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NCT ID: NCT05580666 Recruiting - Clinical trials for HIV Disease Progression

Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)

REVIVE
Start date: May 8, 2023
Phase: Phase 3
Study type: Interventional

A double blinded, placebo-controlled, multicenter trial to evaluate effectiveness of azithromycin prophylaxis on mortality in advanced HIV.

NCT ID: NCT05531448 Active, not recruiting - Retention in Care Clinical Trials

Two-way Texting (2wT) to Improve Antiretroviral (ART) Patient Retention in Malawi

Start date: December 16, 2022
Phase: N/A
Study type: Interventional

Investigators aim to demonstrate that interactive, two-way texting (2WT) to remind patients about their clinic visits and engage patients in their health can increase antiretroviral therapy (ART) retention in a routine setting in Lilongwe Malawi.

NCT ID: NCT05510973 Active, not recruiting - Clinical trials for AIDS-related Kaposi Sarcoma

Evaluation of Advanced HIV Disease Differentiated Care Model in Malawi

Start date: June 1, 2021
Phase: N/A
Study type: Interventional

This study will evaluate the implementation of an enhanced package of care, CD4 and tuberculosis lipoarabinomannan (TB-LAM) tests and the initiation of patients on TB prophylaxis [TPT and CPT], on retention in care and viral suppression ((<50 copies/ml) at 6 and 12 months after AHD care and treatment enrollment. The study will also assess the change in AHD screening, management and service uptake indicators among PLHIV clients before and after implementation of the QI collaborative implementation (QICI) project, evaluate the acceptability and feasibility of the AHD package of care among patients and HCWs providing related health services, and conduct a cost analysis of implementing the enhanced AHD package of care in a hub-and-spoke implementation of care model.

NCT ID: NCT05480800 Recruiting - Clinical trials for Salmonella Infections

A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever

Start date: September 13, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, reactogenicity, and immune response induced by the GlaxoSmithKline Biologicals SA (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid conjugate (iNTS-TCV) candidate vaccine to be administered for the first time in humans. The study intervention will be evaluated in European adults in Stage 1 (a 2-step staggered design) followed by African adults in Stage 2.

NCT ID: NCT05478720 Recruiting - Malaria, Cerebral Clinical Trials

DON in Pediatric Cerebral Malaria

Start date: August 16, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the safety of a single intravenous dose of DON in healthy adults, adults with uncomplicated malaria, and children 6 months-14 years old with clinically defined Cerebral Malaria. The main objectives are: - Determine the pharmacokinetic (PK) profile of a single dose of DON in children with CM - Determine if administration of a single intravenous dose of DON as an adjunctive therapy in children with CM is associated with improved intracerebral blood flow dynamics on transcranial doppler (TCD) - Determine if administration of a single intravenous dose of DON as an adjunctive therapy in children with CM is associated with a reduction in brain volume score on magnetic resonance imaging (MRI) - Determine if administration of a single intravenous dose of DON as an adjunctive therapy in children with cerebral malaria is associated with changes in electroencephalogram (EEG) pattern - Exploratory: Explore the metabolic mechanisms of action of adjunctive DON in children with CM Healthy adult participants will receive: - anti-emetic ondansetron - one dose of DON Adults with uncomplicated malaria will receive: - anti-emetic ondansetron - one dose of DON - artemisinin-combination therapies per Malawi Ministry of Health guidelines Pediatric participants will receive: - one dose of DON - anti-emetic ondansetron and per Malawi Ministry of Health guidelines - enteral lumefantrine therapy, and - artesunate therapy

NCT ID: NCT05452616 Active, not recruiting - Clinical trials for Human Immunodeficiency Virus (HIV) Infection

Same-day Versus Rapid ART Initiation in HIV-positive Individuals Presenting With Symptoms of Tuberculosis

SaDAPT
Start date: October 19, 2022
Phase: N/A
Study type: Interventional

SaDAPT is a pragmatic, randomized, therapeutic-use trial comparing two approaches ("ART first" versus "TB results first") for the timing of ART initiation in PLHIV with presumptive TB, but no signs of central nervous system (CNS) disease, in a routine primary and secondary care setting in southern Africa with regard to HIV viral suppression (VL <400 copies/mL) 26 weeks after enrolment.

NCT ID: NCT05409274 Completed - Covid19 Clinical Trials

Understanding COVID-19 Infections in Pregnant Women and Their Babies in 5 African Nations (periCOVID Africa)

Start date: November 1, 2020
Phase:
Study type: Observational

Develop coronavirus disease 2019 (COVID-19) surveillance in pregnancy in The Gambia, Kenya, Malawi, Mozambique and Uganda Estimate the seroepidemiology of COVID-19 infection among pregnant women in these countries Define the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in pregnant women and their babies and determine the presence of antibodies in cord blood Work with communities to develop understanding of infection prevention and control techniques to reduce the spread of COVID-19 amongst the pregnant population

NCT ID: NCT05383742 Recruiting - Clinical trials for Tuberculous Meningitis

Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide Versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents With Tuberculous Meningitis

Start date: December 7, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare a 6-month regimen of high-dose rifampicin (RIF), high-dose isoniazid (INH), linezolid (LZD), and pyrazinamide (PZA) versus the World Health Organization (WHO) standard of care (SOC) treatment for tuberculosis meningitis (TBM).

NCT ID: NCT05361122 Recruiting - Prematurity Clinical Trials

Prevention of Developmental Delay and Xylitol (PDDaX) Study

Start date: April 4, 2023
Phase: N/A
Study type: Interventional

The goals of this study are to: evaluate and validate the low-cost, transportable, easily-administered Malawi Developmental Assessment Tool (MDAT) for neurodevelopmental assessment of children aged 4-8 years old in Malawi, as compared to the gold-standard yet more cumbersome and costly Kaufman Assessment Battery for Children-II (KABC-II) among (1) n=500 formerly preterm children and (2) n=500 formerly term children. Additionally, we will evaluate the effects of gestational xylitol exposure compared to a lack of gestational xylitol exposure on neurodevelopmental outcomes of children aged 4-8 years old in Malawi through the following four neurodevelopmental tests: (3) KABC-II (cognitive outcomes), (4) EF Touch (executive functions), (5) Strengths and Difficulties Questionnaire (social-emotional outcomes), and (6) MDAT (motor and cognitive outcomes). The researchers will leverage subjects who completed the parent Prevention of Prematurity and Xylitol Trial, which enrolled 10069 pregnant individuals in Malawi and demonstrated a significant 24% reduction in incidence of preterm birth and low birthweight offspring in gravidae who chewed xylitol-containing chewing gum compared to those who did not. By ensuring that these offspring did not have higher rates of neurodevelopmental impairment, the study will promote promising multi-center international and domestic trial evaluating the impact of xylitol-containing chewing gum use and optimal dosage during pregnancy.

NCT ID: NCT05343390 Completed - Clinical trials for Human Immunodeficiency Virus

Package of Resources for Assisted Contact Tracing: Implementation, Costs, and Effectiveness

PRACTICE
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Having health workers assist HIV-infected persons with the recruitment and testing of their sexual contacts and biological children is an effective and efficient way of identifying additional HIV-infected persons in need of HIV treatment and HIV-uninfected persons in need of HIV prevention. However, in Malawi, a country with a generalized HIV epidemic, health workers lack the counseling and coordination skills to routinely assist their HIV-infected clients with these services. This study will determine how to help health workers to effectively and efficiently provide these services to their patients through a set of digital capacity-building tools.