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.
The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV administered as heterologous prime-boost vaccine regimens in healthy adult participants.
The purpose of this pre-licensure cohort study is to estimate the incidence of adverse events of special interest (AESI), other adverse events (AE) leading to hospitalisation or death, meningitis and malaria in sub-Saharan African children under 5 years of age. The outcomes of this study will provide the baseline data for the post-licensure EPI-MALARIA-003 (115056) study that will evaluate the safety, effectiveness and impact of the RTS,S/AS01E vaccine. An interim analysis was performed on a sub-group of study participants enrolled in active surveillance from sites where the vaccine is currently implemented, having 6 months of follow-up following the administration of dose 3 of DTP/HepB/Hib vaccine (6-12 weeks group), or 6 months after Visit 3 (mimicking the RTS,S/AS01E primary vaccination schedule) for the 5-17 months group; corresponding to Visit 5. The interim analysis concerned primary safety endpoints and the main secondary endpoints.
Early accurate diagnosis is one of the first crucial steps in care for infants born to HIV-infected mothers. Early initiation of antiretroviral therapy (ART) relies upon early diagnosis and results in significant reductions in infant morbidity and mortality. The investigators recently concluded a successful randomized controlled trial in Kenya entitled, "Improving uptake of early infant diagnosis of HIV for prevention of mother-to-child HIV transmission (PMTCT): a randomized trial of a text messaging intervention" (ClinicalTrials.gov # NCT01433185). In this study, text messages developed using a behavioral theoretical framework significantly improved maternal attendance at post-partum clinic appointments and rates of testing to facilitate early infant diagnosis of HIV in a selected population and controlled setting. Understanding the effectiveness of this intervention (and its limitations) in a real-world, routine-care setting represents the next step in the translational pathway to public health impact. The investigators therefore now propose a cluster randomized, stepped wedge trial in 20 clinics operated by the Kenyan Ministry of Health in the Nyanza region of Kenya and use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (REAIM) framework to understand the effectiveness of the text messaging to improve testing (TextIT) intervention. Our specific aims are: 1. To determine the effect of TextIT on maternal attendance at postpartum clinic visits during the randomized stepped-wedge rollout of the intervention. Hypothesis 1: A greater proportion of women at health facilities implementing TextIT will attend clinic within eight weeks postpartum compared to women at health facilities implementing standard care. 2. To determine the effect of TextIT on virological infant HIV testing within eight weeks after birth during the randomized stepped-wedge rollout of the intervention. Hypothesis 2: Infants of women at health facilities implementing TextIT will be more likely to have virological HIV testing compared to infants of women at health facilities implementing standard care. 3. To determine the costs and cost-effectiveness of TextIT. The investigators will estimate the cost per patient and per health gain achieved (disability-adjusted life year, DALY) comparing TextIT to current standard care. Hypothesis 3: The TextIT intervention will be more cost-effective than current standard care.
The study will be carried out to provide supportive clinical data on the feasibility, efficacy, safety, and PK of LPV based therapies in routine treatment setting and will be based on the existing LPV/r pellets which already represent a clear advantage in comparison with the liquid formulation.
Sepsis is a clinical syndrome representing deranged hemodynamics (such as tachycardia) secondary to severe infection. In high-income countries (HICs), early resuscitation of septic patients with protocol-driven therapy, including quantitative fluid administration guided by invasive monitoring, has resulted in improved outcomes for septic patients. Prevalence and mortality of sepsis are thought to be higher in sub-Saharan Africa (SSA) than in high-income countries; however, most hospitals in SSA lack the technology and resources necessary to implement the resuscitation protocols used in HICs and therefore, mortality from sepsis remains high. The World Health Organization (WHO) has recently disseminated an algorithm for resuscitation of septic patients in low resource settings. This algorithm is based on expert consensus only, and its efficacy has never been tested. This study will be conducted in the Casualty Department of Moi Teaching and Referral Hospital (MTRH) in Eldoret, Kenya. The purpose of this study is to describe the epidemiology of patients presenting with severe sepsis, to examine the microbiology causing severe sepsis, to describe current management and outcomes for severe sepsis, and to test the effect of implementation of the WHO resuscitation algorithm at MTRH. The study design is a prospective before and after clinical trial. In an initial observational phase, adult patients presenting to the MTRH Casualty Department with sepsis and severe sepsis (the latter of which will be defined by elevated lactate) will be enrolled into a prospective observational cohort. Demographic data, medical characteristics, and microbiological studies will be obtained, then the management and outcomes of these patients will be observed. In a second phase, patients with sepsis will continue to be enrolled into a prospective observational cohort, while patients with severe sepsis will be enrolled into an intervention group. Patients in the intervention group will be managed according to the WHO resuscitation algorithm. Specifically, the WHO algorithm involves fluid boluses guided by vital signs and physical exam findings, rapid and early administration of empiric antibiotics, and frequent patient monitoring. The outcomes of interest are achievement of lactate clearance, which is a correlate of tissue perfusion, as well as 24-hour, in-hospital, and 30-day mortality.
The purpose of this study is to assess the efficacy, safety and tolerability of a combination of moxifloxacin, PA-824, and pyrazinamide treatments with varying doses and treatment lengths from 4 to 6 months in subjects with drug-sensitive (DS) pulmonary TB compared to standard HRZE treatment. This study will also assess the efficacy, safety and tolerability of a combination of moxifloxacin, PA-824, and pyrazinamide treatments after 6 months of treatment in subjects with multi drug-resistant (MDR) pulmonary TB compared to a combination of moxifloxacin, PA-824, and pyrazinamide treatments in DS-TB subjects.
Retaining HIV-infected patients in care is critical, but loss to follow-up after enrolment often reaches 20%-40% by two years, placing millions of patients at risk of poor outcomes. A strategy to optimize retention within resource constraints is urgently needed. Sequential adaptive strategies - a novel class of public health approaches - may offer a solution. A candidate sequential adaptive strategy would start with a less expensive intervention (e.g., SMS) in all patients and then apply a more costly and intensive one (e.g., navigator) only to patients who show early signs of poor retention. This study involves a sequential multiple assignment randomized trial to evaluate a family of such strategies. the investigators will randomize 1,800 adults newly initiating antiretroviral treatment (ART) at 4 HIV clinics in the Nyanza region of Kenya to (1) standard of care routine education and counselling (REC), (2) SMS text messages, or (3) transport vouchers. Patients with early signs of weakening retention (defined as the first time a patient is 14 days late for an appointment) will be re-randomized to (1) a single episode of outreach (standard of care), (2) SMS combined with vouchers, or (3) a peer navigator. Patients not successfully contacted by 28 days after missed visit (and not verified to have left the area or transferred to another clinic) will also be rerandomized to of one the same three re-engagement interventions. Individuals randomized at first stage to SMS or voucher that do not miss a visit by at least 14 days in the first 12 months of follow up will be re-randomized at 12 months to stop first stage intervention or continue with that same intervention to 24 months. The investigators primary objective is to assess the comparative effectiveness of sequenced intervention strategies to prevent initial lapses in retention and to treat those that occur. The investigators primary endpoint is fraction of time retained in care two years after enrolment. In addition, the investigators will assess the comparative effectiveness of first-stage strategies (REC, SMS, voucher) to prevent lapses in retention, and the comparative effectiveness of second stage strategies (outreach, SMS + voucher, navigator) to re-engage patients after initial lapse. This study will also compare outcomes among patients who continue versus discontinue the SMS and voucher interventions, including a small complementarity component utilizing qualitative methods to examine the voucher approach and the effects of discontinuing this approach after success among a subset of participants. At study conclusion the investigators output will be a menu of adaptive strategies for retention, accompanied by estimates of cost and effectiveness, which policy makers in different settings can use to advance the impact of HIV care and treatment programs in Africa.
The aim of this study is to conduct a 12-week IPT+TAU versus wait list TAU in a cohort of HIV+GBV+ women in Nyanza Province to relieve depression and PTSD and improve ARV adherence. This pilot study will provide data on the efficacy trends, acceptability and feasibility of our IPT intervention and will generate preliminary findings for an R01-funded intervention to test the intervention's efficacy for remediating the effects of GBV trauma on mental health and HIV-related outcomes. Hypothesis 1: IPT+ TAU will be more effective for reduction of depression and PTSD than TAU alone. Hypothesis 2: IPT+TAU will be acceptable and feasible.
Background: Triage in the emergency department (ED) together with initial assessment is used to identify patient's level of urgency and treatment based on their triage level. Triage in the ED is a complex decision-making process, and several triage scales have been designed as decision support systems to guide the triage nurse to a correct decision. Worldwide there are four well known five-level triage systems in use. In 2010, 97% of all EDs in Sweden introduced a process-oriented triage scale with physiological parameters called Rapid Emergency Traige and Treatment System (RETTS). RETTS has two main assessment variables: vital signs and chief complaints, which describe the incident or symptoms that caused the patient to seek care. These two variables are evaluated and results in a color coded 5-level scale. Each level of priority has a defined time limit within which evaluation by a doctor should begin. Although, all international triage system guidelines seem to function well in western countries, they are difficult to implement and have a high failure rate in developing low-income countries. One of the reasons may be the lack of extensive training. Teaching and assessing abilities in performing mass casualty triage in inherently challenging due to the inability to accurately replicate a given disaster environment in a comprehensive way. Disaster drills and simulation exercises are ways of training triage performance and there are different tools available. One tool that can contribute to this kind of training may be the Emergo Train System® (ETS). ETS or similar interactive educational simulation systems could be used to test and evaluate incident and command systems, surge capacity, hospital preparedness and triage. Study objective study III: The aim of the study is to validate the currently practiced system for triage in the ED in Moi Teaching and Referral Hospital in Eldoret, Kenya with RETTS. Furthermore map the current patient outcome of trauma patients.
Antiretroviral therapy (ART) can improve health, prevent complications due to HIV infection, and prevent HIV transmission by making people less infectious. Men who have sex with men (MSM) are at high risk for transmitting HIV, but face stigma and discrimination that can make ART adherence difficult. Our goal is to find out if an intervention involving provider counselling and support from an MSM peer will improve ART adherence and engagement in care among Kenyan MSM. This study will be carried out in the KEMRI clinic in Mtwapa with 70 MSM patient participants who reside in this area, identified through our outreach and testing programs in Mtwapa. Six providers and five peers who are trained for the intervention will also be consented in order to collect data on their feedback and help monitor the study. Our intervention consists of support from a trained peer with experience taking ART and enhanced counselling from providers that is aimed to motivate patients to improve and maintain their health. In an initial pilot test, we will implement our intervention with 10 MSM starting ART for the first time. After any needed revisions to research procedures and training, we will next conduct a small randomized controlled trial with 60 MSM patient participants to determine feasibility, acceptability, tolerability, and safety, and estimate an initial effect size for the adherence intervention. The 60 patient participants will be randomized to our intervention or to standard counselling care, and will be followed for 6 months to evaluate their ART adherence and retention in care. Providers and peers will give feedback at regular project meetings and in in-depth interviews after the pilot test and after the RCT. The work proposed for this project will be carried out over 2 years, from June 1, 2014 through May 31, 2016.