Mbeya

This research aims to improve HIV healthcare for mothers living with HIV and their newborns in Tanzania and Mozambique, focusing on preventing HIV transmission from mother to child. The study evaluates whether adding maternal HIV viral load testing at delivery better identifies mother-child pairs at high risk of transmission and whether high-risk infants receive appropriate prevention and care. It builds on previous findings about early infant HIV treatment challenges and seeks to reduce access inequities in rural areas by expanding HIV testing services through a hub-and-spoke referral system. The study involves maternal HIV viral load testing at delivery to assess vertical HIV transmission risk, combined with WHO clinical criteria for risk classification. The intervention includes personnel support for managing high-risk cases, eHealth tools for sharing test results between health facilities, and enhanced counseling for high-risk mother-baby pairs. High-risk infants and their mothers are followed long-term for up to 12 months to monitor health outcomes and treatment adherence. Participants will undergo HIV testing at birth and follow-up visits at 4-6 weeks, 14 weeks, 6 months, and 12 months, with assessments of viral suppression, drug resistance, and clinical outcomes. The study also collects socio-behavioral data through interviews and questionnaires to understand factors affecting treatment outcomes. Researchers will measure key program indicators such as the proportion of high-risk newborns tested and started on treatment within seven days, turnaround times for testing, and cost-effectiveness of the intervention package. Continuous support and counseling are provided throughout the study duration.

Researchers are investigating new treatment options for adults with newly diagnosed, drug-sensitive pulmonary tuberculosis through a phase 2BC open-label platform study. The trial compares several experimental drug regimens with a standard control treatment to assess efficacy and safety. Participants include adults aged 18 to 65 years with confirmed pulmonary tuberculosis sensitive to rifampicin and isoniazid. The study aims to optimize doses of existing drugs and introduce new medications to improve treatment outcomes. The study is divided into three stages. In stage 1, participants are randomly assigned to the control or one of two experimental arms containing high-dose rifampicin and other drugs for 12 to 17 weeks. Stage 2 adds an experimental arm including the drug BTZ-043, with participants allocated across four arms in varying ratios. Stage 3 begins after stages 1 and 2 complete enrollment, comparing the control arm with two new experimental arms involving novel drug combinations. Treatments are given once daily, with dosages adjusted by arm and weight. Participants will undergo sputum testing, chest X-rays, and molecular tests to confirm tuberculosis and drug sensitivity before enrollment. During the study, researchers will monitor participants through regular clinical assessments, laboratory tests, and electrocardiograms to track treatment response and safety. The main outcomes measured include time to stable culture conversion and changes in mycobacterial load. Safety is evaluated by recording adverse events and laboratory abnormalities over the treatment period, with follow-up continuing up to 12 months after randomization.

Researchers are investigating new treatment combinations for pulmonary tuberculosis TB to find faster and safe alternatives to the standard 24-week regimen. The study involves adults with newly diagnosed, rifampicin-susceptible lung TB, aiming to identify drug regimens with similar or better effectiveness and safety but shorter treatment times. This research is conducted by the UNITE4TB consortium, a team of universities and pharmaceutical companies funded by the European Union. The study has two phases Phase 2B tests up to 12 different drug combinations, including new drugs like BTZ-043, GSK306656, bedaquiline, and delamanid, for 16 weeks to assess safety and effectiveness. Phase 2C will then evaluate the best regimens from Phase 2B at various treatment lengths ranging from 8 to 16 weeks, compared to the standard 24-week treatment. Participants receive daily oral doses of various drugs in different combinations, with treatment durations and regimens randomly assigned. Participants will be followed for a total of 72 weeks to monitor treatment response and safety. Researchers will assess sputum cultures for TB bacteria and record adverse events up to 26 weeks after starting treatment. The study includes regular visits, imaging, laboratory tests, and adherence monitoring to evaluate how well the treatments work and their side effects. The goal is to find effective shorter treatments for both regular and drug-resistant TB.

Researchers are evaluating the safety and effectiveness of two sorfequiline-based treatment regimens combined with pretomanid and linezolid for adults aged 18 to 65 years with newly diagnosed, drug-sensitive pulmonary tuberculosis. This phase 2, randomized, multi-center clinical trial aims to compare a loading dose regimen against a steady dose regimen. The study focuses on adults who have smear-positive pulmonary tuberculosis and have not been recently treated for the disease. The primary goal is to assess safety through treatment-emergent adverse events and other health measures, while also exploring effectiveness and drug behavior in the body. Participants will be randomly assigned to one of two treatment groups. One group receives sorfequiline 200 mg daily for 4 weeks followed by 100 mg daily for 13 weeks, along with pretomanid 200 mg and linezolid 600 mg daily. The other group receives sorfequiline 100 mg daily for 17 weeks, with pretomanid and linezolid dosed the same way. All treatments are taken orally once daily with food. The study includes a screening period, a 17-week treatment period, and a follow-up period lasting 52 weeks after treatment ends. During the study, participants will undergo various assessments including safety monitoring through adverse event reporting, ECGs, vital signs, laboratory tests, vision checks, and neuropathy evaluations. Effectiveness will be measured by the time to stable sputum culture conversion and favorable treatment outcomes at 26 and 52 weeks post-treatment. Researchers will also study drug levels and quality of life. The total participation time spans from screening through one year after completing treatment, with regular visits throughout the treatment and follow-up phases.

Postpartum haemorrhage PPH is a serious cause of maternal deaths worldwide, causing about 70,000 deaths each year. Researchers are evaluating whether giving tranexamic acid TXA just before childbirth can prevent PPH in women who are at higher risk. This Phase 3 trial compares the effects of TXA administered by two different routes, intramuscular IM and intravenous IV, on the occurrence of PPH, side effects, and other important health outcomes for mothers. Participants will be randomly assigned to one of three groups one receiving 1 gram of TXA by two intramuscular injections plus a placebo IV injection, another receiving 1 gram of TXA by slow IV injection plus placebo IM injections, and a third group receiving placebo injections both IM and IV. The packaging and appearance of the TXA and placebo ampoules are identical, and the trial uses a double-blind design. This setup allows the study to evaluate both the effectiveness and tolerability of the two TXA administration methods. Women aged 18 years or older who are admitted to the hospital to give birth vaginally or by caesarean section and who have one or more risk factors for PPH may participate. During the study, researchers will monitor participants for the occurrence of PPH within 24 hours after childbirth and assess side effects and maternal health outcomes. The trial will carefully track participant health and safety throughout the study period, which is expected to continue until September 2025.