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NCT ID: NCT06153862 Active, not recruiting - Malaria Clinical Trials

Africa Ready Malaria Screening

ARMS
Start date: September 23, 2022
Phase: N/A
Study type: Interventional

This study aims to develop immuno-analytical assays for testing the titres of malaria antibodies in Ghanaian patients' and/or donors' sera using a recombinantly produced MSP119 fusion protein and/or MSP119-derived synthetic peptides as antigens.

NCT ID: NCT05964582 Active, not recruiting - Clinical trials for Respiratory Syncytial Virus Infections

Prospective Surveillance of Respiratory Syncytial Virus Disease in Infants and Toddlers

Start date: July 11, 2023
Phase:
Study type: Observational

The study is a multi-center, multi-national, prospective surveillance study in which the study participants will not receive a study vaccine but will provide a baseline blood sample and be followed for acute respiratory disease during 6 months. The 6-month follow-up will occur for the most part during the Respiratory Syncytial Virus(RSV) season (based on enrollment timing and as per feasibility). A maximum of 1000 children from 6 to < 22 months of age are planned to be enrolled in 5 to 10 countries, 1 to 2 sites per country, targeting approximately 100 participants per country. The purpose of the study is to assess the seroprevalence and incidence of RSV disease during the study period in the targeted countries and sites for a Phase III vaccine study.

NCT ID: NCT05703711 Active, not recruiting - Depression Clinical Trials

Combining mHealth and Nurse-delivered Care to Improve the Outcomes of People With Serious Mental Illness in West Africa

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

In West Africa, most people with serious mental illness receive care from traditional or faith healers at prayer camps. The stepped-wedge cluster randomized trial aims to evaluate the effectiveness of a dual-pronged intervention package comprised of a mobile health program designed to train healers to deliver evidence-based psychosocial interventions combined with pharmacotherapy delivered directly to the patients at their prayer camps via a visiting nurse in Ghana.

NCT ID: NCT05180461 Active, not recruiting - Onchocerciasis Clinical Trials

Emodepside Phase II Trial for Treatment of Onchocerciasis

Start date: August 30, 2021
Phase: Phase 2
Study type: Interventional

The trial evaluates safety, tolerability, pharmacodynamics, pharmacokinetics, dose-response, and efficacy of emodepside tablets, administrated as a range of dose regimens, in adults infected with Onchocerca Volvulus.

NCT ID: NCT05178407 Active, not recruiting - Anemia Clinical Trials

Effect of Household Use of Multiple Micronutrient-fortified Bouillon on Micronutrient Status Among Women and Children in Two Districts in the Northern Region of Ghana

Start date: January 16, 2023
Phase: N/A
Study type: Interventional

Background: Micronutrient (MN) deficiencies are severe and widespread in West Africa, particularly among young children and women of reproductive age. Bouillon is a promising food fortification vehicle because the product is centrally processed on large scale, consumed by most households in West African countries (even rural, poor households), and consumed by most members of the household in relatively constant amounts. However, several important research questions remain regarding whether the use of fortified bouillon would be feasible and effective for preventing or reducing micronutrient deficiencies in communities where such deficiencies are common. Specifically, no studies have assessed the impacts of multiple micronutrient-fortified bouillon on micronutrient status. The West Africa Condiment Micronutrient Innovation Trial (CoMIT) Project aims to address this gap, to inform future discussions around fortification of bouillon cubes and related products. Objective: This study aims to assess the impacts of household use of multiple micronutrient-fortified bouillon cubes (containing iodine in addition to vitamin A, folic acid, vitamin B12, iron, and zinc), compared to control bouillon cubes fortified with iodine only, on: 1. Micronutrient status among women 15-49 years of age and children 2-5 years of age after 9 months of intervention 2. Hemoglobin concentrations among women 15-49 years of age and children 2-5 years of age after 9 months of intervention 3. Breast milk micronutrient concentrations among lactating women 4-18 months postpartum after 3 months of intervention Methods: This randomized, controlled doubly-masked trial will be conducted in the Kumbungu and Tolon districts in the Northern Region of Ghana, where prior data indicate that deficiencies in the selected nutrients are common. Potential participants will be: 1) non-pregnant non-lactating women of reproductive age (15 - 49 years old), 2) children 2-5 years of age, and 3) non-pregnant lactating women 4-18 months postpartum. Eligible participants will be randomly assigned to receive household rations of one of two types of bouillon cubes: 1. a multiple micronutrient-fortified bouillon cube containing vitamin A, folic acid, vitamin B12, iron, zinc, and iodine, or 2. a control cube containing iodine only Each participant's household will receive a specific amount of bouillon cube every 2 weeks, and households will be advised to prepare their meals as usual, using the study-provided cubes. The trial duration will be 9 months (38 weeks) for non-pregnant, non-lactating women and children 2-5 years of age, and 3 months (12 weeks) for lactating women. The primary outcomes will be changes from baseline to endline in concentrations of haemoglobin and biomarkers of micronutrient status. Secondary outcomes will include change in prevalence of anaemia and micronutrient deficiency; dietary intake of bouillon and micronutrients; inflammation, malaria, and morbidity symptoms; and children's anthropometric measures and child development.

NCT ID: NCT05041556 Active, not recruiting - Malaria Clinical Trials

Strengthening the Evidence for Policy on the RTS,S/AS01 Malaria Vaccine

MVPE-CC
Start date: April 1, 2021
Phase:
Study type: Observational

The ongoing Malaria Vaccine Pilot Evaluation (MVPE) is being conducted in Ghana, Malawi and Kenya through community and sentinel hospital surveillance systems and a series of household surveys (to measure vaccine coverage). The Malaria Vaccine Pilot Evaluation-Case Control (MVPE-CC) registered here as observational study is embedded within MVPE comprising case-control studies of clinical and mortality outcomes. Each case will require four controls, and caregiver informed consent will be required prior to study activities. These observational case control studies will measure as complementary information to what is being collected through MVPE: 1. Safety among children who received the malaria vaccine, with focus on cerebral malaria, meningitis and severe malaria 2. The impact of the malaria vaccine on all-cause mortality for boys and girls, AND 3. Promote use of case-control approaches by Expanded Programmes on Immunization (EPI) and malaria control programmes.

NCT ID: NCT04935879 Active, not recruiting - Sickle Cell Disease Clinical Trials

A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises

Start date: October 26, 2021
Phase: Phase 3
Study type: Interventional

This Phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (VOCs) in approximately 240 adult and adolescent participants (≥ 12 years of age) with sickle cell disease (SCD). Participants will be randomized to receive inclacumab or placebo.

NCT ID: NCT04904549 Active, not recruiting - COVID-19 Clinical Trials

Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older

VAT00008
Start date: May 26, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this Phase III study is to assess the efficacy, safety, and immunogenicity of two CoV2 preS dTM-AS03 vaccines (monovalent and bivalent) as part of primary series vaccinations in a multi-stage approach, as well as a booster injection of a CoV2 preS dTM-AS03 vaccine, in adults 18 years of age and older. A total of approximately 21 046 participants are planned to be enrolled (5080 per study intervention group in Stage 1 and 5443 per study intervention group in Stage 2). Initial, double-blind, primary series study design is planned for 365 days post-last Initial injection (ie, approximately 386 days total) for each participant. Based on decisions of the Study Oversight Group, Stage 1 and Stage 2 participants will be invited to participate in an unblinded Crossover / Booster study design with duration as follows: - For participants who initially received vaccine: 12 months post-booster (ie, approximately 18 to 24 months) - For participants who initially received placebo: ≥ 4 months post-last dose of the primary series + 12 months post-booster (ie, approximately 28 to 34 months) - For participants who do not consent to continue in the unblinded Crossover / Booster part of the study, all study procedures will be stopped and participants will be discontinued from the study.

NCT ID: NCT04791865 Active, not recruiting - HIV Clinical Trials

Pediatric HIV Disclosure Benefits Study (PhD-BS) - Sankofa 2

Start date: June 15, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to conduct a pragmatic, stepped wedge cluster randomized trial in 12 HIV pediatric clinics in Ghana to determine effectiveness, health benefits, cost and implementation to inform scale-up and sustainability of pediatric disclosure.

NCT ID: NCT04753788 Active, not recruiting - Yaws Clinical Trials

Evaluation of a LAMP Assay for T. Pallidum. Pertenue

LAMP4YAWS
Start date: March 15, 2021
Phase:
Study type: Observational

This is a diagnostic evaluation comparing the performance of real-time PCR performed at a national reference laboratory and a LAMP assay performed at a regional hospital for the diagnosis of yaws