Eldoret

Researchers are evaluating how well etavopivat works to reduce the number of vaso-occlusive crises (painful blood vessel blockages) in adolescents and adults living with sickle cell disease. The study also aims to assess if etavopivat can decrease organ damage, improve exercise tolerance, and reduce fatigue. This is a global Phase 3 study involving participants aged 12 years and older with confirmed sickle cell disease. The study is randomized, double-blind, and placebo-controlled to ensure accurate evaluation of the treatment effects. Participants will receive either etavopivat or a matching placebo by mouth. Which treatment they receive is determined randomly. The study will last about two years, during which participants will take the assigned medication and be monitored closely. Etavopivat is an investigational drug currently under evaluation in multiple studies for sickle cell disease. During the study, participants will have regular assessments including documentation of vaso-occlusive crisis events, blood tests, and physical evaluations. Researchers will track the number of crises that require medical attention over a 52-week period, as well as measures of organ health, exercise ability, and fatigue. Safety and overall health will be monitored throughout the study, with the total participation time lasting approximately two years.

Epilepsy is a serious neurological condition with a high prevalence in sub-Saharan Africa, including Kenya, where it causes significant health challenges. This trial evaluates the effectiveness of an intervention called BEACON, which combines task-sharing supported by an epilepsy medical records system (EMRS) with patient-tracking data. The study aims to improve treatment adherence, care retention, reduce seizure severity, lessen perceived stigma, and enhance quality of life for people with epilepsy in western Kenya, while also assessing cost-effectiveness and building local epilepsy care capacity. The BEACON intervention involves training various healthcare workers in epilepsy treatment to enable a team-based approach, supported by the EMRS with patient tracking to help keep patients engaged in care. Participants are compared between those receiving usual care and those in the BEACON program. Data collection occurs at baseline, 6 months, 12 months, and possibly 18 months, covering treatment adherence, retention, seizure severity, stigma, and quality of life. Participants will be involved in regular assessments including measurement of treatment adherence through self-report and antiseizure medication blood levels, and monitoring retention in care over one year. Researchers will evaluate multiple outcomes such as adherence extent, blood medication levels, and care retention rates. The study supports ongoing clinical and research capacity building in epilepsy care in the region.

Obstetric fistula is a serious condition causing severe urinary incontinence, leading to stigma and reduced quality of life for affected women, mostly in sub-Saharan Africa. This research aims to evaluate and compare two insertable vaginal device models as non-surgical options to manage fistula-related urinary leakage, especially for women awaiting surgery or those whose surgery was unsuccessful. The study also explores user and implementer acceptance of these devices and estimates the costs involved in non-surgical fistula management. The trial compares a silicone vaginal cup alone ('cup') and the cup connected by rubber tubing to a leg-secured urine collection bag ('cup+') for increased urine capacity. Participants use each intervention as well as a no-device leaking period in a crossover design over four days, with each treatment used for 24 hours including day and night. After this, participants are re-randomized to use either the cup or cup+ at home for three months to assess longer-term use and acceptability. Participants will be closely monitored during the study with urine leakage measurements over six hours and self-reported quality of life assessments over one to three months. Data collection includes clinical checklists, interviews, and surveys to assess effectiveness, acceptability, and cost. The total observation includes four days of crossover use followed by three months of home use, aiming to provide a practical and acceptable non-surgical management option for fistula urinary incontinence.

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 study aims to explore the effects and delivery of long-acting (LA) injectable ART using cabotegravir and rilpivirine compared to standard oral ART. It also investigates how LA ART interacts with long-acting contraceptives, addressing challenges faced by this population in HIV treatment and pregnancy prevention. This includes pharmacokinetic and qualitative studies to guide a larger effectiveness-implementation trial in Kenya. Participants may receive LA injectable cabotegravir/rilpivirine as the intervention or continue their standard oral ART regimen. The study includes a sentinel cohort for detailed pharmacokinetic and qualitative research and a 48-week open-label hybrid trial comparing the two treatment approaches. The contraceptive methods studied include injectable depo-medroxyprogesterone acetate (DMPA) and subdermal implants (etonogestrel or levonorgestrel). The study also evaluates drug interactions and implementation outcomes such as acceptability, feasibility, and fidelity of co-delivery. Throughout the study, participants undergo blood draws every 4 to 12 weeks to monitor hormone levels and viral suppression. Researchers conduct interviews and focus groups with participants, healthcare providers, and stakeholders to assess health system readiness and patient preferences. The primary outcomes include hormone concentrations at 12 or 24 weeks and HIV viral suppression at 48 weeks. The study also tracks adherence, contraceptive uptake, continuation rates, and safety measures over the course of participation.

Researchers are developing a pharmacovigilance (PV) surveillance program to monitor adverse pregnancy and newborn outcomes, including congenital abnormalities, among both HIV-positive and HIV-negative women and their infants. This study is conducted at clinical sites affiliated with the International Epidemiology Databases to Evaluate consortium (IeDEA). The goal is to examine the relationships between antiretroviral treatment (ART) and pregnancy as well as infant or birth outcomes. The study has two parts: first, implementing a PV program at two health facilities in western Kenya using a mixed prospective and cross-sectional cohort design to gather data on ART and outcomes. Second, creating standardized protocols and data exchange standards within IeDEA to combine and analyze data from multiple regions. A Data Coordinating Center at Indiana University will manage data collection, sharing, and storage, including data from ongoing studies in South Africa. Participants will be monitored during pregnancy, delivery, and up to 12 months postpartum. Data collected include pregnancy outcomes at delivery and infant outcomes at 1, 6, and 12 months after birth. The program will track adverse events and congenital abnormalities through clinical evaluations and documentation, including photos or videos of infants with suspected congenital abnormalities. This infrastructure aims to support ongoing safety monitoring and research across the IeDEA network.

Researchers are evaluating a program called PT4A that combines peer delivery of medications with a health information technology (HIT) platform to support patients with uncontrolled hypertension in western Kenya. The goal is to see if this approach improves medication adherence and lowers blood pressure compared to usual care. The study uses a two-arm cluster randomized controlled trial design and is guided by the PRECEDE-PROCEED framework. It also aims to explore how trust in the health system and patient activation may influence outcomes, and to assess cost-effectiveness and adaptability of the program. The intervention includes door-to-door peer delivery of medications within patients' communities, along with an HIT platform that offers tailored counseling, teleconsultations among clinicians, peers, and patients, medication refill tracking to ensure accountability, and analytics to manage the medication supply chain. The comparison group receives usual care. The study tracks changes over one year. Participants will be monitored through measurements of systolic blood pressure changes and medication adherence using pill counts at baseline and after 12 months. Researchers also collect data on fidelity to the program, blood pressure control, self-reported adherence, and various implementation metrics. Additional outcomes include the number of electronic signatures and completed health information technology forms. This comprehensive follow-up allows detailed assessment of the program's impact and sustainability over 12 months.

Researchers are evaluating the safety and effectiveness of pramipexole extended release (ER) compared to escitalopram for treating major depressive disorder (MDD) and MDD with mild neurocognitive disorder (MND) in people living with HIV. This phase II, randomized, open-label trial includes an optional sub-study with 36 participants to assess treatment effects on cerebrospinal fluid (CSF) profiles. Participants will be carefully monitored to track treatment response and any side effects. Participants will take either pramipexole ER tablets or escitalopram tablets, both taken orally. The study includes scheduled visits for detailed and brief assessments throughout treatment to check for toxicity, response, and dose adjustments as needed. The sub-study for CSF evaluation is optional and involves a smaller group of participants. During the study, participants will undergo evaluations including the Beck Depression Inventory-II to measure changes in depression symptoms from the start to week 24. Researchers will also monitor for any severe or neuropsychiatric adverse events related to the study drugs throughout the 24 weeks. Participants will be assessed regularly to ensure safety and to observe treatment effects over the study period.

This research aims to evaluate whether a non-invasive remote eye-tracking system (Eyelink Portable Duo) can help predict autism diagnoses in young children. The study focuses on children born to mothers living with HIV in Kenya, including both children exposed to HIV but uninfected (CHEU) and children not exposed to HIV and uninfected (CHUU). It builds on the Tabiri study, which compares neurodevelopmental outcomes between 24-month-old CHEU and CHUU children. Participants will undergo a short eye-tracking session lasting less than 15 minutes, during which eye movements and pupil diameter will be recorded while they view developmentally appropriate pictures and videos. The eye-tracking device uses two cameras to monitor eye and head movements without touching the child. Children will either sit in a highchair or on their caregiver's lap facing a computer monitor. A sticker will be applied to the child's forehead for calibration before visual stimuli are presented. During the visit, researchers will collect eye-tracking data and compare these results to autism diagnoses to assess agreement. The study includes children aged 24 to 72 months and requires caregivers to speak Kiswahili or English. This study will help understand if eye-tracking biomarkers can serve as indicators of autism in children with different HIV exposure histories.

Researchers are evaluating the safety and tolerability of two experimental antibodies, MGD014 and MGD020, in people with HIV (PWH) who are taking antiretroviral therapy (ART). This phase 1, open-label study also examines the effects of adding a latency reversal agent, Vorinostat, or temporarily stopping ART to understand how these treatments impact dormant HIV in cells and how long the antibodies stay in the body. The study aims to compare these approaches to identify potential ways to expose hidden HIV for better treatment. Participants are randomly assigned to one of three groups. All receive four intravenous infusions of MGD014 and MGD020 at 300 mcg/kg over 60 minutes. Group A continues their ART and receives infusions every 2 weeks. Group B receives the same infusions but stops ART for up to 8 weeks under close monitoring. Group C continues ART, receives the antibody infusions on a different schedule, and takes Vorinostat orally at 400 mg every 72 hours in two cycles spanning weeks 0 to 4 and weeks 8 to 12. The total participation time is about 8 months with 13 to 18 visits depending on the group. Throughout the study, participants undergo regular clinical evaluations including safety lab tests, viral load measurements, and CD4+ cell counts. Samples are collected for detailed virologic and immunologic studies to assess viral activity and drug levels. An independent safety monitor reviews all safety and clinical data regularly. Primary outcomes measured include the percentage of participants experiencing significant adverse events related to the treatments and the proportion completing the full treatment course.

Researchers are evaluating treatment outcomes for esophageal cancer at multiple sites within the African Esophageal Cancer Consortium (AfrECC). This prospective observational cohort study aims to describe the treatments patients receive, including chemotherapy, radiation, chemo-radiotherapy, esophageal stenting, surgery, and supportive care. It also seeks to assess patient-reported outcomes and overall survival related to these treatment approaches. Participants will receive standard treatments based on clinical decisions at participating AfrECC centers. Researchers will collect data on the types of treatments given and monitor the effects of these treatments on patients over time. Patient-reported outcomes will be gathered using questionnaires to evaluate quality of life and other relevant measures during and after treatment. Throughout the study, participants will complete questionnaires to report their outcomes, and researchers will track survival and treatment effectiveness for up to four years. The main outcomes include the proportion of patients receiving various treatments, changes in patient-reported quality of life scores, and median overall survival. This long-term follow-up will help understand the impact of current esophageal cancer treatments in the African setting.