Kano

Researchers are evaluating the safety, tolerability, effectiveness, and how the body processes and responds to osivelotor in people with sickle cell disease SCD. This multicenter, Phase 23 study focuses on both adults and adolescents with SCD, aiming to determine the best dose and assess the drugs effects over time. The study has three parts. Part A tests safety, tolerability, and dose-finding in adults with SCD, starting with randomization to different daily doses of osivelotor, ranging from 100 mg to potentially 200 mg, over 12 weeks. Part B compares osivelotor to placebo in adults and adolescents over 48 weeks, with adults receiving an initial 300 mg daily dose for 7 days followed by 150 mg daily, while adolescent dosing will be defined later. The Open Label Extension OLE offers long-term open-label osivelotor treatment for up to two years after Part B. Participants will be monitored throughout the study with regular visits to assess safety, blood responses, and how well they tolerate the medication. The main results will be reviewed through 12 weeks in Part A, 48 weeks in Part B, and approximately 24 months in the OLE. The study includes blood tests, monitoring of vaso-occlusive crises, and other health evaluations to understand osivelotors effects and safety over time.

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 implementation and scale-up of Nigerias national sodium reduction program led by the Nigerian Agency for Food and Drug Administration and Control NAFDAC. This program uses the WHOs SHAKE package, which includes strategies like surveillance of salt intake, industry engagement, labeling standards, consumer education, and promoting healthy eating environments to reduce sodium intake and prevent hypertension. The study uses a type III hybrid, mixed methods design to assess the programs progress and effectiveness in real-world settings. The study involves enrolling adult household representatives from three Nigerian states to participate in repeated waves of data collection. Participants take part in surveys such as the STEPs survey, provide 24-hour and spot urine samples, blood samples for fatty acid estimation, and complete multiple 24-hour dietary recalls. These assessments occur at baseline Wave 1, and follow-ups at around 18 months Wave 2 and 36 months Wave 3 to monitor dietary sodium sources, population sodium intake, and program implementation outcomes. Participants will be involved in interviews, surveys, and biological sample collections over the study period. Researchers will use various frameworks and methods to evaluate program reach, adoption, feasibility, fidelity, acceptability, and cost. Key outcomes include changes in mean population sodium intake and 24-hour urinary sodium from baseline through follow-up waves, along with shifts in dietary sources of sodium and knowledge, attitudes, and behaviors about sodium intake. The total participation period spans approximately three years, with repeated assessments to track progress and impact.

This research aims to evaluate a multimedia social and behavior change SBC intervention in Kano and Kaduna states, Nigeria, focusing on its impact on womens and couples ability to make reproductive and family planning decisions. The study targets unintended pregnancy prevention by assessing how this intervention influences the use and intention to use modern contraception. It also examines cost-efficiency and sustainability, using a mixed-methods, prospective longitudinal cohort design over three years from 2025 to 2028, including comparison with a non-intervention state. The intervention, led by BBC Media Action, uses multiple media channels such as TV drama, radio drama, discussion shows, public service announcements, social media, mobile interactive voice response drama, and community engagement activities to encourage family planning. The study compares three groups areas receiving both the multimedia intervention and supply-side family planning services by Marie Stopes International MSI, areas with only the multimedia intervention, and areas with only MSI supply-side interventions but no multimedia exposure. Participants are women aged 15 to 44 who are sexually active and live in the selected areas. Data collection includes baseline and follow-up surveys two years after intervention start, in-depth interviews with participants and their partners, program monitoring interviews, and key informant interviews with implementing partners. Researchers will measure family planning use, intent to use, attitudes, confidence, communication frequency, and planning related to contraception. The study also collects cost data and evaluates sustainability over the course of the intervention and follow-up period.

Researchers are evaluating a community-based chlorine distribution model to improve access to safe drinking water in Nigeria, where many people lack safely managed water and waterborne diseases cause significant child deaths. This cluster-randomized controlled trial RCT in Kano State aims to measure the impact of this intervention on chlorination rates, water quality, and knowledge about safe water practices over six months. The study divides thirty communities into three groups twenty treatment communities receive community demonstrations and local chlorine redemption points, while ten control communities receive no intervention initially. After three months, half of the control communities receive individual sensitization and a voucher program, and the other half remain as pure controls. The intervention includes community meetings demonstrating water treatment with WaterGuard, a chlorine product, and setting up local points where households can redeem chlorine supplies. Participants will be mainly pregnant women and women with children under five years old, attending community demonstrations and accessing redemption points. Researchers will collect water samples to test for chlorine use and E. coli contamination, track self-reported chlorine use, and assess participants knowledge about chlorine over six months. The study includes monitoring redemption logs and aims to provide evidence on sustainable, low-cost water treatment methods for wider regional use.

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 studying the best ways to develop and use a management package for women with Hypertensive Disorders of Pregnancy HDP in Nigeria. The study aims to find out if a home blood pressure BP monitoring program, tailored for local needs, can improve BP control and cardiovascular health for pregnant women with HDP. This project is conducted at four health institutions in Abuja and Kano, Nigeria. The study has two phases. During the control phase, baseline data like postpartum BP measurements and treatments are recorded. After 12 months, participants switch to the intervention phase where they receive the HDP Implementation Bundle. This bundle includes patient education about BP and HDP risks, training on home BP monitoring with a free automated BP monitor, a standardized follow-up plan, and free antihypertensive medications if needed. Participants will have their BP measured and recorded at enrollment, and again at 6 and 12 weeks postpartum. The study measures differences in systolic and diastolic BP between the control and intervention phases. The researchers will also evaluate how well the program is accepted and followed. This study runs until June 2029, with ongoing monitoring of participants cardiovascular health and BP control.

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 investigating the effects of pre-operative mouthwash and varying oxygen levels during surgery on the rates of pneumonia and surgical site infections in patients undergoing major abdominal surgery. This trial focuses on patients in low and middle-income countries, where postoperative complications are more common and often more severe. The study aims to find ways to reduce these serious complications, which can cause pain, disability, and increased healthcare costs. Participants will be randomly assigned to one of four groups pre-operative chlorhexidine mouthwash combined with high oxygen levels 80-100% FiO2, no mouthwash with high oxygen levels, mouthwash with low oxygen levels 21-30% FiO2, or no mouthwash with low oxygen levels. Treatments are given around the time of surgery, with oxygen delivered during the operation and mouthwash used before surgery. The study includes an internal pilot phase lasting six months to check recruitment and compliance, followed by a larger trial aiming to enroll nearly 13,000 participants. During the study, researchers will monitor participants for up to 30 days after surgery, assessing rates of pneumonia and surgical site infections using CDC definitions. They will also track other outcomes like mortality, repeat surgeries, hospital stay length, return to normal activities, critical care admissions, and healthcare resource use. Follow-up includes evaluating patient recovery and safety, with all data collected to understand how these interventions impact surgical outcomes in these settings.

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.