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NCT ID: NCT02344498 Active, not recruiting - Hepatitis B Clinical Trials

Treatment of Hepatitis B in Resource-limited Settings - a Pilot Program in East Africa

Start date: January 2015
Phase:
Study type: Observational

Viral hepatitis kills nearly one million people each year, even though effective treatment exists. The aim of this study is to establish a treatment protocol for hepatitis B, which is simple and cheap enough to be implemented in resource-limited settings.

NCT ID: NCT02311699 Completed - HIV Clinical Trials

Using Cultural Ceremonies to Reduce Intimate Partner Violence and HIV Transmission

Start date: December 2014
Phase: N/A
Study type: Interventional

Violence against women (VAW), the most extreme manifestation of the unequal power balance between women and men, is a major global public health concern. One of the most common forms of VAW is that perpetrated by a husband or other intimate partner. In Ethiopia, 70.9% of women reported having experienced physical and/or sexual intimate partner violence (IPV) in their lifetime, demonstrating the pervasiveness of the problem. A growing body of evidence has also linked IPV and HIV risk. This study is a cluster randomized controlled trial assessing the impact of a community-based intervention focused on Intimate Partner Violence and HIV delivered in the context of the Ethiopian coffee ceremony, a culturally established forum for community discussion and conflict resolution. Villages will be randomly assigned to one of 4 study arms (3 intervention and one control arm): 1) Women only participate in the intervention, 2) Men only participate, 3) Both men and women (couples) participate, 4) Women and men receive the control intervention comprising a short informational session on violence reduction.

NCT ID: NCT02308956 Completed - Schizophrenia Clinical Trials

Task Sharing for the Care of Severe Mental Disorders in a Low-income Country

TaSCS
Start date: March 2015
Phase: Phase 3
Study type: Interventional

Task sharing mental health care through integration of mental health into primary health care (PHC) is advocated as a means of narrowing the treatment gap for mental disorders in low-income countries. In Ethiopia, it is estimated that only around 10% of people with severe mental disorders (SMDs) ever receive evidence-based treatment for their condition, largely due to scarcity of specialist mental health services. A task-sharing model of mental health care in PHC would be more affordable and accessible to the majority of persons with SMD who do not currently receive evidence-based mental health care. Furthermore, task sharing mental health care with PHC is about to be scaled up in Ethiopia in line with the National Mental Health Strategy. However, the effectiveness of the task sharing model of mental health care for people with SMD has not been evaluated systematically in a low-income country. In this study we propose to investigate non-inferiority of a task sharing model of mental health care in PHC compared to a less accessible, but more specialist, psychiatric nurse-led model of care. The specialist model of care has been demonstrated to be acceptable and associated with improved clinical outcomes for persons with SMD engaged in the service in Ethiopia thus making this an appropriate comparison model against which to evaluate non-inferiority of the task sharing model.

NCT ID: NCT02216123 Completed - Malaria, Vivax Clinical Trials

Study to Assess the Incidence of Hemolysis, Safety, and Efficacy of Tafenoquine (SB-252263, WR238605) Versus Primaquine in Subjects With Plasmodium Vivax Malaria

Start date: April 30, 2015
Phase: Phase 3
Study type: Interventional

This is a prospective, double-blind, double-dummy, multicenter, comparative study. A total of 300 subjects will be randomized to treatment on Day 1, of which a minimum of 50 female subjects must be enrolled that display moderate glucose-6-phosphate dehydrogenase (G6PD) deficiency (>=40% - <70% of the site median G6PD value). Subjects must have a blood smear that is positive for P. vivax at entry. Subjects will be randomized 2:1 to receive tafenoquine (TQ)/chloroquine(CQ) or the active comparator primaquine (PQ)/CQ. All subjects will receive CQ on Days 1 to 3, followed by TQ or PQ and matching placebo beginning on Day 1 or 2. Tafenoquine, or matching placebo, will be given as a single, 300mg dose. Subjects will receive PQ (15mg once daily) or matching placebo for 14 days. The duration of the study is 180 days, including screening and randomization to treatment (Day 1), three in-hospital days (Days 1-3), four out-patient visits while on treatment with study medication (Days 5, 8, 11 and 15) and seven follow-up visits (Days 22, 29, 60, 90, 120, 150 and 180). The primary safety data collected in this study will help to understand the hemolysis risk to both G6PD-normal and G6PD-deficient subjects. The efficacy data produced from this study will support the results for sister study TAF112582, the pivotal phase III efficacy and safety study of the TQ program.

NCT ID: NCT02210884 Completed - Clinical trials for Vitamin D Deficiency

Maternal Vit D Supplements & Infant and Maternal Biomarkers & Outcomes in Southern Ethiopia

Start date: October 2014
Phase: N/A
Study type: Interventional

Synthesis of vitamin D in the skin through the action of sunlight is a major source of vitamin D in parts of the world where foods are not fortified with the vitamin. Skin pigmentation (color), dress habits and season are some of the factors that limit sun exposure and affect vitamin D synthesis in the skin. Maternal vitamin D status is especially important to meet infant needs when newborns are not supplemented with vitamin D. In Ethiopia, vitamin D status of lactating women and infants and breast milk vitamin D concentration have never been assessed. The purpose of this study is to assess changes in maternal and infant markers of vitamin D status before and after vitamin D supplementation of the lactating mothers.

NCT ID: NCT02202343 Completed - Behaviour Clinical Trials

Effectiveness of School-based Health and Nutrition Education to Improve Health and Dietary Practices of Primary School Children From Jimma Zone

Start date: October 2013
Phase: N/A
Study type: Interventional

School based Health and Nutrition Education (SHNE) is a key component of school health and nutrition programs that can address several health and nutrition issues in Ethiopia.

NCT ID: NCT02160249 Completed - Schizophrenia Clinical Trials

RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia)

RISE
Start date: September 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether community-based rehabilitation plus facility-based care is superior to facility-based care alone in reducing disability related to schizophrenia in rural Ethiopia.

NCT ID: NCT02150980 Completed - Clinical trials for Fractures or Dislocations

INternational ORthopaedic MUlticenter Study in Fracture Care (INORMUS)

INORMUS
Start date: April 2014
Phase:
Study type: Observational

Background: Worldwide, injuries from trauma represent a major public health problem. The World Health Organization (WHO) has deemed this problem as one of the most important global priorities, calling 2011-2020 the 'Decade of Action for Road Safety'. Despite this, there is little empirical data in low and middle-income countries quantifying the burden of musculoskeletal injuries. Methods: INORMUS is a global, prospective, multi-center, observational cohort study. The primary objective of the study is to determine the mortality, re-operation and infection rates of musculoskeletal trauma patients within 30 days post-hospital admission. The INORMUS study seeks to enroll 40,000 patients from low-middle income countries in Africa, Asia, and Latin America.

NCT ID: NCT02084225 Active, not recruiting - Pain Management Clinical Trials

Ultrasound Guided Regional Anesthesia for Acute Injury in Low Resource Settings

Start date: January 2012
Phase: N/A
Study type: Observational

The purpose of this study is to determine feasibility, perceived utility and sustainability of training local providers in ultrasound guided regional anesthesia for acute pain management in a limited-resource conflict setting.

NCT ID: NCT02034162 Completed - Helminth Infections Clinical Trials

A Study to Assess the Efficacy and Safety of Mebendazole for the Treatment of Helminth Infections in Pediatric Participants

Start date: December 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of mebendazole compared with placebo in pediatric participants with Helminth infections.