Dar Es Salaam

This research aims to understand the challenges faced in diagnosing breast cancer in Tanzania and to explore the support available to improve hormone receptor testing. It focuses on identifying barriers in the diagnosis process to help enhance breast cancer care in this setting. Participants will engage in behavioral interventions including semi-structured focus group discussions guided by questions about the context, obstacles, and facilitators to implementing improved testing. Additionally, organizational readiness for change will be assessed using a tool where participants rate their agreement with statements about their institution's preparedness to adopt changes related to breast cancer care. During the study, participants such as breast cancer survivors, patient advocates, and key healthcare personnel will be involved. Researchers will conduct interviews, focus groups, and chart reviews to gather information. The main outcome measured over one year is identifying the barriers to breast cancer diagnosis. Participants' consent and language fluency will be confirmed, and the study will monitor organizational and personal factors affecting diagnosis improvements.

Researchers are evaluating the safety, immune response, and effectiveness of a new tuberculosis vaccine called MTBVAC in healthy adolescents and adults aged 14 to 45 years who live in areas where TB is common. This Phase 2b study is randomized, double-blind, and placebo-controlled, involving participants with different immune responses to TB exposure as determined by IGRA testing. The study aims to protect against TB disease confirmed by multiple tests and focuses on those who are HIV-negative. Participants will be randomly assigned to receive either a single intradermal dose of the MTBVAC vaccine or a placebo. The vaccine dose contains approximately 5x10^5 colony-forming units, and the placebo is saline solution, both given as 0.1 mL injections. The study includes two groups based on IGRA status: one with prior immune response to TB and one without, with different randomization ratios. Some participants will be part of safety and immune response sub-cohorts for more detailed monitoring. Throughout the 36-month follow-up, participants will attend regular visits or be contacted to check for signs of TB. They will be trained to recognize TB symptoms and report them for further evaluation, including sputum testing using advanced molecular and culture methods. HIV testing will occur yearly and at times of suspected TB. Safety monitoring includes tracking adverse events and laboratory tests in selected subgroups. Participants diagnosed with TB will be referred for treatment according to local guidelines.

Researchers are developing a culturally tailored yoga therapy program specifically designed for cancer patients undergoing hematopoietic stem cell transplantation (HSCT) in India, Tanzania, and the United States. The study aims to understand cultural norms and factors related to yoga and psychosocial support by interviewing patients from different centers. This program is being pilot tested to measure its effects on patients and optimize its delivery. The yoga therapy program involves up to 12 sessions, held three times per week, starting two weeks before the transplant and continuing through the first 30 days of hospitalization. Sessions may be delivered in person, via telehealth (Zoom), or a combination of both. Participants will also complete four questionnaires about symptoms, anxiety, depression, quality of life, and treatment expectations. At the end of the program, participants will take part in an exit interview conducted remotely by phone or video call. Participants will be involved in assessments throughout the study, including completing the Patient Health Questionnaire-8 (PHQ-8) for about one year. Researchers will monitor adherence to the yoga sessions, aiming for at least half of the patients to complete half of the sessions, and at least 60% to complete follow-up measures two months post-transplant. Safety and feasibility are key focuses, with data collected through questionnaires, interviews, and continuous follow-up.

Researchers are evaluating the effect of a nurse-led stroke transitional care program on stroke survivors, their caregivers, and healthcare providers in Tanzania. The study aims to determine whether this program improves discharge preparedness, disease self-management, and quality of life among stroke survivors. The focus is on participants currently receiving nurse-led stroke transitional care as part of their medical treatment, with follow-up over six months to assess care quality and clinical outcomes. Participants in the intervention group receive usual care plus additional support through nurse-led sessions. During hospitalization, two nurse champions conduct five face-to-face sessions, including individual and group meetings with patients and caregivers. After discharge, two nurse researchers carry out seven follow-up telephone sessions over three months. Face-to-face sessions last 40-60 minutes, and phone calls last 20-30 minutes. Stroke survivors and their caregivers will be followed for six months to evaluate outcomes such as self-efficacy, quality of life, discharge preparedness, resilience, and quality of transition care. Assessments include both patient and caregiver perspectives, with outcomes measured at one month and six months after discharge. The study monitors clinical and transitional care results to understand the program's impact fully.

Researchers are evaluating the Familia Imara program, a group-based, couples-focused parenting intervention delivered by community health workers, to reduce intimate partner violence (IPV), harsh discipline, and to improve child development and nutrition outcomes. This cluster-randomized controlled trial is taking place in the Mara and Geita regions of Tanzania and is designed to assess both the program's effectiveness and its potential for scale within government systems. The study involves villages randomly assigned to intervention or control groups and is conducted in two sequential cohorts to compare delivery models and integration approaches. The Familia Imara program includes twice-monthly sessions over about 10 months, combining joint couples' meetings and separate peer groups for mothers and fathers. Trained male and female community health workers co-facilitate these approximately 2-hour sessions, covering topics such as preventing IPV and harsh discipline, promoting responsive caregiving, early learning stimulation, nutrition, positive communication and conflict resolution, stress management, and gender roles. Cohort 1 focuses on program delivery supported by implementing partners, while Cohort 2 transitions to a government-led delivery model to evaluate scalability. Control villages initially receive no intervention but later receive the program during the second cohort phase. Participants include couples with a child under two years old living together with their child. The study collects data at baseline, 11 months, and 22 months through surveys measuring maternal IPV victimization, child dietary diversity, parental discipline practices, and early child development using caregiver reports. Approximately 2,072 couples enroll in the first cohort, with an additional 1,036 couples joining in the second. The research monitors outcomes over time to inform policies and practices for preventing family violence and promoting early childhood development at scale in Tanzania.

Open tibial shaft fractures are common serious injuries where the bone breaks through the skin, often leading to infections and long-term disability. This research aims to evaluate whether applying the antibiotic gentamicin directly to the open fracture wound can reduce infection risk compared to standard treatment with saline. The study is a Phase 4 randomized controlled trial conducted in Tanzania, focusing on preventing fracture-related infections in a low-income country setting, with findings potentially relevant worldwide. Participants will receive either liquid gentamicin or normal saline applied locally to the open fracture site during surgery. Both groups also receive standard intravenous antibiotics. The study compares these two treatments to see if gentamicin can better prevent infections. This trial represents the first high-quality evaluation of local gentamicin use in open tibial fractures. Throughout the 12-month follow-up, researchers will monitor participants for infections related to the fracture. They will assess healing progress and record any complications or adverse effects. The main outcome measured is the occurrence of fracture-related infection one year after treatment. Participants will undergo regular check-ups to track their recovery and safety during the study period.

Researchers are studying children and adolescents aged 3 to 18 years with newly diagnosed B- or T-cell acute lymphoblastic leukemia (ALL) or mixed phenotype acute leukemia. This study aims to understand how nutritional status, which can be measured and changed, affects cancer progression, treatment toxicities, and long-term health outcomes. The study includes participants from various global centers to represent different nutritional and economic backgrounds. The study involves collecting and storing biological specimens such as stool and blood samples at key points during treatment: diagnosis, end of induction, beginning of maintenance, end of treatment, and one year after treatment ends. Alongside these, clinical data including disease details, treatment side effects, survival information, and nutritional measurements like height, weight, and arm size will be gathered. There is no treatment intervention in this study. Participants will provide demographic information, lifestyle data including diet and physical activity, and nutritional assessments at multiple times during their treatment and follow-up. The data collected will help build a biorepository to support future research on how nutrition and biology impact leukemia outcomes. The study will observe and collect this information over a total period of seven years to monitor changes and long-term effects.

Researchers are studying viral suppression in people living with HIV who have high viral loads despite being on dolutegravir (DTG)-based antiretroviral therapy (ART) for at least six months. The study aims to fill gaps in data about viral suppression rates without changing the ART regimen and to monitor the emergence of drug-resistant mutations linked to DTG and their effects on viral control. The research is conducted across multiple countries including Kenya, Mozambique, Tanzania, and Lesotho. Participants will continue their DTG-based ART throughout the study, which lasts up to 12 months. Those with viral loads of 200 copies/mL or higher will receive enhanced adherence counseling during scheduled visits every three months. The counseling includes at least three sessions focused on improving medication adherence and managing other causes of viral load increase. For participants who achieve viral suppression below 200 copies/mL during follow-up, an additional viral load test will be done after three months, with longer-term outcome data collected up to 24 months. Throughout the study, participants will have viral load testing at enrollment and every three months if suppression is not reached. Researchers will track viral suppression rates at 6 and 12 months and analyze factors linked to success, development of DTG resistance mutations, and opportunistic infections. The study also collects routine clinical data such as loss to follow-up and mortality. Participants may be evaluated for eligibility in a nested clinical trial focused on managing those who develop drug resistance during the cohort study.

Researchers are evaluating a distribution program for low dead-space syringes and needles (LDSS/N) among people who inject drugs in several low- and middle-income countries, including Armenia, Georgia, Tanzania, Egypt, Nigeria, Vietnam, India, Ukraine, and South Africa. This study aims to identify the best ways to implement and sustain high use of LDSS/N by understanding community preferences and program feasibility. It also seeks to assess the impact of LDSS/N on blood borne virus transmission risks such as HIV and Hepatitis C. The study includes multiple phases. Initially, focus group discussions (FGDs) with people who inject drugs will help select LDSS/N products based on their preferences. Then, a 6-week pilot distribution phase will allow participants to try these products alongside usual services at needle and syringe programs (NSPs). Afterward, a scaled-up distribution of selected LDSS/N products will occur while collecting routine program data and running an observational cohort study with approximately 240 participants per country (480 in Nigeria). Participants will undergo HIV and Hepatitis C testing and complete surveys at baseline, 6, 12, and 18 months. Additional FGDs and interviews with staff and stakeholders will explore program acceptability and feasibility. Participants will attend NSP sites or outreach services to access LDSS/N and answer questions about their use. Researchers will monitor LDSS/N uptake through routine data and cohort surveys. The primary outcome is how well the community-informed LDSS/N distribution increases LDSS/N use over 18 months. Mathematical modeling will estimate the public health impact and cost-effectiveness of scaling up LDSS/N distribution. The total participant involvement includes baseline and follow-up testing and surveys over an 18-month period, alongside qualitative feedback sessions.

Researchers are evaluating the effects of different doses of iron in multiple micronutrient supplements (MMS) on moderate or severe anemia in pregnant women. This Phase 3 trial focuses on pregnant women in Tanzania and compares MMS containing 60 mg and 45 mg of iron to the standard formulation with 30 mg of iron. The study aims to guide decisions on the appropriate iron dose to prevent anemia during pregnancy. Participants will receive one of three daily oral supplements starting from the time they join the study until delivery. The groups include MMS with 30 mg iron (standard UNIMMAP formulation), MMS with 45 mg iron plus other micronutrients, and MMS with 60 mg iron plus other micronutrients. The supplementation is intended to assess the impact on maternal anemia in the third trimester. Women in the study will be monitored for moderate or severe anemia during the third trimester of pregnancy, between weeks 28 and 42. Researchers will track adherence to supplement intake and collect information on hemoglobin levels to measure anemia status. The study includes follow-up until six weeks after delivery to assess maternal health and anemia outcomes.