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NCT ID: NCT05409274 Active, not recruiting - Covid19 Clinical Trials

Understanding COVID-19 Infections in Pregnant Women and Their Babies in 5 African Nations (periCOVID Africa)

Start date: November 1, 2020
Study type: Observational

Develop coronavirus disease 2019 (COVID-19) surveillance in pregnancy in The Gambia, Kenya, Malawi, Mozambique and Uganda Estimate the seroepidemiology of COVID-19 infection among pregnant women in these countries Define the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in pregnant women and their babies and determine the presence of antibodies in cord blood Work with communities to develop understanding of infection prevention and control techniques to reduce the spread of COVID-19 amongst the pregnant population

NCT ID: NCT05372484 Recruiting - Cervical Cancer Clinical Trials

PEER Trial: Part 2

Start date: March 24, 2021
Phase: N/A
Study type: Interventional

The study aims to compare the accuracy of the lateral flow test to detect HPV at the POC with the commercially available GeneXpert HPV test and to determine the diagnostic accuracy and reliability of a multimodal optical imaging system to detect cervical dysplasia, with the gold reference standard of histopathology.

NCT ID: NCT05362682 Recruiting - Clinical trials for Effectiveness Evaluation of the Sinopharm Vaccine in Mozambique

Effectiveness Evaluation of the Sinopharm Vaccine in the Dondo District in Mozambique

Start date: February 24, 2022
Study type: Observational [Patient Registry]

Three complementary activities will be implemented:1) Baseline and repeat census of the catchment population; described in a separate protocol (IVI-ECOVA-03-WS1); 2) Enhanced surveillance for COVID-19 disease, and 3) AEFI-enhanced surveillance. The mass vaccination campaign will be conducted by the Government and is not part of this protocol.

NCT ID: NCT05343312 Recruiting - Malaria Clinical Trials

In Vivo Efficacy of Artemether-Lumefantrine, Amodiaquine-Artesunate, Dihydroartemisinin-Piperaquine, and Pironaridine-Artesunate in Mozambique

Start date: March 16, 2022
Phase: Phase 4
Study type: Interventional

This is a classical in vivo clinical trial, following World Health organization's recommendations, ran as a multisite study within Mozambique trying to assess the efficacy and safety in 5 sites of the four oral ACTS artemether-lumefantrine (AL), Amodiaquine-Artesunate (AQ-AS), Dihydroartemisinin-Piperaquine (DHP) and Pironaridine-Artesunate for the treatment of uncomplicated malaria in children aged<5 years.

NCT ID: NCT05306067 Recruiting - Malaria Clinical Trials

Plasmodium Falciparum Genomic Intelligence in Mozambique

Start date: October 12, 2021
Study type: Observational

Mozambique is among the ten countries with the highest burden of malaria worldwide, with an estimated 9.3 million cases in 2018, and constitutes a core target for the World Health Organization (WHO) and the Roll Back Malaria Partnership to End Malaria's country-led 'high burden to high impact' initiative. At the same time, the National Malaria Control Program (NMCP) of Mozambique seeks to accelerate elimination in the south, where transmission is lowest. NMCP is currently working with partners (Malaria Consortium, PMI, Global Fund) to set up a high-resolution surveillance system that can drive decision-making across all transmission strata through strengthening of routine data quality, data use and data to action packages. However, decisions become more complex as control reveals heterogeneity and better tools are required for a strategic use of information to drive impact. The overall objective of the study is to operationalize a functional malaria molecular surveillance (MMS) system that generates reliable and reproducible genomic data over time for programmatic decisions. The integration of genomic data into routine surveillance activities has the potential to increase the actionable intelligence for making programmatic decisions on the optimal mix of control and elimination measures in Mozambique by: 1. Informing drug and diagnostic choices through the monitoring of antimalarial drug resistance and diagnostic resistance (hrp2/3 deletions); 2. Targeting the reservoirs sustaining transmission through the use of transmission network models to quantify parasite importation, identify sources and characterize local transmission in near-elimination settings; 3. Improving stratification, monitoring and impact evaluations in different epidemiological and health system contexts through the use of measures of P. falciparum genetic diversity (routinely from positive cases) to supplement traditional surveillance, especially where it is sparse; 4. Using alternative, cost-effective, approaches targeting easy-access populations (e.g. pregnant women at antenatal care clinics) to monitor transmission and antimalarial/diagnostic resistance.

NCT ID: NCT05303168 Recruiting - COVID-19 Clinical Trials

Prevalence and Impact of COVID-19 on Maternal and Infant Health in African Populations

Start date: July 1, 2021
Study type: Observational [Patient Registry]

There is growing evidence that COVID-19 threatens maternal and perinatal health. Pregnant women are at higher risk of severe complications (severe pneumonia, hospitalizations, intensive care unit admission, invasive mechanical ventilation, extracorporeal membrane oxygenation) and death compared to age-matched non-pregnant women. On the other hand, the number of confirmed COVID-19 cases reported in sub-Saharan Africa (SSA) continues to increase, where the highest maternal mortality rates in the world are registered. The World Health Organization (WHO) estimates that this region alone accounted for roughly two-thirds (196 000) of all maternal deaths in 2017, which among other reasons is explained by the inequalities in access to quality antenatal care (ANC) services and the low numbers of skilled health workers in the region. The spread of SARS-CoV-2 in SSA is threatening the already fragile health services, affecting mainly the most vulnerable populations such as pregnant women. This project aims to describe the burden and effects of SARS-CoV-2 infection during pregnancy in women living in malaria endemic areas and high prevalence of HIV infection. Pregnant women attending ANC clinics in selected sites from Libreville and Lambaréné (Gabon) and Manhiça (Mozambique) will be enrolled in a cohort study to determine the frequency of SARS-CoV-2 infection and COVID-19 during pregnancy and its effects on maternal and neonatal health. Participants will be tested for SARS-CoV-2 infection whenever reporting respiratory symptoms suggestive of COVID-19 during routine ANC follow-up and six weeks after the end of pregnancy. The presence of antibodies (IgG/IgM) against SARS CoV-2 in blood samples will be determined. The clinical presentation of COVID-19 in pregnancy will be also characterised, and the incidence of infection during pregnancy and the risk factors of maternal and neonatal morbidity and mortality associated with SARS-CoV-2 infection and the frequency of mother- to- child transmission of SARS-CoV-2 will be assessed. The findings of this project will contribute to the understanding of the impact of SARS-CoV-2 and COVID-19 among pregnant women living in SSA countries where malaria and HIV infections are highly prevalent.

NCT ID: NCT05228639 Recruiting - COVID-19 Clinical Trials

COVID-19 Surveillance in Rural Mozambique for Prompt and Effective Response

Start date: December 1, 2020
Study type: Observational [Patient Registry]

Extraordinary times require extraordinary measures. The current COVID-19 pandemic is the paradigmatic example of how infectious diseases may menace the world's health and economy, and particularly contribute to enhancing current inequities in health-related to wealth. The main goal of the proposed study is to understand the epidemiology and natural history of COVID-19 in a rural area in Southern Mozambique

NCT ID: NCT05186363 Not yet recruiting - Malaria Clinical Trials

Effectiveness of Seasonal Malaria Chemoprevention in Nampula Province, Mozambique: Type Two Hybrid Implementation Study

Start date: January 10, 2022
Phase: Phase 4
Study type: Interventional

We describe a Type II hybrid effectiveness-implementation study design which evaluates the effects of a clinical intervention on relevant outcomes whilst collecting information on implementation. It is designed to determine feasibility and effectiveness of an innovative intervention, as well as the protective efficacy of the drugs used. The study consists of three components: 1) Conducting a cluster randomized controlled trial (cRCT) through household surveys establishing confirmed malaria cases in children; 2) Conducting a prospective cohort study to determine the chemoprevention efficacy of sulfadoxine-pyrimethamine and amodiaquine (SPAQ) and whether drug concentrations or parasite resistance influence the duration of protection; and 3) Conducting a resistance markers study in children 3-59 months to measure changes in resistance marker prevalence over time.

NCT ID: NCT05103033 Recruiting - Clinical trials for Mental Health Disorder

Systems Analysis and Improvement Approach to Optimize the Task-shared Mental Health Treatment Cascade (SAIA-MH)

Start date: March 14, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to test the effectiveness of a multicomponent implementation strategy entitled the Systems Analysis and Improvement Approach for mental health (SAIA-M) using a cluster randomized trial at the health facility level. SAIA-MH focuses on improving the mental health treatment cascade in primary outpatient mental healthcare. The mental health treatment cascade is a model that outlines the sequential, linked treatment steps that people with mental illness must navigate, from initial diagnosis to symptom/function improvement. This study will also assess the potential mechanisms by which the SAIA-MH implementation strategy works, or does not work, along with the cost and effectiveness of scaling-up SAIA-MH in Mozambique.

NCT ID: NCT05085340 Not yet recruiting - Malaria Clinical Trials

MULTIple Doses of IPTi Proposal: a Lifesaving High Yield Intervention

Start date: January 2022
Study type: Observational

MULTIPLY is a multi-country 40-month implementation research project, which aims to catalyse country uptake of Intermittent Preventive Treatment of malaria in infants (IPTi) and inform future policy and guidelines in moderate-to-high malaria transmission settings. The project has been conceived following a before-after evaluation design of the impact of the intervention. The primary outcome measure will be the coverage of three or more doses of IPTi in children under 2 years of age (U2) attending the Expanded Programme on Immunisation (EPI) in project areas. IPTi will be delivered at health facilities and mobile-outreach EPI clinics to all children living in project districts. The number of IPTi doses a child will receive will be based on the EPI schedule of the country, with a maximum of 6 doses in the first 2 years of life. The prophylactic effect of IPTi provides protection for up to 6 weeks in infants. Therefore, in the current WHO-recommended IPTi scheme, infants are exposed to the infection for about 4 months during a critical period of high susceptibility to harmful effects of the infection. Exploiting additional opportunities to administer IPTi to children in their first years of life could be of great public health interest. In settings where vitamin A deficiency is a public health problem WHO recommends vitamin A supplementation, habitually done through the EPI scheme starting at 6 months of age, at 6 months intervals; thus, the addition of IPTi at 6, 12, 15-18 months of age to vitamin A administration would improve malaria prevention during a critical time in the first year of life and expand it into the second. Moreover, the integration of these two interventions might help increase the coverage of vitamin A supplementation, which ranges between 53%-57% in sub-Saharan Africa and importantly will help reduce the prevalence of anaemia in young children by combining the effect of malaria prevention and of vitamin A on increasing haemoglobin levels. Additionally, in recent years the inclusion of a booster dose of measles immunisation in the EPI, between 15-18 months of age, also offers the opportunity of further expanding malaria protection in the second year of life using IPTi. This is particularly relevant given that severe malaria cases are more prevalent between 1 and 3 years of age in high and moderate transmission areas.