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.
Integration of antigen-detecting rapid diagnostic tests (Ag-RDT) for COVID-19 into services that provide care for vulnerable populations such as pregnant women, children, people with HIV infection, and patients with tuberculosis (TB) will identify more people with Coronavirus infection. This will allow for earlier treatment and tracing of contacts to decrease the spread of the coronavirus. This study is looking at two models for providing the testing in Maternal, Newborn and Child Health (MNCH), Tuberculosis (TB) and HIV clinics in Cameroon and Kenya. In some clinics, attendees with be screened for Coronavirus symptoms and history of exposure and if positive they will receive the rapid coronavirus test right in the clinic. In other facilities, all people attending the clinic with be provided with the coronavirus testing even if they screen negative to see how many people are infected but do not show any symptoms. Hospitalized and non-hospitalized patients with the coronavirus infection will be followed to document their illness and health outcomes. We will also ask health care workers about how well the testing in these clinics is working and what are some of their challenges, and collect information about the costs associated with both the models of testing.
Daily oral pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV acquisition, but uptake in Kenya remains low. Barriers to clinic-based PrEP delivery exist (e.g., long wait times, stigma), thus the delivery of PrEP via online pharmacy platforms has the potential to expand the reach of PrEP access in Kenya. In this pilot study, the investigators will test a new model of PrEP delivery that has never been tried in a sub-Saharan African setting: online pharmacy-delivered PrEP. The investigators will work in collaboration with MYDAWA, an online pharmacy in Kenya, to deliver PrEP on their platform for 18 months. Online PrEP delivery will include a PrEP eligibility assessment, HIV self-test delivery, a remote clinical encounter, PrEP medication delivery, and virtual PrEP support tools. If a participant is identified as eligible for pre-exposure prophylaxis (PEP), then PEP will be prescribed for 29 days and the participant will be asked to make another appointment at the end of this time to reassess for PrEP eligibility. The investigators will measure PrEP uptake and continuation over time and also measure a number of implementation outcomes, including acceptability and costs. The investigators anticipate that online pharmacy PrEP delivery will result in high uptake and continuation (similar to that or greater than public clinics), will be acceptable to clients, and will be low cost.
Mobile health (mHealth) interventions such as interactive short message service (SMS) text messaging with healthcare workers (HCWs) have been proposed as efficient, accessible additions to traditional health care in resource-limited settings. Realizing the full public health potential of mHealth for maternal health requires use of new technological tools that dynamically adapt to user needs. This study will test use of a natural language processing computer algorithm on incoming SMS messages with pregnant people and new mothers in Kenya to see if it can help to identify urgent messages.
The present research study will involve investigating the efficacy of large-scale dissemination models of evidence-based character strength interventions in secondary schools in Kenya. This intervention, derived from a previously tested intervention named Shamiri, or thrive in Kiswahili, uses positive psychology and accessible life skills to build individual resilience and wellness. This will be a one-arm trial with participants recruited from 20 secondary schools in Nairobi, Kiambu and Makueni counties. The investigators estimate a sample size of 3000 youth, working on an intention to treat basis. All interested participants will be admitted to the program, with no exclusion criteria applied. The investigators will report on the efficacy of character strength interventions on wellbeing and mental health outcomes. Further, the investigators will also assess the scalability and acceptability of the program post intervention. Additionally, the investigators will examine moderator effects on the participants, baseline attributes of the participants, and potentially the effects of candidate mediators on intervention effects.
Every year, rabies, a disease transmitted to humans by rabid dogs, is estimated to kill 59,000 people globally, mostly children 15 years and below in Africa and Asia. This is despite the availability of effective vaccines against rabies in humans, and in dogs. Following a dog bite, there are two critical steps required to prevent clinical disease and death: thorough wound washing with clean running water for at least 15 minutes; and immediate injection with anti-rabies vaccine on the day of being bitten followed by other four injections over the course of one month. Delay in seeking first dose of anti-rabies or failure to complete the recommended dosage may result in clinical rabies and death. The investigators proposed to assess the effect of short message system (SMS) phone text reminders sent to bite patients ahead of their scheduled visits on the adherence to scheduled anti-rabies doses among bite patients in rural eastern Kenya. The investigators enrolled bite patients presenting at Makueni County Referral Hospital between October 2018 and March 2019. Bite patients presenting to the facility between January and March 2019 received SMS reminder written in both English and local dialect a day before each dose of anti-rabies vaccine. These data were compared to those presenting to the health facility in the period prior (October to December 2018) before the introduction of the SMS reminder. This group received routine hospital cards as reminder of their next dose of anti-rabies vaccine injection. Each study participant was contacted after one month from the time of the bite and a phone interview completed to assess compliance and factors associated with completion of the five doses of anti-rabies vaccine.
The objective of the PATHOME study is to (1) develop statistical and computational methods for examining a complex disease system of interactions between and amongst children, animals, the environment, and enteric pathogens and (2) build a virtual laboratory for predicting which social and environmental developmental improvements best prevents multi-pathogen transmission to infants in urbanizing areas of high disease burden countries. Investigators will characterize how social and environmental development of urban neighborhoods in disease endemic settings modifies the "enteric pathome", i.e. the microbial communities of viral, bacterial, and protozoan pathogens transmitted by human and animal feces in the environment to infants. They will measure the impact of societal development on pathogen transmission to infants by applying a One Health ecosystem-based approach to characterizing interactions between enteric pathome agents in the environment and their transmission via interactions between infants, caregivers (CGs), animals, and environmental materials across domestic and public spaces and climate conditions. Data-validated statistical and computational models can quantify pathogen-specific attributable risk of infection through multiple pathways, and the extent that these risks are due to pathogen interactions with each other and the environment. The overall study hypothesis is that joint modeling of enteric pathome agents across urban households and neighborhoods representing transitional improvements in societal development will show that development leads to lower pathogen-specific detection frequencies, and thus evolution of the pathome from complex to simple microbial community structures. By studying spatial scale, developed and underdeveloped neighborhoods, specific transmission pathways, and seasonality in this process, the conditions that lead to the greatest declines in enteric disease incidence can be identified. This virtual laboratory will be built upon extensive data collection in two different Kenyan cities, including household and neighborhood economic indicators, clinical, zoonotic, and environmental microbiology, behavioral observation, geotracking of humans and domestic animals, climate conditions, population density, and infant anthropometry. This initial virtual lab will provide an evidence-based tool for predicting effective urban interventions to control fecally-transmitted disease in cities globally undergoing epidemiological transitions in infectious disease.
The main aim of this study is to evaluate the efficacy of S-217622 versus placebo among outpatient adults with mild and moderate COVID-19 starting intervention within 3 days of symptom onset.
The serum or plasma ferritin concentration (referred to hereafter as ferritin) is the most widely used indicator to detect iron deficiency and a low ferritin indicates depleted iron stores. However, the threshold ferritin that defines iron deficiency remains unclear and diagnostic ferritin cutoffs from expert groups vary widely. Our study aim is to define the ferritin in Kenyan young women at which the body senses iron depletion and begins to upregulate iron absorption from the diet; this approach could provide a functionally defined threshold of iron deficiency in Sub-Saharan African women.
BACKGROUND: Current Kenya National Anti-retroviral (ARV) Guidelines and World Health Organization (WHO) Guidelines recommend first-line therapy of tenofovir disoproxil fumarate (TDF), lamivudine (3TC) and dolutegravir (DTG) for adult people living with HIV (PLHIV). This regimen has limitations, particularly for the aging PLHIV who are more likely to have pre-existing comorbidities and higher risk of developing comorbidities, including osteopenia, osteoporosis, and renal insufficiency. Abacavir, the preferred alternative nucleoside reverse transcriptase inhibitor (NRTI) in Kenya, is associated with increased cardiovascular risk that also limits its use in elderly populations. B/F/TAF is highly efficacious, well tolerated, co-formulated in a small pill, and does not have the same bone, renal or cardiovascular risks associated with currently recommended regimens in Kenya. We are not aware of any clinical trial to date that has been fully powered to compare ARV regimens for the increasing population of elderly PLHIV. BROAD OBJECTIVE: We will compare the efficacy, safety, and impact on bone mineral density of switching to B/F/TAF to that of remaining on current ARV regimen in a population of elderly patients (60 years old or greater) with no prior confirmed treatment failure in Kenya.
The effectiveness of long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS) in western Kenya are threatened by insecticide resistance and vector behaviour changes toward early evening and outdoor biting malaria vectors. New tools to control malaria are needed to reduce and even interrupt malaria transmission. Attractive Targeted Sugar Bait (ATSB) is a promising new intervention designed to attract and kill mosquitoes, including those that IRS and LLINs do not effectively target. The ATSB 'bait stations' are A4-sized panels containing thickened fruit syrup laced with a neonicotinoid insecticide, dinotefuran, to attract and kill the foraging vectors. Entomological field trials in western Mali showed that ATSBs successfully reduce mosquito densities and longevity and thus have the potential to reduce malaria transmission. In Kenya, the investigators will conduct an open-label cluster-randomized controlled trial in 80 village clusters (40 per arm) to evaluate the effect of ATSBs on the burden of malaria. During two years, households in half of these village clusters will receive two or three ATSB bait stations per household structure on exterior walls approximately 1.8 meters above the ground. ATSBs will be replaced every six months. The primary outcome will be the incidence of clinical malaria in children aged 1-<15 years enrolled in a prospective cohort followed monthly for about six months each during a 2-year period. Secondary outcomes include malaria infection prevalence assessed by rapid diagnostic tests through household surveys and the case burden of clinical malaria assessed by passive facility-based and community-based surveillance. The study includes entomological monitoring and nested acceptability, feasibility, and health economics studies. The stand-alone trial in western Kenya is a part of a multi-country ATSB consortium conducting similar trials in Zambia and Mali.