Abuja

Researchers are investigating the safety, tolerability, and immune response of the rVSV94G-LASV-GPC vaccine in adults and children living in West Africa. This Phase 2 randomized, double-blinded, placebo-controlled trial builds on earlier studies that showed the vaccine was safe and triggered immune responses in animals and adults. The trial includes healthy adults, adults living with HIV, and children, aiming to expand knowledge before future effectiveness trials. Participants will receive one of two doses of the rVSV94G-LASV-GPC vaccine or a placebo. The study groups include healthy adults aged 18 to 70, HIV-infected adults aged 18 to 50, adolescents aged 12 to 17, children aged 6 to 11, and younger children aged 18 months to 5 years. The trial is randomized and triple-blinded, ensuring unbiased comparison between vaccine doses and placebo. The study monitors participants over several months to assess immune responses and vaccine shedding. During the study, participants will undergo medical evaluations, blood tests for antibody responses and vaccine presence, and monitoring for any side effects. Researchers will measure safety and tolerability up to seven months after vaccination and track immune responses and vaccine levels in blood, saliva, urine, and possibly reproductive fluids for up to 2.5 years. Participants and caregivers will complete questionnaires and attend follow-up visits as scheduled throughout the study duration.

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 effects of etavopivat in adolescents and adults with sickle cell disease. This study aims to confirm whether etavopivat reduces the number of painful vaso-occlusive crises caused by blood vessel blockages. It also examines if the medicine helps reduce organ damage, improve exercise tolerance, and decrease fatigue. The study is a phase 3, randomized, double-blind, placebo-controlled trial lasting about two years. Participants will be randomly assigned to receive either oral etavopivat or a placebo. The treatment is given by mouth, and neither the participants nor the researchers know which treatment is given during the study to ensure impartial results. The primary treatment period is 52 weeks, during which the number of vaso-occlusive crises with medical contact will be measured. Secondary assessments include changes in hemoglobin levels, fatigue scores, walking distance, and other blood markers related to sickle cell disease. During the trial, participants will undergo regular evaluations including blood tests, walking tests, and fatigue assessments from baseline to week 52. Researchers will monitor the safety and effectiveness of etavopivat throughout the study. The total participation time is about two years, with ongoing follow-ups to observe the treatment effects and any side effects. All procedures aim to provide detailed information on how etavopivat affects sickle cell disease symptoms and patient well-being.

Researchers are evaluating the effects of school-based life skills training, with and without digital literacy training, on adolescent girls in secondary schools in Nigeria. This study aims to understand how these programs influence school performance, retention, socio-emotional and digital skills, health, marriage, fertility, and work outcomes. The study uses a cluster randomized controlled trial design involving girls aged 15 to 20 in three Nigerian states Kaduna, Katsina, and Kano. Participants are divided into three groups one group receives a 12-month safe space-based life skills training covering negotiation, communication, sexual and reproductive health, gender-based violence, and climate change another group receives the same life skills training plus a digital literacy program including word processing, database management, online marketing, online safety, and programming a third group receives no training during the study. The interventions are delivered within schools, and the trial runs from baseline through midline and endline surveys. Participants will complete surveys before the interventions, six months after intervention completion, and again two years later. These surveys include interviews with the girls and their caregivers to assess outcomes like school graduation, retention, marriage, income activities, digital financial literacy, socio-emotional skills, and many other educational, economic, and health-related measures. The study involves 8,463 girls from 273 schools, with ongoing monitoring to evaluate the impact of these training programs.

Tuberculosis TB remains a major global health issue with over 3 million people undiagnosed each year and 1 million deaths. The ADAPT study aims to reduce this burden by evaluating new point-of-care TB diagnostic tests that are faster, simpler, and less costly. The study focuses on adolescents and adults with suspected TB symptoms or risk factors, assessing these novel tests in real-world outpatient settings in high TB burden countries. The study also evaluates the usability and acceptability of these tests by health workers. Participants will be involved in testing novel TB triage and diagnostic tools, including semi-automated or automated molecular assays based on tongue swabs. These tests will be compared against standard reference methods like sputum Xpert MTBRIF Ultra and mycobacterial culture. The study plans to enroll about 450 participants per year at each of three sites to assess various diagnostic tests and 50 health workers to evaluate test usability. During the study, participants will undergo diagnostic testing and screening based on TB symptoms or risk factors. Health workers will be observed and surveyed regarding the ease of use and acceptance of the new tests. Researchers will track the proportion of positive and negative test results among participants with and without TB over two years. The study involves follow-up visits and consent, ensuring adherence and data collection, with the goal of improving rapid TB diagnosis and management worldwide.

This research aims to improve cervical cancer screening and follow-up care for women living with HIV WLWH in Nigeria. It focuses on adapting and implementing a home-based screening program using the MoMent peer support model to better reach and support this high-risk group. The study evaluates how well the program works, how widely it is adopted, and its long-term sustainability. The study will adapt the MoMent program, which pairs experienced WLWH called Mentor Mothers with newly diagnosed women, to include home-based HPV screening using the GeneXpert HPV test. Women who test positive for high-risk HPV types receive follow-up care, including visual inspection with acetic acid VIA and treatment such as thermal ablation or excision if needed. Those testing negative are invited for retesting after one year. The programs reach, effectiveness, adoption, and fidelity will be assessed over 18 months. Participants will self-collect vaginal samples at home, and Mentor Mothers will assist in notifying and scheduling follow-up care for those with positive results. The study includes questionnaires and process evaluations to identify barriers and facilitators. The main outcomes measured are program reach, effectiveness, adoption, and fidelity at baseline, 6 months, and 18 months. The study runs from December 2024 to June 2026 and focuses on women aged 25 to 50 living with HIV.

This research aims to evaluate two training protocols designed to improve a physicians ability to screen and treat high-grade intraepithelial lesions HSILs to prevent anal cancer. The study focuses on comparing the current standard training developed in high-income countries with a new training tailored specifically for the Nigerian healthcare setting. The goal is to determine if the tailored training leads to better performance in anal cancer screening and treatment within an HIV care context. The study will first apply the standard training for 12 months to observe baseline screening and treatment practices. Then, an enhanced training called e-STH, developed through an iterative process based on local barriers and facilitators, will be implemented over 6 months. Following this, a 12-month period will evaluate the impact of the enhanced training on HSIL detection and treatment. Finally, a 6-month phase will assess the sustainability of the improved screening and treatment practices with minimal involvement from the research team. Participants involved are a single physician undergoing these training protocols at one clinic. Researchers will monitor the proportion of HSIL cases detected and treated, as well as secondary outcomes related to reach, efficacy, implementation, and sustainability of the screening program. The study uses a non-randomized, sequential design to evaluate these outcomes over a total period of 36 months, with ongoing assessments throughout each phase.

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.

This research aims to improve the use of hydroxyurea HU for managing sickle cell disease SCD in Nigeria, where most patients currently do not receive evidence-based care despite HUs potential to reduce complications and mortality. The study addresses provider barriers to HU adoption using a practical approach based on previous NIH-funded trials and Nigerian health guidelines. It focuses on increasing HU adoption by healthcare providers through a tailored strategy in clinical settings. The study compares two approaches at 20 clinical sites one group receives educational information about task sharing SIM, and the other group receives an enhanced strategy called TASSH TCP, which includes healthcare worker training, clinical reminders, and practice facilitation to support SCD management. The study follows a cluster randomized design to assess which approach leads to better adoption of HU treatment over 12 months. The implementation and sustainability of these methods are also evaluated at 12 and 24 months. Participants include SCD patients registered at local clinical sites, with assessments including screening, HU treatment initiation, and dosage monitoring at 12 months. Data on adoption rates, implementation fidelity, and mediators affecting these outcomes are collected. The study will help identify scalable and sustainable ways to improve HU use in Nigeria and monitor patient outcomes through electronic medical records over the study period, which runs until May 2028.

Researchers are conducting an observational study called the Multinational Observational Cohort of HIV and Other Infections MOCHI to understand the number of new HIV infections among people vulnerable to acquiring HIV. This study is carried out across multiple international sites and focuses on individuals aged 14 to 55 years who engage in behaviors that increase their risk of HIV. It aims to gather information on HIV incidence as well as other sexually transmitted infections STIs. The study is divided into two steps. Step 1 enrolls participants aged 14 to 55 years who are vulnerable to HIV and evaluates them every 12 weeks for HIV and other STIs. Participants diagnosed with HIV in Step 1 move to Step 2, where they receive more frequent evaluations including viral load and other HIV-related tests every four weeks for 12 weeks, then every 12 weeks, with a total follow-up of 48 weeks in Step 2. Participants will attend regular visits for testing and evaluation throughout the study period. In Step 1, evaluations occur every 12 weeks, while in Step 2, participants have more frequent visits for detailed monitoring of their HIV status and viral load. Researchers will measure HIV incidence, STI prevalence, and willingness to participate over a 10-year period. The study includes collecting information on risk behaviors and monitoring participants health through laboratory tests and questionnaires.