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NCT ID: NCT05677087 Enrolling by invitation - Health Literacy Clinical Trials

PREPARE: Remote Nutrition Education, Ghana

Start date: January 9, 2023
Phase: N/A
Study type: Interventional

In the wake of the pandemic, it is important to explore remote nutrition education programs during the pre- and postnatal period. This is the second phase of a bigger project, where a 6-week intensive remotely delivered nutrition and health education program called the PREPARE program will be piloted. Prepare stands for "Perinatal Remote Education for Pandemic Resilience", and it is a nutrition and health education program meant for pregnant and lactating women aimed at improving maternal and infant dietary diversity, maternal health literacy and increasing COVID-19 awareness. One hundred women will be selected from a pool of 233 women who completed a baseline survey last year. Fifty of them will receive the intervention and the other 50 will receive a delayed intervention.

NCT ID: NCT05619406 Recruiting - Hypertension Clinical Trials

Systematic Investigation of Blacks With Stroke - GENOMICS

Start date: August 20, 2022
Phase: N/A
Study type: Interventional

The overall goal of SIBS-GENOMICS is to utilize the best available contextual data on stroke in Africa to develop & validate stroke risk estimation models, translate the best model into a mobile phone app and conduct a randomized control trial of the app with a co-created motivational education video, to determine their effectiveness for improvement of stroke risk factor awareness and global risk reduction among Africans.

NCT ID: NCT05506683 Recruiting - Pediatric ALL Clinical Trials

Improving Nighttime Access to Care and Treatment; Part 2- Ghana

Start date: November 16, 2022
Phase: N/A
Study type: Interventional

Globally, leading causes of death among children one month to 5 years old are pneumonia, diarrheal disease and malaria which are treatable early in the disease-course with low-cost medications. However, these diseases can progress to emergencies when access to care is delayed. In response, a telemedicine and medication delivery service (TMDS) was designed to improve nighttime access to pediatric care and treatment. Over 9-months, the TMDS will be implemented in a Ghanaian community to evaluate the clinical safety and operational feasibility of implementing the service.

NCT ID: NCT05444504 Not yet recruiting - Fistula Clinical Trials

Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

The investigators propose a clinical trial and nested qualitative study to 1) quantify the effectiveness of an insertable vaginal cup to manage fistula urinary incontinence, 2) examine user and implementer acceptability, and 3) quantify fistula management cost. Two intervention models will be compared among women awaiting fistula surgery or whose surgery was unsuccessful: 1) a vaginal cup ('cup'), and 2) the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity.

NCT ID: NCT05382403 Not yet recruiting - Clinical trials for Postpartum Hemorrhage

Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

This will be the first, definitive, randomized control trial (N=424) to test the hypothesis that the Jada® System is effective, safe and cost-effective in treating PPH, compared to standard care.

NCT ID: NCT05340777 Completed - Clinical trials for Postpartum Hemorrhage

Ghana: The Barriers and Facilitators of Scaling up the Ellavi UBT for Postpartum Hemorrhage

Start date: November 18, 2020
Study type: Observational

The purpose of this implementation science study is to generate evidence that informs the successful uptake and adoption of the Ellavi UBT within Ghana's PPH management programs. The investigators aim to improve the likelihood that the Ellavi UBT will be integrated into the health care system by obtaining critical feedback from stakeholders and health care providers on the barriers and facilitators towards its successful adoption and roll out. The research will be done in three purposively selected facilities near Accra Ghana: Tema General Hospital, Ridge Hospital, and Kasoa Polyclinic. This study uses a nonexperimental design to collect data on implementation (e.g. # staff trained, usability, user confidence, acceptability, feasibility). The study team will train all obstetric healthcare staff (i.e. obstetricians, midwives, medical officers, clinical officers) involved in PPH management at the 3 participating healthcare facilities on the Ellavi UBT. The investigators will gather feedback from the obstetric healthcare workers (post-training and post-PPH) to understand the barriers to and facilitators of use in order to evaluate acceptability and feasibility among facilities providing different levels of care (level 4, level 5 (county), level 6 (tertiary)). This process will help to generate training and facility level recommendations for improved uptake and integration into the local maternal care package. Case report forms and semi-quantitative surveys will be completed by obstetrical care providers to evaluate the primary outcomes of acceptability and feasibility by measuring: context of use, accuracy of use, perceptions of the device, user confidence, acceptability, usability, facilitators of use, barriers to use, use-patterns, and insights into training effectiveness. The secondary outcomes will include financial data to determine the cost of introducing the Ellavi UBT into the Kenyan PPH management protocols and the health system. The study will not involve the storage of biological samples. There is not a direct benefit of the study to the individual participants. All study participants will sign consent forms.

NCT ID: NCT05280951 Recruiting - Postpartum Care Clinical Trials

Focused-PPC: An Integrated Postpartum Care, Education, and Support Model for Women in Ghana

Start date: February 26, 2022
Phase: N/A
Study type: Interventional

The purpose of this project is to test and evaluate an innovative postpartum care, education, and support model that integrates recommended clinical care, education, and support for women in a group setting. Aim 1. Develop an innovative integrated group postpartum care, education, and support model entitled Focused-PPC for postpartum women up to one year after delivery. Aim 2. Implement and evaluate this integrated postpartum care model entitled Focused-PPC in a parallel randomized controlled trial with 192 postpartum women at 4 health centers in Tamale, Ghana.

NCT ID: NCT05200715 Recruiting - Uveitis Clinical Trials

AutoInflammatory Disease Alliance Registry (AIDA)

Start date: August 6, 2020
Study type: Observational [Patient Registry]

Autoinflammatory diseases (AID) are clinical entities characterized by recurrent inflammatory attacks in absence of infection, neoplasm or deregulation of the adaptive immune system. Among them, hereditary periodic syndromes, also known as monogenic AID, represent the prototype of this disease group, caused by mutations in genes involved in the regulation of innate immunity, inflammation and cell death. Based on recent experimental acquisitions in the field of monogenic AID, several immunologic disorders have been reclassified as polygenic/multifactorial AID, sharing pathogenetic and clinical features with hereditary periodic fevers. This has paved the way to new treatment targets for patients suffering from rare diseases of unknown origin, including Behçet's disease, Still disease, Schnitzler's disease, PFAPA (periodic fever, aphthous stomatitis, pharyngitis and cervical adenitis) syndrome, chronic recurrent multifocal osteomyelitis (CRMO), non-infectious uveitis and scleritis. Gathering information on such rare conditions is made difficult by the small number of patients, along with the difficulty of obtaining an accurate diagnosis in non-specialized clinical settings. In this context, the AIDA project promotes international collaboration among clinical centres to develop a permanent registry aimed at collecting demographic, genetic, clinical and therapeutic data of patients affected by monogenic and polygenic AID, in order to expand the current knowledge of these rare conditions.

NCT ID: NCT05180461 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 Enrolling by invitation - 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.