There are about 644 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 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.
HIV remains a global pandemic with 37 million infected. In western Kenya, 16% of women in the general population and 29% of the poorest women have HIV. The HIV and sexually transmitted infection (STI) epidemics overlap with broader reproductive health concerns. Menstrual hygiene management is a big problem in low- and middle-income countries and a lack of menstrual products negatively impacts women's work-life. This comes from cultural taboos, stigma, and discrimination, promoting secrecy around menstruation, high cost of menstrual products, use of traditional materials (e.g. rags, cotton wool, etc.) causing leakage and odor, and lack of water and safe hygiene facilities. Menstrual cups designed for use during sex may help women prevent Bacterial vaginosis (BV) and STIs through hygienic period practices, and may help them avoid bad practices in an attempt to maintain vaginal dryness. The goal of this interventional trial is to test the impact of menstrual cups on vaginal microbiome, BV, and STIs of poor women at high risk for STIs and HIV. We predict to see 25% less BV, our primary outcome, over one year. This trial aims to learn more about the safety of the intervention, and understand what is needed to fully implement the program.
Accurate, precise, and comparable hemoglobin measurements is of great importance, both for clinical value in diagnosing anemia and ensuring pregnant women receive appropriate treatment. The Masimo Total Hemoglobin SpHb® is a continuous and non-invasive handheld device with an optical sensor placed on the finger that measures hemoglobin levels using pulse oximetry. The objective of this study is evaluate the compatibility of hemoglobin measurements between SpHb and the gold standard laboratory-based assessment (complete blood count assessed via five-part autoanalyzer) throughout the course of pregnancy and at six weeks postpartum.
The goal of this study is to investigate whether a virtual peer support group improves ART knowledge, adherence, and mental health in youth living with HIV in Kenya.
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. About 72 AGYW will be enrolled from each ward (total N= about 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, about 500 exit surveys with men, and about 96 qualitative interviews with 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.
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 and Kenya) with a two parallel arm cluster randomized controlled trial design. The study duration will approximately be 16 months.
This study is a Phase 3, multicenter, randomized, placebo-controlled study to evaluate the efficacy of voxelotor and standard of care for the treatment of leg ulcers in participants with sickle cell disease. The study is divided into a 5 study periods: Screening, Run-in, Randomized Treatment, Open-label Treatment, and Follow-up/End of Study (EOS). The study will be conducted in approximately 80 eligible participants at approximately 20 global clinical trial sites.
With over 6 billion mobile phone subscribers and 75% of the world having access to a device, global health communities increasingly recognize the potential for using these devices to improve access to health care and health outcomes-especially in sub-Saharan Africa (SSA), where device ownership has grown dramatically. Less attention, however, has been given to developing the research capacity to allow these countries' public health researchers to collaborate with software developers and the users of mobile health applications (henceforth apps) to develop their own interventions. If mobile health apps are to be adopted, effective, and scalable, they must be designed by and with these individuals, the people most knowledgeable about the issues affecting technology use and disease management in their countries. Human-centered design (HCD), or design thinking, is a promising design strategy that prioritizes the needs of the intended population. It has also been successfully used to develop innovative and locally relevant health interventions that improve health outcomes. The purpose of this R21 proposal is to introduce Kenyan public health researchers and software developers to the HCD process and then collaboratively develop and evaluate an mobile health app that targets a growing epidemic among middle-to-late adolescents (13-18 yrs.) in Kenya-Type 1 Diabetes (T1D). To achieve this goal, we will pursue these specific aims: (1) train Kenyan health practitioners and software developers in HCD; (2) use HCD to build a prototype mHealth intervention for adolescents in Kenya with T1D; and (3) assess the prototype's usability, accessibility, and feasibility in using it to increase adolescents' knowledge of T1D and management of the disease. Our long-term goals include: (1) building research capacity by establishing a research network between health researchers at The Kenyan Diabetes Management and Information Center (DMI-a non-profit organization that works with adolescents with T1D) and mobile software developers at Lake Hub (an innovation space) so they can design future mobile health apps; (2) developing a commercially available app that Kenyan adolescents can use to manage T1D and stay healthy; and (3) evaluating the HCD process as it applies to developing mobile health interventions that improve health outcomes.