There are about 743 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 long-term evaluation of long-acting injectable cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in eligible participants who have completed DAIDS (Division of AIDS) sponsored studies HPTN 083 and HPTN 084 and associated sub-studies. Participants will continue receiving CAB LA and be followed for new HIV diagnosis, SAEs (serious adverse events), Grade 3 and Grade 4 ISRs (injection site reactions), and AEs (adverse events) leading to withdrawal.
Neospot device is a 5-in-1 wearable vital signs monitor designed to measure temperature, blood pressure, pulse rate (PR), respiratory rate (RR) and blood oxygen saturation (SPO2). We propose to study the experiences of patients and nurses regarding spot measurement of vital signs at the outpatient department in primary care facilities in Kenya. The study aims to investigate the capability, opportunity, and motivation of nurses to use the Neospot device for vital signs measurement in level 3 facilities in Kenya by validating the accuracy of the Neospot and assessing the experience of patients while using the Neospot, the study also aims to assess the experiences of nurses as they use the Neospot and determine how the Neospot affects their workflow.
Introduction: Mental health disorders are a leading cause of disability among youth globally, and this has been worsened by the COVID-19 pandemic. In low and middle-income countries like Kenya and in rural Indiana, there is an enormous treatment gap for youth mental disorders due to limited mental health care resources. Goals: The purpose of this project is to examine the implementation of community-based, peer-led management of mental health care screening, and treatment for adolescents in Eldoret, Kenya using the REAIM framework. Methods: We shall conduct a one-week training to peer-mentors on screening for common mental health problems using the SDQ, PHQ-9, GAD-7, and YTP and treating adolescents who screen positive using a 5 session Problem Solving Treatment (PST), an evidence-based treatment for common youth mental health problems. We will then select five of the peers to deliver the intervention under the supervision of the study team at the largest community-based youth drop-in center, Family Health Options Kenya (FHOK), in Eldoret, where the peers already provide mentorship to adolescents. We will use the REAIM Framework to assess the reach, effectiveness, adoption, implementation, and maintenance of this intervention.
The goal of this observational study is to learn about how snakebite risk varies in different environments in Kenya and understand how this information can be used to support decision makers. The main questions it aims to answer are: 1. To what extent can information on snakebite cases and data on geographic, climatic and sociodemographic factors be used to predict geographical variation in snakebite risk in Kenya and Eswatini? 2. What is the most effective means of presenting outputs from spatial analysis of snakebite risk to ensure its effective use in research and healthcare decision making? Participants in the community survey will be asked survey questions about the history of snakebite in their household. Participants in the key informant interviews will be interviewed to understand how data on snakebite risk can be best presented to support their work.
This study seeks to improve mental health, pregnancy, and HIV outcomes among pregnant and postpartum women living with HIV with common mental health disorders in Kenya. The investigators will tailor a collaborative care model for peripartum women with HIV experiencing mental health symptoms and evaluate its impact on participants' mental health, antenatal, and HIV care outcomes. The investigators will actively engage key stakeholders throughout the process and assess scalability and sustainability through multi-method approaches. This study will contribute to the overall goal of achieving optimal health outcomes for women living with HIV and their families in sub-Saharan Africa.
Iron deficiency (ID) anemia (IDA) is a global public health problem, with the highest prevalence in Africa. Vaccines often underperform in low- and middle-income countries (LMIC), and undernutrition, including ID, likely plays a role. Recent studies have shown the importance of iron status in vaccine response. Intravenous iron given at time of vaccination improved response to yellow fever and COVID-19 vaccines in IDA Kenyan women. Whether oral iron treatment would have a similar beneficial effect on vaccine response is uncertain. Also, timing of oral iron treatment needs further investigation. The co-primary objectives of this study are to assess 1) whether IDA in Kenyan women impairs vaccine response, and whether oral iron treatment improves their response; 2) the timing of oral iron treatment to improve vaccine response (prior to vaccination vs at time of vaccination). We will conduct a double-blind randomized controlled trial in southern Kenya to assess the effects of iron supplementation on response to three single-shot vaccines: Johnson & Johnson COVID- 19 (JJ COVID-19), the quadrivalent meningococcal vaccine (MenACWY) and the typhoid Vi polysaccharide vaccine (Typhim Vi). Women with IDA will be recruited and randomly assigned to three study groups: group 1 (pre- treatment) will receive 100 mg oral iron as ferrous sulfate (FeSO4) daily on days 1-56; group 2 (simultaneous treatment) will receive matching placebo daily on days 1-28, and 200 mg oral iron as FeSO4 daily on days 29-56; and group 3 (control) will receive matching placebo daily on days 1-56. Women in all groups will receive the JJ COVID-19 vaccine, the MenACWY and the Typhim Vi vaccine on day 28. Cellular immune response and serology will be measured at 28 days after vaccination in all groups.
MATRIX-001 will examine the safety, PK, modeled PD, and acceptability of inserts containing the combination of TAF and EVG applied vaginally, daily for 3 days, then every other day for 14 days. The inserts are ultimately intended to be the basis of an event-driven, on-demand method for prevention of HIV and HSV sexual infection.
The activities described in this proposal are aimed at addressing health care provider stress and unconscious bias to improve quality of maternal health care, particularly related to the person-centered dimensions of care-i.e. care that is respectful and responsive to women's needs, preferences, and values. The investigators focus on health provider stress and unconscious bias because they are key drivers of poor-quality care that are often not addressed in interventions designed to improve quality of maternal health care. The investigators plan to (1) test the effectiveness of an intervention that targets provider stress and bias to improve PCMC; (2) assess the cost-effectiveness of CPIPE; (3) examine the mechanisms of impact of CPIPE on PCMC; and (3) assess impact of the CPIPE intervention on distal outcomes including maternal health seeking behavior and maternal and neonatal health.
The study is a randomized, double-blind, placebo-controlled, multicenter, clinical trial to assess the prophylactic efficacy, safety, and immunogenicity of the investigational M72/AS01E-4 Mtb vaccine when administered intramuscularly (IM) on a 0,1-month schedule to adolescents and adults. This trial will be conducted in 3 cohorts: Interferon gamma release assay (IGRA)-positive Cohort, IGRA-Negative Cohort and Human Immunodeficiency virus (HIV) Cohort.
Document evidence, via cluster randomized controlled trial, of the effectiveness of the ARCHES intervention, a brief, clinic-based counselling intervention demonstrated to reduce intimate partner violence and reproductive coercion and promote women's reproductive health, as scaled in government health facilities in Kenya, to (1) decrease unintended pregnancy, (2) increase family planning uptake and use/continuation, (3) decrease experiences of reproductive coercion and intimate partner violence of women and girls aged 15 to 49 years seeking family planning services, and, to (4) improve quality of care, (5) increase gender equitable attitudes, and, (6) increase self-efficacy to provide comprehensive family planning counseling among providers trained in ARCHES.