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NCT ID: NCT06444555 Recruiting - Clinical trials for Nutrition Deficiency Due to Insufficient Food

Adolescent Nutrition in Girls in Burkina Faso and Ethiopia

Adonut
Start date: May 28, 2024
Phase: N/A
Study type: Interventional

Adolescents' diets are key to breaking the intergenerational cycle of malnutrition. This study will guide policies and programs on the adequacy, acceptability, and feasibility of implementing balanced energy protein and multiple micronutrient supplementations to fill nutrient gaps in adolescent girls. Using a trial, the study will assess dietary intake and nutrient gaps, acceptability of balanced energy protein and multiple micronutrient supplementations. In addition to the trial, the study will the assess willingness to pay for the supplements and the most effective delivery platform and model to reach vulnerable adolescent girls. The most effective delivery platform and model to reach vulnerable adolescent girls cost-effectively will also be assessed through interviews with (inter)national experts, producers, and the donor community.

NCT ID: NCT06285110 Recruiting - Hiv Clinical Trials

HIV-1 Subtype-specific Drug Resistance in Patients Failing Dolutegravir (DTG) Based Regimen

DTG-Resist
Start date: June 13, 2022
Phase:
Study type: Observational

This is a prospective observational study enrolling People Living with HIV (PLHIV) who are on a Dolutegravir-based AntiRetroviral Treatment (ART) regimen and experiencing virologic failure. Virologic failure is defined as two consecutive viral load measurements of >1000 copies/mL of blood. The main aim of the study is to identify the drug-resistance mutations in the viral genome that are associated with this failure. To achieve this goal, patients fulfilling the eligibility criteria will be invited for a single study visit for the collection of blood. The extracted HIV virus will be sequenced through whole genome sequencing methods to identify the drug-resistance mutations. The study is conducted in 15-20 countries within six regions of the IeDEA cohort (International epidemiology Databases to Evaluate AIDS).

NCT ID: NCT06257810 Completed - Malaria Clinical Trials

Impact of Differential and Systematic Diagnosis of Dengue, Chikungunya and Malaria on Patient Management and Antibiotic Use in West Africa

Start date: June 1, 2023
Phase: Phase 4
Study type: Interventional

The differential and systematic diagnosis of malaria, dengue and chikungunya in patients with fever (≥38.5°C) of undetermined etiology would allow the identification of infection by these pathogens and thus limit the inappropriate use of antibiotics (discontinuation or non-initiation) and optimize the clinical management and prognosis of patients.

NCT ID: NCT06225739 Recruiting - Pregnancy Related Clinical Trials

Evaluation of Electronic Pregnancy Registers and Mobile Applications for Monitoring Pregnancy Outcomes ( EVAPREAP )

Start date: October 1, 2023
Phase:
Study type: Observational [Patient Registry]

Monitoring pregnancy outcomes during pregnancy is very important in assessing the effectiveness of interventions. This study aims to create pregnancy registers and evaluate pregnancy mobile applications as a potential tool for monitoring pregnancy outcomes in future placental malaria (PM) vaccine trials, as well as for the implementation of any other intervention in this target group.

NCT ID: NCT06162078 Recruiting - Clinical trials for Maternal Malaria During Pregnancy - Baby Not Yet Delivered

Malaria Burden in Pregnant Women and the Incidence of Pregnancy in a Cohort of Nulligravida

EPI-PAM
Start date: August 25, 2023
Phase:
Study type: Observational [Patient Registry]

The overarching aims of this study are to longitudinally determine the occurrence of pregnancy in a cohort of nulligravida at the community level and to estimate the burden of malaria infection during the course of the pregnancy till delivery.

NCT ID: NCT06064591 Recruiting - Severe Malaria Clinical Trials

Host Immune and Metabolic Determinants of Sexual Conversion in Plasmodium Parasites IMMETASEX

IMMETASEX
Start date: December 13, 2023
Phase:
Study type: Observational [Patient Registry]

Understanding the sexual conversion of the malaria parasite is essential to interrupt malaria transmission. A new tool is developed that, based on expression analysis of sexual stage biomarkers, will estimate sexual conversion rates in natural infections.

NCT ID: NCT06010719 Not yet recruiting - Malnutrition, Child Clinical Trials

Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition

AMOUR
Start date: August 2024
Phase: Phase 4
Study type: Interventional

Amoxicillin is recommended by the World Health Organization (WHO) as adjunctive therapy for the treatment of uncomplicated severe acute malnutrition (SAM). Because children with uncomplicated SAM may have asymptomatic infection due to immune suppression, presumptive treatment with a broad-spectrum antibiotic may be beneficial by clearing any existing infection and improving outcomes. Two randomized placebo-controlled randomized trials have evaluated amoxicillin for uncomplicated SAM and have found conflicting results. These results may indicate either that antibiotics are not helpful for the management of uncomplicated SAM, or that a better antibiotic is needed. Recently, the investigators demonstrated that biannual mass azithromycin distribution as a single oral dose reduces all-cause child mortality in sub-Saharan Africa. Children with uncomplicated SAM, who have an elevated risk of mortality relative to their well-nourished peers, may particularly benefit from presumptive azithromycin treatment. Our pilot data demonstrated feasibility in rapid enrollment of children with uncomplicated SAM in our study area, and showed no significant difference between azithromycin and amoxicillin, demonstrating equipoise for a full-scale trial. Here, the investigators propose an individually randomized trial in which children will be randomized to a) azithromycin, b) amoxicillin, or c) placebo, and evaluated for differences in weight gain, nutritional recovery, and the gut microbiome. The results of this study will strengthen the evidence base for policy related to the use of antibiotics as part of the management of uncomplicated SAM, including additional evidence of amoxicillin versus placebo as well as evaluation of an antibiotic class that has not been considered for uncomplicated SAM, which may lead to changes in guidelines for treatment.

NCT ID: NCT05974267 Recruiting - Malaria Infection Clinical Trials

Efficacy, Safety, and PK of M5717 in Combination With Pyronaridine as Chemoprevention in Adults and Adolescents With Asymptomatic Plasmodium Falciparum Infection (CAPTURE-2)

Start date: November 28, 2023
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of a single dose of M5717 plus pyronaridine tetraphosphate in clearing current Plasmodium falciparum infection and protecting against recurrent infections in asymptomatic adults and adolescents. The study will also assess the duration of protection provided by different doses of M5717 plus pyronaridine and the additional contribution of M5717 to the duration of protection using external study data.

NCT ID: NCT05951751 Recruiting - Hiv Clinical Trials

The TRIple Elimination Model Of Mother-to-child Transmission Program (TRI-MOM)

TRI-MOM
Start date: March 18, 2024
Phase: N/A
Study type: Interventional

The TRI-MOM program aims to implement and evaluate a simplified (based on inexpensive rapid diagnostic tests), integrated (in governmental health facilities) and coordinated (between health care workers) strategy for the triple elimination of HIV, syphilis and HBV mother-to-child transmission (MTCT) in nine maternal and child health services, 5 in Burkina Faso and 5 in The Gambia. The TRI-MOM program has two components: 1. an "intervention" component consisting of a pilot study to reinforce the antenatal screening and prevention of MTCT (PMTCT) capacities for the 3 targeted infections through the implementation of a simplified, integrated and coordinated strategy of triple elimination of MTCT. 2. an "evaluation" component which will assess the impact of the TRI-MOM strategy on PMTCT services, reduction of HBV MTCT and women empowerment.

NCT ID: NCT05946980 Recruiting - Clinical trials for Hand Hygiene Effectiveness

hands4health: A Multi-component Intervention on Hand Hygiene in Primary Health Care Facilities in Burkina Faso and Mali

h4h
Start date: January 30, 2023
Phase: N/A
Study type: Interventional

The goal of this cluster randomized controlled trial is to assess the effectiveness of the hands4health multi-component hand hygiene intervention in patients and health care providers in primary health care facilities in Burkina Faso and Mali. The main question it aims to answer is: * Can the hands4health multi-component hand hygiene intervention have a positive effect on the health determinants of our study population? Participants will be structurally observed for assessing their handwashing behavior, answer to a self-reported RANAS survey and provide a hand-rinse sample at base line, follow-up and end line. In addition specific pre-defined health outcomes and absenteeism will be tracked with a journal approach in the facilities. Intervention facilities will receive a Gravit'eau handwashing system, a RANAS behaviour change intervention, WASH FIT support, and chlorination support. Control facilities will receive nothing at the beginning, but once all of the data is collected, they will receive the same intervention as the intervention facilities have received. Researchers will compare the intervention and control groups to see if the hands4health intervention has any positive effects on the populations health determinants (e.g. handwashing behavior, perceptions towards hand hygiene, perceived risks, etc.).