There are about 340 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.
The purpose of this study is to evaluate a multilevel economic and food security program (Support to Able-Bodied Vulnerable groups to Achieve Food Security; SAFE) in rural central Malawi as implemented and assigned by CARE-Malawi on HIV vulnerability and other health outcomes. Hypothesis: HIV vulnerability can be reduced through a coordinated set of locally tailored individual and structural interventions that reduces poverty, reduces food insecurity, strengthens community bonds, and addresses gender inequality.
This prospective study will evaluate the safety and acceptability of the ShangRing device for medical male circumcision (MMC) during routine service delivery in Namitete, Malawi
Pre-eclampsia and eclampsia cause 50,000 deaths annually. While MgSO4 is a widely accepted and relatively inexpensive treatment for these conditions, barriers to delivery via IV injection in low-resource settings pose a large obstacle to reductions in mortality. AutoSyP is a low-cost, low-powered automatic syringe pump that could overcome this barrier to the delivery of MgSO4. We propose to conduct a pilot clinical evaluation of its ability to deliver MgSO4 to women with pre-eclampsia or eclampsia in Malawi. AutoSyP will be the subject of a 2 phase pilot clinical community trial in Malawi. Prior to the start of the study, all nurses will receive a 4-hour training on AutoSyP use to ensure proper procedures are followed. Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women. The study will continue to Phase 2 where, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia. 1. Prior to the start of the study, all nurses will receive a 4-hour training on AutoSyP use. 2. Eligible and willing participants will provide informed consent. Then, baseline demographic and relevant medical history information will be collected. 3. In Phase 1, subjects will receive IV saline fluids by the Nurse. In Phase 2, the Nurse will provide loading dose of MgSO4 with the AutoSyP and research staff will monitor and record device performance and treatment specifications. 4. Subsequent maintenance doses of saline or MgSO4 will be administered and observations monitored and recorded for up to 24 hours as clinically indicated. Others may benefit from this study in the future as AutoSyP is a new delivery system is needed to break down the barriers to IV delivery of MgSO4 in low-resource settings. The results of this study will be made available to the Ministry of Health, NHSRC, COMREC, the College of Medicine Library, the Department of Paediatrics, and other partners working in neonatal and child health. Findings will be published in academic journals and conference proceedings in an effort to disseminate results to potential end-users. The research findings of this study will be critical in the evaluation of future interventions.
The feasibility of Sayana Press self-injection and the potential for this practice to increase contraceptive continuation has never been assessed in family planning programs in low-resource settings. The Malawi Ministry of Health (MOH) and the United States Agency for International Development (USAID) Malawi Mission requested the Advancing Partners and Communities (APC) project to assess self-injection of Sayana Press to inform their decision-making for procurement of Sayana Press and distribution through the health system in Malawi.
The purpose of the study is to help make a lower cost automatic blood pressure monitor device for diagnosis and monitoring of pre-eclampsia in pregnant women, where automatic blood pressure monitoring is limited or not available. The study will compare this low cost device to a commercially available system used for pre-eclamptic women in many United States hospitals that the investigators will be bringing to Malawi as a part of this study. The team hopes to show that this lower cost blood pressure machine works well and can help women with pre-eclampsia. The study also aims to see if this machine is easy for the nurse to use. 20 women who are either at-risk or diagnosed with pre-eclampsia will be enrolled at Queen Elizabeth Central Hospital. First, a nurse will fit the test device cuff on one arm of the subject and the commercially available cuff on the opposite arm. A trained research assistant and the nurse will record the blood pressure measurements and document any alarm indications made by each device. Blood pressure measurements will continue until monitoring is no longer clinically prescribed. The results of this study will help researchers understand the performance and usability of this device in Malawi and help decide if any design changes are needed.
Randomized, double-blind, placebo controlled trial of a combined intervention of zinc, albendazole, and multiple micronutrients in improving environmental enteropathy in Malawian children.
This epidemiology study is planned to run in parallel with the EPI-MAL-002 and EPI-MAL-003 studies, enrolling from the same health and demographic surveillance system (HDSS) (or equivalent system) populations. The co-primary objectives are to produce longitudinal estimates of parasite prevalence in humans, and record malaria control measures usage in areas where EPI-MAL-002 and EPI-MAL-003 studies will take place.
To characterize safety, durability, antiretroviral treatment (ART) resistance, and clinical outcomes for mothers and infants exposed to the efavirenz-based Option B+ regimen for Prevention of Mother to Child Transmission (PMTCT) and HIV treatment in Malawi.
Inpatient treatment for complicated severe acute malnutrition (SAM) continues to have a high mortality in Africa. This is partly because children are commonly brought for admission because they are seriously ill, rather than being brought to hospital because of malnutrition alone. Mortality rates are especially high where SAM is complicated by HIV or TB. The early phase of inpatient nutritional treatment for severe acute malnutrition is based on a low-protein milk known as F75, which is given to improve metabolic homeostasis prior to the re-feeding to achieve catch-up growth. F75 provides a high proportion of energy from carbohydrates, including sucrose, lactose and maltodextrin. However, malabsorption of different types of carbohydrates, but lactose in particular, is known to occur in SAM and may lead to osmotic diarrhoea. Diarrhoea is common in children with SAM and is associated with increased mortality. Furthermore, switching from a catabolic state to a high energy diet that consists of predominantly carbohydrates can lead to 're-feeding syndrome' that may lead to severe electrolyte abnormalities and multiple organ dysfunction. The aim of this trial is to determine whether reducing the carbohydrate content of F75, and removing lactose, improves the stabilisation of severely malnourished children. The trial will involve randomising children who are eligible to receive F75 milk to either the current formulation or a revised formulation. Both formulations will be given according to current recommendations regarding frequency of feeding and caloric value. Since the purpose of F75 is to stabilise the child metabolically and biochemically, the primary endpoint of the trial will be time to stabilisation (the end of the first phase of treatment for severe acute malnutrition). Blood and stool samples at admission and after three days will be used to determine the effects on carbohydrate and fat malabsorption and evidence of the re-feeding syndrome. Children will be followed up until discharge from hospital. The project has been planned in consultation with the World Health Organisation (WHO) and, if the revised formulation of F75 results in improved outcomes, will lead to a global change in recommendations for its formulation.
Malaria is an important contributor to ill-health experienced by school-children and may have profound consequences for their learning and educational achievement, and there is a small, but growing, body of evidence that suggests malaria control can help improve educational outcomes. In Malawi, school-aged children are estimated to experience 0.59 clinical attacks of malaria each year, equivalent to 2.1 million attacks among Malawian school-aged children. To avert this health burden and potential education consequences, Save the Children in partnership with the Malawian Ministry of Health is providing treatment of symptomatic malaria cases in schools in southern Malawi, as part of the provision of first aid kits (known as Learner Treatment Kits, LTKs) in schools. To evaluate the impact of this intervention, a cluster randomised trial is being conducted among 58 schools in Traditional Area Chikowi in Malawi, over 12 months. Twenty nine schools are randomly selected to receive LTKs, which include malaria rapid diagnostic tests (RDTs) and artemisinin-based combination therapies (ACTs) to treat uncomplicated malaria, and 29 schools serve as the control group. The primary outcome is school attendance, with secondary outcomes of grade repetition, school drop-out and enrolment as well as morbidity, Plasmodium falciparum infection and anaemia. The study aims to conduct several quantitative and qualitative assessments to help evaluate the external validity of the findings.