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NCT ID: NCT02744690 Withdrawn - Glaucoma Clinical Trials

Mitomycin C Trabeculectomy Trial for Glaucoma in Ethiopia

Start date: March 1, 2015
Phase: N/A
Study type: Interventional

This study is a randomized, double-masked trial to examine the response to trabeculectomy surgery. In this study, patients will be randomized to receive MMC via subconjunctival injection or topical sponge application.

NCT ID: NCT02620943 Completed - Anemia Clinical Trials

Dietary Diversity is Associated With Maternal Anemia and Key Prenatal Outcomes in Ethiopia

Start date: August 2014
Phase: N/A
Study type: Observational

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

NCT ID: NCT02506543 Completed - Domestic Violence Clinical Trials

Creating Opportunities Through Mentoring, Parental Involvement and Safe Spaces - Ethiopia

COMPASS
Start date: August 2015
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02501252 Completed - Clinical trials for Maternal Care Patterns

Effectiveness and Acceptability of Availing Skilled Birth Attendance (SBA) Services Through Community Reproductive Health Nurses (CORN) to a Household Level at Rural Communities of Ethiopia; A Cluster Community Trial in Gedeo Zone, SNNPR

CORN
Start date: November 2014
Phase: N/A
Study type: Interventional

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

NCT ID: NCT02484495 Completed - Infant Morbidity Clinical Trials

Extended Pilot Project Community Based Production of Complementary Food in Ethiopia

Start date: March 2015
Phase: N/A
Study type: Interventional

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?

NCT ID: NCT02479815 Completed - Infant Morbidity Clinical Trials

Impact of Low Dose Iron-containing Micronutrient Powders on Iron Status and Morbidity of Young Children in Ethiopia

Start date: March 2015
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02448394 Completed - HIV Clinical Trials

Assessment of a Community Support Worker Intervention for Persons Living With HIV (PLWH) in Rural Ethiopia

SHAMA
Start date: October 2015
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02409290 Completed - MDR-TB Clinical Trials

The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB

STREAM
Start date: March 2016
Phase: Phase 3
Study type: Interventional

Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected person transmits their saliva through the air by coughing or sneezing. Despite the availability and effectiveness of affordable six-month treatments for tuberculosis (TB), the worldwide control of this disease is currently being impacted by the emergence of multidrug resistant TB (MDR-TB). MDR-TB refers to TB that is resistant to at least isoniazid and rifampicin. These are the two most powerful first-line drugs used to treat pulmonary TB. MDR-TB usually develops while a person is taking TB treatment due to either inappropriate treatment or failure of patients to comply with their treatment. This strain of drug-resistant bacteria can also be spread to other people through the air. With the incident rate of MDR-TB on the rise, there is a need to investigate optimal treatment regimens using effective drugs.

NCT ID: NCT02373657 Completed - Trachoma Clinical Trials

Water Uptake for Health in Amhara Pilot

WUHA
Start date: April 2014
Phase: N/A
Study type: Interventional

Trachoma is a blinding disease caused by ocular strains of Chlamydia trachomatis. The Carter Center and Proctor Foundation have been jointly conducting trachoma research in the Goncha Siso Enese woreda of Amhara for the past 8 years, through a series of clinical trials. We have found that repeated mass administration of oral azithromycin can greatly reduce the prevalence of trachoma, but mass antibiotics have been unable thus far to eliminate infection. The World Health Organization recommends not only antibiotics for control of trachoma, but an entire SAFE strategy (Surgery for in-turned eyelids, Antibiotics, Facial hygiene promotion, and Environmental improvements such as latrines and water points). Trachoma is more common in villages and households with poor access to water and latrines, so improving the public health infrastructure is thought to be important for limiting transmission of trachoma. However, there is very little evidence to support the efficacy of installing new water points for trachoma. There has been only one previous attempt to study the role of hand dug well installation for trachoma control, and this study, conducted in Niger, found that installing wells was not effective. We now propose a project to improve the public health infrastructure of Goncha Siso Enese woreda by helping with the construction of water points (e.g., hand-dug wells) and providing hygiene education, in order to determine whether improving access to water and hygiene information will be effective for control of trachoma and soil-transmitted helminths.

NCT ID: NCT02363985 Completed - Clinical trials for Vitamin A Deficiency

Using Stable Isotope Techniques to Monitor and Assess the Vitamin A Status of Children Susceptible to Infection

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

The combination of infectious diseases and malnutrition is the most prevalent, preventable public health problem in the world, responsible for millions of deaths annually, particularly in infants and children. Approximately 13 million children die each year in developing countries from infectious diseases, with the majority of these deaths related to malnutrition. The relationship between infections and malnutrition is synergistic, each further compromising the outcome of the other. Malnutrition compromises natural immunity leading to increased susceptibility to infections, more frequent and prolonged disease episodes, and increased severity of disease. Likewise, infections can aggravate or precipitate malnutrition through decreased appetite and food intake, nutrient malabsorption, nutrient loss or increased metabolic needs. Another issue is that infections (as well as overweight and obesity status) affect nutritional biomarkers making it difficult to assess the real magnitude of some nutritional problems. This is the case of vitamin A. Vitamin A deficiency is defined to be of severe public health importance if 20% or more of a defined population has a serum retinol concentration of less than 0.7 µmol/L. However, circulating concentrations of serum retinol are reduced by infections and in such situations serum retinol concentration is not a good indicator of vitamin A status. Serum acute-phase proteins can indicate the severity and duration of an infection. Correcting vitamin A deficiency is addressed in Ethiopia through vitamin A supplementation of children, dietary diversity and using bio-fortified foods. However, assessing vitamin A status, and the effectiveness of government interventions, is challenging in settings where infectious diseases are endemic, as in most area of the country. Evaluation of vitamin A status is relatively insensitive when based on changes in serum retinol concentrations, which are homeostatically controlled and negatively affected by subclinical infections. Liver stores of vitamin A, the best indicator of vitamin A status, cannot be routinely evaluated. The isotope dilution technique is the preferred method for determining vitamin A status and assessing the efficacy and effectiveness of intervention programs aimed at improving vitamin A status. It is the only indirect assessment method that provides a quantitative estimate of vitamin A status across the continuum of deficient to excessive stores.