Dar Es Salaam

Researchers are studying the challenges and support related to breast cancer diagnosis in Tanzania. This observational study focuses on understanding barriers to hormone receptor testing in breast cancer patients and the healthcare system. The goal is to improve the diagnosis process by gathering insights from survivors, patient advocates, and key healthcare personnel. The study involves behavioral interventions such as semi-structured focus group discussions and the use of a survey tool called Organizational Readiness for Implementing Change ORIC. The focus groups explore contextual factors, barriers, and facilitators to implementing changes, while the ORIC tool assesses how prepared organizations are for change using participant ratings on a 5-point scale. Participants include breast cancer survivors, patient advocates, and healthcare workers involved in breast cancer care. Participants will engage in focus groups and complete readiness assessments. Data collection involves interviews and chart reviews to identify diagnosis barriers over one year. The research team evaluates organizational preparedness and collects participant feedback through discussions. The study is expected to continue until April 2027, with no direct treatment involved, focusing on improving breast cancer diagnosis support and processes.

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 developing and testing a culturally tailored yoga therapy program for cancer patients undergoing hematopoietic stem cell transplantation HSCT in India, Tanzania, and the United States. This program aims to address cultural norms and provide psychosocial support through yoga to improve patient well-being during and after transplant. The study focuses on creating a sensitive, patient-centered approach by involving patients from each center in interviews and program design. Participants will engage in gentle yoga movements, breathing exercises, relaxation techniques, and meditation tailored to their individual needs. The program includes up to 12 yoga sessions, delivered three times per week starting two weeks before the transplant and continuing throughout the first 30 days of hospitalization. Sessions may be conducted in person, via telehealth, or a combination of both. Participants will also complete questionnaires about symptoms, anxiety, depression, quality of life, and treatment expectations, along with exit interviews. During the study, researchers will monitor adherence to the yoga sessions and completion of follow-up assessments at two months post-transplant. Participants will be assessed using the Patient Health Questionnaire-8 PHQ-8 over about one year. The study includes interviews and questionnaires to evaluate the programs acceptability and impact. The total involvement includes the yoga program during hospitalization and follow-up assessments to understand patient outcomes and feasibility of the intervention.

This observational study evaluates the effects of a nurse-led stroke transitional care program on stroke survivors, their caregivers, and healthcare providers. The goal is to see if this program improves discharge preparedness, disease self-management, and quality of life for stroke survivors. Participants are stroke survivors and their caregivers who are already receiving this program as part of their medical care. The research is sponsored by Shandong University and focuses on stroke patients in Tanzania. Participants receive usual care plus the nurse-led stroke transitional care, which includes face-to-face and telephone sessions. During hospitalization, two nurse champions conduct five face-to-face sessions, including individual and group sessions with patients and caregivers. After discharge, two nurse researchers provide seven follow-up phone call sessions over three months. Face-to-face sessions last 40-60 minutes, and phone calls last 20-30 minutes. Stroke survivors and their caregivers are followed for six months to assess the quality of transitional care and various clinical outcomes. Researchers measure self-efficacy, quality of life, discharge preparedness, resilience, depression, anxiety, care satisfaction, mortality, readmission rates, and length of hospital stay. These assessments occur at specific times from admission through six months after discharge to monitor the programs impact and participant well-being.

Researchers are evaluating the Familia Imara program, a group-based, couples-focused parenting intervention aimed at reducing intimate partner violence IPV, harsh discipline, and improving child development and nutrition in the Mara and Geita regions of Tanzania. This cluster-randomized controlled trial will assess the programs effectiveness, implementation, and scalability in community settings, focusing on families with children under two years old. The study is conducted in two sequential cohorts to compare traditional delivery with government-led scale-up. The Familia Imara program is delivered by trained community health workers CHWs who facilitate joint couples sessions and separate peer group sessions for mothers and fathers. Sessions last about two hours and occur twice monthly over approximately 10 months. Cohort 1 compares intervention villages receiving the program to control villages on a waitlist. In Cohort 2, intervention villages receive the program under government-led delivery, while control villages transition to receive the intervention with combined support from partners and government supervisors. Participants include couples with a child under two years living together who consent to participate. Data collection involves surveys at baseline, 11 months, and 22 months to measure outcomes such as maternal IPV victimization, child dietary diversity, harsh disciplinary practices, and early child development using the Caregiver Reported Early Development Instrument. Secondary outcomes include attitudes toward IPV, parenting, child nutrition knowledge, and gender norms. The study also assesses program delivery models and supports policy development for family violence prevention and child development.

Open tibial shaft fractures, which are common serious injuries to the lower leg involving a break in the skin, often lead to infections and problems with bone healing. Researchers are evaluating the effect of locally applying the antibiotic gentamicin directly to the wound to reduce infections after these open fractures. This randomized controlled trial aims to measure whether local gentamicin can lower the risk of infection in patients with open tibial fractures in Tanzania, potentially offering a cost-effective strategy to reduce complications globally. Participants will be randomly assigned to receive either 80mg of gentamicin liquid diluted in 5 mL of saline or a placebo of 5 mL normal saline, injected directly into the fracture wound using a needle. The injection is given immediately after wound closure through an anteromedial approach at the fracture site. Both groups receive a total of 5 mL of study solution. This trial uses masking to keep participants and researchers unaware of the treatment assignment. During the study, participants will be followed for 12 months to monitor for fracture-related infections and other outcomes such as bone healing, need for unplanned surgeries, and quality of life measured by questionnaires. Clinical evaluations, imaging assessments, and questionnaires will be used to track healing and complications. Safety and health status will be closely observed throughout the study period to understand the effects of the local gentamicin treatment compared to placebo.

Researchers are investigating the nutritional status and its impact on treatment outcomes in children and adolescents newly diagnosed with B- or T-cell acute lymphoblastic leukemia or mixed phenotype acute leukemia. This observational study aims to create a biobank of clinical data and biological specimens from participants aged 3 to 18 years, enhancing understanding of cancer progression, prognosis, treatment toxicities, survivorship, and late effects, especially in low and middle income countries. Participants will have biological samples such as stool and blood collected at key treatment milestones including diagnosis, end of induction, beginning of maintenance, end of treatment, and one year post-treatment. Alongside, data on socioeconomic status, food security, diet, physical activity, and nutritional measurements like height, weight, and arm size will be gathered throughout the treatment period and follow-up. During the study, researchers will collect demographic, lifestyle, clinical, and nutritional information at various timepoints to accompany the biorepository. The main outcomes include establishing a multinational biobank and compiling comprehensive data on treatment-related toxicities, survival, and nutrition over seven years. Participant involvement includes multiple assessments and sample collections over the treatment course and one year after treatment ends.

Researchers are studying people living with HIV-1 infection who are on dolutegravir DTG-based antiretroviral therapy ART but have a viral load above 1,000 copiesmL after at least six months of treatment. The goal is to understand viral suppression rates and the emergence of DTG-associated drug-resistant mutations in these individuals. This multi-country prospective observational study takes place in Kenya, Mozambique, Tanzania, and Lesotho, addressing gaps in data about managing virologic failure without changing the ART regimen. Participants will continue their DTG-based ART for up to 12 months while receiving enhanced adherence counseling if their viral load remains above 200 copiesmL. Study visits and viral load testing happen at enrollment and every three months during the active follow-up period. Enhanced adherence counseling includes at least three sessions per visit to support medication adherence and address other causes of viral increase. The study also collects routine program data for up to 24 months to assess how well viral suppression lasts over time. During the study, participants undergo viral load testing, counseling, and assessments at regular intervals. Researchers will analyze viral suppression rates at 6 and 12 months and evaluate factors that predict suppression or the development of drug resistance. They will also monitor the patterns and timing of drug-resistant mutations and opportunistic infections. The study plans to enroll 6,600 participants and may invite eligible individuals to join a nested randomized clinical trial focusing on managing drug resistance.

The trial investigates the implementation and evaluation of a distribution program for low dead-space syringes and needles LDSSN among people who inject drugs across multiple low- and middle-income countries. The study aims to provide evidence on how best to run LDSSN distribution programs to improve acceptability and maintain high usage levels, potentially reducing transmission of blood borne viruses such as HIV and hepatitis C. This observational study involves participants who access needle and syringe programs NSPs at existing sites. The study includes three phases initially, focus group discussions FGDs will gather participant feedback on various LDSSN products to guide selection for pilot distribution. Then, over a 6-week pilot period, participants will use the selected LDSSN products alongside usual NSP services. Finally, a scaled-up distribution of selected LDSSN products will be offered at study sites, with routine program data collection and a concurrent observational cohort study running alongside. Participants in the cohort will undergo HIV and HCV testing and complete surveys at baseline, 6, 12, and 18 months. Participants will be engaged through multiple FGDs to discuss their experiences and preferences with LDSSN products at different stages. The cohort study involves repeated HIV and HCV antibody testing and behavioral surveys to assess uptake and impact over 18 months. Additional data collection includes routine program records and interviews with staff and stakeholders to evaluate program feasibility and effectiveness. The study will also use mathematical modeling to estimate the public health impact and cost-effectiveness of LDSSN distribution in these settings.

Researchers are investigating the impact of multiple micronutrient supplements MMS with varying iron doses on preventing moderate or severe anemia in pregnant women. This Phase 3 randomized controlled trial focuses on comparing MMS containing 60 mg and 45 mg of iron against the standard MMS containing 30 mg of iron, aiming to provide guidance for countries like Tanzania on the most suitable iron dose during pregnancy. Participants are randomly assigned to one of three groups receiving MMS with either 30 mg, 45 mg, or 60 mg of elemental iron daily from the time of randomization until delivery. All groups receive the standard UNIMMAP formulation with 15 micronutrients, differing only in the iron content. The supplements are taken orally once a day as part of routine antenatal care. During the study, pregnant women will be monitored through the third trimester and up to 6 weeks postpartum. Researchers will assess anemia levels, hemoglobin concentration, iron status, pregnancy complications, maternal symptoms, birth outcomes, and infant health measures. Study visits include evaluations of blood tests, maternal and infant health, and questionnaires on symptoms such as fatigue and depression. The total participation duration covers pregnancy through 6 weeks after delivery.