Kisumu

Researchers are evaluating new medicines to prevent HIV-1 Human Immunodeficiency Virus Type 1 infection. This Phase 3 clinical study aims to determine if taking the drug MK-8527 once a month can prevent HIV-1 infection as well as or better than the standard daily pre-exposure prophylaxis PrEP. The study also assesses the safety and tolerance of MK-8527 in participants. Participants are randomly assigned to one of two groups. One group receives 11 mg of MK-8527 once monthly along with a daily placebo pill matching FTCTDF. The other group receives a daily dose of FTC245 mg TDF and a monthly placebo matching MK-8527. This treatment period lasts for approximately two years, followed by an additional 28-day period where all participants receive open-label FTCTDF daily. During the study, participants will undergo regular monitoring to check for HIV-1 infection and any adverse events. Researchers will track the number of participants who acquire HIV-1, experience side effects, or stop treatment due to side effects over the two-year period. Safety and adherence assessments will be conducted to evaluate the study treatments. The total participation time includes the two-year treatment phase plus the 28-day follow-up with open-label FTCTDF.

Respiratory syncytial virus RSV is a common virus affecting children, especially young babies, premature infants, and those with heart or lung problems. It is a leading cause of hospitalization for children under 5 years old globally, with many severe cases and deaths occurring in low- and middle-income countries. This research evaluates the safety of an RSV vaccine called ABRYSVO given to pregnant women and how well it protects their infants from severe RSV infections during the first six months of life, particularly in African and lower-middle income countries where data is limited. Pregnant women will receive either the ABRYSVO vaccine or a placebo in a randomized, double-blind trial. The vaccine contains stabilized RSV prefusion F antigens from virus subgroups A and B. The study will enroll pregnant women at the approved gestational age for vaccination, with participants randomly assigned to receive either the vaccine or placebo in equal numbers. The trial will monitor the safety of the vaccine in mothers and infants and measure how well the vaccine prevents severe RSV lower respiratory tract infections in babies up to 180 days old. Participants will attend antenatal clinics and provide informed consent for themselves and their infants. Researchers will follow the women through pregnancy and delivery, recording any preterm births and birth weights. Infants will be monitored for RSV infections confirmed by laboratory tests, and hospitalizations due to RSV will be tracked up to six months of age. Safety assessments include monitoring adverse events in mothers and babies, with follow-up visits and telephone contacts to ensure comprehensive data collection throughout the trial period.

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 new medicines to prevent infection with Human Immunodeficiency Virus Type 1 HIV-1. This Phase 3 clinical trial aims to find out if taking MK-8527 once a month is more effective than a daily standard pre-exposure prophylaxis PrEP in preventing HIV-1 infection in women. The study also monitors the safety and tolerability of MK-8527 compared to standard treatment. Participants are randomly assigned to one of two groups one group receives 11 mg of MK-8527 once monthly along with a placebo daily pill resembling EmtricitabineTenofovir Disoproxil Fumarate FTCTDF, and the other group receives the daily FTCTDF pill plus a monthly placebo resembling MK-8527. This treatment phase lasts for up to approximately two years. Afterward, all participants take open-label FTCTDF daily for an additional 28 days. During the study, participants attend regular visits for up to about two years, during which researchers check for new HIV-1 infections, record any adverse events or side effects, and monitor if participants stop the study medication due to side effects. The primary outcomes include the number of participants who acquire HIV-1 infection, those who experience adverse events, and those who discontinue due to adverse events, all tracked over the treatment period.

Researchers are studying pediatric cryptosporidiosis to better understand how this infection presents and progresses in children aged 6 to 59 months. The focus is on characterizing the clinical features and course of diarrhea caused by Cryptosporidium, a parasite common in certain regions. This observational study aims to gather detailed information on symptoms and outcomes in affected children. Participants are children with diarrhea due to Cryptosporidium infection confirmed by specific stool tests. The study observes children with varying durations of diarrheafrom acute to chronicand different nutritional statuses. The study follows children for up to 21 days, monitoring diarrhea severity, dehydration, and parasite presence without administering any treatment. During participation, children will be assessed at multiple time points including baseline, days 3, 7, 14, and up to day 21. Researchers will collect stool samples and evaluate dehydration severity, diarrhea resolution time, and parasite shedding. Additional factors like age, nutritional status, and breastfeeding history will be analyzed to understand their association with illness duration and severity. Participants will be followed closely to capture the natural course of infection and symptoms.

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 efficacy, safety, and immune response of MTBVAC, a candidate vaccine against tuberculosis TB, in adolescents and adults aged 14 to 45 years living in regions where TB is common. This Phase 2b study is randomized, double-blind, and placebo-controlled, aiming to compare MTBVAC to a placebo in preventing TB disease, particularly in participants who have tested positive or negative for latent TB infection using IGRA tests. Most participants likely received BCG vaccination in infancy. Participants are assigned to receive a single intradermal dose of MTBVAC at 5x105 CFU or placebo on Study Day 1. Those who test IGRA-positive at baseline are randomized 11 to either MTBVAC or placebo, while IGRA-negative participants are randomized 31. Subgroups of participants will be closely monitored for safety and immune responses, with specific evaluations in selected safety and immunogenicity sub-cohorts. The study also includes follow-up screening for pulmonary TB disease and HIV testing yearly and during suspected TB episodes. During the study, participants will attend regular visits or have contacts to monitor for TB signs and symptoms, with sputum tests performed if TB is suspected. Safety assessments include monitoring adverse events and laboratory tests in sub-cohorts. The main outcome is the protective effect of MTBVAC against bacteriologically confirmed pulmonary TB over 36 months, along with safety and immune response evaluations. Participants diagnosed with TB will be referred for standard treatment, and those who seroconvert for HIV will receive appropriate care. The study runs until March 2028.

Researchers are evaluating the pharmacokinetics and safety of etavopivat in children with sickle cell disease SCD. This phase 12 open-label study involves pediatric participants divided into four age groups, starting with the oldest and moving sequentially to younger cohorts after reviewing safety and pharmacokinetic data. The study aims to understand how the drug behaves in the body and its safety profile in this pediatric population. Participants will receive oral tablets or granules of etavopivat once daily. Each age group, ranging from 6 months to under 18 years, will be treated for a 24-week primary treatment period. Following this, participants will enter a 72-week extension treatment phase to further assess long-term safety and pharmacokinetics. The total duration for each participant is approximately 96 weeks. During the study, participants will undergo various assessments including measuring drug levels in the blood and monitoring for adverse events throughout the 24-week primary treatment and 72-week extension periods. Researchers will also evaluate hemoglobin response, changes in vaso-occlusive crisis frequency, fatigue levels, and blood flow velocity by ultrasound at multiple time points. Safety monitoring and dose adjustments will be tracked, and participants will be followed closely to understand the long-term effects of etavopivat.

Researchers are investigating the effects of crizanlizumab compared to a placebo in adolescents and adults with Sickle Cell Disease who experience frequent vaso-occlusive crises VOCs. This Phase III, randomized, double-blind study involves patients aged 12 years and older who have had 4 to 12 VOCs managed by healthcare professionals in the past year. The study evaluates the safety and effectiveness of crizanlizumab with or without standard hydroxyureahydroxycarbamide therapy. Participants are randomly assigned in a 21 ratio to receive either crizanlizumab at a dose of 5 mgkg or a placebo, both given alongside standard care. The treatment is administered intravenously as a concentrate for infusion. The study is stratified by hydroxyurea use and geographical region to ensure balanced groups. The main treatment period lasts for one year. During the study, participants will attend regular visits for treatment and monitoring. Researchers will assess the number of healthcare-managed VOCs, including those treated in person or via remote consultation, and measure various other outcomes such as time to first VOC, VOC duration, antibody development to crizanlizumab, adverse events, and changes in hemoglobin levels. Safety and efficacy will be observed over two years, with detailed documentation of VOC events and other health assessments throughout participation.

Researchers are evaluating a multisectoral agricultural intervention called Shamba Maisha aimed at improving reproductive and sexual health among adolescent girls and young women AGYW aged 15-19 in Kisumu and Migori counties of Western Kenya. This region has high rates of HIV and sexually transmitted infections STIs, along with widespread food insecurity and poverty, which contribute to vulnerability to these infections. The study focuses on reducing the incidence of gonorrhea and chlamydia and improving related health outcomes by addressing household food security and adolescent-caregiver relationships. The Shamba Maisha intervention includes providing families with water pumps, seeds, and farming tools, along with training on agricultural techniques delivered at both home and school demonstration farms. Girls will engage in practical farming activities at school, which also benefits the wider school community. Additionally, families participate in sessions to strengthen communication and reduce stress between caregivers and adolescents, including discussions on sexual health. Control group participants will have the chance to receive the full intervention after the study concludes. Participants will be followed for 18 months, with data collected through surveys and testing for STIs and pregnancy at four time points baseline, 6, 12, and 18 months. Researchers will measure outcomes such as STI incidence, household food insecurity, adolescent and caregiver mental health, body mass index, condom use, intimate partner violence, empowerment, and educational attainment. The study will also assess factors affecting implementation and costs, aiming to inform sustainable strategies to reduce food insecurity and improve HIV prevention among vulnerable youth.