Lindi Street

Researchers are evaluating a urine test called the 3-metabolite biosensor to detect colorectal cancer CRC and precancerous polyps in adults living in Ghana, Tanzania, and South Africa. The study focuses on participants who either have symptoms of colorectal cancer, are undergoing screening colonoscopy, or have had recent colonoscopy or pathology results related to CRC or polyps. Participants will be observed using the 3-metabolite biosensor, which is designed to identify colorectal cancer and precancerous polyps from urine samples. The study includes individuals with various colonoscopy findings, including those with diagnosed CRC, adenomatous polyps, or no malignancy, and those presenting symptoms such as rectal bleeding. During the study, participants will provide urine samples for testing with the biosensor. Researchers will measure the sensitivity of the biosensor in detecting colorectal cancer and precancerous polyps over up to one year. Participants are asked to be willing to participate and meet the age criteria of 18 years or older. The study is observational and does not involve treatment interventions.

Researchers are evaluating the safety and effectiveness of a new tuberculosis TB prevention treatment using bedaquiline compared to standard WHO-recommended treatments among people living with HIV PLHIV and high-risk close contacts of adults with drug-sensitive or rifampin-resistant TB. This Phase IIIII open-label trial aims to find out if four weeks of bedaquiline is not worse than existing treatments in preventing confirmed or probable TB over 72 weeks of follow-up. Participants will be assigned to one of three treatment groups 4 weeks of daily bedaquiline, 3 months of weekly isoniazid and rifapentine, or 6 months of daily levofloxacin. The trial includes adults, adolescents, children, and pregnant individuals who are close contacts of TB patients or are PLHIV. Each treatment is given according to weight and age, with specific dosing schedules over 1 to 6 months, and participants will be monitored closely for safety and treatment completion. During the study, participants will undergo assessments including chest X-rays, laboratory tests for liver and kidney function, pregnancy tests when applicable, and monitoring for adverse events. Researchers will track treatment completion, safety by adverse drug reactions, and whether participants develop TB disease during the 72-week follow-up after starting treatment. The study involves careful follow-up visits to collect data on health status, medication adherence, and any side effects experienced by participants.

This research aims to validate the B-COMPASS, a computational model developed by the BEAMER project to improve patient adherence to treatment across various diseases. Adherence to treatment is a widespread issue leading to increased healthcare use and premature death, with about half of medications not taken as prescribed. The study evaluates the models ability to predict adherence, identify patient support needs, and enhance healthcare engagement in six therapeutic areas, including cardiovascular, endocrinology, immunology, neurology, oncology, and rare diseases. Participants complete the BEAMER questionnaire, which the B-COMPASS uses to group patients based on their adherence needs and predict their adherence. Patients are randomized into a control group receiving standard care or an intervention group receiving enhanced engagement through educational materials for healthcare providers tailored to the patients B-COMPASS profile. Engagement occurs in person or by phone, depending on patient schedules, and healthcare providers may also be randomized to limit knowledge of the B-COMPASS in control groups. Participants are involved in two main data collections spaced from 2 weeks to 6 months apart, during which adherence measures, patient support needs, and perceptions of engagement are assessed. The study measures the accuracy, validity, and reliability of B-COMPASS predictions, its impact on adherence, patient and provider perceptions, and cost-effectiveness. The total participation timeline varies by site and disease area, with continuous monitoring of healthcare utilization and patient experience.

Researchers are evaluating the use of nanopore sequencing to diagnose breast cancer in Tanzania. This observational study aims to show that this new sequencing method is not worse than the current standard of care, which includes histopathology and biomarker analysis for estrogen receptor, progesterone receptor, and HER2 status. The goal is to provide faster, cost-efficient, and accurate diagnosis to improve treatment planning in resource-limited settings. In this study, excess fresh tissue from patients suspected of having breast cancer will be analyzed using nanopore sequencing alongside the standard methods. This sequencing includes low-pass whole genome analysis and DNA methylation-based classification to identify breast cancer and its subtypes quickly, potentially delivering results within hours at the point of care. The study does not alter treatment based on nanopore sequencing results. Participants will provide excess tissue samples collected during biopsy or surgical resection after consent. Researchers will continuously assess the agreement between nanopore sequencing and standard care, the feasibility of the method, and the time taken to deliver results over about one year. Quality of life and patient experiences with diagnostic procedures will also be evaluated using questionnaires at baseline, 6 months, and 12 months after enrollment.

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 studying how individual health behaviors and broader societal factors like environment, policies, and health system quality affect health outcomes such as death and the development of chronic diseases. This study also explores genetic influences on non-communicable diseases through both a cross-sectional and a prospective cohort approach. It aims to understand these relationships across different socioeconomic and health resource settings worldwide. Participants are adults aged 35 to 70 years at enrollment. The study involves observing various health-related behaviors, societal determinants including built environment, food and nutrition policies, psychosocial and socioeconomic factors, and tobacco use. Researchers will track the incidence of chronic diseases like cardiovascular disease, cancer, respiratory conditions, diabetes, kidney disease, obesity, hypertension, and injuries over time, without administering any specific treatments. Participants will be followed for an average of 10 years, during which researchers will monitor health events such as new cases of cardiovascular disease and other illnesses, hospitalizations, and mortality. Data will be collected on genetic factors and changes in risk factors like smoking and diet. The study measures the impact of health systems and environmental influences on outcomes. Participants will be involved through regular assessments but will not receive interventions as this is an observational study.

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.

This research aims to develop and test a locally tailored intervention called P-KIDs CARE to improve the triage process for injured children in Tanzania. The study focuses on pediatric injury patients, family members, and healthcare providers in two health facilities in the Kilimanjaro Region. Researchers want to understand the barriers to timely care and improve assessment, stabilization, and referral processes to reduce delays in receiving definitive treatment. The P-KIDs CARE intervention includes two main parts training healthcare providers with the World Health Organizations Basic Emergency Care Course, which uses presentations and hands-on practice, and an online decision support tool adapted for local needs. This tool incorporates models to assess mortality risk and assist with referral decisions. The intervention will be developed through workshops and refined with feedback from providers and community members before being piloted in the study facilities. Participants will include about 200 pediatric injury patients enrolled in a registry, 10 healthcare providers, and family members of patients. The study involves interviews, focus groups, surveys, and exit interviews to evaluate how feasible and acceptable the intervention is. Researchers will track outcomes like mortality, time to definitive care, patient disposition, and morbidity using tools such as the Glasgow Outcomes Scale-Extended Pediatrics. Data collection will occur over multiple years, including baseline and post-intervention periods separated by 1.5 years.

Researchers are conducting a prospective observational study through the African Esophageal Cancer Consortium AfrECC to examine treatment outcomes for adults diagnosed with esophageal cancer. The study aims to describe various treatment methods used, assess patient experiences during and after treatment, and evaluate overall survival rates across participating sites. Participants in this study will receive standard treatments such as chemotherapy, radiation, chemo-radiotherapy, esophageal stenting, surgery, or supportive care as determined by their healthcare providers. The research involves collecting data from medical records and administering questionnaires to capture patient-reported outcomes related to these treatments over up to four years. During the study, participants will complete questionnaires, and their medical charts will be reviewed to gather information on treatment types and patient experiences. Researchers will measure the proportion of participants receiving different treatments, track changes in patient-reported symptom scores over time, and monitor overall survival. The study is planned to continue through June 2027, supporting long-term evaluation of treatment effects and patient quality of life.