Eldoret

Researchers are evaluating the effects of etavopivat in adolescents and adults with sickle cell disease. This study aims to confirm whether etavopivat reduces the number of painful vaso-occlusive crises caused by blood vessel blockages. It also examines if the medicine helps reduce organ damage, improve exercise tolerance, and decrease fatigue. The study is a phase 3, randomized, double-blind, placebo-controlled trial lasting about two years. Participants will be randomly assigned to receive either oral etavopivat or a placebo. The treatment is given by mouth, and neither the participants nor the researchers know which treatment is given during the study to ensure impartial results. The primary treatment period is 52 weeks, during which the number of vaso-occlusive crises with medical contact will be measured. Secondary assessments include changes in hemoglobin levels, fatigue scores, walking distance, and other blood markers related to sickle cell disease. During the trial, participants will undergo regular evaluations including blood tests, walking tests, and fatigue assessments from baseline to week 52. Researchers will monitor the safety and effectiveness of etavopivat throughout the study. The total participation time is about two years, with ongoing follow-ups to observe the treatment effects and any side effects. All procedures aim to provide detailed information on how etavopivat affects sickle cell disease symptoms and patient well-being.

This research aims to learn about the effectiveness of a task-sharing approach supported by an epilepsy medical records system called BEACON in improving treatment adherence and retention in care for people with epilepsy in western Kenya. Epilepsy is a serious neurological condition with a high burden in this region, and delays or poor adherence to treatment can worsen health outcomes and quality of life. The study compares patients receiving the BEACON intervention to those receiving usual care to assess differences in outcomes such as seizure severity and stigma. Participants are assigned to either the usual care group, where they receive standard epilepsy care from clinicians including consultations and prescriptions, or the BEACON group, where trained clinicians share epilepsy management tasks supported by a medical records system for patient tracking. Reminders about follow-up appointments are given by phone or text, and community health workers help contact participants who miss appointments. Both groups use the same antiseizure medications. During the study, participants will be assessed at baseline, 6, 12, and possibly 18 months. Researchers will collect data on medication adherence through questionnaires and blood levels, retention in care, seizure severity, quality of life, perceived stigma, safety, and mortality. The study also aims to build clinical and research capacity for epilepsy care in the area. Participation involves regular visits and follow-up contacts to support care and monitor progress over time.

This research aims to evaluate two insertable vaginal devices for managing urinary leakage caused by obstetric fistula, a condition that severely impacts quality of life and carries social stigma. The study compares a vaginal cup alone and the cup connected to a leg-attached urine collection bag to increase urine holding capacity. It involves women awaiting fistula surgery or those with unsuccessful surgery, addressing the need for a non-surgical management option in settings with limited access to repair. Participants will use each intervention and a period of leaking freely in a crossover design over four days, with each condition lasting 24 hours, including day and night use. After this short-term phase, participants are re-randomized to use either the cup or the cup device at home for three months. Data collection includes self-reports and clinical checklists to assess device effectiveness, acceptability, and costs. Throughout the study, participants will undergo assessments of urine leakage volume, quality of life, stigma, sleep satisfaction, coping skills, empowerment, safety perception, and device acceptability at multiple time points up to three months. The study also examines material and opportunity costs associated with fistula management. The total observation includes intensive short-term monitoring followed by longer-term home use and follow-up evaluations.

Researchers are studying adolescent girls and young women aged 15 to 24 years living with HIV who are already on oral antiretroviral therapy ART and have viral suppression. The research includes foundational pharmacokinetic PK and qualitative studies to understand the effects and delivery challenges of long-acting LA injectable cabotegravirrilpivirine compared to standard oral ART, conducted within a large HIV treatment program in Kenya. This study aims to inform a future hybrid effectiveness-implementation trial by evaluating drug interactions and health system readiness. The study involves several components a PK study with five groups to assess drug interactions between LA ART and injectable or implantable contraceptives a qualitative study with participants and stakeholders exploring preferences and system preparedness for co-delivery of LA ART and contraceptives and a 48-week open-label trial randomizing participants to switch to injectable cabotegravirrilpivirine or continue oral ART. Participants also receive contraceptives such as injectable DMPA or hormone implants based on group assignment. Participants are monitored through regular blood sampling every 4 to 12 weeks to measure hormone levels and viral suppression over 48 weeks. Researchers assess adherence and persistence to ART and contraceptive use, as well as implementation outcomes like acceptability and feasibility. Data collected will guide future studies and wider implementation of LA ART and contraceptive co-delivery to improve treatment adherence and reproductive health among young women living with HIV.

Researchers are studying a pharmacovigilance surveillance program to monitor adverse pregnancy and infant outcomes, including congenital abnormalities, among HIV-positive and HIV-negative women and their infants. This study involves clinical sites affiliated with the International Epidemiology Databases to Evaluate consortium IeDEA and aims to develop a multiregional system to better understand how antiretroviral treatment relates to pregnancy and birth outcomes. The study has three parts first, pregnant women attending antenatal clinics at two health facilities in western Kenya will be enrolled prospectively, including all HIV-positive and a sample of HIV-negative women. Data will be collected from medical records at delivery for all women delivering at the site. Infants suspected of having congenital abnormalities will be assessed through photos and videos reviewed by experts. Second, cross-sectional data will be collected retrospectively from delivery records at the site. Third, the study will establish standardized protocols and a Data Coordinating Center at Indiana University to support data collection and analysis across multiple regions. Participants will be monitored at delivery and followed up at 1, 6, and 12 months after birth to assess pregnancy and infant outcomes. Mothers of infants with major congenital abnormalities will be contacted by phone during this period to check on their infants health and care status. The study collects detailed medical record data, images of infants with abnormalities, and follow-up information to evaluate pregnancy outcomes and infant health over time.

Researchers are evaluating a new approach to help people with uncontrolled hypertension in western Kenya by combining peer-based medication delivery with a Health Information Technology HIT platform. This approach aims to improve medication adherence and lower blood pressure. The study uses the PRECEDE-PROCEED framework to test if this integrated method works better than standard care. The research is led by a multidisciplinary team from NYU Langone Health and focuses on innovative, scalable strategies for global hypertension control. The study compares two groups one receiving door-to-door peer delivery of medications supported by the HIT platform and a control group receiving standard care or standard care with peer medication delivery. The HIT platform offers personalized counseling, teleconsultation among clinicians, peers, and patients, medication refill tracking, and analytics to manage the drug supply chain. The trial is a two-arm cluster randomized controlled implementation research hybrid type 2 trial. Participants will be followed for one year, during which researchers will measure changes in systolic blood pressure, medication adherence using pill counts, and implementation fidelity. Other assessments include blood pressure control, self-reported adherence, and various RE-AIM metrics. Data on patient e-signatures and completed HIT forms will also be collected to monitor engagement. The study starts in November 2025 and continues through April 2028.

Researchers are evaluating whether eye-tracking measures can predict autism diagnoses in young children born to mothers with HIV in Kenya. The study focuses on children who were either exposed to HIV but uninfected CHEU or not exposed and uninfected CHUU, aiming to identify neurobehavioral markers linked to autism outcomes. This research builds on the Tabiri study, which compares neurodevelopmental outcomes between these two groups at 24 months of age. The study uses a non-invasive, remote eye-tracking system called Eyelink Portable Duo to collect data on eye movements and pupil diameter while children view pictures and videos. Children aged 24 to 72 months enrolled in the Tabiri study will participate in a one-time eye-tracking session lasting about 15 minutes, during which their eye activity is recorded without any equipment touching the child. The child will sit in a highchair or on a caregivers lap facing a computer screen where visual stimuli are shown. Participants will complete the standard developmental evaluation from the Tabiri study, followed by this eye-tracking activity. Researchers will measure how well the eye-tracking biomarker score agrees with autism diagnoses. The study involves caregivers who speak Kiswahili or English and includes children regardless of HIV status. The entire process is brief and designed to be child-friendly, with outcomes focused on improving early autism detection in this population.

Researchers are evaluating the safety and tolerability of two experimental antibodies, MGD014 and MGD020, combined with antiretroviral therapy ART in people living with HIV. The study also looks at the effects of adding Vorinostat, an oral medication that helps expose hidden HIV in cells, or temporarily stopping ART to understand their impact on non-active HIV. This phase 1, pilot, open-label study aims to compare these treatment approaches and measure how long the antibodies stay in the body. Participants will be randomly assigned to one of three groups. All receive four doses of MGD014 and MGD020 by intravenous infusion over several weeks. One group continues ART with the antibodies, another stops ART temporarily while receiving the antibodies, and the third group receives the antibodies plus Vorinostat taken orally every 72 hours in two treatment cycles. The infusions and oral medication schedules vary by group, spanning about 8 months with 13 to 18 visits depending on the assigned arm. During the study, participants undergo regular clinical assessments including safety labs, viral load, and CD4 cell counts. Blood samples are collected for detailed virologic and immunologic testing. An independent safety monitor reviews safety data throughout the trial. The main outcomes measured are adverse events related to the treatments and completion of the full course. Pharmacokinetics of the antibodies and formation of anti-drug antibodies are also monitored over time.

Researchers are conducting a prospective observational study through the African Esophageal Cancer Consortium AfrECC to examine treatment outcomes for adults diagnosed with esophageal cancer. The study aims to describe various treatment methods used, assess patient experiences during and after treatment, and evaluate overall survival rates across participating sites. Participants in this study will receive standard treatments such as chemotherapy, radiation, chemo-radiotherapy, esophageal stenting, surgery, or supportive care as determined by their healthcare providers. The research involves collecting data from medical records and administering questionnaires to capture patient-reported outcomes related to these treatments over up to four years. During the study, participants will complete questionnaires, and their medical charts will be reviewed to gather information on treatment types and patient experiences. Researchers will measure the proportion of participants receiving different treatments, track changes in patient-reported symptom scores over time, and monitor overall survival. The study is planned to continue through June 2027, supporting long-term evaluation of treatment effects and patient quality of life.

This research aims to compare a six-month treatment plan using higher doses of rifampicin, isoniazid, linezolid, and pyrazinamide with the World Health Organizations standard nine-month treatment for tuberculous meningitis TBM in adults and adolescents. Tuberculous meningitis is a serious condition with high risk of death and severe neurological problems. This Phase II, randomized, open-label trial seeks to evaluate if the shorter high-dose regimen can improve functional outcomes compared to the standard care.