Thika

Researchers are evaluating the safety and effectiveness of astegolimab compared to a placebo in adults aged 40 to 80 years who have chronic obstructive pulmonary disease (COPD). The study focuses on participants who are former or current smokers with a history of frequent COPD flare-ups. This phase III trial aims to determine how well astegolimab reduces moderate and severe COPD exacerbations over one year. Participants will be randomly assigned to receive either subcutaneous astegolimab every two or four weeks or a placebo every two weeks. All participants will continue their optimized COPD maintenance treatments, which may include combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists. Study treatments will be administered over a 52-week period. Throughout the study, researchers will monitor the annual rate of moderate and severe COPD exacerbations. Participants will undergo lung function tests, chest imaging, and assessments of breathlessness and lung health. The study will also carefully track the safety of the treatments, including any infections or heart-related problems. The total participation time is 52 weeks, during which the effectiveness and safety of astegolimab will be evaluated.

This research aims to evaluate the long-term safety and explore the effectiveness of astegolimab in people with chronic obstructive pulmonary disease (COPD) who have already completed a 52-week treatment in previous studies GB43311 or GB44332. The study focuses on participants aged 40 to 90 years and is a Phase III open-label extension trial designed to continue monitoring patients after their initial treatment period. Participants will receive astegolimab as a subcutaneous injection every two weeks during this extension study. This treatment continues from the prior placebo-controlled phase, allowing researchers to observe any ongoing effects and safety concerns over a longer period. The study does not include a placebo group during this extension phase, and all participants receive the active treatment. Throughout the study, researchers will closely monitor participants for any adverse events up to 12 weeks after the last dose of astegolimab. Participants will be assessed regularly to ensure their safety and to gather data on the treatment's long-term impact. The total duration of participant involvement depends on when they completed the parent studies but involves continued monitoring during and after the treatment period.

Researchers are evaluating a youth-led, data-driven implementation strategy to expand an evidence-based Adolescent Transition Package (ATP) designed to improve the transition from pediatric to adult HIV care for youth living with HIV in Kenya. This study builds on a previous trial and aims to improve the number of youth receiving the ATP, provider adoption, and consistent use of the ATP over time. The study also assesses the cost-effectiveness of this implementation approach and its impact on health outcomes such as viral suppression and retention in care. The study will involve 32 HIV clinics randomized to either the standard of care implementation strategy (Trainer of Trainers) or an enhanced strategy called ATP-Youth Enhanced Strategy (ATP-YES), which adds youth-led data audits, feedback, and collaborative learning. The ATP is delivered by healthcare workers during routine clinic visits for youth aged 10 to 24 years. Older youth (15-24 years) will participate in surveys and focus groups, while healthcare workers will engage in surveys, interviews, and quality improvement activities throughout the 36-month study period. Participants will have their routine medical records reviewed, and healthcare workers and youth will provide feedback on implementation experiences. The study will measure outcomes including ATP reach, effectiveness on viral suppression and retention, adoption by healthcare workers, fidelity to ATP processes, and maintenance of the intervention. Costs and budget impact will also be examined over the 42 months from enrollment through 6 months after study end.