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Researchers are evaluating the long-term safety and effects of etavopivat, a new oral medicine being developed for inherited blood disorders such as sickle cell disease and thalassaemia. These conditions affect haemoglobin, the protein responsible for carrying oxygen in the blood. This phase 3 study involves participants who have already completed treatment in a prior etavopivat study and aims to understand how etavopivat performs over an extended period of up to 264 weeks, though the study may end earlier if the drug gains approval locally. Participants will receive oral doses of etavopivat, with different forms A, B, or C given based on their age and condition. Those aged 12 years and older will receive etavopivat A or C, while children under 12 years will receive etavopivat B. The study includes several groups covering various sickle cell disease and thalassaemia categories, including transfusion-dependent and non-transfusion-dependent cases. Treatment is continuous during the study period. Throughout the study, participants will undergo regular monitoring for side effects and treatment responses, including tracking treatment emergent adverse events, hospitalizations, vaso-occlusive crises, hemoglobin concentration changes, and blood transfusion needs. These assessments will help evaluate the drugs safety and efficacy across age groups and disease types. The study is open-label and non-randomized, with follow-up lasting up to about six years.

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.

Researchers are evaluating the pharmacokinetics and safety of etavopivat in children with sickle cell disease SCD. This phase 12 open-label study involves pediatric participants divided into four age groups, starting with the oldest and moving sequentially to younger cohorts after reviewing safety and pharmacokinetic data. The study aims to understand how the drug behaves in the body and its safety profile in this pediatric population. Participants will receive oral tablets or granules of etavopivat once daily. Each age group, ranging from 6 months to under 18 years, will be treated for a 24-week primary treatment period. Following this, participants will enter a 72-week extension treatment phase to further assess long-term safety and pharmacokinetics. The total duration for each participant is approximately 96 weeks. During the study, participants will undergo various assessments including measuring drug levels in the blood and monitoring for adverse events throughout the 24-week primary treatment and 72-week extension periods. Researchers will also evaluate hemoglobin response, changes in vaso-occlusive crisis frequency, fatigue levels, and blood flow velocity by ultrasound at multiple time points. Safety monitoring and dose adjustments will be tracked, and participants will be followed closely to understand the long-term effects of etavopivat.

Researchers are evaluating ways to improve cervical cancer screening and treatment among women living with HIV WLHIV in Nigeria, a country with a large population affected by HIV and high rates of cervical cancer deaths. This study compares two sets of strategies to integrate cervical cancer services into existing HIV care programs, aiming to enhance screening, treatment, referral completion, and retention in care. The goal is to improve health outcomes and life expectancy for WLHIV facing both HIV and cervical cancer. The trial involves two groups receiving different implementation strategies. One group follows Core Implementation Strategies including ongoing consultation, educational meetings, strengthening referral systems, and preparing patients to participate actively. The other group receives these Core strategies plus enhanced approaches like community engagement through the Health Beginning Initiative Model and the use of Smart Cards to support patient involvement. The study uses a cluster randomized design to compare these approaches. Participants are women living with HIV aged 25 to 64 years. Researchers will monitor how well the cervical cancer screening and treatment services reach patients and how sustainable these services are over time. Outcomes include measuring reach at 12 months after enrollment and sustainment near study completion, along with assessing cervical cancer screening and treatment effectiveness 15 months after treating pre-invasive cancer. The study will track participant progress and service delivery throughout the study period ending in 2027.

Obesity is a major global health concern linked to heart disease, type 2 diabetes, and some cancers. This study is evaluating how metformin, a diabetes medication, affects weight loss, cardiovascular risk, and insulin resistance in obese Black Nigerian adults without diabetes. Researchers aim to understand metformins impact in this population, which may respond differently due to genetic and environmental factors. Participants will be randomly assigned to take either metformin extended release tablets, starting at 500 mg once daily and increasing up to 1500 mg daily, or a matching placebo that looks identical. The trial is blinded and placebo-controlled to fairly compare outcomes over two years. During the 24-month study, participants will have their weight, waist size, waist-to-hip ratio, cardiovascular risk, and insulin resistance regularly measured. Safety and medication adherence will be monitored throughout. This long-term follow-up will help determine metformins effects on obesity-related health measures in this population.

This research aims to collect real-world data on the characteristics, management, healthcare use, and outcomes of patients living with type 2 diabetes, hypertension, heart failure, and chronic kidney disease. It is an international observational registry that includes patients from many countries to better understand how these conditions are treated in everyday clinical practice. Participants in this registry are observed without receiving experimental treatments. Data are collected both retrospectively and prospectively using a cloud-based electronic case report form accessible to investigators and a scientific committee. The registry includes groups of patients with type 2 diabetes, hypertension, chronic kidney disease, or heart failure, either as their primary condition or as a coexisting condition. Patients provide information about their health status, treatments, and outcomes over time. Researchers collect data on demographics, disease characteristics, laboratory tests, treatments, healthcare visits, hospitalizations, and lifestyle factors. The study measures many outcomes such as blood sugar levels, kidney function, heart function, medication use, and health events over an average of three years. Participation is voluntary and ongoing, with data collection continuing until the study end date in 2030.

Researchers are evaluating two combination interventions aimed at addressing adolescent HIV infection among youth aged 15 to 24 in Nigeria. These parallel 48-week hybrid effectiveness and implementation trials focus on improving HIV case finding and HIV treatment outcomes, particularly among young men who have sex with men YMSM. The study aims to identify youth living with HIV, link them to care, and support medication adherence and viral suppression in newly diagnosed individuals. The first intervention is a single-arm trial focusing on HIV case finding and linkage to care, using peer navigation and motivational interviewing to encourage HIV testing and pre-exposure prophylaxis PrEP uptake among those who test negative. The second is a randomized controlled trial comparing a combination HIV treatment intervention involving peer support and SMS reminders to standard care adherence support among youth newly starting antiretroviral therapy ART. Participants will be engaged over 48 weeks, with assessments including HIV testing, linkage to care, ART adherence, and viral load monitoring. Researchers will collect data on intervention effectiveness and implementation success, measuring outcomes such as HIV-positive serostatus, viral suppression, linkage to HIV care, and PrEP initiation. The study includes behavioral components like social media outreach and peer navigation to promote testing and treatment adherence.

Researchers are evaluating the efficacy, safety, tolerability, and pharmacokinetics of VX-147 in adults and children aged 10 to 65 who have APOL1-mediated proteinuric kidney disease. This study includes participants with specific APOL1 genotypes and aims to understand how VX-147 affects kidney function over time in this population. Participants are randomly assigned to receive different doses of VX-147 or a matching placebo. Those in the initial phase Part A will receive their assigned treatment for at least 96 weeks. Participants who complete Part A will then receive VX-147 for an additional 96 weeks in Part B. The study uses tablets taken orally and includes a placebo control group. During the trial, participants will be monitored regularly for changes in urine protein to creatinine ratio and kidney function measured by estimated glomerular filtration rate eGFR. Safety and tolerability are assessed through tracking adverse events throughout the study, which may last around four years after the last participant enrolls. Blood levels of VX-147 will also be measured, and pediatric participants will be asked about their satisfaction with the tablet form.

Researchers are evaluating whether taking azithromycin as a preventive treatment can reduce the risk of death in adults with advanced HIV disease. This is a Phase 3, double-blind, placebo-controlled trial involving multiple centers. The study aims to understand if azithromycin prophylaxis can lower mortality compared to a placebo in this vulnerable population. Participants will be randomly assigned to receive either an oral azithromycin tablet or a matching placebo tablet once daily for 28 days. After this treatment period, they will be followed for 24 weeks to measure the main outcome of all-cause mortality. The total study participation will last 48 weeks to monitor both short-term and longer-term effects. During the study, participants will undergo assessments to track survival and hospitalizations at 12 and 24 weeks after starting the treatment. Researchers will closely monitor health outcomes and any hospital stays to evaluate the impact of azithromycin prophylaxis. Safety and adherence will be followed throughout the trial to ensure accurate measurement of results.

Researchers are evaluating a training program for Nigerian radiologists to perform ultrasound-guided breast biopsies using mobile health mHealth devices. This approach aims to create a practical and sustainable method to integrate ultrasound-guided biopsies into clinical practice for women with suspicious breast masses. The study focuses on improving diagnostic accuracy compared to current biopsy methods used in Nigerian hospitals. Women with a solid breast mass detected by ultrasound and suspected of breast cancer are included in the study. Instead of the usual blind biopsy or surgical excision, participants will receive an ultrasound-guided breast biopsy performed by a trained radiologist using the mHealth technology. This method is considered the standard of care in the United States due to its improved accuracy. Participants will be assessed based on the number of successful ultrasound-guided breast biopsies within one year. The study involves monitoring the biopsy procedures and outcomes to evaluate the training programs effectiveness. The study runs from September 2022 to September 2027 and is sponsored by Memorial Sloan Kettering Cancer Center.