There are about 279 clinical studies being (or have been) conducted in Ethiopia. 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.
This program is a comprehensive evaluation of rheumatic valvular heart disease (RVHD), Atrial fibrillation (AF)/flutter and stroke. A prospective, randomized, parallel group, open-label clinical trial of rivaroxaban versus standard vitamin K antagonists (VKA) therapy to evaluate non-inferiority of rivaroxaban to VKA, with testing for superiority if non-inferiority is satisfied.
Young children in Ethiopia lack sufficient protein and micronutrients for growth and development. The overall purpose is to assess the effects of promoting egg and eggshell powder consumption on improving the nutritional status of children 6 to 15 months in Halaba Special Woreda, Southern Ethiopia. The hypothesis is that providing chickens to produce eggs (egg and eggshell) for young children will improve growth in otherwise malnourished young children. Upon providing chickens, the nutritional status of young children prior and after the intervention (by 6 months) will be assessed. Identification of the knowledge, attitude and practices (KAP) of mothers on egg and eggshell powder consumption by their children before and after the intervention in the intervention group will be done. Caregivers will be instructed to give each child 1 egg (cooked) and 1/4 "bottle cap" of eggshell (500 mg calcium) per day in the intervention. Hemoglobin will be measured as an indicator of overall nutritional status. Throughout the study, any problems arising in keeping chickens will be recorded in order to assess the feasibility and practicality of raising chickens as way to improve nutritional status of young children. The study is novel in that investigators are providing a way to have increased protein, increased micronutrients, and use of eggshell as a source of calcium.
Physicians know that their patients can react differently to the same medical treatment: for some of them, the drug will prove inefficient, whereas for others it might provoke side-effects, sometimes rather serious. Such differences in response to drug intake are due to several factors, of which molecular variations in specific genes, named " ADME " (Absorption, Distribution, Metabolism, Excretion). This project aims at investigating the evolutionary mechanisms responsible for the diversity of ADME genes in human populations. Because of their role at the interface between the organism and its chemical environment, ADME genes are likely targets of recent selective pressures linked to changes in the environments in which humans evolved, such as changes in dietary habits for instance. The aim of this project is to study the diversity of ADME genes and of their expression in five populations located along a latitudinal axis that extends from East Africa to Central Europe, passing through the Arabian Peninsula and the Mediterranean area, so as to take into account environmental factors that might have influenced the evolution of this diversity. This project is thus intended to evidence the evolutionary mechanisms that shaped genomic regions that are functionally important from the clinical and epidemiological point of view. Moreover, it will allow us to extend the knowledge of human molecular diversity and its evolution to a key-region of the peopling history of our species.
Alive & Thrive is an initiative that aims to scale up nutrition to save lives, prevent illness, and ensure healthy growth and development through improved infant young child feeding (IYCF) practices. The purpose of this study is to evaluate whether the Alive & Thrive intervention package, consisting of interpersonal communication, community mobilization activities, and radio campaign, can increase complementary feeding practices (minimum dietary diversity and minimum meal frequency) while sustaining exclusive breastfeeding rate among children less than two years of age. The impact evaluation uses a cluster-randomized design where 20 geographic clusters (woredas/districts) were randomized to two study arms - 10 intervention areas and 10 comparison areas. Repeated cross-sectional baseline and endline surveys will be used to assess program impact.
Background: Maternal and child under-nutrition is the underlying cause of death for millions across the globe. Anemia during pregnancy is among the leading nutritional disorders with serious short and long term consequences to both the mother and fetus. Objective: Examine the effect of dietary diversity on maternal anemia, nutritional status and key pregnancy outcomes of pregnancy. Methods: A prospective cohort study design, involving a total of 432 eligible pregnant women, in their second antenatal care visit was conducted between August 2014 to March, 2015. The individual dietary diversity Score (IDDS) was used as the exposure variable to select, enroll and follow the mothers. Epi-data, SPSS and STATA software are used to enter and analyze the data. Chi-square test, independent 't'-test, and GLM are used to calculate risk, association and differences between key variables at P < 0.05
The study is a randomized controlled trial of COMPASS, an intervention for adolescent girls in three refugee camps in Ethiopia. The study design will employ a two group wait-list cluster randomized controlled trial where girls will be invited to participate in the COMPASS program, assigned to groups of approximately 20 for the purposes of the program, complete a pre-test baseline assessment, and will then be randomized by group to the intervention or control condition. In addition, qualitative research will address additional questions of acceptability, processes of change and best practice. Groups in three refugee camps - Sherkole, Bambasi, and Tongo - will be randomized to determine whether the participants receive the intervention or are placed on the wait-list immediately following the baseline. Those that do not get the curriculum during the study will receive it following the endline phase of the study so as to not create tensions or jealousies. The intervention, the COMPASS program, will involve a structured intervention for girls between the ages of 13-19 that is intended to engage adolescent girls, those who are influential in their lives, service providers and other stakeholders, with the ultimate goal of co-creating environments in which girls are valued and safe. The program is centered on establishing or supporting community-supported safe spaces for girls where they can come and gather among themselves and participate in a structured life-skills curriculum.
Rationale: Every year, 287,00 million women, and 3.1 million neonates continue to die, and the majority of these deaths have been identified as being avoidable. A proxy indicator of Millennium Development Goal (MDG) 5, birth with skilled attendance is low in Sub-Saharan Africa(47%) and the lowest (13%) is for Ethiopia, with the greatest number of maternal deaths. The Ethiopia health system has established a vast network of health infrastructure that extends to rural areas with the establishment of over 15,000 health posts and deployment of over 30,000 health extension workers throughout the country. Although these unprecedented situations made health services more accessible than ever, it is yet to be exploited for improving rural women's access to clean and safe delivery and postpartum care. Lack of usage of delivery care in the country is related not only to accessibility but also acceptability of the services. In fact, the vast majority of women with home deliveries saw institutional delivery as "unnecessary" and a "non-customary practice". Therefore, instituting an innovative, culturally sensitive, and practically amenable strategy, deployment of CORNs for example might be the best remedy, in this case. Objective: To evaluate the effectiveness and acceptability of availing Home based Skilled Birth Attendance (SBA) Services through Community Reproductive Health Nurses (CORN) in rural communities of Ethiopia. Study design: Cluster Randomized Controlled Community Trial that will be conducted in four phases. Study population: Study participants will be all pregnant women who will give birth at home and health facility (including health post) during the study period. Intervention: The study will be conducted in four phases as discussed below. During the first (preparatory) phase, sensitization of relevant stakeholders and recruitment of trainees will be conducted. In the second phase, formative and baseline assessment as well as training of CORNs will take place. In the third phase, which will be actual intervention phase, deployment of CORNs in their respective study site will be done and in the final phase, final evaluation and dissemination of study findings will be done. The intension behind deploying CORNs to the grassroots level is just to give a backup skilled delivery and other MNH services to poor rural mothers who have difficult of accessing modern health facilities for various reasons; it has no any intention to promote or encourage home deliveries or replace institutional deliveries. Perhaps it will help to assimilate rural mothers to modern health facilities Main study parameters/endpoints: The main study end point is percentage of skilled birth attendance which is very low in local and national level. In addition secondary study parameters are percentage changes of maternal & related services uptakes. These include focused Antenatal; care (ANC), long term family planning, Prevention of Mother to Child Transmission of HIV (PMTCT) and postnatal care. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: the burden and risks associated with participation to the study is very minimal. To mention few; physical examinations (Leopold manoeuvre) or the routine investigations of pregnancy this will be anonymous except for the CORNs keeping the principles of shared confidentiality in mind. Similarly all questionnaires or medical charts will be kept confidential. All CORNs will obtain intensive training on ethical principles that will help to minimize any physical and physiological discomfort associated with participation, the risks associated with the investigation treatment. The study period and Budget: the study will be carried out in a total of 18 months which holds a period from the development of protocol to the terminal evaluation and submission of reports. The overall study budget will be 99, 987.95 USD (Ninety nine thousands, nine hundred eighty seven dollars and ninety five cents
The purpose of the study is to evaluate the impact of a package of interventions including production and distribution of locally produced complementary foods (via so-called "Grain-banks") and Micronutrient Powders (MNPs) supplementation, and optimized food based Complementary Feeding Recommendation, on growth and micronutrient status of infants and young children. The impact of the intervention package will be evaluated in a quasi-experimental matched-control cluster design in infants and young children between 6 - 29 months of age. The impact, outcome, and output indicators of infants/children will be assessed in cross-sectional samples at baseline, after 9 and 18 months. A total of60 pair clusters are selected in which 15 households per cluster will be identified from the eligible population. A total of 1800 children from intervention and match-controlled clusters, will be sampled in the target age groups. Qualitative and quantitative data will be collected to gather information on Knowledge, Attitude and Practice (KAP), Infant and Young Child Feeding practices, anthropometry and anemia, following the impact pathway developed for the study. Research questions to be answered in this program evaluation are: 1. What impact does the extended pilot (implementation of local complementary food production and MNP) have on: 1. Growth in children 17-29 months of age 2. Infant and Young Child Feeding practices in children (6-23m), and 3. Anemia status in children 11-23 m? 2. What are determining factors for the impact/no impact related to: 1. Immediate outcomes: skills and capacity; knowledge, attitude and practices; and improved access 2. Intermediate outcomes: utilization; provision, and ensuring enabling environment 3. Program performance as measured by program monitoring data on output and activities?
The purpose of the study is to assess the safety of iron supplementation in MNPs. A quasi-experimental matched-control cluster design will be used in, purposely selected, 18 intervention and 18 matched-control clusters of Oromia and South Nations Nationalities and People (SNNP) regions of Ethiopia. A total of 2340 infants 6-11 months of age, from intervention and non-intervention clusters will be enrolled and followed longitudinally for 12 months. Morbidity data using standardized questionnaire, will be collected at baseline, and every two weeks for a period of 12 months Research questions to be answered in this study are: 1. Is the provision of low dose iron-containing Micronutrient Powders (MNPs) to young children with or without iron deficiency safe, as assessed by their morbidity from infectious diseases? 2. What is the impact of the provision of low dose iron-containing Micronutrient Powders (MNPs) to young children on (body) iron status? Morbidity data will be collected at baseline, and every two weeks in the same cohort of children. Body iron status will be assessed at baseline and endline as measured by serum ferritin, serum transferrin receptor, hemoglobin concentration, CRP and AGP. In addition data on the following outcomes will be collected in these children: 1. Anthropometry (weight, height, MUAC) every 4 months 2. Breastfeeding status and consumption of processed complementary food portions in the previous week -every 4 months 3. Compliance to study intervention.
This study, to be conducted in southern Ethiopia, is a randomized community trial, evaluating the use of local community support workers who provide for HIV patients education, counseling/social support, and linkage to the HIV Clinic. Patients will be followed for at least three years, with a primary goal of improving retention in HIV care, and secondary goals of improving client knowledge, attitudes about being HIV-positive, feelings of social support and clinical health status.