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.
Surgical site infections (SSI) constitute a significant health-economic and clinical challenge. The investigators conducted a cluster-randomized, cross-over study to compare the efficacy of plain soap and water (PSW), used ubiquitously across sub-Saharan Africa for surgical hand preparation, to alcohol-based hand rub (ABHR), with SSI rates as the main outcome measure. A total of 3317 patients undergoing clean and clean-contaminated surgery were included in the study and followed up for 30 days.
Objectives: Primary: Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Kenyan infants born to HIV-1-infected mothers. Secondary: - HIV-1 immunogenicity comparison between MVA.HIVA and age-matched unvaccinated control arms in each cohort (breastfeeding or formula feeding) - HIV-1 immunogenicity comparison between breastfeeding and formula feeding infants receiving MVA.HIVA - HIV-1 immunogenicity comparison between breastfeeding and formula feeding infants in the age-matched unvaccinated control group - Comparison of responses to certain Kenyan Extended Programme on Immunization (KEPI) vaccines (OPV, DTP, HBV, and HiB) between MVA.HIVA versus age-matched unvaccinated controls in each cohort, between breast versus formula feeding infants in the age-matched unvaccinated control group, and between breast versus formula infants receiving MVA.HIVA - Comparison of immune activation and phenotypic profile of lymphocytes between breast and formula feeding infants in each cohort (MVA.HIVA and age-matched unvaccinated control) - Build capacity for Infant HIV-1 Vaccine Clinical Trials Centre in Nairobi, Kenya.
This study will evaluate the safety and acceptability of an intermittent and daily PrEP regimen using Tenofovir Disoproxil Fumarate plus Emtricitabine (FTC/TDF) in men and women at risk for HIV, and it will directly compare adherence and intracellular drug levels in daily and intermittent PrEP recipients. It will also evaluate the relationship between drug adherence, sexual behavior and intracellular drug levels with an intermittent PrEP regimen. In addition it will evaluate the relationship between adherence to an intermittent PrEP regimen and timing of sexual activity in relation to PrEP dosing. The study will use objective medication event monitoring medication event monitors (MEMS) adherence measurement and evaluate the feasibility of newer adherence measurements such as hair sampling and plasma drug levels. The study will also evaluate the feasibility of using SMS (text messages) to collect sexual activity data in an African setting. It will allow study teams and communities to prepare for potential subsequent larger trials of intermittent PrEP. This study is not sized to evaluate efficacy. If the intermittent PrEP regimen is shown to be safe, feasible in terms of adherence, and achieves intracellular drug levels similar to daily PrEP, these data could be used to design a larger phase 2 study with one or more intermittent PrEP regimens. The goal of such a trial would be to provide bridging data if daily PrEP regimens are found to be effective or to prepare for efficacy or non-inferiority trials of intermittent versus daily PrEP. Investigation of immune responses associated with FTC/TDF will also be evaluated in the pilot study. The proportion of volunteers on FTC/TDF with HIV-specific immune responses, due to exposures that did not lead to established HIV infection, will be assessed at 2-3 time points and compared to responses in volunteers assigned to placebo. Immune responses may be correlated with risk behavior and host factors, such as human leukocyte antigen (HLA) type. As noted above, very few HIV infections are expected to occur during the study, so correlation of HIV-specific immune responses and protection from infection or attenuation of disease progression will not be possible until a larger study is conducted.
This trial aims to test the hypothesis that mortality among Kenyan children with severe malnutrition following initial stabilisation is due to ongoing vulnerability to infectious disease, and that long term daily co-trimoxazole prophylaxis will reduce mortality. The objective is to conduct a randomized, double blind, placebo-controlled trial of cotrimoxazole prophylaxis for 6 months among HIV-uninfected children with severe malnutrition following stabilization. The primary outcome will be survival at one year. Secondary outcomes are toxicity, growth, the frequency and causes of hospitalisation and microbial resistance to antibiotics. Cotrimoxazole has striking protective efficacy against mortality among children with HIV, despite not altering the underlying immune deficiency. It is hypothesised that co-trimoxazole prophylaxis will have a similar effect in children immunocompromised because of severe malnutrition. Worldwide, severe malnutrition is commoner than HIV in childhood and co-trimoxazole is cheap and widely available, making it easily translatable to policy.
This study seeks to determine the most effective way to reach and provide pregnant women with accessible, comprehensive, and high quality HIV care and treatment.
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication), safety and antiviral activity to support dose recommendations by body weight of darunavir with low-dose ritonavir (DRV/rtv), in combination with other antiretroviral drugs (ARVs), in treatment-experienced Human immunodeficiency virus 1 (HIV 1) infected children.
The purpose of this study is to determine whether dapivirine gel 4759 is safe for daily use by healthy women in Kenya, Malawi, Rwanda, South Africa and Tanzania.
In many areas of the world most severely affected by the HIV/AIDS pandemic, insect and water-borne diseases such as malaria and diarrheal disease are common causes of illness and death. In addition, diarrhea and malaria are more common and more severe among adults and children infected with HIV. These infections may modulate the immune system, affect the replication of the HIV virus and could result in more rapid HIV disease progression in co-infected individuals. Access to practical, inexpensive and easy to use interventions to prevent these diseases may be effective in delaying HIV progression. Current Kenya government and World Health Organization guidelines recommend the use of cotrimoxazole (trimethoprim-sulfamethoxazole [TMP/SMX]) to prevent co-infections, including malaria. Despite the provision of TMP/SMX to HIV-infected adults, infections with malaria and pathogens causing diarrhea remain common causes of morbidity and mortality in many resource-limited settings. In addition, TMP/SMX may not prevent all infections with malaria or other pathogens due to alternative mechanisms of action, antimicrobial resistance and non-compliance due to adverse events or other reasons. We propose a study to evaluate the impact of providing insecticide treated bednets and a simple water filtration device on markers of HIV disease progression among a cohort of ART naïve, HIV infected adults prescribed TMP/SMX in Kenya. In addition, we propose to evaluate the effect of these interventions on malaria and diarrheal disease incidence and on compliance with TMP/SMX.
The purpose of this study is to evaluate the safety, tolerability and effectiveness of TMC207 in combination with an individualized background regimen (BR) of antibacterial drugs as treatment for MDR-TB
This study is a prospective, company-sponsored, non-interventional cohort study of up to 5000 patients in European countries and countries in Middle East who are newly prescribed any available OC. Patients will be followed up approximately 6 months after initial visit. Selection of Study Population: Women can be enrolled after decision for treatment with Yasmin or any other OC has been made. Physicians should consult the full prescribing information for the respective OC before enrolling patients and familiarize themselves with the safety information in the product package label.