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NCT ID: NCT03730805 Not yet recruiting - Khat Abuse Clinical Trials

The Adaptation and Evaluation of the WHO's ASSIST-linked Brief Intervention to Khat-Using Ethiopian University Students

KhatAssist
Start date: November 15, 2018
Phase: N/A
Study type: Interventional

The leaves of the khat tree (catha edulis) are traditionally chewed in the countries around the Horn of Africa. They contain the amphetamine-like alkaloid cathinone and their use can produce a Substance Use Disorder. The researchers intent to validate an Amharic and an Oromo version of the WHO's ASSIST-linked Brief Intervention among khat-using Ethiopian university students. In an RCT, khat using students of Jimma University with initial motivation to stop or cut down khat use will be randomised to either an intervention or a control group. In the intervention group, the WHO's ASSIST-linked BI will be delivered in a single session by trained local counsellors. In the control group, participants will receive a neuropsychological assessment (Raven's Standard Progressive Matrices, SPM; Raven, 1972). Khat use, the neuropsychological variables and psychiatric symptoms will be assessed before the intervention and two weeks after it. Additionally, the researchers will measure the participants resistance during the session. The control group will receive the intervention after the post test. In order to study state variables that influence brief intervention effectivity, e.g. by increasing or reducing resistance, the researchers randomise subjects in each study arm to several short pre-interventions that are based on Gollwitzer's empirically well established Mindset Theory of Action Phases (for summary: Gollwitzer & Keller, 2016). This means, before delivering the ASSIST-linked BI (intervention group) or before the SPM assessment (controlgroup) a specific psychological state will be induced by a brief writing task that theoretically should affect the openness to the intervention: (1) implemental mindset, (2) deliberative mindset, (3) no mindset induction. The researchers expect that khat use will be reduced more in the intervention condition compared to the control condition and that induced states influence the effectiveness of the intervention.

NCT ID: NCT03681132 Recruiting - Clinical trials for Hepatitis B, Chronic

The Norwegian Nucleoside Analogue Stop Study

Nuc-Stop
Start date: September 20, 2018
Phase: Phase 4
Study type: Interventional

Globally, an estimated 257 million individuals have chronic hepatitis B-virus infection (CHB). In the absence of treatment 15-40% of these will progress to liver cirrhosis and/or hepatocellular carcinoma. Oral antiviral treatment suppresses the virus and improves prognosis, but less than 0.5% per year achieve a "functional cure" (i.e. HBsAg loss). One remaining controversy, therefore, is whether antiviral treatment must continue life-long. Observational studies have assessed stopping antiviral treatment after years of viral suppression; however, HBsAg loss has rarely been seen. But interestingly, a few small trials that chose watchful waiting instead of re-initiation of treatment when reactivation occurred, achieved 40% HBsAg loss during 6 years follow-up. The present proposal is a randomized controlled trial that will assess the safety, efficacy, and cost-effectiveness of treatment discontinuation - and delayed restart - in HBeAg negative CHB. The study is sufficiently powered to address the hypotheses, and a pilot study that demonstrates feasibility has been performed. Patients will be enrolled at 12 Norwegian hospitals, in addition to our collaborating institution in Ethiopia - the largest CHB treatment center in sub-Saharan Africa. If the study shows that discontinuation is safe and effective, it will directly impact both national and international treatment guidelines. Main objective: -To study whether stopping nucleoside analogue (NA) therapy - and delaying re-start - can trigger an immune response and set off a functional cure (viz HBsAg loss) Secondary objectives: - Assess whether stopping NA therapy - and delaying re-start - leads to a higher chance of HBsAg loss - Assess the safety of stopping NA therapy - and delaying re-start - in terms of hepatic decompensation, fibrosis progression, and/or adverse events - Study whether stopping NA therapy - and delaying re-start - leads to a higher chance of sustained off-therapy immune control (low viral load and normal ALT) - Assess the quality of life and cost-effectiveness of stopping NA therapy - and delaying re-start - Identify predictors of HBsAg loss

NCT ID: NCT03639961 Active, not recruiting - Leadership Clinical Trials

The Effect of Integrated Leading, Managing and Governing for Result Model on Maternity Health Services

Start date: May 27, 2017
Phase: N/A
Study type: Interventional

The need for leading people, managing work, and governing organizations never changed over the civilization paths of society. However, people in every pole of the globe observe: over-led and under-managed, over-managed and under-governed, and even out of these organizations. These disparities have remained worse in the health system of developing countries like Ethiopia. To date, Ethiopia put a goal of ending preventable child and maternal death, in achieving universal healthcare by 2035. Nevertheless, the investment on integrated leadership, management and governance is limited. Therefore, this study hypothesize that maternity health services are expressively linked with integrated health system leading, managing and governing for results model among health facilities staff in northwest Ethiopia?

NCT ID: NCT03627156 Recruiting - Counseling Clinical Trials

The Effect of Guided Counseling in Improving Dietary Practice, Nutritional Status and Birth Weight of Pregnant Women

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

Poor dietary intake affects maternal wellbeing, fetal growth, and development. However, many pregnant women in Ethiopia have a poor dietary intake. To improve the dietary intake of pregnant women, nutrition education is often given at the community level during a home visit and at the health institution during antenatal care. Yet, there is no evidence on the effect of nutrition education on dietary intake, nutritional status, and birth weight in the study area. Hence, the objective of this study was to evaluate the effect of guided counseling in improving dietary practice, nutritional status and birth weight of the pregnant women. A two-arm parallel cluster randomized community trial will be conducted among pregnant women in West Gojjam Zone, Amhara region, Ethiopia from May to December 2018. Baseline data on dietary practice and nutritional status of pregnant women will be collected from May to July 20/2018 (10weeks). Endline data will be collected from October to December 30. Guided counseling using health belief model and theory of planned behavior will be implemented in the intervention arm (11 clusters) for 10 months. Pregnant women will be selected using a cluster sampling method. A validated interviewer-administered structured questionnaire will be used for collecting data on the study subjects both at the baseline and after the intervention. Data will be checked, coded and double entered into Epi-Info version 7.2.2 and exported to SPSS version 23 for statistical analysis. The outcome of the study finding will be useful for health and nutrition policymakers and other concerned bodies in decision making and to design effective intervention strategies to improve dietary practices of pregnant women as a result to prevent malnutrition. 19,553 US dollar is needed to conduct the study.

NCT ID: NCT03612362 Recruiting - Clinical trials for Acute Respiratory Infection

Impact of Improved "Injera" Baking Stove Use on Childhood Acute Respiratory Infection Prevention in Northwest Ethiopia

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

In Ethiopia, great majorities (95%) of households rely on solid biomass fuels such as wood, muck, crop residues, and charcoal burned in highly polluting stoves to meet the basic household energy needs with its severe health consequences due to emission of toxic indoor air pollutants. Correspondingly, household air pollution (HAP) from biomass fuel use is now estimated to be responsible for nearly 3.5 million premature deaths annually, with the highest disease burdens experienced by countries in sub-Saharan Africa. HAP ranks as the highest environmental risk factors to premature deaths globally and 2nd leading risk factor next to childhood underweight in most of sub-Saharan Africa countries as well as 3rd leading risk factor of disease next to childhood underweight, and suboptimal breastfeeding in Ethiopia. Usually prevention efforts aimed at reducing HAP and related health burdens have been focused on the use of energy efficient cookstoves. There is, however, rigorous lack of evidence in Ethiopia or in other similar settings whether it is possible to achieve adequate HAP reduction and improve health with locally made energy efficient baking stoves from a public health point of view. Particularly, the popular Ethiopian energy efficient "Injera" baking stove has not been researched through stove trial inquiry. Therefore, research studies are required in Ethiopia on health benefits achieved when households adopt energy efficient baking stoves. In view of that, cluster randomized controlled trial will be employed with experimental study design for one year to test the effectiveness of the Ethiopian improved "Injera" baking stove intervention on reducing HAP and childhood acute respiratory infection (ARI) through comparing equal size groups of children before and after part of households received an improved "Injera" baking stove. Accordingly, the proposed stove trial aims to address an important research gap by determining whether the Ethiopian improved "Injera" baking biomass stove intervention can adequately reduce HAP exposure to prevent childhood acute respiratory infection. With this objective, the proposed stove trial will test the hypothesis that there is a statistically significant difference in HAP levels and incidence of childhood ARI when using traditional versus improved "Injera" baking stove in Northwest Ethiopia

NCT ID: NCT03590717 Recruiting - Malnutrition Clinical Trials

Impact Evaluation of WFP's Fresh Food Voucher Pilot Programme in Ethiopia

Start date: June 27, 2018
Phase: N/A
Study type: Interventional

To assess the impact of WFP's Fresh Food Voucher Pilot Programme in Ethiopia on children's and mother's diets

NCT ID: NCT03585361 Completed - Pregnancy Clinical Trials

Utilizing All Health System Contacts to Offer Postpartum Family Planning (PPFP) in Ethiopia

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

This study is investigating whether use of postpartum family planning (PPFP) increases if messages on PPFP and, if desired, PPFP services are integrated into as many contacts as possible between women/couples and the health system during pregnancy and the first year after birth. Health system contacts may be at health facilities (including antenatal, labor and delivery, postnatal, and child immunization visits) or, with Ethiopia's Health Extension Program, at households or health posts in the community.

NCT ID: NCT03549754 Recruiting - Type 2 Diabetes Clinical Trials

DISCOVER Global Registry

Start date: February 17, 2018
Phase:
Study type: Observational [Patient Registry]

To provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes and established micro- and/or macrovascular disease

NCT ID: NCT03523156 Not yet recruiting - Trachoma Clinical Trials

Trachoma Elimination Study by Focused Antibiotic (TESFA)

Start date: December 2018
Phase: Phase 4
Study type: Interventional

The study population consists of all households residing in eligible kebeles (sub-districts) within districts in Amhara National Regional State which are identified as having a high prevalence of trachoma and infection measured from recent trachoma impact assessments. Within each study kebele, one village will be randomly selected to serve as the sentinel study site for that kebele. Once these villages are chosen, the study team will use government-provided census records, or perform a census in each village, and will randomly choose 50 children to serve as the sentinel children for the study. After the baseline visit, all kebeles will be randomized into one of the two treatment arms to either receive standard-or-care treatment, which is an annual community-wide mass drug administration (MDA), or the enhanced antibiotic treatment. Recruitment will take place at the selected children's household. Oral informed consent will be sought from village leader/chairmen before surveys are conducted in a village. Oral informed consent will then be obtained from household heads of those houses included in the study; and then from each participating individual. Oral consents will be obtained given the low literacy rates in rural Amhara. Data collection will occur at baseline, week 4, month 12, and month 24 in both arms of the study. A head of household will be asked a series of household level questions, which will be followed by a household-level census, where all consenting participants residing in the selected households will have their eyes examined for trachoma signs. This is a non-invasive procedure whereby a trained trachoma grader flips each eyelid and examines for trachoma signs. Lastly, the selected child and one randomly selected adult will have their right eye lid swabbed for evidence of trachoma infection. The total estimated respondent burden is 30 to 45 minutes.

NCT ID: NCT03506698 Recruiting - Low Birth Weight Clinical Trials

Kangaroo Mother Care Implementation Research for Accelerating Scale-up

Start date: June 15, 2017
Phase:
Study type: Observational

The implementation research project aims to develop and evaluate models for scaling up KMC in health facilities across India and Ethiopia and thereby develop effective approaches to achieve high population coverage