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NCT ID: NCT03855995 Not yet recruiting - Malaria Clinical Trials

A Study to Evaluate the Safety, Effectiveness and Impact of the GlaxoSmithKline Biologicals' Malaria Vaccine- RTS, S/AS01E in Young Children in Sub-Saharan Africa

EPI-MAL-003
Start date: March 21, 2019
Phase:
Study type: Observational

The RTS, S/AS01E vaccine has been developed for routine immunization of children living in malaria-endemic countries of sub-Saharan Africa. This study is intended as a post-implementation safety study (after vaccine implementation), with the primary objective to evaluate the safety of vaccine after its administration. In addition to the primary objective, the study will also evaluate the impact and effectiveness of the vaccine.

NCT ID: NCT03806465 Enrolling by invitation - Mortality Clinical Trials

Malaria Vaccine Evaluation Programme

MVPE
Start date: February 25, 2019
Phase:
Study type: Observational

This is an evaluation of feasibility, safety and impact of the RTS,S/AS01 vaccine introduction, implemented in a pilot programme by Ministries of Health using an expanded schedule of their routine EPI contacts in moderate to high malaria transmission settings in Ghana, Kenya and Malawi. The Ministries of Health in Ghana, Kenya and Malawi plan to introduce the malaria vaccine, sub nationally. This provides an opportunity in each country to evaluate the following : 1. To evaluate the programmatic feasibility to deliver a 4 dose schedule; 2. To collect information on a larger scale on the safety of the malaria vaccine with focus on cerebral malaria and meningitis; 3. To evaluate the impact of the malaria vaccine on all cause mortality.

NCT ID: NCT03800407 Recruiting - Tuberculosis Clinical Trials

Contributing Factors for Poor HIV Treatment Response in Children With TB/HIV Coinfection

Start date: January 28, 2019
Phase:
Study type: Observational

Efavirenz (EFV)-based antiretroviral therapy (ART) remains the preferred regimen in human immunodeficiency virus (HIV)-infected children aged 3 years or older on rifampin-containing antituberculosis (anti-TB) therapy. This is because drug interactions between first-line anti-TB therapy with protease inhibitors (PIs) are more severe to adjust for, and interactions with integrase strand transfer inhibitors (INSTIs) are not well studied in that age group. Although, current weight-based EFV dosing recommendation is not optimal in some children, pharmacokinetic-treatment response (PK-PD) data to guide optimal dosing of EFV during concurrent rifampin-containing therapy in children is very limited. The study team propose that EFV concentrations outside the optimal therapeutic range in children will be associated with virologic failure due to lack of efficacy because of low concentrations or increased central nervous system (CNS) toxicities from high concentrations leading to poor medication adherence. The study will determine virological suppression rates in HIV-infected children with and without TB coinfection treated with standard efavirenz-based therapy and examine the factors contributing to poor virologic response.

NCT ID: NCT03800394 Recruiting - Tuberculosis Clinical Trials

Pharmacokinetics of Intracellular TFV-DP and FTC-TP in HIV-infected Adolescents

Start date: January 28, 2019
Phase:
Study type: Observational

Tenofovir (TFV) disoproxil fumarate (TDF) plus emtricitabine (FTC) or lamivudine (3TC) is the preferred nucleoside backbone of first-line antiretroviral therapy (ART) for adolescents in sub-Saharan Africa. In addition, TDF/FTC is recommended for preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection in adolescents at substantial risk of acquisition of HIV infection, as well as for hepatitis B virus (HBV) treatment in those with HBV/HIV coinfection. The efficacy TDF and FTC are dependent on intracellular concentrations of the active phosphate anabolites, called TFV diphosphate (TFV-DP) and FTC triphosphate (FTC-TP). However, the intracellular pharmacokinetics of TFV-DP and FTC-TP to examine the adequacy of current dosages in African adolescents has not been previously studied. Thus, examining the pharmacokinetics (PK) of these widely used antiretrovirals in African adolescents is important as ART outcomes remain poor and the recommended dosages of these drugs for children and adolescent were extrapolated from drug approval clinical trials in adult in the United States and Europe.

NCT ID: NCT03800381 Recruiting - Tuberculosis Clinical Trials

Adequacy of the New Pediatric Isoniazid/Rifampin/Pyrazinamide (HRZ) Tablet

Start date: January 28, 2019
Phase:
Study type: Observational

Lack of quality-assured pediatric formulations of the first-line antituberculosis (anti-TB) drugs is barrier to optimized tuberculosis (TB) treatment outcome in children. In 2010 and subsequently modified in 2014, the World Health Organization (WHO) recommended increased dosages of the first-line anti-TB drugs for children, but there were no child-friendly fixed-dose combination (FDC) formulations based on the guidelines. A large proportion of children treated with the new guidelines using old formulations did not achieve the desired rifampin peak concentration (Cmax) > 8 mg/L and pyrazinamide Cmax > 35 mg/L. The TB Alliance and the WHO led the development of a new child-appropriate isoniazid/rifampin/pyrazinamide (HRZ) and isoniazid/rifampin (HR) FDC formulation in line with current WHO recommended dosing guidelines. The new formulations dissolve quickly in liquid, have palatable fruit flavors, and are expected to improved daily adherence but no studies have evaluated the pharmacokinetics (PK) of the FDC formulation in children. The study team hypothesize that the new dispersible HRZ FDC tablet, dosed according to current WHO weight-band dosing recommendations will result in better PK parameters for each drug component than that achieved by the old formulation.

NCT ID: NCT03797950 Recruiting - Clinical trials for Immunization Coverage

Mobile Nudges to Increase Early Vaccination Coverage in Rural Areas

GEVaP
Start date: November 1, 2018
Phase: N/A
Study type: Interventional

Despite major progress made in vaccination coverage overall, timeliness of vaccines remains a key concern in many settings. At the same time, access to mobile phones has increased rapidly, offering new opportunities to track and deliver health services. This research project uses these newly available mobile phone networks to simultaneously address two of the biggest bottlenecks in vaccine delivery: timely documentation of births, and lack of maternal effort or access to get essential vaccines. To increase documentation, investigators will train volunteers in each community to report new births via mobile phone to a central coordinator, and send small monetary rewards via mobile phone to volunteers for this reporting. To increase vaccination coverage, investigators will send reminder messages directly to mothers, and will also test small monetary rewards to volunteers and to mothers as an incentive to complete recommended vaccinations. The designs to provide vaccination encouragement will be tested through a small community randomized controlled trial in 15 selected villages in Ghana's Northern region. The primary outcome for the pilot study will be the percentage of children who received both the polio birth dose (OPV0) vaccination within two weeks of life (14 days) and the BCG vaccination within the first four weeks (28 days) of life.

NCT ID: NCT03755635 Recruiting - Neonatal SEPSIS Clinical Trials

Neonatal Sepsis at Neonatal Intensive Care Units in Ghana

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Background: Neonatal sepsis is a major contributor to global under five mortality. In developing countries a major proportion of neonatal sepsis is thought to emanate from the healthcare setting, due to challenges in infection prevention practices. Aim: To study the epidemiology of neonatal sepsis and evaluate the effect of multimodal infection control interventions on the incidence of neonatal sepsis; and colonization by multidrug resistant Gram negative bacteria (MDRGNB). Methods: A controlled before and after interventional trial comprising a 7 month pre- intervention phase, 5 month intervention phase and 7 month post-intervention phase. Neonates admitted at the Neonatal Intensive Care Unit (NICU) at Korle-Bu Teaching Hospital (KBTH) will be enrolled prospectively and followed up for diagnosis of sepsis and outcome of admission. This will be used to describe the epidemiology of neonatal sepsis. Swabs will be collected from a subpopulation of included neonates at intervention site (KBTH) and control site (37 Military Hospital) NICUs to assess colonization of neonates with MDRGNB. Environmental swabs will be collected from surfaces at the NICU to assess MDRGNB contamination of the environment. The intervention comprises infection prevention strategies including implementation of the WHO multimodal hand hygiene strategy. The primary endpoint is incidence of neonatal sepsis. Expected Outcome: This study will contribute to improved infection prevention practices in the participating NICUs and highlight lessons which other national and regional NICUs may learn from.

NCT ID: NCT03754998 Completed - Clinical trials for Iron Deficiency Anemia (IDA)

Community Interventions to Improve Iron and Iodine Status in Mother and Child Dyads in Northern Ghana

Start date: May 20, 2017
Phase: N/A
Study type: Interventional

BACKGROUND Ghana has reduced food insecurity prevalence by 49.2% in two decades. However, prevalence of malnutrition especially stunting (in <children5yr) has not matched the changes in food security levels. Of several key nutritional factors that lead to stunting, nutritional status of such trace minerals as iodine, iron and zinc has not been studied. Nutritional inadequacy of these trace minerals may be detected by estimation of dietary intake, and time-consuming and costly biochemical measurements of respective biomarkers. Since there is no means to estimate dietary intake of the trace minerals in Ghana, due to incomplete food composition data of the nutrients, identifying validated non-invasive, dietary approaches to predict the biomarker status of these trace minerals are critical in counteracting the challenges surrounding the persistent stunting due to micronutrient deficiencies in Ghana. Additionally, exploring alternative approaches to providing access to foods rich in trace minerals at household level is crucial. STUDY AIMS AND HYPOTHESIS The ultimate goal of this research is to increase knowledge base on improving trace mineral status in mother-child (6-23 mo) dyads through a sustainable community-based interventions in northern Ghana. Investigators will begin with iron and iodine that impair mothers and young children's growth and cognitive development most with three aims: 1) to develop dietary screening tools that are validated by biomarkers for early detection of deficiencies, 2) to determine efficacy (dose responses) of feeding indigenous nutrient-rich meals in preventing deficiencies and improving iron and iodine status, and 3) to demonstrate sustainable and scalable improvement of food systems through a container gardening project for iron-rich Hibiscus sabdarifa for consumption and income by empowering women during the dry/lean season in northern Ghana. • Aims 1: To develop dietary screening tools that are validated by biomarkers for early detection of deficiencies among children 6-23 months and their mothers H1.1: Dietary diversity score can predict iron deficiency among children 6-23 months and their mothers. H1.2: Dietary diversity score can predict iodine status deficiency among children 6-23 months and their mothers. - Aims 2: Indigenous nutrient-rich meals of hibiscus sabdarifa improves iron and iodine status of dyads H2.1: Indigenous nutrient-rich meals of hibiscus sabdarifa improves iron status of dyads H2.2: Indigenous nutrient-rich meals of hibiscus sabdarifa improves iodine status of dyads - Aims 3: to demonstrate that container gardening can provide sustainable and scalable improvement of food systems for iron-rich Hibiscus sabdarifa for consumption and income during the dry/lean season in northern Ghana H3.1: Container gardening can provide adequate amounts of vegetables for mother and child dyad during the dry season H3.2: Container gardening can provide adequate income to purchase iodized salt and Amani for mother and child dyad during the dry season SIGNIFICANCE This project addresses the gap in our knowledge and practices pertaining to serious and persisting trace mineral deficiencies that result in stunting and cognitive impairment in northern Ghana. Early detection of iron and iodine deficiencies with validated non-invasive dietary screening tools (aim 1), effective indigenous nutrient-rich meal-based programs (aim 2) and sustainable/scalable and women-led community-based food-system changing agricultural project (aim 3) are expected to be the most creative approach to counteract iron and iodine deficiencies in northern Ghana. This project will utilize science and education to change practices, environments and policies to reduce the prevalence of trace mineral deficiencies at the local, regional, national and global levels.

NCT ID: NCT03724214 Recruiting - Gastroschisis Clinical Trials

Multi-Centre Gastroschisis Interventional Study Across Sub-Saharan Africa

Start date: October 8, 2018
Phase: N/A
Study type: Interventional

This study is a multi-centre interventional study at seven tertiary paediatric surgery centres in Ghana, Zambia, Malawi and Tanzania aimed at reducing mortality from gastroschisis.

NCT ID: NCT03704649 Not yet recruiting - Malnutrition Clinical Trials

Evaluating a Participatory Nutrition Education Model on Nutrition Literacy of Adolescent Girls in Rural Ghana.

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

Adolescent girls in the Upper Manya Krobo (UMK) district, Ghana are disproportionately burdened by ill-health in relation to their male counterparts. Research also shows that this demographic lacks access to nutrition education and health services. This research aims to assess the feasibility and influence of an intervention that utilizes a participatory video education model on adolescent girls' nutrition knowledge, dietary habits and health behaviour. To address our research objectives, we will conduct a school-based cluster randomized control pilot trial with adolescent girls, 12-16 years of age, who are part of existing girls' clubs in 20 schools of the Upper Manya Krobo district. The intervention group (10 schools) will use a participatory video education model and the control group consists of standard-of-care education received in regular girls' club gatherings. The intervention groups develop a storyboard and produce a short 5-7 minute film on a nutritional issue. These videos can be used by teachers as a means of sharing nutrition information with students and in stimulating discussion around the nutrition topic. Baseline and end line surveys will be conducted to assess nutrition literacy indicators and nutrition behaviour. We will use surveys to assess nutritional knowledge and attitude; food frequency questionnaire to record dietary intakes; and in-depth interviews with participants and school staff to assess challenges and strengths of the nutrition education model being delivered.