Clinical Trials Logo

Filter by:
  • Enrolling by invitation  
  • Page [1]
NCT ID: NCT05746819 Enrolling by invitation - Malaria Clinical Trials

An MRI Ancillary Study of a Malaria Fever Investigation

MRIA
Start date: January 2, 2021
Phase:
Study type: Observational

This study will seek consent from parents of children enrolled in the Malaria FEVER study to obtain neuroimaging and 12-month neuropsychiatric outcomes data and kidney function on their child. The imaging and evaluations for this observational study will occur after the child has recovered from the acute malaria infection and has otherwise completed the RCT intervention and safety evaluations.

NCT ID: NCT05119959 Enrolling by invitation - Child Development Clinical Trials

Zambia Infant Cohort Study - Brains Optimized for Surviving and Thriving

ZICS-BOOST
Start date: April 14, 2022
Phase: N/A
Study type: Interventional

Children exposed to HIV in-utero but uninfected (CHEUs) number 14.8 million globally. In Zambia, an estimated 56,000 CHEUs are born annually, a staggering fraction of the national birth cohort. Multiple studies establish that CHEUs are more neurodevelopmentally vulnerable than HIV-unexposed peers. In Zambia, there are existing effective early childhood developmental (ECD) interventions that target other vulnerable populations, but never trialed specifically for CHEUs. Scaling up ECD is now a priority of Zambia's national strategy, but CHEUs are not currently targeted. There is a need to better understand the scope and mechanism of CHEU-related neurodevelopmental differences and what interventions are most effective. This randomized clinical trial (RCT) is a true effectiveness trial as the intervention will deploy a home-based adaptation of the same curriculum that is currently used elsewhere in the country, named Scaling Up Early Childhood Development In Zambia (SUPERCDZ). The effectiveness of a scalable early childhood development (ECD) intervention for CHEUs will be evaluated using normalized Z-scores of neurodevelopmental testing at age 24 months. In this RCT the investigators will test the following hypotheses: Hypothesis 1: An ECD intervention delivered by community health workers via bi-weekly home visits will improve neurodevelopmental outcomes in CHEUs. Hypothesis 2: CHEUs have significantly worse neurodevelopmental outcomes than unexposed peers at 24 months, mediated by preterm birth, disease stage or antiretroviral (ARV) exposure. This RCT will build on an existent, actively recruiting cohort of 1500 pregnant women-infant dyads in a peri-urban hospital in Zambia, the Zambian Infant Cohort Study (ZICS), by extending the follow-up of a subsample of infants from 6 months to 2 years amongst the last 525 children enrolled (ZICS-BOOST- Brains Optimized to Survive and Thrive). The study will have three arms: Arm 1) CHEU + ECD intervention (n=175); Arm 2) CHEU without ECD intervention (n=175); Arm 3) HUU without intervention (n=175).

NCT ID: NCT03739736 Enrolling by invitation - Tuberculosis Clinical Trials

TB Reduction Through ART and TB Screening Project

TREATS
Start date: June 12, 2018
Phase:
Study type: Observational

Tuberculosis (TB) has overtaken HIV as the leading infectious cause of death worldwide and requires a major policy shift for it to be controlled in line with the WHO Stop-TB goal to "end TB". However, how to control TB at population level in the context of HIV, is unknown. Some of the best evidence to date comes from the Southern African ZAMSTAR trial, where a household-level TB /HIV intervention including TB symptom screening, HIV counselling and testing with linkage to care and isoniazid preventive therapy (IPT) as indicated, was offered to all household members of TB patients. Despite only reaching ~6% of households in the intervention communities, the data showed a nearly 20% reduction in TB disease prevalence and 50% reduction in TB infection incidence at the population-level. Increasing the scope of the intervention to all households and thus all community members, may therefore significantly change the burden of TB and "end TB". The proposed TREATS project builds on the experience of ZAMSTAR and is nested within the ongoing HPTN 071 (PopART) trial (NCT01900977), the largest ever trial of a combination HIV/TB prevention intervention being conducted in Zambia and South Africa. The project consists of 4 linked studies that will provide definitive cluster-randomised evidence of the effect of a household-level combined HIV and TB prevention intervention on the burden of TB at population level. The project will produce two major outputs of global importance to public health policy. The first will provide definitive evidence of the effectiveness of scaled up combination TB/HIV prevention interventions on TB. The second output will improve understanding of the best ways to measure the impact of public health interventions on TB burden. This is a unique opportunity to assess the impact of combination HIV prevention, including universal HIV testing and treatment, combined with population screening for active TB on the burden of TB. The HPTN071(PopART) trial,a cluster randomised trial in 21 communities in Zambia and South Africa with a population size of approximately 1 million individuals, is unlikely ever to be repeated. The recently adopted WHO guidelines of a "universal treatment" strategy for HIV, will prompt policy-makers to seek strategies of case-finding for HIV offering an opportunity to conduct TB screening on a large scale. The results from the TREATS project will therefore provide unique and timely information of the additional costs and benefits of combined TB and HIV prevention strategies at population level. TREATS will also assess novel methods to measure the effect of interventions on burden of TB in the trial communities. The latest interferon gamma release assay QuantiFERON® Gold Plus will be assessed for measuring impact of TB interventions on incidence of infection. A combination of Xpert® MTB/RIF and computer aided digital X-ray (CAD4TB) will be assessed for measuring prevalence of active TB. These new methods will provide important information about the best way of measuring TB incidence and prevalence rates and allow triangulation of the different methods to inform global estimates of TB burden in the post MDG era. The TREATS consortium will stimulate synergy between leading African research groups (Zambart, HST); new European technology (Delft Diagnostic Imaging, Qiagen); international TB bodies (The Union) and European research centres (LSHTM, Imperial College, Sheffield University and KNCV), as well as with the US funders of the HPTN071/PopART trial.