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NCT ID: NCT04904549 Active, not recruiting - COVID-19 Clinical Trials

Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older

VAT00008
Start date: May 26, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this Phase III study is to assess the efficacy, safety, and immunogenicity of two CoV2 preS dTM-AS03 vaccines (monovalent and bivalent) as part of primary series vaccinations in a multi-stage approach, as well as a booster injection of a CoV2 preS dTM-AS03 vaccine, in adults 18 years of age and older. A total of approximately 21 046 participants are planned to be enrolled (5080 per study intervention group in Stage 1 and 5443 per study intervention group in Stage 2). Initial, double-blind, primary series study design is planned for 365 days post-last Initial injection (ie, approximately 386 days total) for each participant. Based on decisions of the Study Oversight Group, Stage 1 and Stage 2 participants will be invited to participate in an unblinded Crossover / Booster study design with duration as follows: - For participants who initially received vaccine: 12 months post-booster (ie, approximately 18 to 24 months) - For participants who initially received placebo: ≥ 4 months post-last dose of the primary series + 12 months post-booster (ie, approximately 28 to 34 months) - For participants who do not consent to continue in the unblinded Crossover / Booster part of the study, all study procedures will be stopped and participants will be discontinued from the study.

NCT ID: NCT04808778 Active, not recruiting - Stroke Clinical Trials

Stroke Prevention in Young Adults With Sickle Cell Anemia

SPIYA
Start date: May 17, 2021
Phase:
Study type: Observational

Sickle cell disease (SCD) is the most common genetic disease, affecting about 25 million people worldwide. Approximately 150,000 Nigerian children are born each year with sickle cell disease (SCD), making it the country with the largest burden of SCD in the world. Recent advancements in care for children with SCA have translated into improved survival of children in both high and low-resource settings. However, more complications of SCD are seen in those who survive to adulthood. Silent cerebral infarcts (SCI) and strokes are among the most devastating complications of SCD, affecting 40% and 10% of children, respectively. The overall goal of this study is to extend the Investigator's successful capacity-building effort in the assessment of neurological morbidity in children with SCD living in northern Nigeria (Kano) to young adults with SCD living in the same region. About 50% of all adults with SCD live in Nigeria. Despite the high prevalence of SCD in Africa, the neurological morbidity is not well characterized, limiting opportunities for primary and secondary stroke prevention strategies. At least 50% of young adults with sickle cell anemia (SCA), the most severe form of the disease, will have SCIs and an estimated 10% will have strokes, based on studies in high-resource settings. In high-resource settings, screening for abnormal transcranial Doppler (TCD) velocities in children with SCA, coupled with regular blood transfusion has resulted in a 92% reduction of relative risk for strokes. Despite this effective strategy, regular blood transfusion therapy does not seem sustainable in sub-Saharan Africa due to shortages and the risk of transfusion transmissible infections. Additionally, there is a lack of evidence-based stroke prevention strategies in young adults with SCA, either in the high-income or in low-resource settings. Based on the foregoing, the Investigators propose to determine the prevalence of neurological injury (overt stroke, transient ischemic attacks, and silent cerebral infarcts) in young adults at the transition age from 16-25 years. The Investigators will also, for the first time, assess conventional risk factors of stroke in the general population to determine whether a different prevention strategy is required to reduce the incidence of neurological injury in this high-risk population.

NCT ID: NCT04710784 Active, not recruiting - HIV/AIDS Clinical Trials

A Pragmatic Trial to Expand Youth-friendly HIV Self-testing

I-TEST
Start date: May 10, 2021
Phase: N/A
Study type: Interventional

The current study extends the study team's earlier efforts described in ClinicalTrail ID#: NCT04070287 and NCT03874663. The I-TEST (Innovative Tools to Expand Youth-friendly HIV Self-Testing) study known locally as the 4 Youth by Youth project, sought to develop and evaluate novel youth-friendly HIVST services in Nigeria using open challenges and apprenticeship training informed by a participatory learning collaborative model. The study thus aims to reach young Nigerians that remain undiagnosed for HIV and to facilitate linkage and retention in preventive services (includes STI testing/treatment, PrEP referral, condom use).

NCT ID: NCT04704336 Active, not recruiting - Hypertension Clinical Trials

Integration of Hypertension Management Into HIV Care in Nigeria

TASSH NIMR
Start date: September 13, 2021
Phase: N/A
Study type: Interventional

This study evaluates a tailored-practice facilitation (PF) strategy for integrating a task strengthening strategy for hypertension control (TASSH) for the care of patients living with HIV (PWH) within primary health centers (PHCs) in Lagos, Nigeria.

NCT ID: NCT04331847 Active, not recruiting - Clinical trials for Abortion Complication

Abortion-related Morbidity and Mortality in Conflict-affected and Fragile Settings Study

AMoCo
Start date: September 3, 2019
Phase:
Study type: Observational

To describe and estimate the burden of abortion-related complications, particularly near-miss complications and deaths, and their associated factors among women presenting for abortion-related complications in health facilities supported by Médecins Sans Frontières (MSF) in African fragile and/or conflict-affected settings.

NCT ID: NCT04290975 Active, not recruiting - Epilepsy Clinical Trials

Bridging the Childhood Epilepsy Treatment Gap in Africa

BRIDGE
Start date: June 16, 2020
Phase: N/A
Study type: Interventional

About half of the world's children with epilepsy do not receive treatment - known as the epilepsy treatment gap - with significantly higher rates (67%-90%) in low- and middle-income countries (LMICs). We will conduct the first cluster-randomized clinical trial (cRCT) to determine the efficacy, implementation, and cost-effectiveness of a novel intervention shifting childhood epilepsy care to epilepsy-trained community health extension workers in an effort to close the epilepsy treatment gap. This research will provide information to help extend epilepsy treatment to children in LMICs and worldwide who suffer from untreated seizures.

NCT ID: NCT04218084 Active, not recruiting - Sickle Cell Disease Clinical Trials

Study to Evaluate the Effect of GBT440 on TCD in Pediatrics With Sickle Cell Disease

HOPE Kids 2
Start date: November 11, 2020
Phase: Phase 3
Study type: Interventional

This study is a Phase 3, randomized, double-blind, placebo-controlled study of voxelotor in pediatric participants, aged ≥ 2 to < 15 years old, with Sickle Cell Disease. The primary objective is to evaluate the effect of voxelotor on the TCD (Transcranial Doppler Ultrasound) measurements in SCD participants in this age range.

NCT ID: NCT04158154 Active, not recruiting - Hypertension Clinical Trials

Transforming Hypertension Treatment in Nigeria Using a Type II Hybrid, Interrupted Time Series Design

HTN
Start date: February 1, 2020
Phase: N/A
Study type: Interventional

The purpose of the Transforming Hypertension Treatment in Nigeria Program is to improve awareness, treatment, and control of hypertension in Nigeria through the adaptation, implementation, and evaluation of the effectiveness and implementation of a system-level hypertension control program.

NCT ID: NCT04090762 Active, not recruiting - Clinical trials for Utilization, Health Care

Improving Perinatal Outcomes Using Conditional and Targeted Transfers

IMPACTT
Start date: July 8, 2019
Phase: N/A
Study type: Interventional

It has been estimated that increasing the use of skilled care during childbirth could prevent up to 1.5 million maternal and newborn deaths and stillbirths by 2025. Conditional cash transfer programs, in which women receive cash payments conditioned on the use of maternal health services, are increasingly being used as a mechanism to increase uptake. In this study, the investigators randomly assign households to receive varying cash amounts conditioned on uptake of recommended pregnancy and delivery care. The investigators crosscut this with an intervention in which pregnant women receive information about their risk type. This randomized trial will provide new evidence about the potential efficacy of targeting cash transfers by pregnancy risk. This study will take place in 288 primary health service areas (HSAs) in Nigeria.

NCT ID: NCT03017872 Active, not recruiting - HIV Infections Clinical Trials

Dolutegravir and Darunavir Evaluation in Adults Failing Therapy

D²EFT
Start date: November 23, 2017
Phase: Phase 4
Study type: Interventional

D²EFT is a randomised, open-label study in HIV-1 infected patients failing first-line antiretroviral therapy (ART). The study compares 2 regimens of second-line ART (dolutegravir and darunavir pharmaco-enhanced with ritonavir and dolutegravir and 2 prespecified NRTIs) with the WHO recommended regimen of 2NRTIs plus a ritonavir-boosted PI (Standard of Care (SOC)). 1,010 participants from 14 predominantly low-middle income countries will be followed for 96 weeks with the primary endpoint at week 48. The design is based on the hypothesis that one or both of the new regimens will be non-inferior to SOC in terms of virologic control while being easier to take, economically viable and affording simplification of treatment programs.