Mwanza

Researchers are conducting a large multi-country project to estimate the prevalence of high-risk human papillomavirus (HPV) infections among girls and women aged 9 to 50 years in South Asia and sub-Saharan Africa. The study also aims to understand the incidence of persistent HPV infection over two years among sexually active young women. Alongside these surveys, qualitative studies will explore how gender norms and stigma affect HPV risk and access to prevention and treatment services. The study uses two main approaches: cross-sectional surveys (CSS) and longitudinal studies (LS). The CSS will enroll girls and women aged 9-50 from urban and rural areas, collecting urine samples for HPV testing and gathering data on demographics, sexual history, and HPV awareness. The LS will follow sexually active girls and women aged 15-35 for up to 24 months, testing for persistent HPV infection every six months using self-collected vaginal swabs and urine samples. In some countries, blood samples may also be collected. Qualitative sub-studies involving interviews and focus groups will be conducted in selected countries to better understand risk factors and barriers. Participants will provide samples and complete questionnaires on demographics, sexual and reproductive history, HPV vaccination, and screening. The study will measure HPV prevalence at a single time point and the incidence of infections lasting six months or longer. Safety and ethical considerations include informed consent for adults or assent with guardian consent for minors. The study is planned to run from late 2023 through 2026, with ongoing data collection and analysis across multiple countries and populations.

Researchers are evaluating new treatment regimens for pulmonary tuberculosis (TB) to find faster, safe, and effective options compared to the standard 24-week treatment. This trial is conducted by the UNITE4TB consortium, involving universities and pharmaceutical companies across multiple continents. The study includes adults with newly diagnosed rifampicin-susceptible pulmonary TB and aims to identify novel drug combinations and optimal treatment durations that could also work for drug-resistant TB. The trial has two parts: Phase 2B and Phase 2C. In Phase 2B, up to 700 participants will be randomly assigned to one of twelve treatment arms, including the standard 24-week regimen or various 16-week combinations of drugs such as bedaquiline, delamanid, moxifloxacin, BTZ-043, and GSK3036656. Phase 2C will evaluate the best regimens from Phase 2B by testing different treatment lengths of 8 to 16 weeks in up to 1800 participants. Treatments are given orally daily, and some drugs have specific dosing schedules. Participants will be involved for a total of 72 weeks and will undergo regular assessments including sputum tests to measure bacterial levels, imaging, laboratory tests, and safety monitoring. The study will measure the rate of bacterial clearance and favorable clinical outcomes at 48 weeks. Safety will be monitored closely through adverse event reporting and interim analyses to guide decision-making. The trial aims to improve TB treatment by identifying shorter and effective regimens with acceptable safety profiles.

Researchers are conducting a long-term study to observe people with sickle cell anemia (SCA), focusing on how the medicine hydroxyurea affects their growth, puberty, fertility, and pregnancy outcomes. Hydroxyurea helps increase fetal hemoglobin, which can reduce serious SCA complications and improve overall health, especially in areas with limited access to safe blood transfusions. Despite its benefits, the long-term effects of hydroxyurea on development and reproductive health are still not fully understood. Participants will be followed over several years, visiting the clinic every few months for health check-ups and blood tests. Girls who have started menstruating will have pregnancy tests every six months, while boys may be asked to provide semen samples if they agree. Regular health and fertility questionnaires will also be completed by all participants. The study will track clinical outcomes from enrollment up to 10 years, monitoring growth, development, fertility, and reproductive health among adolescents and young adults with SCA. This ongoing observation aims to provide important information about the long-term effects of hydroxyurea treatment and pregnancy outcomes in this population.

Researchers are evaluating the safety and effectiveness of rilzabrutinib in people aged 10 to 65 years with sickle-cell disease (SCD). This multicenter study is a phase 3, randomized, double-blind, placebo-controlled trial designed to assess rilzabrutinib’s impact on clinical vaso-occlusive crises (VOC) over a 52-week period, followed by an open-label long-term extension (LTE) phase. Participants include adults and children who have had multiple VOC episodes and meet specific health criteria. Participants will be randomly assigned to receive either oral rilzabrutinib tablets or placebo tablets during the 52-week double-blind period (Part A). About half of the participants enrolled initially will be adults until an interim analysis is completed, after which both adults and children will be enrolled. Those who complete Part A may continue into the open-label LTE period (Part B), which lasts up to 52 weeks from the first participant’s entry into this phase. Treatment dosing remains stable and consistent throughout the study. During the study, participants will visit the study sites regularly based on a set schedule for assessments. Researchers will monitor the annualized rate of clinical VOC events at week 52 as the primary outcome. Safety and efficacy will be evaluated through medical exams, laboratory tests, and ongoing health monitoring. Participants' use of hydroxyurea and L-glutamine will be recorded, and adherence to stable dosing will be maintained throughout. The study aims to provide long-term safety and efficacy data on rilzabrutinib for this population.

This research aims to understand if infants and young children with sickle cell disease (SCD) develop sufficient protection after receiving measles vaccines. The study focuses on evaluating the immune response following the first and second doses of the measles vaccine, without assessing long-term protection. It involves children eligible for measles vaccination according to national guidelines. Families of children with SCD who are due for measles vaccination will be invited to participate. The study includes two groups: one receiving the first measles vaccine dose (MV1) and another receiving the second dose (MV2). Blood samples will be collected before vaccination, then again at 4 weeks and 8 weeks after vaccination to measure immune response. Participants will have blood drawn three times to assess antibody levels, helping researchers understand vaccine effectiveness in this group. The main outcome measured is the rate of seroconversion, or development of antibodies, 8 weeks after vaccination. The study requires participants to follow up for sample collection and evaluations over the 8-week period after vaccination.