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.
This research study aims to develop a stigma-responsive educational intervention which includes simplified scripts that provide clear messages about HPV and video aimed at addressing fears and misperceptions from a peer perspective. These educational components will be incorporated into 'Elimisha' HPV a multi-level stigma-responsive cervical cancer prevention service delivery model.
The goal of this study is to measure the clinical impact and cost-effectiveness of a wireless vital signs monitor, neoGuard, for hospitalized newborns at a tertiary healthcare facility in Kenya. The main questions it aims to answer are: 1. Does the neoGuard vital signs monitor detect meaningful vital sign changes in hospitalized newborns? 2. Does the neoGuard vital signs monitor generate valid signals to trigger a timely response from nurses? 3. Is the neoGuard vital signs monitor associated with improved patient outcomes and lower mortality? 4. What is the cost-effectiveness of the neoGuard vital signs monitor in comparison to the standard-of-care monitoring system? Participants will be enrolled within the first 24 hours of admission and monitored for a period of 7 consecutive days or until they are discharged (whichever comes sooner). The study will consist of an intervention group and a comparison group. Researchers will compare nurses' response time to patients in distress, newborn complication rates and treatment outcomes between the two groups.
A Global Multi-center, Randomized, Blinded, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (LVRNA009) for the Prevention of COVID-19 in Participants Aged 18 Years and Older
The purpose of this study is to compare a single dose of rifaximin with loperamide to the current standard approach of single dose azithromycin with loperamide for the treatment of acute watery traveler's diarrhea (TD). The study requires 1) taking a single dose antibiotic plus loperamide to treat TD, 2) providing blood and stool samples at different time points to evaluate infection and immune responses, 3) completing a daily symptom diary following treatment, 4) being seen by the study doctor to monitor illness and recovery, and 5) completing a brief electronic questionnaire at 3 months. Participants will be randomly assigned to one of the two treatment groups. The two groups are 1) rifaximin 550 mg as a single dose with loperamide 4 mg initially followed by 2 mg after each unformed stool or 2) azithromycin 500 mg as a single dose with loperamide 4 mg initially followed by 2 mg after each unformed stool. Both groups will take the antibiotic dose and 4 mg of loperamide.
This effectiveness-implementation hybrid-3 study evaluates dissemination, implementation, and effectiveness of myPlanKenya. myPlanKenya will be disseminated through formal and informal sectors. This clinical trial portion of the study enrolls women at risk for intimate partner violence (IPV) who are referred to myPlanKenya by disseminators (i.e. "end-users"). This trial aims to evaluate the effectiveness of myPlanKenya referral on resilience, health and safety among a cohort of women referred to myPlanKenya based on disclosure of IPV or assessed to have IPV related risks.
This study will test the effectiveness of a youth-designed multilevel intervention, Tu'Washindi, to increase PrEP use and reduce intimate partner violence (IPV) among Kenyan AGYW and to identify implementation challenges and strategies to facilitate future scale-up in programmatic settings to maximize public health impact. Through a cluster randomized controlled trial (cRCT) design, twenty-two administrative wards in Siaya County, western Kenya will be randomized in a 1:1 ratio to receive either the 6-month Tu'Washindi intervention plus usual HIV prevention services or usual HIV prevention services alone. Approximately 72 AGYW will be enrolled from each ward (N= 1,584), with follow-up visits at months 3, 6, and 12 post-enrollment. A mixed methods process evaluation will also be conducted using programmatic data, follow-up questionnaires from trial participants, approximately 500-1000 exit surveys with men, and approximately 100 qualitative interviews with AGYW participants, male partners, and intervention providers. These data will characterize fidelity and quality of intervention implementation, explore and test mechanisms of change, and capture contextual factors influencing intervention outcomes, with the goal of informing future refinement and implementation. The population for this study is AGYW ages 15-24 in Siaya County, Kenya; their male partners, ages 15 or older; and health providers delivering the intervention, ages 18 and above, who are working with this population.
This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations.
PRIORITY is designed as a 2-arm, randomized-controlled trial focused on postpartum women. The trial will recruit women who are diagnosed with moderate anemia based on a blood sample taken 6-48 hours after childbirth. A total of 4,800 eligible women, or 600 women per research site, will be consented and enrolled in the trial. The study hypothesizes that at 6 weeks post-delivery, prevalence of the non-anemic state in women in that received a single-dose IV iron infusion between 6 and 48 hours after delivery and prior to discharge from the facility will be greater than that of women given a supply of oral iron tablets taken twice daily for 6 weeks.
The study aims to assess the acceptability; feasibility; implementation cost; and penetration of the birth companion intervention introduced at health facilities. It is a multi-country study (Ethiopia, Kenya and Nigeria) with a two parallel arm cluster randomized controlled trial design. The study duration will approximately be 16 months.
IMPALA is a randomized, open-label, multicenter, interventional study of 540 virologically suppressed HIV-1 infected adults who have a history of sub-optimal adherence to daily oral ART and/or engagement in HIV care. The study will seek to demonstrate non-inferior antiviral effectiveness of the 2-monthly long-acting injectable combination of cabotegravir/rilpivirine as compared to continuation of first line oral antiretroviral therapy.