Abuja

Researchers are conducting a Phase 2 randomized, double-blinded, placebo-controlled trial to assess the safety, tolerability, and immune responses of the rVSV94G-LASV-GPC vaccine in adults and children living in West Africa. This vaccine candidate has shown safety and protective effects against Lassa Fever in animals and was well tolerated in a previous Phase 1 trial. The study aims to expand safety and immune response data to include adults with HIV, older adults, and healthy children to prepare for a future efficacy trial in the region. Participants will receive one of two dosage levels of the rVSV94G-LASV-GPC vaccine or a placebo on Day 1. The study includes groups of adults, adolescents, and children divided into specific age strata. The trial evaluates vaccine safety and immune responses at multiple time points, including early periods of 14 and 28 days, and extended follow-up up to 7 months. The research will also examine vaccine shedding in saliva, urine, and possibly other bodily fluids in some participants. During the study, participants will be monitored closely with medical examinations, laboratory tests, and assessments of immune responses. HIV testing and counseling will be provided when applicable. Safety checks include blood tests, hearing exams, and screening for other infections. Participants are required to comply with contraception guidelines if sexually active and of childbearing potential. The total participation time includes follow-up visits over several months to ensure safety and gather detailed information on immune protection.

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.

Researchers are evaluating the effects of school-based life skills training delivered in safe spaces, with and without added digital literacy training, on adolescent girls in secondary schools in Northern Nigeria. The study aims to understand how these trainings influence school performance, retention, socio-emotional skills, digital skills, health, marriage, fertility, and labor market outcomes. This cluster randomized controlled trial includes girls aged 15 to 20 from Kaduna, Katsina, and Kano states. The participants are divided into three groups: one receiving a 12-month safe space-based life skills training covering topics such as negotiation, communication, sexual and reproductive health, gender-based violence, and climate change; another group receiving the same life skills training plus digital literacy training focusing on word processing, database management, online marketing, online safety, and programming; and a control group receiving no training during the study period. The interventions are delivered at school, and the digital literacy is integrated with life skills training for the second group. Girls and their caregivers participate in baseline surveys before the intervention, followed by midline surveys six months after completion, and endline surveys two years post-intervention. Researchers assess outcomes including high school graduation, school retention, marriage status, engagement in non-farm income activities, digital financial literacy, and socio-emotional skills at both six months and 24 months after the interventions. A total of 8,463 girls from 273 schools are involved, with ongoing monitoring of educational, economic, and health-related outcomes.

Researchers are evaluating new, faster, simpler, and less expensive tests to diagnose tuberculosis (TB) at the point of care. The study focuses on adolescents and adults suspected of having TB based on symptoms or risk factors, aiming to reduce the large number of undiagnosed TB cases and deaths worldwide. The study includes clinical evaluations in outpatient health centers in high TB burden countries and assesses how well these new tests work compared to standard sputum tests recommended by the World Health Organization (WHO). The study will examine molecular tests using samples collected by tongue swabs that can be done near or at the point of care. These tests will be compared against established reference tests like sputum Xpert MTB/RIF Ultra and sputum cultures to measure their ability to correctly identify TB cases. Additionally, the study will explore how usable and acceptable these new tests are by observing and surveying healthcare workers who perform routine TB testing. Participants will be interviewed and examined for TB symptoms and risk factors, and undergo diagnostic testing using both standard and novel methods. The study will monitor the proportion of correct positive and negative test results over two years. Healthcare workers involved in TB testing will also be included to provide feedback on the novel tests. The overall goal is to improve rapid TB diagnosis and treatment by validating these new diagnostic tools and understanding their practical use in healthcare settings.

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.

The DELIVER project in Nigeria aims to tackle the low quantity and variety of vegetables consumed in northern Nigeria by supporting smallholder farmers to increase vegetable production and promoting healthier diets among farmers and their neighbors. This evaluation studies the effectiveness of GAIN's DELIVER program in increasing vegetable consumption among participating smallholder farmer households and nearby non-farming neighbor households. The assessment uses a quasi-experimental design based on the RE-AIM framework, which evaluates reach, effectiveness, adoption, implementation, and maintenance of the program. The DELIVER program builds the capacity of smallholder farmers through collaboration with lead farmers who establish demonstration plots showcasing advanced agricultural techniques and technologies. These plots serve as training hubs covering vegetable production, postharvest handling, business, and market planning. The project also encourages farmers to recruit at least one neighbor family to whom they regularly sell vegetables, thus promoting vegetable consumption in the wider community. Additionally, the program supports livelihood improvements by enhancing market connections and access to finance for farmers. Participants are involved in the study over a two-year period from April 2025 to April 2027, with assessments at baseline and endline. Researchers measure the quantity and variety of vegetables consumed by households during this time. Participants must be adult members of farmer or neighbor households within the intervention area who can speak English or Hausa and provide informed consent. This evaluation helps understand how the DELIVER program influences vegetable consumption and dietary diversity in the target communities.

This research aims to develop effective strategies for implementing breast cancer screening using clinical breast examination (CBE) in primary health centers located in Abuja, Nigeria. The study focuses on understanding the challenges and supports present in these primary care settings to improve the screening process for breast cancer detection. The study involves engaging multiple stakeholders including healthcare workers, volunteers, and community members to collaboratively identify barriers and facilitators for CBE screening. Participants will allow researchers to observe clinic workflows and contribute through interviews and focus group discussions about implementing CBE screening in primary care clinics. During the study, researchers will assess various aspects related to the implementation process over one year, including intervention characteristics, inner and outer settings, individuals involved, and overall implementation domains. Participants will be monitored for their experiences and insights to help shape practical strategies for breast cancer screening in this community.

Researchers are evaluating a program aimed at improving heart health for pregnant women with obesity and their children in Abuja, Nigeria. The study focuses on adapting a proven intervention called Parents as Teachers (PAT) combined with Healthy Eating Active Living Taught at Home (HEALTH) to this community. The main goals are to see if the intervention helps women lose more weight by 18 months after giving birth and if it encourages healthier lifestyle habits for both mothers and their children compared to those not receiving the program. Participants in the intervention group will receive 40 biweekly sessions of the adapted PAT+HEALTH curriculum led by community health educators during home visits. Each session lasts about 60 to 90 minutes. The study will compare these women and children to a control group that does not receive the intervention, monitoring outcomes over a period extending to two years after delivery. Women enrolled will undergo baseline surveys, clinical assessments, lab tests, and body measurements at the start, at birth, and every six months up to 24 months after delivery. Researchers will track changes in maternal body weight from baseline through 18 months postnatal follow-up. The study also collects data on cardiovascular health behaviors and monitors safety and health outcomes for mothers and children throughout the study period.

The Enhancing Access to Safe and Nutritious Diets 2.0 (ENSAND) project in northern Nigeria aims to improve the low consumption of vegetables in both quantity and variety. This evaluation study assesses the effectiveness of GAIN's ENSAND program in increasing vegetable consumption among smallholder farmer households and their neighbor households. The study uses a quasi-experimental design guided by the RE-AIM framework, which looks at reach, effectiveness, adoption, implementation, and maintenance of the program's impact. The ENSAND 2.0 program works by building the capacity of smallholder farmers through collaboration with lead farmers who set up demonstration plots. These plots showcase advanced techniques in vegetable production, postharvest handling, and business and market planning. Farmers participating in the program recruit at least one neighbor family to whom they regularly sell vegetables, aiming to increase vegetable consumption in the wider community. Participants are evaluated based on the quantity and variety of vegetables they consume, measured at baseline in April 2025 and again one year later in April 2026. The study involves adult participants aged 18 years or older who are farmer or neighbor households involved in the ENSAND project. Researchers collect data on vegetable consumption patterns to assess the program's effectiveness over the one-year period.