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.
Background: Background: Testing with antigen-detecting rapid diagnostic tests (Ag-RDTs), including in asymptomatic individuals, has the potential to promptly identify more Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections and consequently decrease spread of coronavirus-19 disease at the community level. In addition, rapid test results are important for immediate clinical management and isolation of patients with SARS-CoV-2 infection, and for contact tracing and quarantining of contacts. Data on SARS-CoV-2 infection rates, the acceptability of Ag-RDT, and the cost of conducting widespread testing in these communities are limited in Africa. Study Aim and Objectives: To generate evidence evaluating the use of Ag-RDTs for community identification of SARS-CoV-2 infections within large gathering venues such as work places, schools, places of worship, and markets. The primary objective is to determine the SARS-CoV-2 case detection rate through a mass testing approach in large gatherings. Secondary objectives include determining the proportion of asymptomatic and symptomatic infections detected, acceptance of mass SARS-CoV-2 Ag-RDT testing, the prevalence of circulating variants, and the cost of implementing this community testing strategy. Study Design: The investigators propose a serial cross-sectional study design targeting approximately 15,000 persons, who will be offered testing in up to 50 different high attendance venues of Kiambu County that will be identified as possible points of community-based transmission. The study will follow an opt-in consent approach, with those accepting to participate providing additional information to the trained research assistant and/or health worker. Outcome: Evidence will be generated to provide recommendations to the Kenya Ministry of Health, and more broadly to inform the field on the use of Ag-RDTs for large scale community screening by identifying best practices and stratifying risk areas for community transmission based on rates of infections detected within various settings.
The Kenyan Critical Care Registry was started in December 2020 and currently involves 10 critical care units in 6 Hospitals. As an initial registry output, we aim to describe patient epidemiological characteristics, initial management and outcomes of critically ill patients in Kenya. This project will provide a much-needed source of clinico-demographic and outcomes data for participating Kenyan critical care units. It will also help to identify processes and outcomes which can be targeted by quality improvement projects, the impact of which can then be evaluated later using the registry.
The risk for Human Papillomavirus (HPV) infection persists through an individual sexual life and duration of protection is critical to vaccine effectiveness in protection from oncogenic hrHPV infection. HIV-infected individuals have an increased risk for HPV infection, and persistent infection. Most vaccine efficacy data among HIV-infected adolescents is represented by immunogenicity data, and there is little published literature on vaccine effectiveness as assessed by persistent incident genital HPV infection. Investigators shall re-enroll a cohort of previously vaccinated HIV-infected girls and boys for assessment of genital HPV infection 9-years post initial 3 doses of vaccination with quadrivalent HPV vaccine at ages 9 to 14 years.
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.
The study is designed as a Phase III, double-blind, multicenter, randomized, active-controlled, parallel-group design in which two groups of participants will receive either SII-YFV or STAMARIL® - a licensed and WHO pre-qualified YFV. The study will start only after the approval from the applicable ethics committees and national regulatory agencies.
This is a Phase IIIb, multinational, multicenter, randomized, open-label study to evaluate patient preference of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous use (PH FDC SC) administration in the home setting compared with the hospital setting during the cross-over period of adjuvant treatment in participants with early or locally advanced/inflammatory human epidermal growth factor receptor 2-positive (HER2+) breast cancer.
Develop coronavirus disease 2019 (COVID-19) surveillance in pregnancy in The Gambia, Kenya, Malawi, Mozambique and Uganda Estimate the seroepidemiology of COVID-19 infection among pregnant women in these countries Define the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in pregnant women and their babies and determine the presence of antibodies in cord blood Work with communities to develop understanding of infection prevention and control techniques to reduce the spread of COVID-19 amongst the pregnant population
East and Southern Africa is home to 6.2% of the world's population but includes 54% of all people living with HIV (PLWH). In this region, three out of five PLWH are women, and there is a particularly high burden of HIV amongst adolescent girls and young women (AGYW). Over half of African women use family planning (FP) services. Integration of HIV prevention and treatment with FP services holds promise for supporting progress toward the UNAIDS 95-95-95 targets for testing, treatment, and prevention. Nonetheless, integration of even basic HIV prevention and treatment services into FP clinics remains low and how best to integrate these services is still unknown. In a previous trial, the Systems Analysis and Improvement Approach (SAIA), was an effective implementation strategy for improving HIV counseling and testing in a small selection of FP clinics in Mombasa County, Kenya when delivered by research staff. SAIA incorporates a cascade analysis tool, sequential process flow mapping, and cycles of micro-intervention development, implementation, and assessment to improve a care cascade. More data is needed to understand if SAIA is effective for also improving linkage to HIV care and screening and linkage to pre-exposure prophylaxis (PrEP) in FP clinics when SAIA is delivered at scale by Kenyan public health workforce. The first objective of this study is to conduct a cluster-randomized trial evaluating the effectiveness of SAIA versus control (usual procedures with no specific intervention) for increasing HIV counseling, testing, linkage to HIV care, and screening and linkage to PrEP in new FP clients and new and returning AGYW clients. There will be a particular focus on the HIV prevention and treatment of AGYW in this study and any AGYW presenting for FP care will be prioritized. Quantitative and qualitative data will be analyzed using the RE-AIM framework to evaluate the program's Reach, Effectiveness, Adoption, Implementation, and Maintenance. To understand how SAIA could be integrated into national Ministry of Health policies and programs, activity-based costing will be conducted to estimate the budget and program impacts of SAIA, scaled to a County level, from a Ministry of Health perspective. It is hypothesized that compared to control, SAIA will be effective at increasing HIV counseling, HIV testing, linkage to HIV care, and screening and linkage to PrEP for new FP clients and all new and returning AGYW FP clients when delivered at scale by Kenyan public health staff. The implementation evaluation, costing, and budget impact analysis will establish a road map for national-level implementation, positioning Kenya as a global leader in integrating FP/HIV services.
The purpose of this study is to evaluate the safety and tolerability of one-time subcutaneous (SC) administration of monoclonal antibody (MAb) L9LS in healthy Kenyan children aged 5 months to 10 years, as well as the protective efficacy of one or two doses of L9LS against naturally occurring Plasmodium falciparum (Pf) infection among Kenyan children aged 5 to 59 months at enrollment, in a setting of perennial high transmission.
Visceral leishmaniasis (VL) is a fatal disease caused by Leishmania parasites and transmitted by female phlebotomine sandflies. The disease is a serious public health problem in eastern Africa; including Kenya where an estimated 4000 cases occur annually and 5 million people are at risk of infection. Accurate diagnosis of VL is critical for appropriate treatment. Currently, VL diagnosis in Kenya is based on testing suspected patients with the IT-Leish rK39 rapid diagnostic test (RDT) followed by other tests such as the Direct Agglutination Tests (DAT) and microscopy of tissue aspirates (splenic, bone marrow, lymph node) on rK39-negative patients. However, these diagnostic tools present several challenges including; the need for expertise, equipment and low diagnostic sensitivity of (85%) for DAT and rK39. Alternative VL diagnostic tools that are readily available, easy to use with increased sensitivity are needed to improve VL surveillance and control in Kenya. In the present study, we will assess rK28 as a diagnostic tool including performance with increased sensitivity when used together with IT-Leish rK39 and its potential for inclusion in VL diagnosis algorithms and evaluate Kala-azar Detect rK39 for potential use in Kenya. Suspected patients presenting at VL testing facilities in Marsabit, Turkana and Wajir Counties will be recruited prospectively and tested using IT-Leish rK39 followed by DAT for case confirmation according to the national guidelines. Alongside the case confirmation, samples from participants will also be tested using the rK28 and Kala-azar Detect rK39 in whole blood and serum. The collected data will be analyzed and compared separately between the RDTs as well as in combination, and the performance of the algorithms determined retrospectively. This design will enable the assessment of the sensitivity of combining rK28 and rK39 (Kala-azar Detect) compared to rK39 (IT-Leish/Kala-azar Detect) alone. Microscopy will be used as confirmatory test. We will also assess the feasibility, usefulness, and cost-effectiveness of rK28 in the VL diagnostic algorithm, through sensitivity analyses. The improved understanding of rK28 as a VL diagnostic tool and its potential for inclusion in the VL diagnosis algorithm could enable faster and more effective management of cases and accelerate elimination of VL.