Masaka

Researchers are investigating the safety and effectiveness of crizanlizumab compared to a placebo in adolescents and adults aged 12 years and older who have Sickle Cell Disease and experience frequent vaso-occlusive crises (VOCs). This phase III, multicenter, randomized, double-blind study includes patients who have had between 4 and 12 healthcare professional-managed VOCs in the past year. Participants may or may not be taking hydroxyurea or hydroxycarbamide therapy alongside the study treatment. Participants will be randomly assigned in a 2:1 ratio to receive either crizanlizumab at a dose of 5 mg/kg or a placebo, both given as intravenous infusions. The randomization is stratified based on whether they are using hydroxyurea/hydroxycarbamide and by geographic region (South America, North America, and sub-Saharan Africa). Crizanlizumab and placebo are provided in single-use vials for infusion. Treatment will be monitored over a planned period of at least 52 weeks. Throughout the study, participants will be closely monitored for the number of VOCs that require healthcare professional management, including those handled in a healthcare facility or remotely, over one year. Medical history, laboratory tests, and other assessments will be used to document VOCs and evaluate safety. Participants who are on hydroxyurea/hydroxycarbamide or erythropoietin stimulating agents must maintain stable doses during the study. The study aims to assess both the rate of VOCs and the overall safety profile of crizanlizumab in this patient population.

Researchers are evaluating a digital-first, multi-component care strategy to improve self-care for patients with Heart Failure (HF) at six Regional Referral Hospital outpatient departments in Uganda. This stepped wedge, cluster-randomized trial will assess both implementation and clinical outcomes, including the effectiveness of an enhanced standard-of-care clinical bundle and a digital health intervention called Medly Uganda. The study focuses on improving HF self-care and reducing mortality and hospitalization rates over time. The study involves training healthcare providers in an enhanced HF clinical care bundle (Core-HF) that includes a treatment protocol, patient and provider self-care training, and medication stock management. After this, the digital health intervention Medly Uganda will be introduced, offering a mobile app for patients to report symptoms and receive self-care guidance, alongside a clinician dashboard for monitoring and nurse-guided management. This phased approach supports standardized care and digital monitoring for better management of HF. Participants will be assessed regularly at baseline and every six months up to 36 months for self-care using the Self-Care of Heart Failure Index and clinical effectiveness including mortality and hospitalizations. The study will also collect qualitative and quantitative data to guide ongoing improvements. Patients must have access to a mobile phone and basic reading skills in specific local languages or English. Continuous monitoring and evaluation throughout the study aim to optimize care delivery and patient outcomes in this setting.

Researchers are evaluating the safety and effectiveness of a single infusion of anti-COVID-19 hyperimmune intravenous immunoglobulin (hIVIG) compared to a placebo in adults recently diagnosed with SARS-CoV-2 infection who do not need hospitalization. This Phase 3, double-blind, randomized trial aims to assess participants' clinical status seven days after treatment using a five-category scale ranging from no symptoms to critical illness or death. The study also examines outcomes in two groups: those receiving other approved antiviral treatments and those who are not. Participants receive either a single 3.5-gram infusion of hIVIG or a 35-milliliter infusion of saline placebo, with equal chance of assignment to each group. The randomization is stratified by study site and whether participants are receiving standard antiviral care. The infusion occurs once, and participants are monitored thereafter to compare the effects of hIVIG plus standard care versus placebo plus standard care. During the study, participants provide written consent and agree to follow study procedures through 28 days. Researchers assess clinical status seven days after infusion and track safety and disease progression. The study excludes those with prior immune therapies or certain medical conditions and requires participants to avoid other COVID-19 treatment trials through Day 7 unless hospitalized or experiencing significant disease worsening. Clinical assessments and monitoring continue to ensure participant safety and capture outcomes related to COVID-19 illness severity.

Researchers are evaluating ways to improve the start and continued use of oral pre-exposure prophylaxis (PrEP) for HIV prevention among adolescent girls and young women aged 15 to 24 living in high HIV-risk areas of Uganda. This study focuses on addressing barriers such as stigma, lack of social support, and financial challenges that reduce PrEP uptake and adherence. The study aims to assess a combination of HIV risk reduction education, peer support, and economic empowerment to help overcome these obstacles. The study involves three groups of participants randomly assigned within 30 health care sites: one group receives HIV risk reduction sessions; the second group receives these sessions plus peer support from women experienced with PrEP; the third group receives the sessions, peer support, and economic empowerment through matched savings accounts and financial literacy workshops. These interventions last 20 months, with peer support sessions held at least eight times and financial education provided in six workshops. Participants will be followed up at the start, and then at 12, 24, and 36 months to monitor PrEP initiation and adherence. Researchers will collect data on participants' behaviors, social support, and financial status, as well as study the cost and effectiveness of the interventions. The study includes regular assessments to understand how these combined strategies influence PrEP use and HIV prevention over time.