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NCT ID: NCT03610568 Active, not recruiting - Reproductive Health Clinical Trials

Global Early Adolescent Study - Kinshasa

GEAS_KI
Start date: June 20, 2017
Phase: N/A
Study type: Interventional

The Global Early Adolescent Study (GEAS) is the first international study exploring how gender norms evolve over time and inform a spectrum of adolescent health outcomes, including sexual and mental health, through the adolescent years. Institutional Review Board (IRB) oversight for all instrument development was provided for the first phase of the GEAS under IRB #00005684. The present study is in reference to the second, longitudinal phase of the GEAS. This phase, like the first, will be conducted in multiple international sites. However, because the longitudinal phase will likely be paired with different interventions or approaches in the partner sites, protocol details will vary and thus IRB approval will be sought for each site separately. The present application is for conducting Phase 2 of the Global Early Adolescent Study in Kinshasa, Democratic Republic of the Congo (DRC). In addition to conducting the study for "pure science" purposes, the GEAS will be used to evaluate the effectiveness of an intervention implemented by Save the Children.

NCT ID: NCT03600844 Recruiting - Clinical trials for Malaria in Pregnancy

Evaluating the Effects of Community Delivery of Malaria Intermittent Preventive Treatment on Pregnant Women and Babies

TIPTOP
Start date: April 2, 2018
Phase: N/A
Study type: Interventional

This study evaluates the effectiveness of community delivery of sulfadoxine-pyrimetamine (SP) for intermittent preventive treatment of malaria in pregnancy (IPTp) in increasing the coverage of IPTp among pregnant women in selected districts in Democratic Republic of Congo (DRC), Madagascar, Mozambique and Nigeria, compared to comparison districts where SP for IPTp is distributed as usual in facilities through routine antenatal care (ANC).

NCT ID: NCT03568344 Recruiting - Malaria Clinical Trials

Community Access to Rectal Artesunate for Malaria

CARAMAL
Start date: June 15, 2018
Phase:
Study type: Observational

Many malaria deaths occur in places where people have poor access to preventive and curative health services. Prompt access to quality health services is critical in the case of severe childhood diseases, among which severe malaria is particularly frequent in endemic areas. In communities where parenteral treatment of severe malaria is not available, the World Health Organization (WHO) recommends administration of a single rectal dose of artesunate (RAS) to children less than 6 years, followed by immediate referral to an appropriate facility where the full package of care for severe malaria can be provided. Many African countries have already endorsed the use of pre-referral RAS. But treatment guidelines vary widely across these countries and often do not align with the WHO recommendation. With the impending availability of quality-assured rectal artesunate (QA RAS) and countries poised to scale-up this intervention, it is critical to investigate the safe and effective implementation of RAS as part of a continuum of care for severe malaria patients. To ensure that RAS is well targeted, it is equally urgent to learn more about frequency, treatment seeking and risk factors for severe malaria at community level. The CARAMAL project has two major components: the pilot implementation of QA RAS in selected areas of the Democratic Republic of the Congo (DRC), Nigeria and Uganda, and operational research on the introduction of QA RAS into established integrated community case management (iCCM) platforms. The CARAMAL project is funded by Unitaid and coordinated by the Clinton Health Access Initiative, Inc. (CHAI). UNICEF is responsible for QA RAS implementation. Swiss TPH in partnership with the local research organizations Akena Associates Ltd. in Nigeria, Kinshasa School of Public Health in DRC and Makerere University School of Public Health in Uganda carries out the operational research component to generate evidence for the responsible implementation of RAS. Finally, the CARAMAL project will generate a better understanding of severe febrile illness, its management at all levels and key determinants of health outcomes.

NCT ID: NCT03567382 Recruiting - Hepatitis B Clinical Trials

Arresting Vertical Transmission of Hepatitis B Virus

AVERT-HBV
Start date: September 24, 2018
Phase: Phase 4
Study type: Interventional

The purpose of this pilot study is to demonstrate the feasibility of adding HBV screening and treatment of pregnant women to the existing HIV PMTCT platform in order to prevent mother-to-child transmission of hepatitis B virus.

NCT ID: NCT03520621 Completed - Kwashiorkor Clinical Trials

The Role of Sulfur Amino Acids in Risk of Kwashiorkor

Start date: June 1, 2016
Phase:
Study type: Observational

This observational cross-sectional study is investigating if young children in populations with higher prevalence of kwashiorkor malnutrition have lower dietary sulfur amino acid intake than populations with lower prevalence of kwashiorkor, controlling for multiple potential confounding factors. Intake is estimated through diet recalls during interviews with a child's caregiver, analysis of urine samples and analysis of food samples for their amino acid profiles.

NCT ID: NCT03363308 Recruiting - Stillbirth Clinical Trials

Effects of a Health Workforce Capacity Building and Quality Improvement Intervention in Kinshasa

Start date: November 16, 2017
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate a health workforce capacity building and quality improvement intervention focused on integrated day-of-birth and post-pregnancy care at 16 hospitals in Kinshasa, Democratic Republic of Congo. The intervention package consists of a low-dose, high-frequency (LDHF) training of health workers, support for quality improvement teams, and provision of critical equipment, supplies and drugs within a quality improvement (QI) framework.

NCT ID: NCT03356665 Recruiting - Clinical trials for Sleeping Sickness; West African

Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP2 Passive Case Detection

DiTECT-WP2
Start date: August 1, 2017
Phase: N/A
Study type: Interventional

The study determines the diagnostic performance and cost of rapid diagnostic tests (RDTs) performed on human African trypanosomiasis clinical suspects in peripheral health centres, whether or not followed by serological and/or molecular tests on dried blood spots done at regional reference centres

NCT ID: NCT03303963 Recruiting - Clinical trials for Tuberculosis, Multidrug-Resistant

DIAgnostics for Multidrug Resistant Tuberculosis in Africa

DIAMA
Start date: May 4, 2017
Phase: N/A
Study type: Observational

Recent advances in molecular diagnostics of tuberculosis, especially the GeneXpert Mycobacterium tuberculosis/Rifampicin test have reduced the time to diagnose Rifampicin Resistant Tuberculosis (RR-TB) but only rifampicin resistance is diagnosed, leading to presumptive diagnosis of resistance to isoniazid and maybe other drugs. Thus in low and middle income countries, most drug sensitivity testing relies on phenotypic drug resistance testing, which takes up to 4 months. In addition, currently, culture on monthly sputum samples is recommended by the World Health Organization for follow-up of Rifampicin Resistant Tuberculosis patients under treatment. Unfortunately, culture is often not locally available and samples need to be transported from field to culture laboratories. The associated transport delays lead to high rates of contamination and false negative culture, particularly in laboratories in low resource settings. Many gaps for the diagnosis and management of RR-TB patients still need to be addressed and the DIAMA project (DIAgnostics for Multidrug resistant tuberculosis in Africa) study aims to address some of them.

NCT ID: NCT03289663 Active, not recruiting - Clinical trials for Insecticide Resistance

Effectiveness Study of New Generation Bednets in the Context of Conventional Insecticide Resistance in the Democratic Republic of the Congo

Net-PBO
Start date: October 2, 2017
Phase: Phase 4
Study type: Interventional

Despite the mass distribution of LLINs (long-lasting insecticidal nets) as a Malaria control strategy, populations are still continuously exposed to a high frequency of malarial inoculation in some countries. The situation can be explained by a swift increase in the resistance of Anopheles to common insecticides. To preserve the gains of insecticides and improve their effectiveness, a new generation of bednets treated with piperonyl butoxide combination insectides have emerged.But more evidence is needed to plead for scale up of their usage. The lack of information relating to the additional impact of that combination on the transmission of Malaria, its relative efficacy in real-life setting and its safety in users are the rationale for more investigation.This will be a randomized controlled study on a dynamic cohort of households with 1680, 0-10 years-old subjects in 30 villages will be recruited to compute the effectiveness of this new tool. The findings will be useful information for decision-making by national malaria control programs, their partners, the international community and the bednet manufacturers with regard to the effectiveness of the new combination of insecticides in real-life context. The results will also enable a better design of the tool in the future and a broader understanding of long-term dynamics for sustainability, as well as identification of some factors with negative impacts on the benefits of the strategy.

NCT ID: NCT03265756 Recruiting - Pneumonia Clinical Trials

Multimometer - Vital Signs Device for Diagnosis of Pneumonia

Start date: June 20, 2017
Phase: N/A
Study type: Observational

Pneumonia is a major cause of illness in young children. The investigators are developing and testing a new thermometer like device called Multimometer, to measure the respiration rate (RR), temperature, heart rate (HR) and the degree of blood oxygenation (SpO2) of children who may suffer from pneumonia. These are called vital signs and their measurements greatly help to diagnose pneumonia. In the first part of the study, and in order to optimize and better align the size of the device with the face, the investigators will measure the average size and dimensions of young children's face. In the second part of the study, the investigators will compare the vital signs measurements with measurements obtained by other commonly used devices in ill children who are suspected to suffer from pneumonia.