A framework for stakeholder engagement in the adoption of new anti-malarial treatments in Africa: a case study of Nigeria.

BACKGROUND: Recent reports of artemisinin partial resistance from Rwanda and Uganda are worrisome and suggest a future policy change to adopt new anti-malarials. This is a case study on the evolution, adoption, and implementation of new anti-malarial treatment policies in Nigeria. The main objective is to provide perspectives to enhance the future uptake of new anti-malarials, with an emphasis on stakeholder engagement strategies. METHODS: This case study is based on an analysis of policy documents and stakeholders' perspectives drawn from an empirical study conducted in Nigeria, 2019-2020. A mixed methods approach was adopted, including historical accounts, review of programme and policy documents, and 33 qualitative in-depth interviews and 6 focus group discussions. RESULTS: Based on policy documents reviewed, the adoption of artemisinin-based combination therapy (ACT) in Nigeria was swift due to political will, funding and support from global developmental partners. However, the implementation of ACT was met with resistance from suppliers, distributors, prescribers, and end-users, attributed to market dynamics, costs and inadequate stakeholder engagement. Deployment of ACT in Nigeria witnessed increased developmental partner support, robust data generation, ACT case-management strengthening and evidence on anti-malarial use in severe malaria and antenatal care management. A framework for effective stakeholder engagement for the future adoption of new anti-malarial treatment strategies was proposed. The framework covers the pathway from generating evidence on drug efficacy, safety and uptake; to making treatment accessible and affordable to end-users. It addresses which stakeholders to engage with and the content of engagement strategies with key stakeholders at different levels of the transition process. CONCLUSION: Early and staged engagement of stakeholders from global bodies to community level end-users is critical to the successful adoption and uptake of new anti-malarial treatment policies. A framework for these engagements was proposed as a contribution to enhancing the uptake of future anti-malarial strategies.

Outcomes of childhood severe malaria: a comparative of study pre-COVID-19 and COVID-19 periods.

BACKGROUND: The collateral damages from measures adopted to mitigate the coronavirus disease 2019 (COVID-19) pandemic have been projected to negatively impact malaria in sub-Saharan Africa. Herein, we compare the prevalence and outcomes of childhood severe malaria during the pre-COVID-19 and COVID-19 periods at a tertiary health facility in Nigeria. METHODS: This was a retrospective review of cases of severe malaria admitted from 1st January to 31st December 2019 (pre-COVID-19 period) and 1st January to 31st December 2020 (COVID-19 period). We extracted relevant information, including demographics, the duration of symptoms before presentation, forms of severe malaria, and outcomes of hospitalization (discharged or death). RESULTS: In the pre-COVID-19 period, there were a total of 2312 admissions to the EPU and 1685 in the COVID-19 period, representing a decline of 27%. In contrast, there were 263 and 292 severe malaria admissions in the pre-COVID-19 and COVID-19 periods, respectively, representing an 11% increase in the absolute number of cases. The prevalence rates were 11.4% in the pre-COVID-19 period and 17.3% in the COVID-19 period, representing an increase of 52% in the percentage differences. The mortality rate in the COVID-19 period was higher than the pre-COVID-19 period ([10.3%; 30/292 vs. 2.3%; 6/263], p 0.001). The death rate increased by 350% during the COVID-19 period. The odds ratio (OR) of a child dying from severe malaria in the COVID-19 era was 4.9 [95% confidence interval (CI): 2.008 to 11.982]. In the COVID-19 era, presentation at a health facility was also delayed (p = 0.029), as were the odds of multiple features of severe malaria manifestations (OR-1.9, 95% CI, 1.107 to 3.269; p = 0.020). CONCLUSION: This study shows that the prevalence of severe childhood malaria increased by as much as 11.0%, with a disproportionate increase in mortality compared to the pre-pandemic level. Most children with severe malaria presented late with multiple features of severe malaria, probably contributing to the poor hospitalization outcomes (death) observed in this study.

Ethical considerations in deploying triple artemisinin-based combination therapies for malaria: An analysis of stakeholders' perspectives in Burkina Faso and Nigeria.

BACKGROUND: Artemisinin-based combination therapies (ACTs) are the recommended treatment for uncomplicated Plasmodium falciparum malaria in all malaria endemic countries. Artemisinin resistance, partner drug resistance, and subsequent ACT failure are widespread in Southeast Asia. The more recent independent emergence of artemisinin resistance in Africa is alarming. In response, triple artemisinin-based combination therapies (TACTs) are being developed to mitigate the risks associated with increasing drug resistance. Since ACTs are still effective in Africa, where malaria is mainly a paediatric disease, the potential deployment of TACTs raises important ethical questions. This paper presents an analysis of stakeholders' perspectives regarding key ethical considerations to be considered in the deployment of TACTs in Africa provided they are found to be safe, well-tolerated and effective for the treatment of uncomplicated malaria. METHODS: We conducted a qualitative study in Burkina Faso and Nigeria assessing stakeholders' (policy makers, suppliers and end-users) perspectives on ethical issues regarding the potential future deployment of TACTs through 68 in-depth interviews and 11 focus group discussions. FINDINGS: Some respondents suggested that there should be evidence of local artemisinin resistance before they consider deploying TACTs, while others suggested that TACTs should be deployed to protect the efficacy of current ACTs. Respondents suggested that additional side effects of TACTs compared to ACTs should be minimal and the cost of TACTs to end-users should not be higher than the cost of current ACTs. There was some disagreement among respondents regarding whether patients should have a choice of treatment options between ACTs and TACTs or only have TACTs available, while ACTs are still effective. The study also suggests that community, public and stakeholder engagement activities are essential to support the introduction and effective uptake of TACTs. CONCLUSION: Addressing ethical issues regarding TACTs and engaging early with stakeholders will be important for their potential deployment in Africa.

Appraising Neonatal Morbidity and Mortality in a Developing Country Categorized by Gestational Age Grouping and Implications for Targeted Interventions.

Introduction: Despite the relatively higher neonatal morbidity and mortality in developing countries, there are limited data on the detailed analysis of the burden in Nigeria. With a database of over 14,000 admissions, this study presents a compelling picture of the current trends disaggregated by their gestational age groups. It provides unique opportunities for better-targeted interventions for further reducing newborn mortality in line with SDG 3, Target 3.2. Methods: This prospective observational study involved newborn babies admitted to the Neonatal Intensive Care Unit of the University of Ilorin Teaching Hospital, Kwara State, Nigeria, between January 2007 and December 2018. The outcome was the neonatal mortality rates. The exposure variables included birth weight, gestational age (preterm versus term), and clinical diagnosis. Frequencies were generated on tables and charts, and the trends or associations were determined. Results: Of the 14,760 neonates admitted, 9,030 (61.2%) were term babies, 4,847 (32.8%) were preterm babies, and in 792 (5%) of the admissions, the gestational ages could not be determined. Males constituted a higher proportion with 55.9%, and the total number of deaths in the study period was 14.7%. The mortality ratio was highest among babies with a birth weight of less than 1,000 g (38.0%) and gestational age of less than 28 weeks (65.5%). The trend analysis showed that the mortality rate decreased from 17.8 to 13% over the 12 years, p-value < 0.0001. For term babies, mortality decreased by 45%, from 15.7% in 2007 to 8.7% in 2018, while the decline in mortality for preterm babies was 28.4%, from 25.7% in 2007 to 18.4% in 2018. For both categories, p-values were < 0.001. Regarding morbidity in term babies, asphyxia occurred in (1:3), jaundice (1:5), sepsis (1:6), and respiratory disorders (1:6) of admissions. For mortality, asphyxia occurred in (1:2), sepsis (1:5), jaundice (1:8), and respiratory disorders (1:10) of deaths. The leading causes of morbidity among preterm babies were asphyxia (1:4), sepsis (1:5), respiratory disorders (1:9), and jaundice (1.10). For mortality, their contributions were asphyxia (≈1:2); sepsis (1:5); respiratory disorders (1:9), and jaundice (1:10). Conclusion: There was a marked improvement in neonatal mortality trends. However, severe perinatal asphyxia, sepsis, hyperbilirubinemia, and respiratory disorders were the leading conditions contributing to 75% of the morbidities and mortalities. Measures to further accelerate the reduction in neonatal morbidity and mortality are discussed.

Ethical, Regulatory and Market related aspects of Deploying Triple Artemisinin-Based Combination Therapies for Malaria treatment in Africa: A study protocol.

Introduction: According to the World Malaria Report 2019, Africa accounts for 94% of the global malaria deaths. While malaria prevalence and mortality have declined over the years, recent reports suggest that these gains may stand the risk of being reversed if resistance to Artemisinin Combination Therapies (ACTs) spreads from Southeast Asia to Africa. Efforts are being made to develop new treatments that will address the looming threat of ACT resistance, including the development of triple artemisinin combination therapies (TACTs). The proposed study seeks to explore the views of stakeholders on the key ethical, regulatory and market-related issues that should be considered in the potential introduction of triple artemisinin combination therapies (TACTs) in Africa. Methods: The study employed qualitative research methods involving in-depth interviews and focus group discussions (FGDs) with stakeholders, who will be directly affected by the potential deployment of triple artemisinin combination treatments, as regulators, suppliers and end-users. Participants will be purposively selected and will include national regulatory authorities, national malaria control programs, clinicians, distributors and retailers as well as community members in selected districts in Burkina Faso and Nigeria. Discussion: The proposed study is unique in being one of the first studies that seeks to understand the ethical, social, regulatory and market position issues prior to the development of a prospective antimalarial medicine.

Epidemiology of COVID-19 and Predictors of Outcome in Nigeria: A Single-Center Study.

There is a paucity of information regarding the epidemiology and outcome of COVID-19 from low/middle-income countries, including from Nigeria. This single-center study described the clinical features, laboratory findings, and predictors of in-hospital mortality of COVID-19 patients. Patients admitted between April 10, 2020 and June 10, 2020 were included. Forty-five patients with a mean age of 43 (16) years, predominantly male (87%), presented with fever (38%), cough (29%), or dyspnea (24%). In-hospital mortality was 16%. The independent predictors of mortality were hypoxemia (adjusted odds ratio [aOR]: 2.5; 95% CI: 1.3-5.1) and creatinine > 1.5 mg/dL (aOR: 4.3; 95% CI: 1.9-9.8).

Population genomics diversity of Plasmodium falciparum in malaria patients attending Okelele Health Centre, Okelele, Ilorin, Kwara State, Nigeria.

BACKGROUND: Plasmodium falciparum, the most dangerous malaria parasite species to humans remains an important public health concern in Okelele, a rural community in Ilorin, Kwara State, Nigeria. There is however little information about the genetic diversity of Plasmodium falciparum in Nigeria. OBJECTIVE: To determine the population genomic diversity of Plasmodium falciparum in malaria patients attending Okelele Community Healthcare Centre, Okelele, Ilorin, Kwara State. METHODS: In this study, 50 Plasmodium falciparum strains Merozoite Surface Protein 1, Merozoite Surface Protein 2 and Glutamate Rich Protein were analysed from Okelele Health Centre, Okelele, Ilorin, Nigeria. Genetic diversity of P. falciparum isolates were analysed from nested polymerase chain reactions (PCR) of the MSP-1 (K1, MAD 20 and RO33), MSP-2 (FC27 and 3D7) and Glutamate Rich Protein allelic families respectively. RESULTS: Polyclonal infections were more in majority of the patients for MSP-1 allelic families while monoclonal infections were more for MSP-2 allelic families. Multiplicity of infection for MSP-1, MSP-2 and GLURP were 1.7, 1.8 and 2.05 respectively. CONCLUSION: There is high genetic diversity in MSP - 2 and GLURP allelic families of Plasmodium falciparum isolates from Okelele Health Centre, Ilorin, Nigeria.

Perinatal Mortality in a Northwestern Nigerian City: A Wake up Call.

BACKGROUND: In Nigeria, of the over 900,000 children under the age of 5 years that die every year, perinatal mortality is responsible for a little over 20%. Previous reports are largely from the southern part of the country. This is the first report of perinatal data from the northwest of Nigeria. METHODS: A case control study of perinatal deaths in the three major public hospitals in Katsina metropolis was carried out to determine the pattern of perinatal deaths in the metropolis. Data were collected over a 6 week period on maternal socio-demographic, antenatal, and delivery variables. Data were similarly obtained on neonatal profile and morbidities. RESULTS: There were 143 perinatal deaths (94 stillbirths and 49 early neonatal deaths) out of 1104 live and stillbirths during the study period. The perinatal mortality rate was thus 130 per 1000 births with a stillbirth rate of 85 per 1000 births and an early neonatal mortality rate of 49 per 1000 live births. Stillbirths during the intrapartum period were twice as frequent as macerated stillbirths (2:1). Maternal factors significantly associated with perinatal deaths included chorioamnionitis, ruptured uterus, multiple gestation, medically induced delivery, prolonged labor, unbooked pregnancies, antepartum hemorrhage, and prolonged rupture of membranes. Antepartum hemorrhage was the strongest determinant of perinatal death. Significant neonatal determinants were multiple gestation, severe birth asphyxia, apnea, and necrotizing enterocolitis. Apnea was the strongest neonatal determinant. The majority (83.2%) of perinatal deaths were due to severe perinatal asphyxia (SPA) (54.5%), normally formed macerated stillbirths (20.3%), and immaturity (8.4%). CONCLUSION: In conclusion, Perinatal Mortality in Katsina metropolis in northwest Nigeria is unacceptably high as we approach the timeline for the millennium development goals. Antepartum hemorrhage and SPA are major determinants.

Comparative analysis of glucose-6-phosphate dehydrogenase levels in pre-term and term babies delivered at University of Ilorin Teaching Hospital.

Glucose-6-phosphate (G6P) is an enzyme in the hexose monophosphate shunt required for the production of reducing equivalents needed to mop up free radicals. thereby keeping hemoglobin in its free state. Deficiency of the enzyme can cause severe neonatal jaundice. The aim of this study was to compare G6PD levels in pre-term and term babies, and evaluate the extent to which G6PD deficiency determines the severity of jaundice in various gestational age groups. Samples of cord blood collected from consecutively delivered babies in the University of Ilorin Teaching Hospital, Nigeria, were assayed for G6PD levels, and the babies were observed for jaundice during the first week of life. Those who developed jaundice had serial serum bilirubin measured. Nine hundred and thirty-three babies had G6PD assayed, with 348 being G6PD deficient, giving a hospital based prevalence of 37.3%. Of the 644 who were followed up, 143 (22.2%) were pre-term and 501(77.8%) were term babies. Babies with gestational age (GA) 27-29 weeks had the highest G6PD levels. However, there was no significant variation among the different gestational age groups (F=0.64, P=0.64). Jaundice occurred more in pre-term compared to term babies with a relative risk of 2.41 (χ(2)=60.95, P=0.00001). Occurrence of jaundice in pre-term babies was irrespective of G6PD status (χ(2)=0.2, P=0.66, RR=1.09, CI=0.83

Familial ectrodactyly syndrome in a nigerian child: a case report.

Ectrodactyly, also known as Split-Hand/Split-Foot Malformation (SHFM) is a rare genetic condition characterized by defects of the central elements of the autopod. It has a prevalence of 1:10,000-1:90,000 worldwide. The X-linked and autosomal dominant types have been described. It can occur as an isolated malformation or in combination with other anomalies, such as tibial aplasia, craniofacial defects, and genitourinary abnormalities. Ectrodactyly-ectodermal dysplasia-clefting syndrome (EEC) is an example of ectrodactyly syndrome accompanied by multiple organ defects. Ectrodactyly has been reported in Africa, especially in several families in remote areas of central Africa but there has not been any published work on ectrodactyly in Nigeria. A baby was born in Ilorin, North Central Zone of Nigeria, with an uneventful prenatal and delivery history but was noticed to have malformation of the two hands and the two lower limbs at birth which are replica of the father's malformation. We present this case to highlight familial ectrodactyly in Nigeria and prepare us to improve upon simple prenatal diagnosis and management of the challenges associated with patients with congenital malformation in Nigeria and other developing countries.

The impact of recycled neonatal incubators in Nigeria: a 6-year follow-up study.

Nigeria has a record of high newborn mortality as an estimated 778 babies die daily, accounting for a ratio of 48 deaths per 1000 live births. The aim of this paper was to show how a deteriorating neonatal delivery system in Nigeria may have, in part, been improved by the application of a novel recycled incubator technique (RIT). Retrospective assessment of clinical, technical, and human factors in 15 Nigerian neonatal centres was carried out to investigate how the application of RIT impacted these factors. Pre-RIT and post-RIT neonatal mortalities were compared by studying case files. Effect on neonatal nursing was studied through questionnaires that were completed by 79 nurses from 9 centres across the country. Technical performance was assessed based on 10-indices scores from clinicians and nurses. The results showed an increase in neonatal survival, nursing enthusiasm, and practice confidence. Appropriately recycled incubators are good substitutes to the less affordable modern incubators in boosting neonatal practice outcome in low-income countries.