There are about 335 clinical studies being (or have been) conducted in Malawi. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
SARS-CoV-2 transmission was expected to have a devastating impact in sub-Saharan African countries. Instead, morbidity and mortality rates in nearly the whole region are an order of magnitude lower than in Europe and the Americas. To identify what is different requires a better understanding of the underlying immunological substrate of the population, and how these factors affect susceptibility to infection, progression of symptoms, transmission, and responses to SARS-CoV-2 vaccination. Study objectives 1. Determine the risk and predictors of infection and disease among contacts of SARS-CoV-2 infection subjects in Malawi 2. Determine whether innate immune responses lower the risk of SARS-CoV-2 infection and disease, and acquisition and duration of vaccine responses. 3. Assess whether alterations in innate immune responses relevant to SARS-CoV-2 are associated with malaria or intestinal parasite infections. 4. Assess the acquisition and longevity of antibodies (Ab) and cellular adaptive responses elicited by SARS-CoV-2 infection and vaccination. 5. Assess whether malaria and intestinal parasite infections, chronic/mild undernutrition, and anemia mediate alterations in Ab and other adaptive cellular responses to SARS-CoV-2 through innate immune responses or a different unknown mechanism.
To achieve global goals for the treatment of HIV, many countries are piloting and scaling up differentiated service delivery models (DSD). A handful of efforts have been formally described and evaluated in the literature; many others are being implemented formally or informally under routine care, without a research or evaluation goal. For most countries however, we have little evidence on progress and challenges at the facility level-the number of patients actually participating in DSD models, health outcomes and non-health outcomes, effects on service delivery capacity and clinic efficiency and operations, and costs to providers and patients. AMBIT is a set of data synthesis, data collection, and data analysis activities aimed at generating information for near- and long-term decision making and creating an approach and platform for ongoing evaluation of differentiated models of HIV treatment delivery. The first AMBIT protocol, "Gathering Records to Evaluate Antiretroviral Treatment" (GREAT, Malawi NHRC 2376), collects and analyzes comprehensive patient medical record data, allowing us to assess the effect of DSD models on patients' clinical outcomes and to evaluate uptake of DSD models at scale. The Sentinel-Malawi study, the second AMBIT protocol, is examining the effect of DSD models on patient and provider satisfaction, service delivery capacity and quality, costs to patients, and other outcomes for which data are not routinely collected in patient-level medical records. The first round of Sentinel-Malawi was conducted in 2021. We are now amending the protocol to allow up to two additional annual rounds of data collection, in 2022-2023. We collected clinic aggregate data, conducted surveys of patients and providers, and observed operations at a selected set of 12 Malawian healthcare facilities and their affiliated DSD models in Round 1. Round 2 and 3 will collect the same types of data at 12 facilities in Malawi and will expand the study's research questions to include differentiated models of HIV testing and linkage to care. Results are expected to inform Malawian policy makers and other local and international stakeholders on the actual implications of DSD models for patients, health system operations, and healthcare budgets.
This study aims to assess the impact of multiple community-based behaviour change approaches on sanitation and hygiene behaviours in rural Malawi. Three different sub-districts (Traditional Authorities) in Chiradzulu District will be selected, each receiving a different combination of community-based interventions or will serve as controls. Eligible communities, households, and individuals will be randomly selected in each Traditional Authority and sanitation and hygiene behaviours assessed through self-report and direct observation after 1 year of intervention.
This is a phase 2B/C, open label platform study that will compare the efficacy, safety of 3 experimental regimens with a standard control regimen in participants with newly diagnosed, drug sensitive pulmonary tuberculosis. In stage 1, participants will be randomly allocated to the control or one of the 2 rifampicin-containing experimental regimens in the ratio 1:1:1. In stage 2, the experimental arm 4 containing BTZ-043 will be added. The allocation ratio will be changed to co-enrol the remaining participants in arms 1- 3 simultaneously with arm 4. When arms 1-2 are fully enrolled and arm 4 is not, further participants will be randomized 1:1 to control and experimental arm 4. Not all countries will participate in stage 2.
The MaMa study aims to assess feasibility and validity of an infant wearable in a rural settings. Altogether N~100 infants will be recruited and measured multiple times at homes from age 6 months to age 18 months. Neurodevelopment of the infants is assessed at 18-24 months of age to compare motor development trajectories with the later neurodevelopmental outcome.
Acute hypoxemia is common and deadly in resource variable settings. While studies in high income countries (HICs) have indicated a possible benefit to high flow oxygen as compared with standard flow oxygen, rigorous studies in low or lower middle income countries (LMICs) have not been performed. Studies in sepsis have demonstrated that interventions that improve outcomes in one context may actually be neutral or harmful in a different context. The goal of this study is to test whether high flow oxygen results in better outcomes for hypoxemic adult patients, as compared with standard flow oxygen, in five LMIC hospitals. The main questions it aims to answer are: 1. For hypoxemic adults in these LMIC study settings, does high flow oxygen or standard flow oxygen result in lower mortality? 2. What are the facilitators and barriers to using high flow oxygen in these settings? 3. Does high flow or standard flow oxygen use more oxygen? Participants will be randomized to receive either high flow oxygen through a large nasal cannula, or to receive standard flow oxygen, through nasal cannulas, face masks, or non-rebreather masks. Researchers will compare the outcomes for the two groups, to see if one group of patients has better outcomes than the other. The study will also examine how much oxygen is used by the two patient groups, as well as other factors relevant to the feasibility of implementation of high flow oxygen in these sites.
This is a proof-of-concept trial that aims to compare the efficacy of an 8-week treatment with higher-protein-Ready-to-Use Therapeutic Foods (RUTF) with standard RUTF in improving levels of markers of growths, height, nutritional recovery, and lean mass deposition among children with severe wasting. The study will also assess the safety and acceptability of the high-protein RUTF in comparison to the standard RUTF. The study will be conducted at four outpatient therapeutic programs in the Blantyre district of Malawi.
A double blinded, placebo-controlled, multicenter trial to evaluate effectiveness of azithromycin prophylaxis on mortality in advanced HIV.
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.
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