Ibadan

Researchers are evaluating the safety and activity of a new medicine called etavopivat in children aged 12 to 16 years with sickle cell disease who are at higher risk for stroke. The study focuses on how etavopivat affects blood flow velocity in brain arteries, measured by transcranial Doppler (TCD) ultrasound. Participants are divided into two groups based on their TCD results and whether they are receiving hydroxyurea, a medication commonly used in sickle cell disease treatment. The study is a Phase 2, open-label trial aiming to better understand etavopivat’s effects in this pediatric population. Participants will take 400 mg of etavopivat daily, given as two 200 mg tablets by mouth, which can be taken with or without food. The treatment period lasts 52 weeks (one year). One group includes participants with conditional or abnormal TCD results who are not taking hydroxyurea, while the other includes those with similar TCD results who are on a stable dose of hydroxyurea. After the 52-week treatment, participants may have the option to join a 48-week extension phase to continue evaluating the safety of etavopivat. If appropriate, participants might also be offered to join a separate study to keep receiving etavopivat after completing these phases. Throughout the study, participants will visit the clinic regularly for assessments, including TCD ultrasound to measure blood flow velocities in specific brain arteries at baseline and week 12. Researchers will monitor safety and treatment effects closely. The primary outcome is the change in the highest blood flow velocity measured by TCD in any of the left or right internal carotid or middle cerebral arteries. Caregivers and participants will be involved in ongoing evaluations to ensure safety and adherence during the study's full duration and optional extension period.

The trial investigates the safety, tolerability, effectiveness, and how the body processes and responds to osivelotor in people with sickle cell disease (SCD). This Phase 2/3, multicenter study involves adults and adolescents with SCD, aiming to find the best dose and compare osivelotor to a placebo. The study also includes a long-term extension to assess ongoing safety and blood-related effects. Osivelotor is given orally as tablets. The study has three parts: Part A focuses on determining a safe and effective dose in adults; Part B compares osivelotor to placebo in adults and adolescents over 48 weeks; and the Open Label Extension (OLE) offers continued treatment to those who completed Part B to monitor long-term safety and responses. Participants will be monitored throughout the study periods with assessments of safety, tolerability, and treatment effects. These include evaluations at 12 weeks (Part A), 48 weeks (Part B), and approximately 24 months after the last participant joins (OLE). Researchers will track blood values, side effects, and disease-related events to understand how the drug works and its impact on SCD over time.

Researchers are evaluating the long-term safety and effectiveness of etavopivat, a new oral medicine being developed to treat inherited blood disorders such as sickle cell disease and thalassemia. These disorders affect hemoglobin, the protein responsible for carrying oxygen in the body. This phase 3 study aims to monitor how well etavopivat works and its safety profile over an extended period. Participants will receive one of three forms of etavopivat (A, B, or C) as oral doses. The study is open-label and multicenter, involving adults, adolescents, and children who have previously completed treatment in an etavopivat parent study and continue to benefit clinically. The treatment period can last up to 264 weeks but may end earlier if etavopivat is approved in the participant's country. During the study, researchers will track the number of treatment-emergent adverse events and adverse reactions for each participant by indication and age group from baseline through the end of the study, which can last up to 316 weeks. Participants' safety and response to long-term treatment will be closely monitored throughout this period.

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.

This research aims to study breast cancer treatment specifically for Nigerian women who have HER2-positive breast cancer. The focus is on evaluating the effectiveness and safety of anti-HER2 therapies given before and after surgery. The study is designed to understand how these targeted treatments work in this population and to improve cancer care. Participants will receive a combination of anti-HER2 drugs, including trastuzumab with pertuzumab (PHESGO), alongside chemotherapy drugs such as docetaxel and trastuzumab emtansine. Hormone therapies like tamoxifen, letrozole, and goserelin are also part of the treatment plan. Treatments are given both before surgery (neoadjuvant phase) and after surgery (adjuvant phase) to assess their impact on the cancer. Throughout the study, participants will undergo regular assessments including biopsies, ultrasounds, blood tests, and heart function tests to monitor safety and treatment effects. Researchers will track the pathological complete response over a 10-year period to measure long-term outcomes. The study includes thorough safety checks and follow-up visits to ensure participants' well-being during and after treatment.

Tuberculosis (TB) is a serious infectious disease causing millions of cases and deaths globally, with a high burden in developing countries like Nigeria. TB mainly affects young adults and is worsened by HIV infection. Current TB treatments are long and challenging, leading to poor compliance and drug resistance. Researchers are studying whether atorvastatin, a cholesterol-lowering drug, can improve TB treatment by making the bacteria more vulnerable and reducing lung damage. Previous Phase II studies showed atorvastatin to be safe and possibly effective, warranting further investigation in this Phase IIC trial. This trial is a multicenter, randomized, open-label study comparing four treatment arms: standard TB drugs alone or combined with daily atorvastatin at doses of 20 mg, 40 mg, or 60 mg for 16 weeks. All participants receive standard anti-TB treatment for 24 weeks. The study will evaluate safety, how quickly the bacteria disappear from sputum, improvements in chest X-rays, and lung function. Participants will be followed closely for 12 months after starting treatment. Participants aged 12 to 65 with confirmed pulmonary TB will have multiple assessments including sputum tests, blood tests, lung function and chest X-rays at various points during and after treatment. Researchers will monitor safety by recording any serious side effects and will measure treatment effectiveness by the time to stable bacterial clearance and disease-free survival at six months. This extended follow-up aims to provide detailed data to support future larger trials.

Young people living with HIV (Y-PLWH) often experience psychological distress and depression, which negatively affect their medication adherence and disease management. This issue is particularly challenging in low- and middle-income countries like Nigeria, where mental health resources are limited and frequent clinic visits can impose high costs, inconvenience, and stigma. The trial evaluates the use of Change My Story, an interactive narrative game, combined with Problem Solving Therapy (PST) compared to PST alone to address depression and psychological distress among Y-PLWH aged 16 to 24 years in Nigeria. Participants will be randomly assigned to either receive PST alone or PST combined with Change My Story. PST is a cognitive-behavioral therapy based on seven steps to improve problem-solving skills and manage stress. Change My Story is a choose-your-own-adventure style game designed to help players navigate emotional challenges and address key drivers of psychological distress. The study aims to compare feasibility, acceptability, engagement, satisfaction, and preliminary effectiveness of these interventions over three months. During the study, participants will be monitored for engagement and satisfaction with the intervention, feasibility of the treatments, and acceptability at various time points up to three months. Researchers will use questionnaires, assessments, and implementation research frameworks to understand factors influencing the interventions' delivery and participant experience. The total study duration for participants is at least three months, during which mental health and adherence outcomes will be evaluated.

This research aims to improve HIV treatment engagement, medication adherence, and viral suppression among young men who have sex with men (YMSM) and young transgender women (YTW) aged 15 to 29 living with HIV in Nigeria. The study focuses on adapting and testing a combination peer navigation and mobile health (mHealth) intervention called the Intensive Combination Approach to Rollback the Epidemic in Nigeria (iCARE Nigeria). It evaluates the intervention's initial effectiveness, feasibility, satisfaction, and acceptability in community-based settings. Participants will be randomly assigned in a 1:1 ratio to receive either the adapted iCARE Nigeria intervention or usual care for 24 weeks. The intervention includes peer navigation and SMS text message medication reminders tailored to YMSM and YTW, delivered through community outreach. The study aims to shift the intervention from a clinic-based to a community-based approach, using feedback from stakeholders and iterative design principles. During the 24-week study, researchers will assess viral load suppression at baseline and week 24 as the primary outcome. Secondary outcomes include antiretroviral drug adherence and retention in treatment, measured through medical record review. Implementation outcomes such as reach, adoption, and maintenance will be evaluated using mixed methods involving participants, interventionists, and community center representatives. Participants will be monitored for treatment engagement and adherence throughout the study period.

This research aims to promote cervical cancer screening and follow-up treatment for women living with HIV in Nigeria, a group at higher risk for cervical cancer. It focuses on adapting and implementing a tailored program called MoMent, originally designed as a peer support system for HIV care, to include home-based cervical cancer screening. The study also seeks to evaluate the program's reach, effectiveness, adoption, and fidelity, and to understand barriers and facilitators for sustaining the program long term. The study uses the MoMent program, which pairs trained HIV-positive women called Mentor Mothers with newly diagnosed women to support their care. This program is being adapted to promote home-based HPV screening using the GeneXpert HPV test. Stakeholders including women living with HIV, peer counselors, clinical managers, and policymakers contribute to tailoring the program. The study will enroll about 1,500 women and follow them through the adapted program to assess how well it works and how it can be maintained and scaled. Participants will perform vaginal self-collection for HPV screening and provide informed consent. Researchers will measure the program's reach, effectiveness, adoption, and fidelity at the start, 6 months, and 18 months. The study also includes a post-implementation evaluation to identify challenges and enablers for sustaining the program. Overall participation spans this evaluation timeline with ongoing monitoring and stakeholder feedback to improve cervical cancer control for women living with HIV in Nigeria.

Researchers are investigating the safety and drug levels of dolutegravir, an HIV medication, in children who have both HIV and tuberculosis (TB). This study focuses on children aged 4 weeks to under 6 years old, as TB is a leading cause of death among children with HIV. Current TB treatment doses with rifampicin often lead to low drug levels, so this research aims to understand how higher doses affect dolutegravir levels and safety in these young patients. The study involves 20 children divided into two age groups: 4 weeks to under 2 years and 2 years to under 6 years. All children will receive standard TB and HIV treatment with dolutegravir taken twice daily alongside rifampicin. During weeks 20 to 21, the rifampicin dose will be increased to a higher level to assess how this affects dolutegravir drug levels and safety. Blood samples will be collected at weeks 20, 22, and 30 to measure drug concentrations and evaluate a biomarker related to drug metabolism. Participants will be closely monitored through clinical and laboratory tests during the 48-week study. Blood samples will also be used to study the activity of enzymes affecting drug processing. The main outcomes measured include dolutegravir levels during both standard and high-dose rifampicin treatment. Safety will be checked regularly to ensure the children's well-being throughout the study period.