There are about 249 clinical studies being (or have been) conducted in Ghana. 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 incidence of malaria, including the incidence in pregnant women, is declining in many African countries. Thus, there is a need to re-examine the efficacy and cost effectiveness of giving intermittent preventive treatment with sulphadoxine-pyrimethamine in pregnancy (SP-IPTp) on several occasions during pregnancy, an intervention that is threatened by increasing resistance to SP. Possible alternatives to SP-IPTp need to be explored. This applies especially to areas with highly seasonal malaria transmission where women are at risk for only a short period of the year. The goal of this project is to determine whether in pregnant women who sleep under a long lasting insecticide treated bed net, screening and treatment at each scheduled antenatal clinic visit is as effective in protecting them from anaemia, low birth weight and placental infection as SP-IPTp. Primigravidae and secundigravidae who present at antenatal clinics in study sites in four West African countries (Burkina Faso, Ghana, Mali and The Gambia) will be randomised to one of two groups. All women will be given a long lasting insecticide treated bed net on first presentation at the antenatal clinic. Women in group 1 (reference group) will receive SP-IPTp according to the current WHO guidelines. Those in group 2 will be screened with a rapid diagnostic test at each scheduled antenatal clinic visit and treated if parasitaemic. Approximately 5000 women will be recruited, 2500 in each group. Women will be encouraged to deliver in hospital where maternal haemoglobin and birth weight will be recorded and a placental sample obtained. Those who deliver at home will be visited within a week of delivery and maternal haemoglobin and infant weight recorded. Mothers and infants will be seen again six weeks after delivery. Also at delivery peripheral maternal blood sample will be obtained for the diagnosis of malaria using RDT, microscopy and PCR. The primary end points of the trial will be birth weight and anaemia at 38 weeks (+/-2 weeks) of gestation. The study is powered to show non-inferiority of group 2 compared to group 1. The costs and cost effectiveness of each intervention will be evaluated. In the light of recent evidence suggesting that malaria infection during pregnancy, particularly in the last trimester may influence an infant's risk of malaria, we proposed to follow infants born to mothers recruited in the Navrongo site in Ghana who have received either IST or IPTp in pregnancy throughout the whole of their first year of life beyond the six weeks originally proposed. We have received approval for this from the ethic committees at Kwame Nkrumah University of Science and Technology, Ghana Health Service and Navrongo Health Research Centre. The aim is to obtain information on the incidence of both symptomatic and asymptomatic malaria infections in these infants during follow up of the infants. The study will provide information to national malaria control programmes on whether there are alternative, safe and effective methods to the SP IPTp regimen for reducing the burden of malaria in pregnancy.
Malaria is caused by a germ that people get from the bites of some mosquitoes. It kills over 2 million people each year. Many of the drugs used to treat malaria do not work as well as they used to and researchers are exploring other vaccines to prevent malaria. The purpose of this study is to learn if the vaccine, called EBA-175 RII-NG, is safe and if it strengthens the body's defenses against malaria. Participants will include 60 healthy adults, ages 18-40, recruited from Accra, Ghana. Several dosages of the vaccine will be tested for safety. The lowest dosages of the vaccine will be tested before the next higher dose is tested. There will be two groups for each dose, one group will receive the vaccine and the other group will receive a placebo (salt water solution). Participants may be involved in study related procedures for up to 398 days.
Iron deficiency and iron deficiency anemia (IDA) are the most prevalent micronutrient deficiencies on a worldwide basis, especially in developing countries. The impact of severe IDA can have mortal consequences, since without adequate hemoglobin, the brain and body become deprived of oxygen and, if allowed to continue, death may ensue. It has been shown that iron supplementation in infants and young children can enhance child development, however, it may also result in increased rates of malaria in high burden areas. The primary objective of this study is to determine the impact of providing encapsulated iron (as a powder added to complementary foods) on the susceptibility to clinical malaria among anemic and non-anemic infants and young children (6-24 months of age) living in a high malaria burden area. The value of performing this research in Ghana is primarily that malaria and anemia remain the most important causes of death and morbidity.
In Ghana, low micronutrient intakes among pregnant women are a major problem. The standard nutritional intervention during pregnancy is iron-folic acid tablets, but adherence is low. The investigators have pioneered the use of multiple micronutrient-fortified semi-solid pastes called Lipid-based Nutrient Supplements (LNS) (made using vegetable oil, groundnut, milk, sugar, and micronutrients), and the investigators' previous studies show that the approach could have great potential for use by pregnant and lactating women. This study aims to evaluate the effects of LNS-P&L designed for pregnant and lactating women and LNS-20gM designed for infants. Pregnant women (n=864) randomly selected from ante-natal clinics in Yilo and Manya Krobo districts of Ghana will be randomized to receive daily (a) Group 1: Iron/ Folic Acid tablets during pregnancy, and a tablet containing calcium (Ca) only (akin to a placebo) during lactation (6 mo), (b) Group 2: Multiple Micronutrient tablets during pregnancy and the first six months of lactation, or (c) Group 3: LNS-P&L during pregnancy and lactation, whilst their infants receive LNS-20gM daily from 6 to 18 months. There are two primary outcomes namely: 1. Maternal primary outcome: Birth length 2. Child primary outcome: Child length-for-age z-score at 18 mo. The investigators hypothesize that a) mean birth length and length-for-age at 18 mo will be greater in children whose mothers are in Group 2 than those whose mothers are in Group 1, and b) children whose mothers are in Group 3 will have greater birth length and length-for-age at 18 mo than the children in either of the other two groups.
Inadequate micronutrient intakes during pregnancy, lactation and infancy remain a major problem in Ghana. Lipid-based nutrient supplements (LNS) made using vegetable oil, groundnut paste, milk, sugar, and micronutrients may offer a solution. The proposed study will test the acceptability of a lipid-based nutrient supplement designed for infants (LNS-20gM) and another designed for pregnant and lactating women (LNS-P&L). Participants will consume a test meal consisting of LNS-20gM (20 infants) or LNS-P&L (20 pregnant and lactating women) mixed with fermented maize porridge, after which they will be given the respective LNS supplement for use at home for 14 d. Primary outcome is the proportion of the test-meal consumed. The investigators hypothesize that subjects will consume at 75% of the test meal offered.
The rationale for the study stems from the goal of reducing the very high unmet need for family planning among women in their first year postpartum. It is understood that the reason this need is so high in general is because postpartum women do not always "demand" family planning services, and family planning providers do not always "supply" services to postpartum (amenorrheic) women who do "demand" them. To address these supply and demand problems, corresponding supply and demand solutions will be tested. 1. Demand Generating Strategy—Integrate into Immunization Services Following birth, return to fertility among postpartum women is dependent on many factors. These include time since last birth, breastfeeding intensity, and menstrual status. However, when and how fertility returns is often misunderstood by women. For instance, many women think that they can not get pregnant before their menses return, or that as long as they are breastfeeding they are protected from pregnancy. Educating women about their return to fertility following giving birth, and reminding women about the importance of birth spacing for their health and the health of their children is the focus of the demand-generating strategy. To reach postpartum women with these messages a demand generating activity at immunization clinics will be conducted, as immunization services are well attended. Based on the recommended immunization schedules for infants, women will make several visits to these clinics throughout the course of their first year postpartum, which provides an ideal opportunity to "hit" them with family planning messages more than once. To aid providers of immunization services in their delivery of family planning messages, a simple job aid was developed. The job aid takes providers through a series of 3 questions that will allow the provider to determine a mother's immediate risk for pregnancy (based on LAM criteria). If a woman is currently at risk for pregnancy, it prompts the provider to give a healthy timing and spacing message and to make a referral to the family planning clinic. If a woman is not currently at risk for pregnancy, the job aid helps the provider instruct the mother about when her risk for pregnancy will change, and therefore when she will need to seek family planning services to achieve proper birth spacing (should this be desirable to the mother). Also, in the family planning (FP) clinics that are located in the same facility as the immunization clinic, providers will be given the pregnancy checklist. This job-aid has already been researched (refer to citations). The purpose of providing it is to make sure that when women are referred to FP clinics by immunization providers, FP providers will supply them with a method. As a consequence, it hoped that by the time women are 9-12 months postpartum, there will be an increase in uptake of non-condom family planning methods. 2. Supply Solution—Diversify Tools Available to Rule-Out Pregnancy The supply strategy focuses on giving providers the tools to give contraceptive methods to women who are amenorrheic. As recommended by the WHO, it is standard practice for FP providers to rule out the possibility of pregnancy before providing many types of methods to their clients. The presence of menses is often used to make this determination. However, return of menses can be delayed for many months in the postpartum period, limiting a provider's ability to supply postpartum women with contraceptive methods. To overcome this challenge, the Pregnancy Checklist was developed. It is a job-aid designed to rule out pregnancy based on client responses to questions concerning her recent sexual and reproductive history. Urine pregnancy testing is another viable option for ruling out pregnancy in non-menstruating FP clients, especially in situations where providers feel they cannot trust women to answer questions honestly. Thus, family planning clinics will be provided with free pregnancy test strips, and the change in same day uptake of FP methods will be measured. Hypotheses 1. Providing family planning messages to women attending immunization clinics with their child will cause them to seek family planning services in a greater proportion at 9-12 postpartum. 2. The availability of free pregnancy testing will increase same day method provision for new and restarting family planning clients.
On a global scale, tuberculosis (TB) is the single most important infectious cause of morbidity and mortality. The World Health Organization has estimated that one-third of the entire world's population carries latent TB infection. A key TB control strategy is therapy of latent TB infection (LTBI). The current standard regimen is 9 months of Isoniazid (9INH). This regimen has excellent efficacy if taken regularly, but its effectiveness is substantially reduced by poor compliance. Serious side effects, such as hepato-toxicity can occur. Three shorter alternatives have been recommended: 6 months INH (6INH), 2 months Rifampin - Pyrazinamide (2RIF-PZA) and 4 months Rifampin (4RIF). The regimen of 6INH is less efficacious than 9INH, while 2RIF-PZA has been largely abandoned because of serious toxicity. Based on some evidence in treatment of LTBI, and extrapolating from extensive experience with treatment of active TB, it is believed that 4RIF has similar efficacy as 9INH. Therefore, the investigators are initiating the first multi-site international randomized trial that will compare the effectiveness of 4RIF and 9INH in preventing active tuberculosis.
With a change in malaria treatment policy to use combination antimalaria therapy, it is envisaged that compliance to combination therapy would be less than that of monotherapy that was being used for case management in Ghana. This is especially so as amodiaquine is unpopular because of its side-effects and the combination therapy is not a single formulation (fixed dose). Compliance may further be enhanced by community supervision through home visits of combination antimalarial therapy in cases of uncomplicated malaria. This study would assess compliance to Artesunate-Amodiaquine therapy. It would also assess the effect of compliance to artesunate-amodiaquine therapy on clinical and parasitological cure rates. This study targeting age groups above ten years, would complement a child artesunate -amodiaquine efficacy study being undertaken by the same investigators in children ten years and below at Kintampo District at the same time. The funding for the child study has been approved by the Gates Malaria Partnership. Findings from both studies, involving all age groups would be made available to the National Malaria Control Programme and other stakeholders as practical information that may be beneficial to implementing policy change process from antimalarial monotherapy to a combination therapy.
The purpose of this observer-blind study is to gather key efficacy, safety, and immunogenicity information on GSK's candidate malaria vaccine in infants and children.
Evaluation of the safety and effectiveness of malaria intermittent chemotherapy and iron supplementation delivered through Expanded Programme on Immunisation vaccination clinics.