Enugu

Researchers are evaluating ways to improve cervical cancer screening and treatment among women living with HIV (WLHIV) in Nigeria, where both HIV and cervical cancer rates are high. Although many WLHIV in Nigeria are receiving antiretroviral therapy, coverage for cervical cancer screening and treatment is still low. The study aims to compare two sets of strategies to better integrate cervical cancer care within existing HIV treatment programs, with the goal of improving health outcomes and life expectancy for these women. The study compares a Core set of implementation strategies, which includes ongoing consultation, educational meetings, strengthening referral systems, and preparing patients to be active participants, with a Core+ enhanced set that adds community engagement and smart cards to support patient involvement. This cluster randomized trial uses these strategies to implement cervical cancer screening, onsite treatment, referral processes, and retention in care for WLHIV. Participants will be monitored for up to 12 months after enrollment to assess how well the strategies reach patients and are sustained over time. Researchers will track outcomes such as screening rates, treatment completion, referrals, and continued retention in care. The study aims to develop culturally adaptable and sustainable methods to integrate cervical cancer services into HIV programs, ultimately supporting the World Health Organization's goal to eliminate cervical cancer by 2030.

Obesity is a chronic health condition linked to cardiovascular disease, type 2 diabetes, and some cancers. This research evaluates the effect of metformin, a drug approved for type 2 diabetes, on weight loss, cardiovascular risk, and insulin resistance in obese, non-diabetic Black Nigerians. The study is a phase 3, blinded, placebo-controlled, randomized trial aimed at understanding metformin's impact in this population, which may have unique genetic and environmental factors affecting obesity and drug response. Participants receive either metformin extended-release tablets, starting at 500mg and increasing to a maximum of 1500mg once daily, or a starch-based placebo that looks identical. The study compares these interventions to assess their effects on weight loss and related health risks over 24 months. During the study, researchers monitor changes in body weight, cardiovascular risk, insulin resistance, waist circumference, and waist-to-hip ratio over two years. Participants undergo regular assessments to track these outcomes, helping to determine the long-term effects of metformin in obese individuals without diabetes.

Researchers are investigating the genetic factors that contribute to Type 2 Diabetes (T2D) and related conditions among the Yoruba people in Ibadan, Nigeria, as well as other African and European ancestry populations. The study aims to better understand how genetic and lifestyle factors interact in causing T2D and its complications, which are major health concerns worldwide. This research includes genome-wide association studies (GWAS) to find genetic variants linked to diabetes and replication studies across different populations. The study involves enrolling 300 unrelated T2D patients and 300 matched controls without diabetes, all of Yoruba ethnicity. Participants will undergo several procedures including questionnaires, blood pressure and body composition measurements, urine and blood sampling, finger prick glucose testing, and eye examinations. Confirmatory blood glucose tests will be done for a small subset when needed. DNA will be extracted from samples for genetic analysis at labs in Nigeria and the NIH. The study will use publicly available software to conduct GWAS and explore gene-environment interactions. Participants will be closely monitored through these assessments to gather detailed health and genetic information about T2D and related cardiometabolic traits. Researchers will collect data on blood glucose levels, hypertension, obesity, kidney disease, and other health factors. The study's outcomes focus on identifying genetic links to T2D and its complications, supporting future prevention and treatment strategies. The involvement includes initial visits for tests and questionnaires and follow-up visits for confirmatory testing when necessary.

Researchers are evaluating two combination interventions designed to address HIV among youth aged 15 to 24 in Nigeria. These interventions include mHealth and Peer Navigation components, focusing on identifying youth living with HIV, linking them to care, promoting pre-exposure prophylaxis (PrEP) uptake among those testing negative, and supporting adherence to antiretroviral therapy (ART) for newly diagnosed individuals. The study involves two parallel 48-week trials conducted in six Nigerian states, aiming to assess both the effectiveness and implementation success of these approaches. The first intervention, HIV Case Finding, targets young men, especially young men who have sex with men (YMSM), to encourage HIV testing and linkage to care if positive, and PrEP initiation if negative. This is a single-arm trial enrolling 6000 participants. The second, HIV Treatment Intervention, is a randomized controlled trial enrolling 600 youth newly diagnosed with HIV who are starting ART for the first time. Interventions include behavioral supports such as peer navigation, motivational interviewing, social media outreach, and SMS reminders alongside standard care. Participants will be involved for 48 weeks, during which they will receive support to promote HIV testing, linkage to care, PrEP uptake, and ART adherence. Researchers will monitor viral suppression and adherence to ART in the treatment group and assess identification of HIV-positive youth and linkage to care in the case finding group. The study will also evaluate the success of intervention implementation in the target populations. Regular follow-up and support through peer navigators and digital messaging are part of the participant experience throughout the study period.

Researchers are evaluating VX-147 for its effectiveness, safety, tolerability, and how the body processes it in adults and children aged 10 to 65 who have apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease. This study is a Phase 2/3 trial designed to better understand treatment options for this specific kidney condition. Participants will receive either VX-147 or a placebo, both given as oral tablets. The study is double-blind and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo during the treatment period. The trial consists of two parts: Part A focuses on treatment effects over at least 48 weeks, while Part B involves continued safety and tolerability observation for approximately four years after the last participant enrolls. Throughout the study, participants will undergo regular assessments including measurements of urine protein to creatinine ratio and kidney function via estimated glomerular filtration rate (eGFR). Safety is monitored by tracking adverse events and serious adverse events. Data will be collected during the treatment period and followed long-term to evaluate both efficacy and safety outcomes, with some measures assessed at interim and final analyses over at least two years.

Researchers are conducting a Phase 3, double-blinded, placebo-controlled, multicenter trial to assess whether azithromycin taken as a preventive treatment can reduce death rates in adults with advanced HIV disease. Participants eligible for the study must have confirmed HIV infection with low CD4 counts or specific treatment histories, reflecting advanced immunosuppression. The trial aims to better understand mortality outcomes related to this preventive approach in this population. Participants will be randomly assigned to receive either azithromycin tablets or placebo tablets for 28 days. All participants will be followed for 24 weeks after randomization to measure the main outcome of death from any cause, with total follow-up lasting 48 weeks. The study compares the effects of azithromycin prophylaxis against an inactive placebo to evaluate its impact on survival. During the study, participants will be monitored regularly to track health outcomes, particularly mortality. They must be able to start or adjust antiretroviral therapy within four weeks of joining the trial. Researchers will closely observe for any adverse effects, treatment adherence, and overall health status throughout the follow-up period to assess the safety and effectiveness of the intervention.

This research aims to train radiologists in Nigeria to perform ultrasound-guided breast biopsies for breast cancer diagnosis. The study focuses on introducing a practical and sustainable training method using mobile health (mHealth) devices to improve diagnostic practices in Nigerian hospitals, where blind biopsy or surgical excision is currently the norm. Women participating in the study will receive ultrasound-guided breast biopsies performed by trained radiologists. This method is considered the standard of care in the United States due to its higher accuracy compared to blind biopsies and equivalence to surgical excision. The study evaluates the use of mHealth technology to facilitate this training and clinical implementation. Participants will be monitored for the number of successful ultrasound-guided breast biopsies within one year. The study collects data on the effectiveness of the training and biopsy procedures, aiming to enhance breast cancer diagnosis at the point of care. Women must consent to participate and meet eligibility criteria, with all procedures and outcomes tracked during the study period.