Mbeya

Tuberculosis (TB) remains the leading infectious cause of death worldwide and significantly impacts people living with human immunodeficiency virus (PLHIV), especially children and adolescents. These groups face challenges like gaps in preventive care, detection, treatment adherence, and knowledge. This research aims to improve TB detection, testing, and preventive treatment strategies tailored for PLHIV to address these challenges and improve care outcomes. The study evaluates patient-centered TB preventive therapy, where participants who have been ruled out for active TB choose their preferred preventive treatment regimen. Participants are then randomized to receive one of two types of adherence support, including enhanced support through weekly text messages and clinic phone calls. These messages encourage communication with healthcare providers to address questions and improve treatment adherence. Participants will be monitored for TB screening and diagnosis over 24 to 32 months, with prevention outcomes assessed at 48 months. Researchers will also evaluate the cost-effectiveness of the TB preventive treatments over 32 months. The study involves ongoing communication between participants and trained healthcare staff to support adherence and tracks treatment success and safety throughout the study period.

Researchers are evaluating ways to improve HIV healthcare for mothers living with HIV and their newborns in Tanzania and Mozambique. The study aims to find out if adding maternal HIV viral load testing at delivery can better identify mother-child pairs at high risk of HIV transmission and whether these high-risk infants are linked to the right prevention and care. This project also seeks to expand HIV testing access in rural areas using a hub-and-spoke referral system. The study involves maternal HIV viral load testing at delivery to assess the risk of vertical HIV transmission. Results will be combined with clinical criteria to determine risk levels. The intervention includes additional personnel support for managing increased testing and high-risk cases, as well as eHealth tools to share test results electronically between health facilities. Smaller health facilities will refer samples to larger centers to ensure rural communities receive these services. Participants will be closely monitored to measure key outcomes like the proportion of HIV-exposed infants who are correctly identified as low- or high-risk and who receive testing and treatment within seven days of birth. The study will collect socio-behavioral data through interviews and questionnaires to understand factors affecting treatment adherence. Mothers and their HIV-positive infants will receive ongoing counseling and care support throughout the study to address challenges related to infant HIV treatment and improve health outcomes.

Researchers are evaluating the safety and effectiveness of new treatment combinations compared to the standard regimen for adults newly diagnosed with drug-sensitive pulmonary tuberculosis. This phase 2B/C open-label trial involves multiple stages and experimental treatment arms, including drugs like rifampicin, pyrazinamide, moxifloxacin, BTZ-043, alpibectir, ganfeborole, delpazolid, and others. The study aims to find optimized doses and new drug combinations that could improve treatment outcomes in this population. Participants will be randomly assigned to different treatment groups across three stages. Stage 1 compares the control regimen with two experimental rifampicin-containing regimens. Stage 2 adds a new experimental arm with BTZ-043, adjusting participant allocation ratios accordingly. Stage 3 begins after stages 1 and 2 complete recruitment and compares the control arm with two more experimental arms, including one containing alpibectir and ethionamide. Dosages and drug combinations vary by arm, with regimens administered mostly once daily by mouth. During the study, participants will be monitored up to 26 weeks to assess how quickly their tuberculosis cultures convert to negative and to measure changes in the amount of tuberculosis bacteria. Evaluations include clinical exams, chest X-rays, sputum tests, and safety monitoring. The total number of participants planned is up to 390 adults aged 18 to 65. The study includes thorough follow-up to understand treatment effects and safety in this group.

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.

Postpartum haemorrhage (PPH), or heavy bleeding after childbirth, causes around 70,000 maternal deaths annually. Tranexamic acid (TXA) is an established life-saving treatment for women who develop PPH. The I'M WOMAN trial aims to find out if giving TXA just before childbirth can prevent PPH in women at higher risk. This Phase 3 trial also compares the effects of tranexamic acid given by intramuscular (IM) injection versus intravenous (IV) injection, and evaluates side effects and other important maternal health outcomes. Participants will receive either tranexamic acid or a placebo, with all treatments packaged identically to keep the study blinded. TXA is usually given slowly by IV injection, but recent findings show IM injection is well tolerated and quickly absorbed, potentially causing fewer side effects. The trial includes women aged 18 or older who are admitted to give birth vaginally or by cesarean section and have one or more risk factors for PPH. During the study, researchers will monitor participants for the risk of postpartum haemorrhage within 24 hours of childbirth. Assessments will include evaluating bleeding, side effects, and other maternal health outcomes. The trial is double-blind and placebo-controlled, ensuring unbiased results. Participant involvement includes hospital admission for childbirth and follow-up during the immediate postpartum period to assess safety and effectiveness of the treatments.