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NCT ID: NCT05426395 Not yet recruiting - Clinical trials for Vitamin B 12 Deficiency

Vitamin B12 Dose Escalation Trial in Pregnancy

MM4MN-B12
Start date: June 30, 2022
Phase: Phase 1
Study type: Interventional

Vitamin B12 is a cofactor for 2 enzymes that have essential functions in pregnancy, both for maternal health and for fetal development. However, there is currently limited data regarding the metabolic fate and optimal dose of supplemental vitamin B12 and its relationship to vitamin B12 status in pregnancy. This is a single-blinded, stratified, dose-ranging trial of maternal vitamin B12 supplementation during pregnancy that will be conducted at the Ifakara Health Institute Bagamoyo Clinical Trial Unit in Tanzania. The investigators will enroll 40 pregnant women (gestational age 25-28 weeks) and 10 non-pregnant women (comparison group). Participants will be blinded to dosing (2.6, 10, and 50 µg) and supplementation will be given for six weeks. With this trial, the investigators aim to enhance our understanding of vitamin B12 bioavailability during pregnancy in people with sufficient and insufficient baseline B12 status, identify priority dose regimens of vitamin B12 in pregnancy for investigation in later phase clinical trials to be conducted in populations where vitamin B12 insufficiency or deficiency is common, and identify biomarkers of vitamin B12 intake appropriate for pregnancy.

NCT ID: NCT05416372 Not yet recruiting - Hypertension Clinical Trials

Engaging Religious Leaders to Reduce Blood Pressures in Tanzanian Communities

Start date: June 2022
Phase: N/A
Study type: Interventional

The investigators hypothesize that communities in which religious leaders are provided with education about blood pressure and how to measure blood pressure will have lower overall average blood pressures than communities in which religious leaders do not receive education about blood pressure.

NCT ID: NCT05374109 Not yet recruiting - HIV-1-infection Clinical Trials

SYV: A Mental Health Intervention to Improve HIV Outcomes in Tanzanian Youth

Start date: June 2022
Phase: N/A
Study type: Interventional

The overall objectives of this proposal are to support positive coping strategies that bolster mental health and lead to improved HIV outcomes among Young People Living with HIV (YPLWH). The central hypothesis is that SYV (Sauti ya Vijana, The Voice of Youth) will be effective to improve antiretroviral therapy (ART) adherence and virologic suppression in YPLWH in Tanzania. The rationale for this project is that by targeting mental health, which is strongly associated with medication adherence, that this will effectively improve adherence and thereby HIV viral suppression. The central hypothesis will be tested in three aims in a hybrid type-1 effectiveness-implementation trial.

NCT ID: NCT05373095 Not yet recruiting - Clinical trials for HIV (Human Immunodeficiency Virus)

Rudi Kundini, Pamoja Kundini: Phase II

RKPK: Phase II
Start date: July 2022
Phase: N/A
Study type: Interventional

This protocol describes an individually randomized trial that will include adult people living with HIV (PLHIV) currently receiving HIV care at one of two participating health facilities and identified as high risk for disengagement from care by a machine learning algorithm. Participants randomized to the control arm will receive standard of care HIV clinical services according to Tanzania's National Guidelines for the management of HIV. For those who meet clinic eligibility criteria for enhanced adherence counseling, which at the included study sites is when client's viral load reaches a detectable level (>1000 copies/ml), this includes the standard provision of three, once-monthly, 60-minute nurse-led individual, enhanced adherence counseling sessions, starting on the day of the result and for two months after. Intervention arm participants will receive the same standard HIV care services plus the offer of a cash transfer paired with visit attendance and attendance at each of the three enhanced adherence counseling sessions.

NCT ID: NCT05363904 Recruiting - Atopic Dermatitis Clinical Trials

Atopic Dermatitis: Sub-Saharan Africa vs. Central Europe

Start date: March 30, 2022
Phase:
Study type: Observational

Many people are affected by atopic dermatitis (AD) worldwide. However, clinical studies on AD in Sub-Saharan Africa are rare and there is a lack of knowledge about possible differences in pathogenesis between European and African AD. This study will collect clinical and laboratory data with the aim to compare clinical characteristics and immune responses in AD patients in Sub-Saharan Africa and Central Europe. Furthermore, relevant allergens as well as the nasal, skin and gut micro- and mycobiome will be investigated.

NCT ID: NCT05361148 Recruiting - Diabetes Clinical Trials

Long-term Health After Severe Acute Malnutrition in Children and Adults: the Role of the Pancreas

SAMPA
Start date: October 12, 2021
Phase:
Study type: Observational

Whilst there is an increasing prevalence of overweight and obesity worldwide, malnutrition remains common. In addition, malnutrition, overweight, and infections often interact. The consequences of malnutrition after birth are little studied. Severe acute malnutrition in childhood remains common in Africa and Asia and many adult patients with tuberculosis or HIV, diseases which are common in Africa and Asia, may become malnourished. We are interested in diabetes, which in Africa and Asia affects people at younger age and lower weight than in Europe. There is evidence that severe postnatal malnutrition increases the risk of later diabetes but the evidence is piecemeal and there is little information as to the mechanisms involved. It is thus difficult to determine what treatments or preventative strategies are appropriate. We wish to focus on the pancreas which is a key organ in digestion and metabolic processes, especially in relation to diabetes. We will investigate pancreas size, microscopic structure, hormone and digestive enzyme production, and the body's response to these hormones among groups of people in Tanzania, Zambia, India and the Philippines. These groups have participated in the research team's previous studies of malnutrition and were malnourished before birth, as children, or as adults. They now live in places with a wide range of access to foods high in fat and sugar which could affect their risk of diabetes. We will compare their pancreas function to that of never-malnourished controls at each site. We will use advanced statistical methods to understand the links between early malnutrition and later diabetes, taking into account the factors often associated with diabetes such as age, current overweight and infection. Even if we find no important link between early malnutrition and later diabetes, the research will lead to improved understanding of the long-term consequences of malnutrition and the presentation and underlying metabolism of diabetes in Africa and Asia. Thus, the project will lead to improved health care for both malnourished and diabetic people.

NCT ID: NCT05357144 Not yet recruiting - HIV Infections Clinical Trials

AmbassADDOrs for Health Study

ADDO
Start date: May 10, 2022
Phase: N/A
Study type: Interventional

The goal of the study is to evaluate Malkia Klabu ("Queen Club") in Tanzania, a loyalty program intervention that creates adolescent girls and young women (AGYW)-friendly drug shops where AGYW can access HIV prevention services and contraception.

NCT ID: NCT05306938 Enrolling by invitation - Contraceptive Usage Clinical Trials

Adolescent Wellness Visits in Tanzania

VITAA
Start date: May 17, 2022
Phase: N/A
Study type: Interventional

This study evaluates the impact of clinic-based 'Adolescent Wellness Visits' (AWVs) coordinated with primary schools that offer a package of evidence-based adolescent-friendly preventative services on HIV testing uptake in Tanzania. Participants: The clinical trial participants are approximately 1500 adolescents in their final year of primary school who will be enrolled in this cluster randomized controlled trial (RCT) from 20 primary schools and followed up for two years post-primary school. [Qualitative data from approximately 250 adult stakeholders will also be collected via focus group discussions (FGDs) and in-depth interviews (IDIs) for implementation science, non-trial related study aims] . Procedures: Adolescent data will include surveys with self-report measures and reviews of their medical records (using REDCap). The adult qualitative data will be in the form of translated and transcribed FGD and IDI transcripts as Word documents.

NCT ID: NCT05301504 Recruiting - Ebola Clinical Trials

A Study in Tanzania of a New Vaccine Against Two Types of Ebola

Start date: March 30, 2022
Phase: Phase 1
Study type: Interventional

An open label, first in human, non-randomised, dose escalation, single centre, phase Ib clinical trial

NCT ID: NCT05271903 Recruiting - Hiv Clinical Trials

Simulation Training for Labor and Delivery Providers to Address HIV Stigma During Childbirth in Tanzania

Start date: January 31, 2022
Phase: Phase 1
Study type: Interventional

This study will work in Tanzania to develop and pilot test a simulation and experiential learning intervention for labor and delivery providers, in order to address HIV stigma during childbirth. The primary endpoint will be patient-rated changes in respectful maternity care, comparing women who deliver in the pre-intervention time period and women who deliver in the post-intervention period.