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Found 15 Actively Recruiting clinical trials
Actively Recruiting
Healthy Volunteer
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.
Actively Recruiting
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.
Actively Recruiting
Healthy Volunteer
This research aims to assess the impact of a combined intervention on people with serious mental illnesses such as psychosis, mania, and depression who receive care at prayer camps in West Africa. The study focuses on improving treatment outcomes by integrating a mobile health training program for traditional healers with nurse-delivered pharmacotherapy directly at the camps. The goal is to enhance evidence-based psychosocial support and medication delivery in these settings where traditional or faith healers provide most mental health care. The intervention includes two main parts: a visiting nurse who administers medications to patients residing at the prayer camps, and a smartphone application called M-Healer used by the camp staff. M-Healer offers training on delivering psychosocial treatments, helps monitor patient health, and supports the protection of human rights within the camps. The study uses a stepped-wedge cluster randomized design where all groups start with enhanced usual care and sequentially transition to receive the full intervention. Participants will be evaluated at baseline, mid-treatment, and after treatment completion for changes in psychiatric and depressive symptoms. Data collection will continue throughout the study to compare symptom improvements. The trial includes assessments of mental health status and ongoing monitoring to ensure safety and treatment adherence. The total study duration includes initial and follow-up evaluations to understand the intervention's effectiveness over time.
Actively Recruiting
Researchers are monitoring the side effects of COVID-19 vaccines globally, focusing on healthcare workers, adults over 65, and schoolteachers. The study aims to estimate how common local and systemic side effects are for different COVID-19 vaccines, understand risk factors related to side effect frequency and severity, and evaluate long-term effects. It also compares the safety of various vaccines and examines how palliative drugs affect short-term side effect relief. Participants receive one or two doses of different COVID-19 vaccines, including Pfizer-BioNTech, Moderna, AstraZeneca, Sinovac, Sinopharm, Sputnik V, Janssen, CureVac, Novavax, and Covaxin. The study has two phases: a cross-sectional survey on short-term side effects occurring within 30 days after vaccination, and a prospective cohort study assessing long-term vaccine safety and effectiveness, including after booster doses, over five years starting in 2022. Participants complete validated online questionnaires reporting side effects, their timing, duration, and intensity. Researchers collect data on local and systemic side effects up to 30 days post-vaccination and monitor long-term outcomes through yearly follow-ups. The study helps evaluate vaccine safety and supports efforts to reduce vaccine hesitancy by providing independent data on side effects and their resolution.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating a behavioral intervention called a docudrama to see if it can increase repeat blood donation attempts among first-time blood donors in Ghana. This pilot cluster randomized controlled trial compares the docudrama to usual engagement practices by blood services. The study also looks at factors like donor retention, attitudes, perceived control, and intentions that may influence blood donation behavior. Participants are divided into two groups: one group watches a 30-minute docudrama right after donating blood, while the control group receives standard communications from the blood service, including a thank you call and a reminder call before their next eligible donation. The study randomizes sites by type (mobile versus fixed) and follows participants for six months after enrollment. Blood donation attempts are tracked through official records and self-reports. During the study, participants’ donation behavior and attitudes are assessed at the start and after six months. The primary outcome is the proportion of participants who make a verified repeat blood donation attempt within six months. The total study duration is 11 months, including five months for enrollment and six months of follow-up for the last enrolled participant.
Actively Recruiting
Researchers are investigating a new program called the Water Quality Assurance Fund in rural areas of Ghana and Kenya. This program aims to improve water safety management by addressing financial and capacity challenges faced by small water suppliers. The study focuses on how this intervention affects water system operators' knowledge, chlorination practices, water quality at the collection point, and consumer satisfaction and awareness. The intervention includes written legal agreements between water systems, centralized laboratories, and the facilitating organization. These agreements ensure regular water quality testing and guarantee payments to laboratories if water systems delay payments. The program also involves regular meetings with water operators and local authorities to review test results and improve water treatment. Additionally, community engagement activities inform residents about the water testing program. Participants will be involved in monitoring water quality at baseline and then every six months up to 24 months. The study will measure chlorine levels in water at the collection point to assess safety. Researchers will also evaluate consumer satisfaction, awareness, and willingness to pay for tested and treated water. Household surveys include participants who are at least 18 years old and customers of eligible water systems.
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Healthy Volunteer
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.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating a modified version of the Many Men Many Voices (3MV) intervention called LAFIYA, aimed at reducing stigma and increasing HIV self-testing among young sexual minority men living in slum communities in the Greater Accra Metropolitan area of Ghana. The study focuses on addressing challenges such as low testing rates, stigma, low-risk perception, and confidentiality concerns that affect HIV testing in this population. The intervention, LAFIYA, is designed as a comprehensive behavioral program developed using the ADAPTT-IT framework to adapt 3MV for this specific community. This modified program intends to tackle intersectional stigma and promote HIV self-testing uptake. The study will pilot this intervention to assess its feasibility and acceptability among participants. Participants will be assessed on changes in how acceptable, appropriate, and feasible they find the intervention from baseline to three months. Researchers will collect data on these outcome measures to evaluate the intervention's potential impact. The study involves young sexual minority men aged 18 to 25 years who have not used unassisted HIV self-testing kits and meet other eligibility criteria related to sexual behavior and residence. Safety monitoring and follow-up assessments will be conducted over this three-month period.
Actively Recruiting
This research focuses on pregnant women living with sickle cell disease (SCD) in Ghana, a country with a high number of newborns affected by SCD each year. The study aims to evaluate whether starting a multidisciplinary care program for these women in a non-academic hospital can reduce maternal deaths by 50% compared to previous care. This program is based on successful strategies used at an academic hospital, which showed significant reductions in mortality through coordinated care by specialists. The study involves implementing a multidisciplinary SCD obstetrics program at a non-academic hospital, adapting protocols and training healthcare providers from the academic hospital's program. This program includes obstetricians, general physicians, anesthesiologists, and nurses working together to manage care from early pregnancy through delivery and postpartum. The study will recruit and follow 198 pregnant women with SCD over several years to assess the program's feasibility and impact. Participants will receive regular clinical monitoring including ultrasound scans to confirm pregnancy and follow-up through delivery and postpartum. Researchers will collect and analyze data on maternal mortality and clinical outcomes up to 40 weeks of pregnancy. The study will also examine barriers and facilitators to implementing this care model in the non-academic hospital setting to support sustainable improvements in care for pregnant women with SCD in Ghana.
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Researchers are evaluating the Jada4 System, a novel vacuum-induced device, for treating postpartum hemorrhage (PPH), a leading cause of maternal death worldwide, especially in low and middle income countries. This trial aims to compare the effectiveness, safety, and cost-effectiveness of the Jada4 System against standard care in women experiencing PPH due to uterine atony after delivery. The study involves 424 women in Ghana, where PPH burden is high, and addresses the urgent need for better treatments beyond current methods that often have limitations or risks. The trial compares two groups: one receiving the Jada4 System, which applies low-level vacuum inside the uterus to stop bleeding rapidly by mimicking natural uterine contractions, and another receiving standard care including uterotonics, tranexamic acid, and condom catheter balloon tamponade. The Jada4 device remains in place for at least one hour with monitoring before removal. If bleeding continues, surgical options like uterine ligation or hysterectomy are available. Standard care patients follow a treatment algorithm with similar surgical options if needed. Participants will be monitored from delivery through six weeks postpartum to assess maternal survival without surgery. Assessments include observing bleeding control, device safety, and treatment costs. Monitoring will continue after device removal to ensure bleeding remains controlled. This comprehensive approach aims to provide clear evidence on the Jada4 System's role in managing PPH and improving maternal outcomes in resource-limited settings.
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