Field workers tracked participants and trial provision of free treatment encouraged adherence. Most interviewees did not identify health benefits from taking supplements. CONCLUSIONS: For success, communities must be convinced of the value of an adolescent intervention. During this safety trial, benefits not routinely available in iron supplementation programmes were important to this low income community, ensuring adolescent participation. Nevertheless, adolescents were obliged to fulfil cultural duties and roles that interfered with regular adherence to the iron supplementation regime. TRIAL REGISTRATION: Trial Registration at clinicaltrials.gov : NCT01210040.
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Fenómenos Fisiológicos Nutricionales de los Adolescentes , Suplementos Dietéticos , Ácido Fólico/administración & dosificación , Hierro de la Dieta/administración & dosificación , Cooperación del Paciente , Atención Preconceptiva , Salud Rural , Adolescente , Fenómenos Fisiológicos Nutricionales de los Adolescentes/etnología , Anemia Ferropénica/epidemiología , Anemia Ferropénica/etnología , Anemia Ferropénica/prevención & control , Burkina Faso/epidemiología , Estudios de Cohortes , Asistencia Sanitaria Culturalmente Competente/etnología , Países en Desarrollo , Femenino , Grupos Focales , Ácido Fólico/uso terapéutico , Estudios de Seguimiento , Humanos , Hierro de la Dieta/uso terapéutico , Defectos del Tubo Neural/epidemiología , Defectos del Tubo Neural/etnología , Defectos del Tubo Neural/prevención & control , Cooperación del Paciente/etnología , Prevalencia , Sistemas de Apoyo Psicosocial , Investigación Cualitativa , Características de la Residencia , Salud Rural/etnologíaRESUMEN
Introduction: The first 1000 days of life are a critical period of growth and development that have lasting implications for health, cognitive, educational and economic outcomes. In sub-Saharan Africa, gender and social norms are such that many men have little engagement with maternal and child health and nutrition during pregnancy and early childhood. This study explores how men perceive their role in three sites in sub-Saharan Africa. Methods: Secondary qualitative analysis of 10 focus group discussions with 76 men in Burkina Faso, Ghana and South Africa. Data were thematically analysed to explore men's perceptions of maternal and child health and nutrition. Results: Men considered themselves 'providers' and 'advisors' within their families, particularly of finances, food and medicines. They also indicated that this advice was out of care and concern for their families' health. There were similarities in how the men perceive their role. Differences between men living in rural and urban settings included health priorities, the advice and the manner in which it was provided. Across all settings, men wanted to be more involved with maternal and child health and nutrition. Challenges to doing so included stigma and proscribed social gender roles. Conclusion: Men want a greater engagement in improving maternal and child health and nutrition but felt that their ability to do so was limited by culture-specified gender roles, which are more focused on providing for and advising their families. Involving both men and women in intervention development alongside policymakers, health professionals and researchers is needed to improve maternal and child health and nutrition.
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BACKGROUND: "Choosing All Together" (CHAT), is a community engagement tool designed to give the public a voice in how best to allocate limited resources to improve population health. This process evaluation explored the mechanisms through which CHAT generates community engagement. METHOD: The CHAT tool was adapted and implemented for use in two rural communities (Nanoro, Burkina Faso, and Navrongo, Ghana) and one urban township (Soweto, South Africa) to prioritize maternal and child nutrition interventions. Community discussions were audio-recorded, transcribed, and translated into English. Twenty-two transcripts, including six each from Navrongo and Soweto and 10 from Nanoro, were analysed thematically to generate data driven codes and themes to explain mechanisms underlying the CHAT process. The process evaluation was based on the UK MRC process evaluation guidance. RESULTS: Seven themes describing the functions and outcomes of CHAT were identified. Themes described participants deliberating trade-offs, working together, agreeing on priorities, having a shared vision, and increasing their knowledge, also the skills of the facilitator, and a process of power sharing between participants and researchers. Participants came to an agreement of priorities when they had a shared vision. Trained facilitators are important to facilitate meaningful discussion between participants and those with lower levels of literacy to participate fully. CONCLUSION: CHAT has been shown to be adaptable and useful in prioritising maternal and child nutrition interventions in communities in Burkina Faso, Ghana, and South Africa. Conducting CHAT in communities over a longer period and involving policy-makers would increase trust, mutual respect and develop partnerships.
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Población Rural , Niño , Humanos , Burkina Faso , Ghana , SudáfricaRESUMEN
Antimicrobial resistance (AMR) is a global concern that is geographically unevenly distributed, with low- and middle-income countries and African countries suffering in particular. The World Health Organization (WHO) Global Action Plan (GAP) for antimicrobial resistance identified five key objectives that aim to ensure the continued treatment and prevention of infectious diseases with the use of antibiotics. Countries signatory to the WHO GAP are expected to develop their own national action plans (NAPs) based on the global model. How low-income countries are able to achieve the GAP objectives is not well understood. This paper analyzes the progress of two West African countries in achieving the GAP targets, Benin and Burkina Faso, countries among the lowest bracket in the World Development Index. We present qualitative data from interviews and focus group discussions with local policy-makers, nurses, doctors, animal breeders, veterinarians, and laboratory researchers, supported by participant observations and surveys within rural communities. The analysis is organized according to the five WHO GAP objectives to show the countries' challenges in fulfilling them. The analysis shows that there are shortcomings in all of the WHO GAP areas in the two countries, making it a compounded and multifactorial problem-a stacking of lacks. In such contexts, calibrating a society toward AMR resilience/prevention requires overall development and attention to interdependencies. Active local research and policy communities with international, sustained financial support are essential for achieving the targets. IMPORTANCE The burden of antimicrobial resistance (AMR) is unequally distributed across the globe. Low-income countries face a more severe AMR situation and have fewer means to solve the problem. This paper brings out the voices of local experts, policy-makers, and members of the community in Benin and Burkina Faso across human health, animal health, and food production sectors, where the majority of antibiotic use is concentrated. We describe the difficulties that they face in implementing global action plans, targets set by the World Health Organization, for securing antibiotics and preventing the spread of antimicrobial resistance. This paper argues that the various deficits in implementation are stacked, multisectoral, and compounded. We highlight the role of active local scientists and policy-maker networks in setting priorities to address the AMR problem; however, their activities need technical and financial support from international partners.
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Antibacterianos , Farmacorresistencia Bacteriana , Animales , Humanos , Antibacterianos/farmacología , Burkina Faso/epidemiología , Benin , Política de SaludRESUMEN
The assessment in real-life conditions of the safety and efficacy of new antimalarial drugs is of greatest interest. This study aimed to monitor and evaluate both clinical and biological safety of pyronaridine-artesunate (PA) in real-life conditions in Burkina Faso's health system. This was a single-arm, open-label study, where patients attending Nanoro health facilities with uncomplicated malaria were consented to be part of a cohort event monitoring (CEM). At inclusion (day-0), PA was administered orally once a day for 3 days. Patients spontaneous reported any clinical adverse events (AEs) occurring within 28 days following the treatment. Additionally, the study focused on AEs of special interest (AESI), namely clinical signs related to hepatotoxicity and increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST). A nested subset of patients with blood sample collection at day-0 and day-7 were monitored to investigate the effect of PA on biochemistry parameters. From September 2017 to October 2018, 2786 patients were treated with PA. About 97.8% (2720/2786) of patients did not report any AE. The most commonly reported events were respiratory, thoracic, and mediastinal disorders (8.3 per 1000), infections and infestations (7.9 per 1000), and gastrointestinal disorders (7.2 per 1000). No clinical or biological hepatotoxicity event related to PA was reported during the follow-up. Changes in biochemistry parameters remained within laboratory reference ranges. The study showed that PA is a well-tolerated drug and should be considered as a good option by malaria control programs in countries where existing first-line antimalarial drugs are continuously threatened by the emergence of drug resistance.
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Antimaláricos , Artemisininas , Enfermedad Hepática Inducida por Sustancias y Drogas , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Malaria , Antimaláricos/efectos adversos , Artemisininas/efectos adversos , Artesunato , Burkina Faso/epidemiología , Enfermedad Hepática Inducida por Sustancias y Drogas/epidemiología , Enfermedad Hepática Inducida por Sustancias y Drogas/etiología , Combinación de Medicamentos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/tratamiento farmacológico , Humanos , Malaria/inducido químicamente , Malaria/tratamiento farmacológico , Naftiridinas , Salud RuralRESUMEN
BACKGROUND: Malaria infection during pregnancy (MIP) is not only deleterious to the woman, but it also puts her fetus at increased risk of adverse outcomes, such as preterm delivery, low birth weight, and intrauterine growth retardation. Additionally, all-cause mortality during the first year of life in babies born to women with malaria during pregnancy is also increased. Many interventions such as IPTp-SP and long-lasting insecticidal nets have proven to be efficient at reducing malaria in pregnancy burden but adherence to recommended policies remains poor. In sub-Saharan Africa, malaria in pregnancy is often asymptomatic and many malaria infections may be missed due to the inadequate performance of the current rapid diagnostic test to detect low-level parasitemias. Therefore, additional strategies such as intermittent screening with ultrasensitive rapid diagnostic tests and treatment with an effective artemisinin-based combination therapy in addition to IPTp-SP could reduce placental malaria, peripheral malaria infection at delivery, and low birth weight. METHODS: This pilot 2-group randomized open trial with a nested qualitative social behavioral will be carried out in Nanoro district in which 340 pregnant women will be recruited. Pregnant women will be randomized into two groups and followed on a monthly basis until delivery. In the intervention group, monthly screening using ultrasensitive rapid diagnostic tests and treatment of those found to be infected with dihydroartemisinin-piperaquine will be performed. In addition, a reminder will be sent to increase the uptake of IPTp-SP doses per woman. During scheduled and unscheduled visits, malaria infection, hemoglobin level, and other clinical outcomes will be assessed and compared by the group. The primary feasibility outcome will evaluate the study site's capacity to enroll participants and the women's perception and acceptability of the intervention. The primary clinical outcome will be the prevalence of placental malaria at delivery. DISCUSSION: The present protocol aims to evaluate the feasibility on a large-scale and also to demonstrate the impact and the operational feasibility of additional screening with ultrasensitive rapid diagnostic tests and treatment with DHA-PQ on placental malaria, low birth weight, and peripheral malaria infection at delivery in a high-burden setting in Burkina Faso. TRIAL REGISTRATION: ClinicalTrials.gov , ID: NCT04147546 (14 October 2019).
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BACKGROUND: In Sub-Saharan Africa (SSA), febrile illnesses remain a major public health problem in children. However, the persistence of hrp2 antigen and the low sensitivity of pLDH RDT negatively affect antimalarials and antibiotics prescription practices. These limitations lead to poor management of febrile diseases and antimicrobial resistance (AMR). To improve the diagnosis of these febrile diseases and subsequent prescription of antimicrobials, it is hypothesized that the implementation of an algorithm including a two-step malaria RDT PfHRP2/pLDH supported by point-of-care (PoC) tests for bacterial infections could significantly improve the management of febrile diseases and thereby tackling AMR. METHODS: To assess the value of the proposed algorithm, an open-label randomized controlled trial with three arms, enrolling febrile children from 6 to 59 months is proposed. In the control arm, febrile children will be managed according to the Integrated Management of Childhood Illnesses (IMCI), which is part of the standard of care in Burkina Faso. Treatment will be done according to national guidelines. In the RDT decisional algorithm (RDT-DA) arm (intervention), the clinical examination based on IMIC will be supported by a two-step malaria RDT and bacterial infections RDTs. Prescription will be left to the discretion of the healthcare workers based on clinical examination and PoC test results. In the e-algorithm arm (intervention), artificial intelligence integrating multiple layers of clinical information such as clinical examination, signs/symptoms and medical history, and biological information such as biomarkers (CRP and WBC) and pathogen-specific PoC tests, and oximetry will be developed. The e-algorithm will serve to guide the diagnostic and management of febrile infections in children. In the 3 arms, the case report forms will be digitalized. A final follow-up visit (day 7) will be scheduled for all participants. Patients will be asked to come back to the health facilities before the scheduled visit if the symptoms persist or in case of health condition worsening. DISCUSSION: If successful, this study could contribute to improve the management of febrile diseases and reduce inappropriate use of antimicrobials. TRIAL REGISTRATION: The trial is registered at ClinicalTrial.gov, NCT05285657. Enrolment started on 4 March 2022 with long-term outcome being assessed completely by 2023.
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Antimaláricos , Malaria Falciparum , Malaria , Algoritmos , Antibacterianos/uso terapéutico , Antimaláricos/uso terapéutico , Inteligencia Artificial , Burkina Faso , Preescolar , Electrónica , Fiebre/diagnóstico , Fiebre/tratamiento farmacológico , Humanos , Lactante , Malaria/diagnóstico , Malaria/tratamiento farmacológico , Malaria Falciparum/diagnóstico , Pacientes AmbulatoriosRESUMEN
BACKGROUND: The management of acute febrile illnesses places a heavy burden on clinical services in many low- and middle-income countries (LMICs). Bacterial and viral aetiologies of acute fevers are often clinically indistinguishable and, in the absence of diagnostic tests, the 'just-in-case' use of antibiotics by many health workers has become common practice, which has an impact on drug-resistant infections. Our study aims to answer the following question: in patients with undifferentiated febrile illness presenting to outpatient clinics/peripheral health centres in LMICs, can we demonstrate an improvement in clinical outcomes and reduce unnecessary antibiotic prescription over current practice by using a combination of simple, accurate diagnostic tests, clinical algorithms, and training and communication (intervention package)? METHODS: We designed a randomized, controlled clinical trial to evaluate the impact of our intervention package on clinical outcomes and antibiotic prescription rates in acute febrile illnesses. Available, point-of-care, pathogen-specific and non-pathogen specific (host markers), rapid diagnostic tests (RDTs) included in the intervention package were selected based on pre-defined criteria. Nine clinical study sites in six countries (Burkina Faso, Ghana, India, Myanmar, Nepal and Uganda), which represent heterogeneous outpatient care settings, were selected. We considered the expected seasonal variations in the incidence of acute febrile illnesses across all the sites by ensuring a recruitment period of 12 months. A master protocol was developed and adapted for country-specific ethical submissions. Diagnostic algorithms and choice of RDTs acknowledged current data on aetiologies of acute febrile illnesses in each country. We included a qualitative evaluation of drivers and/or deterrents of uptake of new diagnostics and antibiotic use for acute febrile illnesses. Sample size estimations were based on historical site data of antibiotic prescription practices for malarial and non-malarial acute fevers. Overall, 9 semi-independent studies will enrol a minimum of 21,876 patients and an aggregate data meta-analysis will be conducted on completion. DISCUSSION: This study is expected to generate vital evidence needed to inform policy decisions on the role of rapid diagnostic tests in the clinical management of acute febrile illnesses, with a view to controlling the rise of antimicrobial resistance in LMICs. TRIAL REGISTRATION: Clinicaltrials.gov NCT04081051 . Registered on 6 September 2019. Protocol version 1.4 dated 20 December 2019.
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Manejo de Caso , Atención a la Salud/métodos , Países en Desarrollo , Fiebre/terapia , Algoritmos , Burkina Faso , Comunicación , Fiebre/diagnóstico , Ghana , Humanos , India , Metaanálisis como Asunto , Mianmar , Nepal , Pacientes Ambulatorios , Ensayos Clínicos Controlados Aleatorios como Asunto , UgandaRESUMEN
PURPOSE: In 2005, Burkina Faso changed its first-line treatment for uncomplicated malaria from chloroquine to artemisinin-based combination therapies (ACTs). Patient adherence to ACTs regimen is a keystone to achieve the expected therapeutic outcome and prevent the emergence and spread of parasite resistance. Eleven years after the introduction of ACTs in the health system, this study aimed to measure adherence level of patients in rural settlement and investigate the determinants of nonadherence. PATIENTS AND METHODS: The study was carried out at public peripheral health facilities from May 2017 to August 2017 in Nanoro health district, Burkina Faso. An electronic semi-structured questionnaire was used for data collection from patients with an ACT prescription at their medical consultation exit visit and during home visit at day 5±2. Adherence level was measured through self-report and pill counts. Logistic regression was performed to identify factors for nonadherence. RESULTS: The analysis was conducted on 199 outpatients who received ACT as prescription. About 92.5% of ACT prescriptions included artemether-lumefantrine tablets. Adherence level was measured in 97.0% of included patients at day 5±2. Of these, 86.0% were classified as "complete adherent" and 14.0% as "nonadherent". In univariate analysis, patients/caregivers who considered that affordability of ACTs was easy seemed to be less adherent to the treatment regimen (OR: 0.26; 95% CI: 0.07-0.70). In univariate and multivariable analyses, patients/caregivers who did not receive advices from health care workers (HCWs) were more likely to be nonadherent to the prescribed ACTs (adjusted OR: 3.21; 95% CI: 1.13-9.12). CONCLUSION: This study demonstrates that majority of those who get an ACT prescription comply with the recommended regimen. This emphasizes that in rural settings where ACTs are provided free of charge or at a subsidized price, patient adherence to ACTs is high, thus minimizing the risk of subtherapeutic concentrations of the drug in blood which is known to increase resistance and susceptibility to new infections. Therefore, to address the problem of patient nonadherence, strategy to strengthen communication between HCWs and patients should be given greater consideration.