There are about 351 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.
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 known locally as the 4 Youth by Youth project, 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).
Background: Coronavirus disease 2019 (COVID-19) has affected almost every country in the world, especially in terms of health system capacity and economic burden. People from sub-Saharan Africa (SSA) often face interaction between human immunodeficiency virus (HIV) infection and non-communicable diseases such as cardiovascular disease. Role of HIV infection and anti-retroviral treatment (ART) in altered cardiovascular risk is questionable and there is still need to further carry out research in this field. However, thus far it is unclear, what impact the COVID-19 co-infection in people living with HIV (PLHIV), with or without therapy will have. The ENDOCOVID project aims to investigate whether and how HIV-infection in COVID-19 patients modulates the time course of the disease, alters cardiovascular risk, and changes vascular endothelial function and coagulation parameters/ thrombosis risk. Methods: In this long-term study, cardiovascular research on PLHIV with or without ART with COVID-19 and HIV-negative with COVID-19 will be carried out via clinical and biochemical measurements for cardiovascular risk factors and biomarkers of cardiovascular disease (CVD). Vascular and endothelial function will be measured by brachial artery flow-mediated dilatation (FMD), carotid intima-media thickness (IMT) assessments, and retinal blood vessel analyses, along with vascular endothelial biomarkers and coagualation markers. The correlation between HIV-infection in COVID-19 PLHIV with or without ART and its role in enhancement of cardiovascular risk and endothelial dysfunction will be assessed. Potential changes in these endpoints by COVID-19 will be followed for 4 weeks across the three groups (PLHIVwith or without ART and HIV negatives). Impact of project: The ENDOCOVID project aims to evaluate in the long-term the cardiovascular risk and vascular endothelial function in PLHIV thus revealing an important transitional cardiovascular phenotype in COVID-19.
This study evaluates a tailored-practice facilitation (PF) strategy for integrating a task strengthening strategy for hypertension control (TASSH) for the care of patients living with HIV (PWH) within primary health centers (PHCs) in Lagos, Nigeria.
The purpose of this study is to identify the safe and effective dose of intravenous cipargamin in participants with moderately severe and severe malaria. The study also intends to evaluate clinical treatment success using a novel clinical endpoint for drug development in severe malaria. Severe malaria is a medical emergency and is affecting primarily young children in Africa. Injectable artesunate is the standard of care for the treatment of severe malaria and is highly efficacious. However, the spread of artemisinin-resistance in Plasmodium falciparum in Asian countries poses a threat for future treatment of patients with this life-threatening disease. To mitigate this risk, there is a need of another drug in malaria endemic countries. Cipargamin treatment results in rapid clearance of parasites including artemisinin resistant parasites.
D²EFT-GIC is a substudy of D²EFT study (NCT03017872), a randomised clinical trial of second-line antiretroviral therapies. The goal of D²EFT-GIC is to evaluate a novel tool, the "Graphical Informed Consent" (GIC), within D²EFT. The GIC is designed to supplement the informed consent process with a set of culturally- and gender-adapted illustrations, with an explanatory script for researchers, that complements the mandatory written participant information sheet and consent form. The investigators propose to assess the acceptability and feasibility of this tool from the participants and researchers perspectives. The GIC will be first pre-tested in one or more site(s) - where the informed consent process is challenging because of literacy, language or culture barriers - in 10 prospective participants for D²EFT. If this stage shows there is no negative impact of the GIC on the consent process, the second stage will study the feasibility of implementing the GIC in the usual practice.
Malaria in pregnancy (MiP) continues to be a significant public health issue, particularly in sub-Saharan Africa. The coverage of pregnant women with three or more doses of intermittent preventive treatment using sulphadoxine-pyrimethamine (IPTp-SP) is recommended to prevent risks associated with MiP in moderate-to-high transmission settings. Evidence has recently become available supporting the emergence of a novel Pfdhps-431V mutation in Nigeria. This new mutation may further confound the existing SP-resistance; thus, the intended follow-on project aims to assess the influence of Pfdhps-431V mutation on the protective efficacy of SP during pregnancy. The aims are to detect P. falciparum positivity at delivery and pregnancy outcome in participants who must have received three or more doses of IPTp_SP. We will attempt to check the presence of existing and new Pfdhps/Pfdhfr mutations in the samples positive for P. falciparum using a quantitative PCR (qPCR). The prevalence of novel Pfdhps-431V mutant and other Pfdhps/Pfdhfr resistance alleles among the study population will be estimated. The significance of the resistance genes on the efficacy of SP will be described by looking at its associations with the reported IPTp use, P. falciparum infection, maternal anaemia, low birth weight, and preterm delivery.
Severe acute malnutrition (SAM) affects 16 million children at any one time and is responsible for the deaths of over 500,000 children under 5 years of age each year. Treatment for severe acute malnutrition is based on the Community-based Management of Acute Malnutrition (CMAM) model. The current methods used for detecting high risk children have not prevented 5% mortality observed in regions using this program. The purpose of the study is to provide evidence that objective methods for detecting high risk children can be used to optimize efficiency of Community-based Management of Acute Malnutrition (CMAM) treatment programs and thus improve child health outcomes.
to determine safety and efficacy of Tranexamic Acid in reducing blood loss during Myomectomy in our institution.