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.
Adolescent substance use is prevalent in Kenya and in the US, and is associated with significant negative health and social outcomes. Unfortunately adolescents in both regions have limited access to substance use treatment because services are costly and scarce. The aim of this study is to pilot study procedures and obtain data on intervention acceptability, fidelity and preliminary efficacy, to determine the feasibility of a definitive randomized controlled trial (RCT) of the efficacy of a peer-delivered substance use brief intervention among adolescents attending an out-patient clinic in Kenya.
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 study aims to perform a head to head comparison of 11 typhoid tests currently in the market and simultaneously develop a sample set that can be used in future evaluations of emerging technologies. The central objective is to evaluate different Typhoid Rapid Diagnostic Tests (RDTs) that are commercially available internationally for detecting antigens or antibodies to Salmonella Typhi and use Blood culture as standard for comparison. The end point will be to determine estimates of sensitivity and specificity for each test, with 95% confidence interval, using blood culture as reference.
Antenatal care (ANC), facility delivery and postnatal care (PNC) are proven strategies that can tackle the high burden of maternal and child mortality and morbidity currently witnessed in sub-Saharan Africa. However very few pregnant women utilize these services. This study aims to assess the impact, cost-effectiveness, and scalability of conditional cash transfers (CCTs) to promote increased and uninterrupted contact between pregnant women and the formal healthcare system in Siaya County, Kenya. The study is a cluster randomized controlled trial with the intervention being a conditional cash transfer to women each time they honour their health appointments for ANC, facility birth and PNC visits until their new-borns reach 1 year of age. Study participants are pregnant women identified during their first ANC visit (n = 7200), and their subsequent new-borns. Mothers and their children are followed up throughout their health visits and at 3 additional time points. Trial clusters are 48 public primary health facilities, (24 in the intervention arm and 24 in the control arm). The primary outcomes are: a) proportion of all eligible ANC visits made during pregnancy; b) delivery at health facility; c) proportion of all eligible PNC visits honoured; d) proportion of referrals honoured during pregnancy and postnatal period; e) proportion of child immunizations received. Secondary outcomes include; health screening and infection control, live birth, maternal and child survival 48 hours after delivery, exclusive breastfeeding, birth spacing and self-rated wellness of mother and new-born at respective time points. Primary outcomes will be measured through abstraction of health records at the health facilities attended by the women during the trial period and supplemented by data collection using an electronic based system that comprises of a card and reader system installed at recruited study facilities. Secondary data will be abstracted from the women's medical records at the health facilities and supplemented by telephone surveys administered at three time-points over the course of the study. Additional quantitative and qualitative data will be collected through questionnaires and phone interviews for process and economic evaluations. This trial will contribute to evidence on effectiveness and cost-effectiveness of conditional cash transfers in facilitating health visits and promoting maternal and child health in Kenya and other similar contexts.
We hypothesis that intake of probiotic yogurt reduces absorption of AFB1 in the gut and subsequently reduce AFM1 and aflatoxins adduct, the biomarker in human urine and blood respectively. We have demonstrated that yogurt made using weisella cibiria NN20 isolated from fermented dough made from pearl millet in eastern part of Kenya sequestered upto 42% of aflatoxin available in our invitro texts.
The aim of the study is to examine the efficacy of ceramic water filters to reduce the burden of waterborne diarrheal illness among infants in selected villages in Kenya. In Kenya very young children are given drinking water or water is used in reconstitution of their food. We hypothesize that ceramic water filters will remove Cryptosporidium from drinking water reducing infection in infants.
The purpose of this study is to determine whether the use of a Computerized Decision Support System (CDSS) in form of alerts to clinicians enhances early detection of immunological treatment failure in HIV patients.