There are about 225 clinical studies being (or have been) conducted in Nigeria. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The purpose of this study was to evaluate an intervention to engage fathers in supporting the dietary diversity and other complementary feeding practices of their young children.
The purpose of this study was to evaluate the effect of a breastfeeding promotion intervention on breastfeeding intentions, early initiation of breastfeeding, and exclusive breastfeeding among clients in private health facilities in Lagos, Nigeria.
Despite the overwhelming impact of vaccines on child health and the tremendous progress in vaccine coverage globally, challenges of vaccine inequities persist. Missed opportunities for vaccination (MOV) is defined as any contact with health services by an individual who is eligible for vaccination which does not result in the recommended vaccines being given. This is common in several countries, and it presents a window of opportunity to provide vaccine services to those vulnerable children accessing healthcare facilities. The overall purpose of this project is to reduce missed opportunities for vaccinations by targeting hospitalized children who are vulnerable to poor health outcomes, but who are also within easy access of the healthcare system. The research team proposes implementing the Missed Opportunities for Vaccination Equity (MOVE), an intervention to improve timeliness and coverage of vaccination, and increase demand for vaccination services, through a combination of sensitization of children's caregivers and health workers, manual vaccination data capture in the ward, and re-purposed vaccination resources. The strategy engages key stakeholders in the design of the intervention through a co-creation workshop; their involvement in the design and execution of the intervention will improve sustainability in the long-term. This intervention builds on existing healthcare systems, and, when scaled up, can target inequities in vaccination coverage in the general population, without placing additional strain on the healthcare system in terms of workforce or financial resources.
Sickle cell disease (SCD) is the most common genetic disease, affecting about 25 million people worldwide. Approximately 150,000 Nigerian children are born each year with sickle cell disease (SCD), making it the country with the largest burden of SCD in the world. Recent advancements in care for children with SCA have translated into improved survival of children in both high and low-resource settings. However, more complications of SCD are seen in those who survive to adulthood. Silent cerebral infarcts (SCI) and strokes are among the most devastating complications of SCD, affecting 40% and 10% of children, respectively. The overall goal of this study is to extend the Investigator's successful capacity-building effort in the assessment of neurological morbidity in children with SCD living in northern Nigeria (Kano) to young adults with SCD living in the same region. About 50% of all adults with SCD live in Nigeria. Despite the high prevalence of SCD in Africa, the neurological morbidity is not well characterized, limiting opportunities for primary and secondary stroke prevention strategies. At least 50% of young adults with sickle cell anemia (SCA), the most severe form of the disease, will have SCIs and an estimated 10% will have strokes, based on studies in high-resource settings. In high-resource settings, screening for abnormal transcranial Doppler (TCD) velocities in children with SCA, coupled with regular blood transfusion has resulted in a 92% reduction of relative risk for strokes. Despite this effective strategy, regular blood transfusion therapy does not seem sustainable in sub-Saharan Africa due to shortages and the risk of transfusion transmissible infections. Additionally, there is a lack of evidence-based stroke prevention strategies in young adults with SCA, either in the high-income or in low-resource settings. Based on the foregoing, the Investigators propose to determine the prevalence of neurological injury (overt stroke, transient ischemic attacks, and silent cerebral infarcts) in young adults at the transition age from 16-25 years. The Investigators will also, for the first time, assess conventional risk factors of stroke in the general population to determine whether a different prevention strategy is required to reduce the incidence of neurological injury in this high-risk population.
Sickle Cell Anemia (SCA) occurs in 300,000 newborns per year in the world, with 150,000 affected births in Nigeria, alone. With improvement in survival for children with SCA in both high- and low-resource countries, neurological morbidity is an emerging significant public health challenge, particularly in countries with a high rate of sickle cell disease (SCD). Both silent cerebral infarcts (SCI) and overt strokes result in significant neurological morbidity and premature death. Five NIH-funded randomized controlled trials (RCT) demonstrated that regular blood transfusion or hydroxyurea therapy are efficacious treatments for primary and secondary stroke prevention in children with SCA. Despite the observation that at least 99% of children with SCA in high-resource settings reach adulthood, and approximately 60% of adults will experience one or more strokes (~50% with SCI and ~10% with overt strokes) and the high disease-burden in Nigeria, the prevalence and incidence rates of new and recurrent stroke (overt and silent strokes)have not been collected systematically in children and young adults (16-25 years old) with SCA. In the last decade, there has been growing use of stroke registries in economically advanced nations, particularly for epidemiological purposes of trend analysis, clinical effectiveness, compliance to guidelines, assessment of implementation, adoption of novel techniques, and quality improvement process. For the first time in clinical centers in Nigeria, the Investigators will conduct an observational epidemiological study to document the prevalence and track the incidence of new and recurrent strokes in children and young adults with SCD. The Investigators will create a stroke registry referred to as the Afolabi Stroke Registry for Children and Young Adults with Sickle Cell Disease in Nigeria. The overall purpose of the stroke registry is to document the natural history of SCD in a low-resource setting and to improve the quality of the care of children and young adults with SCD living in Nigeria.
Triple negative breast cancer (TNBC) is an aggressive disease with higher proportion of Blacks affected and in younger age groups. There is no targeted therapy unlike other types of breast cancer such as hormone positive and Human Epidermal Growth factor 2 (HER2) positive subtypes. Chemotherapy is therefore the main choice of systemic treatment with rapid development of resistance in most cases. At present, there is no blood test to monitor treatment response and disease relapse. This one-stage phase II study with a single arm design will determine the response rate of standard chemotherapy using Epirubicin (60mg/m2), Cyclophosphamide (600mg/m2) , Paclitaxel (120mg/m2) and Carboplatin (6AUC) in TNBC patients. We will measure the blood level of microRNA molecules and circulating tumor DNA during and after treatment to test if changes can be used to indicate drug failure in these patients. Disease status and tumor response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines while toxicity will be assessed using CTCAE v5). The trial will be conducted as per the International Council on Harmonisation Good Clinical Practice (ICH GCP) Guidelines E6 (R1) and other applicable guidelines
The NaSS aims to assess the extent to which the SHAKE program is implemented within Nigeria by the Nigerian Agency for Food and Drug Administration and Control (NAFDAC) using a type III hybrid, mixed method study design.
Tuberculosis (TB) is caused by mycobacterial organism. It is the leading infectious disease cause of death globally, with more than 10 million new cases and over 2 million deaths annually. Developing countries bear the greatest brunt of the disease. The long duration of current treatment is associated with poor compliance, thereby contributing to frequent relapses and to the emergence of drug-resistant TB. In addition, individuals who have been clinically cured may have lung damage, which could be permanent. Therefore, new and more effective therapeutic agents against TB are needed. Emerging evidence has shown that lipid lowering drugs like statins can make the TB bacteria more susceptible to current treatments. This proof-of-concept clinical trial will add the repurposed drug atorvastatin, commonly used to reduce cholesterol levels, to the standard therapies of TB patients in Nigeria. Atorvastatin is a well-tolerated and safe drug, and its addition is expected to accelerate clearance of the TB-causing bacteria without additional side effects. If this research is successful, it could provide evidence for using a common, easily available generic drug to improve treatment of one of the most debilitating infectious diseases.
Summary of the Research Medication non-adherence has a huge economic impact on the patient and the society at large. World Health Organization (WHO) has suggested that noncompliance with medication is a common problem which often leads to compromised health benefits and serious economic consequences in terms of wasted time, money and increased morbidity. Other consequences are waste of medication, disease progression, reduced functional abilities, lower quality of life, and increased use of medical resources such as nursing homes, hospital visits and hospital admissions. Non-adherence is common to patients with chronic diseases, such as hypertension and diabetes, compared to patients with acute conditions. The annual cost of medication non-adherence, which includes hospital and nursing home admissions, increased ambulatory costs, lost productivity and premature deaths, has been estimated to be more than $100 billion per year in the United States. In Canada, hospital expenditures caused by non-adherence was estimated to be more than US$1.6 billion. The potential burden of medication non-adherence outcomes on health care delivery makes it an important public health concern. Many studies have addressed non-adherence to medication in developed countries. Past studies on non-adherence in Nigeria have identified different rates of non-adherence to medications for disease states such as diabetes mellitus and hypertension. Literature is scanty on studies on cost of non-adherence in Nigeria. This study will be focus on cost implications of non-adherence to treatment among patients of selected disease states (hypertension and type 2 diabetes mellitus). Research design The study was a quasi-experimental study among T2D patients that were recruited from the two hospitals using questionnaire-guided semi-structured interview. At the baseline, participants with HbA1c ≥7% were classified as uncontrolled/intervention group, while those with HbA1c <7% were considered as control group. Similarly, participants with blood pressure <140/90mmHg were classified as control/adherent while those with blood pressure ≥140/900mmHg were uncontrolled/intervention group. Methodology A quasi-experimental study among 201-patients with T2D using semi-structured interview. Baseline questionnaire comprised modified 4-items Medication Adherence Questions (MAQ), Perceived Dietary Adherence Questionnaire (PDAQ) and International Physical Activity Questionnaire, to assess participants' adherence to medications, diet and physical activity, respectively. Patients were assigned into control (HbA1c<7%, n=95) and intervention (HbA1c≥7%, n=106) groups. Post-baseline, participants were follow-up for 6-months with educational intervention provided to clarify and resolve identified discrepancies among the intervention group only, while the control group continued to receive the usual care. Costs of management including transportation fare, consultation fee, medications and laboratory investigations were estimated for 6-months pre-baseline and 6-months post-baseline for both groups. Data were summarized using descriptive statistics, while Chi-square, McNemar and paired t-test were used for categorical and continuous variables at p<0.05. Principal exposure: Glycated haemoglobin HbA1c, was measured for Type 2 DM participants and blood pressure was taken for hypertensive participants Outcome variable: Effect of pharmacist-led intervention on therapy non-adherence, reasons for non-adherence and costs of management.
The current study extends the study team's earlier efforts described in ClinicalTrail ID#: NCT04070287 and NCT03874663. The I-TEST (Innovative Tools to Expand Youth-friendly HIV Self-Testing) study sought to develop and evaluate novel youth-friendly HIVST services in Nigeria using open challenges and apprenticeship training informed by a participatory learning collaborative model. The study thus aims to reach young Nigerians that remain undiagnosed for HIV and to facilitate linkage and retention in preventive services (includes STI testing/treatment, PrEP referral, condom use).