There are about 751 clinical studies being (or have been) conducted in Kenya. 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.
Effective and safe strategies to deliver iron to infants and young children in Sub-Saharan Africa are urgently needed. One potential strategy to improve safety of iron fortification is to limit the total amount of unabsorbed iron entering the colon by lowering the daily iron dose but at the same time ensure efficacy by maximizing absorption from this lower dose. In Kenyan infants, the investigators have recently shown that consumption of 7.5 g of the prebiotic galacto-oligosaccharides (GOS) compared to no GOS consumption increased iron absorption from an iron containing micronutrient powder by ≈60%. It is uncertain whether a lower dose of GOS can also enhance iron absorption. Another question is whether HMOs, 'natural prebiotics' found in high concentration in human breast milk, can also increase iron absorption similar to GOS. Therefore, the aim of this study is to measure fractional iron absorption from a maize-based porridge fortified with A) iron as ferrous fumarate, B) iron as ferrous fumarate and GOS and C) iron ferrous fumarate and HMOs, using an established stable iron isotope technique in 55 infants aged 8-12 months living in Msambweni and surrounding rural communities, Kwale County of southern coastal Kenya. Assessing the effect of a low dose of GOS and of HMOs on iron absorption will provide valuable information towards the development of new, highly bioavailable iron formulations for African infants. As per the local standard of care, the participants who will be iron-deficient anemic at the end of the study will be treated with oral iron supplements. To evaluate the effects of iron supplementation on iron and anemia status and to estimate obligatory iron losses in the gastrointestinal tract, blood and fecal samples will be collected before, during and fourteen days after the beginning of the treatment with oral iron supplements. Data about the efficacy of current supplementation strategies in iron-deficient anemic children and obligatory iron losses would provide additional evidence for the optimization of iron supplementation regimens.
This multi-centre study will compare the acceptability, feasibility, cost and incremental cost-effectiveness of intermittent preventive treatment (IPTp) with dihydroartemisinin-piperaquine (DP) with or without azithromycin to the current strategy of IPTp with sulphadoxine-pyrimethamine (SP) to prevent malaria, sexually transmitted and reproductive tract infections in HIV-uninfected pregnant women (IMPROVE).
2.3.3 Short technical protocol summary Background: Pregnant women represent a vulnerable population for malaria. HIV-infected women are particularly at risk. In HIV-infected pregnant women, WHO recommends daily cotrimoxazole (CTX), an antifolate drug, for malaria chemoprevention and prophylaxis against opportunistic infection. However, there is cross-resistance with sulphadoxine-pyrimethamine (SP), and high levels of antifolate resistance threatens the antimalarial effect of CTX. Recent trials with intermittent preventive therapy (IPT) with mefloquine in HIV-infected women on daily CTX, suggested that chemoprevention with an effective antimalarial markedly improves the protection against malaria compared to daily CTX alone. However, mefloquine was not well tolerated. The long-acting combination of dihydroartemisinin-piperaquine (DP) is well tolerated and has shown great promise as IPTp in HIV-negative women in East-Africa. Chemoprevention with monthly DP has also been explored in HIV-infected pregnant women on daily CTX in Uganda. Unfortunately, the study was inconclusive because malaria transmission was too low and a clinically relevant drug interaction with efavirenz (EFV) was found reducing the exposure to DP. WHO now recommends dolutegravir (DTG) based combination antiretroviral therapy (ARTs) as the preferred firstline regimen including for pregnant women in the 2nd and 3rd trimester of pregnancy for the prevention of mother-to-child transmission of HIV. As a result, many countries in Africa are now transitioning to DTG-based combination antiretroviral therapy (cARTs). No such drug-drug interaction is expected between DTG and DP. We will, therefore, assess the safety and efficacy of malaria chemoprevention with monthly DP in HIV-infected women on daily CTX and DTG-based cARTs. Objectives and methods: This is a 2-arm, individually-randomized, multi-centre, placebo-controlled superiority trial comparing the safety and efficacy of daily CTX plus monthly DP ('CTX-DP') versus daily CTX plus monthly placebo-DP (i.e. 'CTX-alone', control arm) to reduce malaria and the adverse effects of malaria in 898 (449 per arm) HIV-infected pregnant women on DTG-based cARTs. The study will be conducted in 8 hospitals in Kenya and Malawi in high SP-resistance areas with a high prevalence of malaria. These are the same sites where the sister trial in HIV-uninfected women is being conducted in Kenya and Malawi (IMPROVE trial). Both the mother and baby will be followed for 6-8 weeks after delivery. The study is powered at 80% (alpha=0.05) to detect ≥50% relative risk reduction (RR=0.50) in the primary outcome (cumulative incidence of malaria infection) from 12% in the CTX-alone arm (control arm) to 6% in in the interventions arm allowing for 20% non-contributors. The trial includes a pharmacokinetic assessment, cardiac monitoring for safety, assessment of antimalarial drug and the impact on immune responses to malaria and other pathogens.
Each year, 10.4 million patients are diagnosed with and 1.7 million people die from Tuberculosis (TB). Despite the availability of highly effective and accessible medications in the developing world where TB is endemic, the 6-18 month treatment regimen is often thwarted as patients fail to comply due to a lack of knowledge about the disease, desire for privacy, and/or stigma avoidance. Successful TB treatment is critical for reducing transmission, the selection of drug-resistant strains and treatment costs. Mobile health interventions promise to increase treatment success, especially in regions where directly observed treatment (DOT) is impractical. The most promising interventions attempted thus far employ a combination of SMS reminders and medication monitors. However, there is relatively little high-quality evidence on their impact, and what evidence there is shows mixed success. In Kenya, the burden of TB is among the highest in the world with a prevalence rate of 558 cases per 100,000 people. There is a great need for the development of alternative protocols, which reduce the costs of treatment and burden of adherence, and more effectively motivate patients to adhere to the program. A substantial and growing literature in the social sciences demonstrates the potential of behavioral interventions for generating large increases in contributions to public goods. Keheala, a feature-phone and Internet-based digital platform that uses Unstructured Supplementary Service Data (USSD) technology to register a patient's self-verification of medication adherence alongside support and motivation, based on proven techniques from the behavioral sciences, was shown in a 1,200-patient randomized controlled trial (RCT) to reduce the unsuccessful TB treatment outcomes in Kenya by two-thirds compared to the standard of care protocol. This 15,500 patient RCT will compare Keheala's scalability, cost-effectiveness and social impact to alternative interventions across diverse regions of Kenya.
The objective of the MoreMilk trial is to assess the effect of a Training, Certification and Marketing intervention for milk vendors in the informal sector on the safety of the milk sold in the markets and on the nutrition of children in peri-urban areas of Kenya. The intervention is a training scheme for dairy vendors designed to improve the vendors' business skills and increase their capacity to handle milk hygienically and recognize good quality milk. It will also support vendors to adopt marketing strategies and pass on messages to their customers on the role of milk for nutrition and good food handling practices. The intervention consists of a 12hr face-to-face training, followed by quarterly visits where milk safety is tested and results are discussed with the participants. To assess the effect of this intervention on milk safety, and selected health and nutrition outcomes, the study will work with two groups of participants: dairy retailers, referred to as dairy vendors, operating in the informal sector and consumer households that purchase milk from recruited vendors. Dairy vendors will be randomly allocated to receiving the training at the beginning of the study (treatment group) or at the end of the study (control group). A baseline survey will be administered to participating vendors and households, and an endline survey will be conducted 12 months after the intervention in the same vendors and households. The vendor baseline and endline surveys will include questionnaire modules on operations, milk handling practices, and business performance. In addition, it will include a women's empowerment module to be administered to all vendors and their spouses (pro-WEAI tool). A sample of milk will also be collected to test the microbiological quality and composition of the milk. Vendors will be visited 2 additional times during the 12 months between intervention and endline, to monitor practices and business performance and to collect a milk sample to be tested for microbiological quality and milk composition. The baseline and endline surveys in households will assess milk and food expenditure, milk handling and consumption practices, and a 24hr dietary recall for the index child, as well as length/height and weight of the index child and his/her mother .
Linear growth failure, a manifestation of chronic undernutrition in early childhood, is a recalcitrant problem in resource constrained settings. The underlying causes of growth failure are multifactorial, but persistent and recurrent infection and inflammation of the gastrointestinal tract and immune activation, a condition commonly referred to as environmental enteropathy, is an important contributor. A highly enriched 13C-Sucrose Breath Test, a measure of sucrase-isomaltase activity, will be evaluated as a non-invasive biomarker of environmental enteropathy, and more specifically of intestinal brush border enzyme activity in 6 resource poor countries (Bangladesh, India, Jamaica, Kenya, Peru and Zambia) in 100 volunteers aged 12-15 months (total n=600) and evaluated relative to the lactose rhamnose test and linear and ponderal growth over a 3-6 month period following biomarker assessment. Field usability will also be assessed.
In the recent past there has been a number of large urban Yellow Fever outbreaks in sub-Saharan Africa, tropical South Americas, The demand for Yellow Fever vaccines in response to the large urban outbreaks occurring concurrently and the risk of further spread through Africa and to Asia was larger than the available global supply. In this situation, the World Health Organisation (WHO) developed recommendations for the use of fractional doses of Yellow Fever vaccine as a dose-sparing strategy. These recommendations were based on data from a limited number of clinical trials, none of which had been conducted in Africa. This was due to the uncertainties on the minimum dose requirement. Our study complements a study which is comparing full standard dose to 1/5th of standard dose of all four WHO-prequalified YF vaccines in adults (ClinicalTrials.gov number: NCT02991495), and is currently ongoing at KEMRI CGMRC and Epicentre, Mbarara which is designed to answer questions on the use of current stock of YF vaccines with a potency as close as possible to each manufacturers' minimum release. Data from this trial will inform a WHO recommendation on using 1/5th of the current standard dose of vaccine for outbreak control. However, since many vials will contain excess YF vaccine such that 1/5th of a vial is likely to be substantially above the current minimum potency requirements, these data may not be scientifically explanatory regarding the minimum dose required for preventive use. The new complementary study, aims to determine the lowest YF vaccine dose that is non-inferior to the current standard full dose among populations in sub-Saharan Africa. The study will be conducted in Kenya (KEMRI Center for Geographical Medicine Research-Coast (CGMR-C), Kilifi) and Uganda (Epicentre, Mbarara) with trial participants recruited at both sites, using vaccine from one WHO-prequalified manufacturer (Institut Pasteur de Dakar, Senegal (IPD)).
In this study, the tetravalent bioconjugate candidate vaccine Shigella4V will be tested to obtain first-in-human data on its safety and immunogenicity in infants and to identify the preferred dose of Shigella4V in 9 month old infants.
This is a randomized clinical trial of doxycycline post-exposure prophylaxis (dPEP) to reduce bacterial STIs among Kenyan women taking pre-exposure prophylaxis (PrEP). The overarching goal is to assess the effectiveness of dPEP on incidence of STIs while also balancing acceptability, cost, and impact on tetracycline resistance to inform public health policy. Participants will be randomized to receive dPEP and standard of care or the standard of care only. Questionnaires, focus group discussions, SMS, and in-depth interviews will be used to study acceptability and changes sexual behavior due to dPEP.
Tenofovir disoproxil fumarate/lamivudine/dolutegravir (TLD) is being used more widely across the world to treat HIV. This is an observational study (a type of study in which participants are observed and certain outcomes are measured). The aim of this study is to observe how successful TLD is at treating HIV, in the following groups of people: - People switching to TLD, after taking anti-HIV medication that contains a nonnucleoside reverse transcriptase inhibitor (NNRTI) drug (such as Efavirenz or Nevirapine) (Group 1). - People switching to TLD, after taking anti-HIV medication that contains a boosted protease inhibitor (PI) drug (such as Lopinavir or Atazanavir) (Group 2). - People taking TLD and receiving medication for TB that includes the drug rifampicin (RIF) (Group 3). These people must be starting one or both of these medications when they enter the study. - People starting TLD who have not taken anti-HIV medication before (Group 4). Another goal of this study is to use genetic testing of the virus (HIV) to see how often HIV is resistant to TLD. Genetic testing of the virus is one way to see if the TLD medication is not working to treat a person's HIV infection.