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NCT ID: NCT04327843 Completed - Schizophrenia Clinical Trials

Reducing the Burden of Chronic Psychotic Disorders in Tanzania (CAPACITY)

CAPACITY
Start date: November 5, 2019
Phase: Phase 3
Study type: Interventional

The proposed, three phase project will refine and test a first-ever care approach in SSA that combines LAI with a behavioral program specifically intended to promote medication adherence in chronic psychotic disorders (CPDs). In addition to the novel focus, innovative elements include: 1.) a manualized curriculum that targets specific barriers and facilitators to medication adherence in Tanzanians with CPD, 2.) targeting known, high-risk individuals with CPD (those who miss ≥20% of prescribed antipsychotic medication, and 3.) using existing injection clinic health workers to deliver the adherence promotion program. Strengths include the highly generalizable methods and use of LAIs that are available in low-resource settings.

NCT ID: NCT04325542 Completed - Hepatitis B Clinical Trials

Prevalence of HBV in Pregnant Women Attending Antenatal Care in Tanzania

HBVPMTCT
Start date: October 1, 2014
Phase: N/A
Study type: Interventional

Chronic Hepatitis B virus (HBV) infection is a neglected disease with devastating consequences, particularly in countries with limited resources for the health sector. Mother-to-child-transmission (MTCT) is responsible for around 50 % of the HBV infections in Tanzania which, in 90 % of the cases, lead to a chronic HBV infection of the child. This infection rate could be reduced with an active immunization directly after birth which is recommended by the World Health Organization (WHO). However, the Tanzanian national immunization programme schedules the first Hepatitis B vaccination for the fourth week after birth which is too late to prevent a perinatal transmission. The aim of the study is to determine the prevalence of Hepatitis B surface antigen (HBsAg) in pregnant women in rural and urban study sites in the region of Mwanza, Tanzania. The blood from the positive -testing mothers should be further examined for viral load, genotype of the virus and for liver transaminases in order to conceive a better understanding of the progression of the infection. Beside the laboratory parameters, risk factors for the infection should be determined with the use of a questionnaire. Furthermore we would like to assess the number of children who were already infected, during the intrauterine period or during birth.

NCT ID: NCT04233242 Completed - HIV-1-infection Clinical Trials

Genotype-Informed Versus Empiric Management of VirEmia

GIVE MOVE
Start date: March 3, 2020
Phase: N/A
Study type: Interventional

HIV infection can be effectively controlled with antiretroviral therapy (ART). However, children and adolescents living with HIV and receiving ART suffer high rates of treatment failure, predominantly caused by suboptimal adherence to therapy and/or viral drug resistance. While high-income countries routinely use genotypic resistance testing (GRT) to determine which drug combinations are likely to be effective, this diagnostic tool is relatively costly and labour-intensive and is not routinely available in most resource-limited settings. GIVE MOVE is a multi-country (Lesotho, Tanzania) randomised clinical trial assessing if rapid GRT after detecting an unsuppressed viral load improves the clinical management and thus health outcomes for children and adolescents living with HIV. Children and adolescents with an unsuppressed viral load despite ART are enrolled and randomly allocated to a control or an intervention arm (50% of participants in each arm). The control arm receives care according to the current standard of care, consisting of three sessions of enhanced adherence counselling at monthly intervals, followed by a second viral load test. Onward treatment is informed by the outcome of this viral load test alongside empirical guidelines and clinical judgement. The intervention arm receives GRT and GRT-informed onward therapy. Participants in the intervention arm also receive three sessions of enhanced adherence counselling, which is informed by GRT results (i.e., if no drug resistance is detected, there is a high chance of suboptimal adherence to ART and this can be directly addressed). This trial will assess if the rapid provision of GRT improves participants' health outcomes at 9 months after enrolment. A nested study will assess the cost and cost-effectiveness of GRT. Thus, this trial will provide evidence on whether the provision of GRT for children and adolescents with HIV should be prioritised in resource-limited settings.

NCT ID: NCT04160169 Completed - Contraception Clinical Trials

Counseling on Injectable Contraception and HIV Risk in Tanzania

Start date: September 1, 2018
Phase:
Study type: Observational

The main objective of the evaluation was to assess the effect of providing injectable and HIV risk counseling messages on contraceptive knowledge and behavior during a three month pilot intervention in ten healthcare facilities in Tanzania.

NCT ID: NCT04129840 Completed - Clinical trials for Arterial Hypertension

Identifying Most Effective Treatment Strategies to Control Arterial Hypertension in Sub-Saharan Africa

coArtHA
Start date: March 5, 2020
Phase: N/A
Study type: Interventional

This study is to compare the effectiveness of three different antihypertensive treatment strategies for reaching a target blood pressure (clinic BP) of </= 130/80 mmHg among patients <65years of age and </= 140/90 mmHg among patients >/=65years of Age in HIV-positive and HIV-negative patients with uncomplicated arterial hypertension in rural Tanzania and Lesotho.

NCT ID: NCT04124055 Completed - MDR-TB Clinical Trials

Saliva and Dried Blood Spot Therapeutic Drug Monitoring for MDR-TB in Tanzania

Start date: September 24, 2019
Phase: N/A
Study type: Interventional

Dried blood spot and saliva samples are collected during multidrug resistant tuberculosis (MDR-TB) treatment to measure the drug concentration of levofloxacin. Feasibility of both analytical procedures in a high burdened setting is explored.

NCT ID: NCT04095806 Completed - Stroke Clinical Trials

Zanzibar Stroke Study: Narrowing the Gaps in Hypertension Care, and Improving Stroke Outcomes (ZanStroke)

ZanStroke
Start date: October 1, 2019
Phase:
Study type: Observational

Background: A previous study in Zanzibar (which Jutta Adelin Jorgensen, PI of ZanStroke, led) showed a high prevalence of hypertension among adults at 33%, in fact higher than average in Sub-Saharan Africa (SSA), and poor performance of the health systems with nearly 90% of people with hypertension not achieving adequate blood pressure control. Uncontrolled hypertension (HTN) and stroke have already become among the commonest causes of admission to and death at hospital in Zanzibar. At the same time, there is little or no data available to quantify the stroke burden on types, treatment and outcomes, cost of stroke care, nor a comprehensive understanding of the causes of poor hypertension control in the population.The Tanzanian Stroke Incidence study (which Richard Walker from Newcastle University led) showed some of the highest stroke incidence rates in the world. However, there are many unanswered questions, and the Zanzibar Stroke Study will be a unique opportunity to look at all stroke admissions from a large island population. Zanzibar Stroke Study: The hypotheses investigated are 1a. Current challenges in stroke care cannot exclusively be explained by limited structural resources, and care delivering processes play an essential role. 1. b. Current organization and quality of care for stroke including rehabilitation could benefit from being aligned with best practices for low resource settings. 2. a. Stroke types, causes, and prognosis are dominated by a higher proportion of hemorrhagic strokes, associated to poorly controlled hypertension, higher 30-day mortality, and worse prognosis in terms of disability and mortality at 12 months than seen in high income settings. 2b Long term stroke outcome is not only depending on stroke severity but also on sociodemographic/economic factors with worse prognosis for the poorest part of the population. 3a. There is a significant first stage delay due to local perceptions and beliefs around stroke which prohibits biomedical treatment in the prognostically important acute phase of stroke 3b. There are untapped resources in the community that could be leveraged to increase adherence to medical treatment to control BP to prevent stroke and re-stroke, as well as making rehabilitation accessible 4a. Introducing a hypertension care package at lowest primary care level for people at high cardiovascular disease (CVD) risk to prevent stroke and re-stroke is cost-effective, affordable, and possible. 4b. With no intervention, the cost of stroke care at hospital level will in 10 years exceed the cost of all reproductive and child health (RCH) services. ZanStroke is an observational, prospective study of stroke admissions to hospitals in Zanzibar (Unguja) enrolling all patients with a recent stroke (< 30 days) over a period of one year to investigate the burden of stroke disease, risk factors and outcome up till 12 months post-stroke. This will be done through establishing a stroke patient register. Participant data will include sociodemographic and -economic information, vascular risk factors and previous medical history, routine head-CT, routine biochemical results and other investigations, as well as early and long-term outcomes (deaths, disability, independence/functionality, quality of life, cognition, medicine adherence, rehabilitation therapy, re-stroke). Approximately 80% of stroke patients in Unguja, Zanzibar who seek hospital care are admitted to the main hospital and the nearby private hospital, and these will undergo CT head scan, but this will not be possible in all of the other six hospitals. We will take blood samples and store serum and deoxyribonucleic acid (DNA) for potential future analysis from the main hospital and the nearby private hospital only. In addition to the clinical epidemiological research, qualitative and health economic evaluation research will be undertaken to understand stroke patients and caretakers life worlds and perspectives, health care providers skills and practices, organization and processes of stroke care at hospital level, and to define a set of most cost-effective interventions to prevent and treat stroke in the particular Zanzibar context.

NCT ID: NCT04090554 Completed - Esophageal Diseases Clinical Trials

Cytosponge™ Feasibility Study in Tanzania

CytoSCCAPE
Start date: September 24, 2019
Phase: N/A
Study type: Interventional

A Tanzanian pilot study to test the feasibility of using the Cytosponge™ device - a less-invasive endoscopy alternative - for research on esophageal squamous cell carcinoma in African settings.

NCT ID: NCT04089423 Completed - Clinical trials for Diagnosis of Tuberculosis in People Living With HIV

FujiLAM Prospective Evaluation Trial

Start date: December 13, 2019
Phase:
Study type: Observational

This is a prospective, multicentre cohort study in which the accuracy and the diagnostic yield of the FujiLAM test will be assessed using a microbiological reference standard, an extended microbiological reference standard and a composite reference standard among inpatient and outpatient people living with HIV (PLHIV).

NCT ID: NCT04071873 Completed - HIV Clinical Trials

A Novel Approach to Community-based HIV Testing With Traditional Healers in Mwanza, Tanzania

Start date: October 14, 2019
Phase: N/A
Study type: Interventional

HIV antiretroviral therapy (ART) has the potential to dramatically decrease HIV transmission worldwide. In Tanzania, HIV prevalence is ~5%, with 1.6 million people living with HIV/AIDS; it is the leading cause of hospitalization and death among Tanzanian adults. However, less than 50% of HIV-infected Tanzanian adults know their status.Successful implementation of community-based services requires an understanding of the social and cultural context that influence community engagement with HIV services. Specifically, many HIV endemic regions are also medically pluralistic communities, where multiple explanatory frameworks for health and disease co-exist. In these areas, HIV testing and ART clinical care do not occur in isolation; traditional healers are commonly utilized instead of or concurrently with biomedical services. Therefore, the success of decentralized, community-based HIV services must be founded upon a thorough understanding of medical pluralism, and engagement with traditional healers as stakeholders in community health. This study will investigate the feasibility of involving traditional healers in HIV testing, and pilot an intervention to expand HIV testing within communities that use traditional medicine in Mwanza, Tanzania.