There are about 191 clinical studies being (or have been) conducted in Mali. 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.
Single site, double-blinded, randomized, placebo-controlled clinical trial of PfSPZ-CVac safety, tolerability, immunogenicity and efficacy against naturally occurring malaria in malaria-exposed Malian adults. The overall goal of the study is to evaluate if a regimen of PfSPZ-CVac (PfSPZ Challenge under chemoprophylaxis) is safe, well-tolerated, and provides sterile protection against naturally-occurring malaria in malaria-experienced adults. The study population includes 62 healthy, malaria-experienced adults aged 18-45 years, inclusive, residing in Bougoula Hameau and surrounding villages, Mali. The primary objective of this study is to assess the safety and tolerability of PfSPZ Challenge compared to placebo among malaria-experienced adults taking chloroquine prophylaxis (PfSPZ-CVac)
Background: Malaria is a serious disease. It is passed by infected mosquitoes. In many parts of Africa, malaria continues to be the main cause of death in young children and pregnant women. Researchers want to find out more about how malaria affects pregnant women and their babies. Objectives: To study the rate of miscarriage and stillbirth during the second and third trimesters among women in a certain district in Mali. To study rates of malaria infection over time among pregnant women and children in this area. Eligibility: Pregnant women of any age and pregnancy stage and their newborns. They must live in Ouelessebougou, Mali. Children up to 10 years old who live there. Design: Information about the study will be shared at community meetings, during visits to the health centers, and during census updates. Participants will read and sign a consent form. Pregnant women will be screened to see if they are eligible. They may have a urine test. They may have an ultrasound to date their pregnancy. Ultrasound uses sound waves to take pictures of the body. Women will be enrolled in the study after they have their babies. Participants may have a physical exam. Some participants will provide a finger/heel prick blood sample. Participants will complete a questionnaire. They will be asked about: Medical history Antimalarial and other interventions Socioeconomic status Their pregnancy Previous pregnancies Health of their newborn...
Background: Researchers are looking for new ways to control and eradicate malaria. They want to test vaccines to block malaria transmission in adults in Mali. These vaccines work by inducing antibodies in a person. The antibody is then taken up with blood by a mosquito that bites the person. This blocks parasite development in the mosquito. This stops malaria transmission to another person. Objective: To test the safety, reactogenicity, immunogenicity, and transmission-blocking activity of the vaccines Pfs25M-EPA and Pfs230D1M-EPA with AS01 in Malian adults. Eligibility: Healthy Malians ages 18-50 living in certain areas in Mali who: Are not pregnant or breastfeeding Are not infected with HIV, Hepatitis B and Hepatitis C Do not have evidence of immunodeficiency Do not have history of severe allergic reaction or anaphylaxis Design: Participants will be screened with: Medical history Physical exam Malaria Comprehension Exam Blood and urine tests Electrocardiogram (for participants in certain study groups) Participants will be randomly assigned to a study group. Participants will be monitored for 12-16 months. For the first 7 months, they will have between 1 and nine visits a month. The number depends on the month and on what group they are in. For the rest of the months, they will have 1 monthly visit. Each visit includes a physical exam. Most include blood tests. Participants will get 3 doses of a study or comparator vaccine. They get the vaccine through an injection in the upper arm. This occurs at their first visit, then 1 month later, and then 5 months later. Participants will be followed for at least 6 months after the last vaccine. If participants develop an injection site rash or reaction, photographs may be taken of the site.
Current lymphedema management protocols are based on the use of simple measures of hygiene (regular washing with soap and water, skin and nail care), use of topical antibiotics or antifungal agents, exercise and footwear. This is considered the "standard of care" in most endemic countries in the absence of any structured treatment programs. Previous controlled clinical trials and extensive field experience have shown the benefit of these measures in reducing the frequency of attacks of acute dermato-lymphangio-adenitis (ADLA) that drive the progression of lymphedema. In the present study, the progression of lymphedema in a group of patients who receive a six-week course of doxycycline will be compared with that of a group who receives doxycycline "look-alike" placebo tablets. However, both groups will be enrolled into a standardized "regimen of hygiene" described above. Thus, patients enrolled in the "placebo" group also will receive the current standard of care, and the placebo used in the study will help to identify the benefits of doxycycline on a background of simple hygiene measures. The regimens will be explained to all participants who will be trained to use established standardized methods of hygiene and be effectively applying it prior to the initiation of the drug treatment. In addition, patients will be evaluated at 3, 6, 12 and 24 months.. A common, generic SOP with handouts that describes methods and the training schedule will be used so that similar methods are employed across all sites.
In the last two decades, cash transfer (CT) programs have emerged as a popular approach to long-term poverty alleviation. While the main goal of cash transfer programs is to reduce poverty, they also have the potential to improve many development outcomes, such as health and education. While many studies, mainly in Latin America and Asia, have investigated the impacts of CTs on poverty and food security and have, for the most part, found positive impacts, less is known about the impacts of CTs in Africa south of the Sahara, and, in particular, West Africa. Moreover, despite the fact that cash transfers have been shown to lead to decreases in poverty, improvements in household food security, and increases in health service utilization, impacts on children's nutritional status (including anthropometric measures) are generally small (Manley, Gitter, and Slavchevska 2013). Consequently, policymakers and governments are left with the question of how to design social safety nets, such as cash transfers, to achieve greater impact on diet quality, health, and nutrition. The overall goal of this research is to generate evidence and knowledge on an integrated program implemented by the Government of Mali that includes a combination of cash transfers and targeted nutrition interventions. The information generated will inform program implementers and policymakers about best options to improve food security and nutrition among vulnerable groups and individuals in West Africa. Specifically, the main objectives of the research are 1. To provide evidence on the contribution of integrated social transfer programs to enhancing household welfare, food security, dietary diversity, and maternal and child nutrition in West Africa. 2. To test different features and combinations of cash transfers and targeted nutrition interventions, and assess their impact on food security and maternal and child nutrition and health outcomes in Mali. 3. To generate knowledge regarding the pathways of impact of these different program packages, identify the most effective and efficient modalities in the context of Mali, and derive lessons learned for other countries in the region.
The purpose of this study is to determine the most efficacious transmission blocking drug regimen for seasonal malaria chemoprophylaxis in Mali. The primary outcome measure will be the proportion of mosquitoes infected pre and post-treatment, assessed through membrane feeding and measured by oocyst prevalence in mosquitoes dissected on day 7 post feed. Primary endpoint will be a within group comparison between the mean of the pretreatment infectivity (Day 0) and infectivity at 7 days post first dose.
Background: Malaria is a disease that affects many people in the country of Mali and other parts of Africa. It is caused by germs that are spread by mosquito bites. Malaria may be mild, but can also be serious or can lead to death if not diagnosed and treated promptly. Children younger than 5 years and pregnant women are at highest risk of malaria. Researchers want to better understand how malaria infection suppresses the immune system. They want to compare a group of adults who receive antimalarial treatment to a group that does not receive it. Objective: To investigate the effect of antimalarial treatment at the beginning of the dry season on the immune system and malaria episodes. Eligibility: Healthy adults ages 18-60 who live in the area of Doneguebougou, Mali. Design: Participants will be screened with a physical exam and health questions. If participants are found to be sick at the screening visit, they will get initial care at the study clinic free of charge. They may get referrals for consultation. Participants will be randomly assigned to a group. One group will get an approved antimalarial drug called Coartem . The other will not receive it. Participants in the Coartem group will take the drug for 3 days. All participants will have blood tests. Al participants will be seen about once a month for about 1 year. At each visit, they will be asked how they are feeling and be examined. Blood will be drawn. If participants become sick at any time, they will come to the clinic to be examined.
Background: Malaria is a disease caused by a parasite. People get malaria if they are bitten by an parasite-infected mosquito. A drug called artemether-lumefantrine (AL) can treat malaria. Although iAL has helped make the malaria problem less severe in the African country of Mali, researchers want to find out if malaria parasites are becoming resistant to this drug. Objective: To test for AL-resistant parasites in children with malaria in Mali. Eligibility: AL resistance monitoring study: children aged 2 17 years who live in Kenieroba, Mali, and have malaria. Blood collection substudy: healthy volunteers aged 18 65 years. Design: Volunteers for the substudy will have blood taken up to 6 times a year. Study participants will be screened with 1 finger-prick blood sample. Girls may have a pregnancy test. Baseline visit: Participants will have a physical exam. Their vital signs and temperature will be measured. They will answer questions about their symptoms. They will give a blood sample. Participants will get 6 doses of AL over 3 days. They will take it in tablet form with milk. Some participants will also stay at the clinic for 2 days. They will have a catheter placed in a vein. They will have blood taken frequently. Participants will have follow-up visits for about 1 month. They may have: Physical exam performed Vital signs and temperature measured Symptom questionnaire administered Finger-prick blood sample and/or a regular blood sample taken Pregnancy test given Antimalarial medications other than AL provided.
Background: Malaria is still a health problem in Sub-Saharan Africa. Death rates are stable and have even increased in some areas. There are malaria vaccines. However, researchers think repeated immunizations with a vaccine called PfSPZ may work better. Objective: To see if PfSPZ is safe, tolerable, and effective against malaria. Eligibility: Healthy adults ages 18 to 50 years who live in the Doneguebougou area in Mali Design: Participants will be screened with medical history and physical exam. Participants will sign or fingerprint the consent form. They will take a survey to see how well they understand the study. Participants will give blood and urine samples. Participants will have at least one ECG: Soft electrodes will be stuck to the skin. A machine will record heart signals. Participants will have HIV counseling. Participants will be assigned to a group. Groups will get a different strength doses. Groups will get a different number of vaccines over different periods of time. If a participant develops a rash or injection site reaction, photographs may be taken. Participants will receive an oral anti-malaria drug during the study. Participants will be monitored for 3 to 6 months after the last vaccine.
The objective of the study is to evaluate the feasibility and interest of a HIV quarterly preventive global care for men who have sex with men (MSM) in sub-Saharan Africa to help reducing HIV incidence in this key population, their female partners, and the general population. This interventional, open label, multicenter, multidisciplinary cohort study will be conducted in Burkina Faso, Ivory Coast, Mali and Togo. All participants will receive a HIV quarterly preventive global care including: i) data collection on health status, symptoms of sexually transmitted infections (STI) and sexual behavior, ii) a clinical examination, iii) STI diagnosis and treatment, iv) counselling adapted for MSM, and v) the provision of condoms and lubricants.