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.
Our long-term goal is to more precisely define the role of mass azithromycin treatments as an intervention for reducing childhood mortality. We propose a single multi-site (multi-country), cluster-randomized trial comparing communities randomized to oral azithromycin with those randomized to placebo. We hypothesize that mass azithromycin treatments will reduce childhood mortality.
The purpose of this study is to determine if enhanced support for women and their families within facilities and/or through community outreach will result in improved retention in the continuum of PMTCT care.
Significant progress has been made in the treatment of Wilms tumor in high income countries, where survival is now around 85% - 90%. Survival in low income countries is much lower; specific challenges include late presentation, malnutrition, less intense supportive care facilities and failure to complete treatment. A comprehensive treatment guideline was introduced in Malawi in 2006 which included nutritional support and social support to enable parents to complete treatment. Survival has increased to around 50%; 95% of children completed their treatment. A multi-disciplinary group of African clinicians and 'state of the art' experts produced a consensus treatment guideline for children with Wilms tumor in sub-Saharan Africa. This guideline will be implemented as a multi-center prospective clinical trial in 2014 in six - eight institutes, expecting about 200 new patients per year. The hypothesis is that 2 year event free survival will be 50%, with <10% failure to complete treatment and <10% treatment related mortality. Other research questions include efficacy and toxicity of preoperative chemotherapy and the comparison of surgical staging, local pathology and central review pathology in stratifying postoperative chemotherapy.
Pediatric cerebral malaria (CM) affects more than 3 million children each year killing ~20% and leaving one third of survivors with long term neurologic and psychiatric sequelae. Seizures occur commonly with CM and are associated with an increased risk of death and neuropsychiatric disabilities. In this Malawi-based, dose- escalation, safety and feasibility study of enteral levetiracetam in pediatric CM, the investigators will lay the groundwork for future efficacy studies aimed at improving seizure control and ultimately decreasing the neurologic morbidity of pediatric CM.
The purpose of this study is to understand the family planning needs and practices of postpartum Malawian women, with a focus on long-acting reversible contraception (LARC). Hypotheses: 1. Postpartum women who are older, who have a history of unintended pregnancy, who do not desire another child within 2 years, and who were counseled about LARC during their pregnancy are more likely to have interest in using LARC. 2. Postpartum women who are older are more likely to be aware of LARC methods. 3. HIV+ postpartum Malawian women will have similar knowledge about LARC as postpartum Malawian women who are HIV-.
This study is a cross-sectional study of 110 Malawian women to compare the ultrasonographic and hormonal characteristics of women and without obstetric fistula. Hypothesis #1: Women with obstetric fistula have a mean cervical length measurement that is at least 10 mm shorter than the mean cervical length measurement of similar women without obstetric fistula. Hypothesis #2: Evaluation of the hormonal and ultrasonographic characteristics of women with obstetric fistula will allow us to assess the cause of amenorrhea in these women.
This research will test alternative methods of ensuring compliance with recommended preparation and targeting of supplementary foods for malnourished children under five years of age. The hypotheses that the proposed study intends to test are as follows: 1. With appropriate behavior change communication (BCC) and social support, and with provision of CSB and FVO in the correct proportions, it is possible to get women to prepare CSB with oil in the recommended ratio of 100:30, and in quantities just sufficient for the target child. 2. Providing CSB to Beneficiary Mothers/Caretakers pre-packaged bags of 2 kg with appropriate messaging and with instructions to direct the food to children and to prepare the CSB with oil in the recommended ratio and feed as instructed will result in better compliance.
A randomised controlled trial to investigate three methods to reduce early mortality in adults, adolescents and children aged 5 years or older starting antiretroviral therapy (ART) with severe immuno-deficiency. The three methods are: (i) increasing the potency of ART with a 12 week induction period using 4 antiretroviral drugs from 3 classes (ii) augmented prophylaxis against opportunistic/bacterial infections and helminths for 12 weeks (iii) macronutrient intervention using ready-to-use supplementary food for 12 weeks.
Children living with HIV from sub-Saharan Africa often present with severe malnutrition. In severe malnutrition, metabolic and/or gut structural derangement may lead to inadequate antiretroviral (ARV) absorption and/or erratic drug levels. The greater surface area to weight ratio in severely malnourished children could also place them at higher risk of under dosing compared to children with mild to moderate malnutrition. However, limited data are available on the pharmacokinetics of ARVs in severely malnourished children. This study addressed this critical gap in knowledge by evaluating the PK of zidovudine (ZDV), lamivudine (3TC), and lopinavir/ritonavir (LPV/r) in severely malnourished children living with HIV, compared to children with normal nutrition to mild malnutrition living with HIV.
Broad - to examine the result of feeding RS to 3-5 year old rural Malawian children on zinc homeostasis and environmental enteropathy (EE). Specific - 1. To measure zinc status using a dual zinc stable isotope assay before and after administering resistant starch (RS) in 20 children. 2. To measure intestinal function using a site-specific sugar absorption test before and after administering RS in 20 children. 3. To determine the relationship between RS and zinc homeostasis. 4. To determine the relationship between RS and environmental enteropathy.