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NCT ID: NCT04033003 Completed - Antenatal Care Clinical Trials

Group Antenatal Care and Delivery Project

GRAND
Start date: July 29, 2019
Phase: N/A
Study type: Interventional

Antenatal care (ANC) has the potential to play a pivotal role in ensuring positive pregnancy outcomes for both mothers and their newborns. A critical component of all ANC is teaching women to recognize the major complications that account for the majority of preventable maternal and newborn deaths. Antenatal care provides an opportunity to promote a healthy lifestyle, to integrate positive health behaviors, and to develop a trusting relationship with a provider and the health system. While group ANC has been delivered and studied in high-resource settings for over a decade, it has only recently been introduced as an alternative to individual care in sub-Saharan Africa. The goal of this research is to improve health literacy and reduce preventable maternal and newborn morbidities and mortality within highly vulnerable, low and non-literate populations that assume a disproportionate burden of poor pregnancy outcomes globally. This research examines a bold, new approach to ANC that takes provision of care out of clinic exam rooms into small groups of women grouped by gestational age in low resource settings with low and non-literate populations. Group ANC has the potential to shift the current clinical practice paradigm of antenatal care for highly vulnerable women to improve maternal and newborn outcomes both globally and domestically. The investigators hypothesize that pregnant women randomized into group ANC will exhibit increased health literacy through: 1) increased birth preparedness and complication readiness (BPCR), including recognition of danger signs and knowledge of how to respond to such signs; 2) higher rates of care-seeking behaviors, including seeking care for problems identified during pregnancy, higher facility delivery rates, and increased attendance at postnatal and postpartum care; and 3) better clinical outcomes for themselves and their newborns than women who received the routine, individual ANC.

NCT ID: NCT03990402 Completed - Asthma Clinical Trials

Achieving Control of Asthma in Children In Africa

ACACIA
Start date: May 16, 2019
Phase:
Study type: Observational

The main aim of the study is to identify altogether 3000 children aged between 12 and 16 years old with asthma symptoms in six sub-Saharan African countries. The study furthermore aims to assess their asthma control, current treatment, knowledge of and attitudes to asthma, as well as the barriers to achieving good asthma control.

NCT ID: NCT03962062 Completed - Onchocerciasis Clinical Trials

A Pharmacokinetic and Safety Study of Moxidectin to Identify an Optimal Dose for Treatment of Children 4 to 11 Years

Start date: March 29, 2021
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to determine a dose of moxidectin for children 4 to 11 years that is equivalent to an 8 mg dose administered for treatment of onchocerciasis in people 12 years and over. The secondary purpose is to evaluate the safety and pharmacokinetics of a single dose of moxidectin in children and adolescents aged 4 to 17 years.

NCT ID: NCT03928717 Completed - HIV/AIDS Clinical Trials

A Text-Based Adherence Game for Young People Living With HIV in Ghana

TAG
Start date: August 23, 2021
Phase: N/A
Study type: Interventional

This study will develop and evaluate a game-based, text message intervention to promote adherence to HIV care among young people living with HIV (YPLH) in Ghana. Intervention development will be guided by feedback from YPLH, their treatment supporters, and clinic staff, consultation with a mobile health services team, and Social Action Theory. Patient participants will be recruited from an urban HIV clinic in Accra, Ghana to complete a randomized pilot of the intervention. All participants will receive a brief adherence counseling session and complete three assessments over the course of 12 months following enrollment. During this time, intervention participants will receive text messages and phone calls from a semi-automated text message system, clinic staff, and other individuals in their life (e.g., family, friends, and partners) who they have identified as supportive of their treatment. The study will provide a wealth of knowledge about YPLH in Ghana, a group vulnerable to poor treatment outcomes, and provide preliminary data on a novel adherence promotion intervention.

NCT ID: NCT03907332 Completed - Pregnant Women Clinical Trials

Using Community Health Nurses and Workers for Home Visits to Pregnant Women to Improve Maternal and New Born Health in Ghana

CHNCHW
Start date: March 1, 2019
Phase: N/A
Study type: Interventional

Title: Using Community Health Workers (CHWs) and Nurses (CHNs) to increase Skilled Attendant at Birth (SAB) and improve Maternal and Neonatal Health in Rural Ghana Background: SAB is a key strategy for improving maternal and new born health since most of the complications occurring at childbirth could be better managed when the delivery is supervised by a doctor, midwife or nurse. The effect of home visits to pregnant women by a CHW/CHN partnership on SAB is yet to be evaluated in a trial in Ghana. This trial will determine the effectiveness of a CHW/CHN home visit intervention to pregnant women on increasing SAB and improving birth outcomes for mothers and their neonates. Methods: Following ethical approval, we will train CHWs and CHNs to provide a package of health education and support for delivery during three home visits to each pregnant woman. This partnership will be evaluated through a cluster randomized controlled trial in 20 electoral areas in Ellembelle district of Ghana: 10 will be randomized to receive the CHW/CHN partnership intervention and 10 to the control arm (usual care), with a target recruitment of 46-50 women per cluster. The CHWs and CHNs will receive technical and financial support throughout the study. Data on SAB, maternal utilization of safe practices during pregnancy, breast feeding initiation, exclusive breastfeeding, immunization coverage for mother and new born, maternal deaths and neonatal death rates will be collected. The impact of the CHW/CHN intervention on these indicators will be reported. Keywords: Community Health Nurse, Community Health Worker, Maternal, New born, Supervised delivery, Post-natal, Effectiveness

NCT ID: NCT03869853 Completed - Women's Health Clinical Trials

Scaling up Women's Agripreneurship Through Public-private Linkages in Rural Ghana

Start date: December 1, 2019
Phase: N/A
Study type: Interventional

Over one-third of rural Ghanaians live below the poverty line and women and children living in poverty are at the highest risk of poor nutrition and health. Sustained integrated approaches that increase agricultural productivity and value addition, diversify incomes, and enhance knowledge and skills among all stakeholders are required to improve the well-being of rural communities. There exists a unique opportunity, building on the results of the Nutrition Links (NL) project, to test sustainable district-level approaches that support women agripreneurs and address existing gender inequities in rural Ghana. This project will test different approaches to enhance the sustainability of activities that will (i) increase access to resources and services for agricultural production and, where relevant, value addition for women, (ii) facilitate access to markets that will enhance women's entrepreneurship, and (iii) help district partners integrate targets and activities to meet a common goal. The 3-y project will include quantitative and qualitative data collection to implement a trial to test a sustainable approach for engaging female agripreneurs in farmers' associations and improving their business successes, with different approaches to integrate new activities in district institutions' programs. The project will be guided by the team of institutions working together with district stakeholders to improve the quality of life of rural Ghanaian women agripreneurs and their families.

NCT ID: NCT03822611 Completed - Sanitation Clinical Trials

Research on the Impact of Targeted Subsidies Within Open Defecation Free (ODF) Communities

Start date: February 18, 2019
Phase: N/A
Study type: Interventional

This study evaluates targeted subsidies as a strategy to improve sanitation infrastructure and behaviours in communities that have reached Open Defecation Free (ODF) status after a Community-Led Total Sanitation (CLTS) program. The investigator's hypothesis is that sanitation subsidies targeted at the most vulnerable households within ODF communities will increase and help sustain latrine coverage, quality, and use amongst the targeted households, and through a spill-over effect, amongst the rest of the community. Half of participating communities will receive the targeted subsidy, while the other half will not receive any treatment.

NCT ID: NCT03797950 Completed - Clinical trials for Immunization Coverage

Mobile Nudges to Increase Early Vaccination Coverage in Rural Areas

GEVaP
Start date: November 1, 2018
Phase: N/A
Study type: Interventional

Despite major progress made in vaccination coverage overall, timeliness of vaccines remains a key concern in many settings. At the same time, access to mobile phones has increased rapidly, offering new opportunities to track and deliver health services. This research project uses these newly available mobile phone networks to simultaneously address two of the biggest bottlenecks in vaccine delivery: timely documentation of births, and lack of maternal effort or access to get essential vaccines. To increase documentation, investigators will train volunteers in each community to report new births via mobile phone to a central coordinator, and send small monetary rewards via mobile phone to volunteers for this reporting. To increase vaccination coverage, investigators will send reminder messages directly to mothers, and will also test small monetary rewards to volunteers and to mothers as an incentive to complete recommended vaccinations. The designs to provide vaccination encouragement will be tested through a small community randomized controlled trial in 15 selected villages in Ghana's Northern region. The primary outcome for the pilot study will be the percentage of children who received both the polio birth dose (OPV0) vaccination within two weeks of life (14 days) and the BCG vaccination within the first four weeks (28 days) of life.

NCT ID: NCT03755635 Completed - Neonatal SEPSIS Clinical Trials

Neonatal Sepsis at Neonatal Intensive Care Units in Ghana

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Background: Neonatal sepsis is a major contributor to global under five mortality. In developing countries a major proportion of neonatal sepsis is thought to emanate from the healthcare setting, due to challenges in infection prevention practices. Aim: To study the epidemiology of neonatal sepsis and evaluate the effect of multimodal infection control interventions on the incidence of neonatal sepsis; and colonization by multidrug resistant Gram negative bacteria (MDRGNB). Methods: A controlled before and after interventional trial comprising a 7 month pre- intervention phase, 5 month intervention phase and 7 month post-intervention phase. Neonates admitted at the Neonatal Intensive Care Unit (NICU) at Korle-Bu Teaching Hospital (KBTH) will be enrolled prospectively and followed up for diagnosis of sepsis and outcome of admission. This will be used to describe the epidemiology of neonatal sepsis. Swabs will be collected from a subpopulation of included neonates at intervention site (KBTH) and control site (37 Military Hospital) NICUs to assess colonization of neonates with MDRGNB. Environmental swabs will be collected from surfaces at the NICU to assess MDRGNB contamination of the environment. The intervention comprises infection prevention strategies including implementation of the WHO multimodal hand hygiene strategy. The primary endpoint is incidence of neonatal sepsis. Expected Outcome: This study will contribute to improved infection prevention practices in the participating NICUs and highlight lessons which other national and regional NICUs may learn from.

NCT ID: NCT03754998 Completed - Clinical trials for Iron Deficiency Anemia (IDA)

Community Interventions to Improve Iron and Iodine Status in Mother and Child Dyads in Northern Ghana

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

BACKGROUND Ghana has reduced food insecurity prevalence by 49.2% in two decades. However, prevalence of malnutrition especially stunting (in <children5yr) has not matched the changes in food security levels. Of several key nutritional factors that lead to stunting, nutritional status of such trace minerals as iodine, iron and zinc has not been studied. Nutritional inadequacy of these trace minerals may be detected by estimation of dietary intake, and time-consuming and costly biochemical measurements of respective biomarkers. Since there is no means to estimate dietary intake of the trace minerals in Ghana, due to incomplete food composition data of the nutrients, identifying validated non-invasive, dietary approaches to predict the biomarker status of these trace minerals are critical in counteracting the challenges surrounding the persistent stunting due to micronutrient deficiencies in Ghana. Additionally, exploring alternative approaches to providing access to foods rich in trace minerals at household level is crucial. STUDY AIMS AND HYPOTHESIS The ultimate goal of this research is to increase knowledge base on improving trace mineral status in mother-child (6-23 mo) dyads through a sustainable community-based interventions in northern Ghana. Investigators will begin with iron and iodine that impair mothers and young children's growth and cognitive development most with three aims: 1) to develop dietary screening tools that are validated by biomarkers for early detection of deficiencies, 2) to determine efficacy (dose responses) of feeding indigenous nutrient-rich meals in preventing deficiencies and improving iron and iodine status, and 3) to demonstrate sustainable and scalable improvement of food systems through a container gardening project for iron-rich Hibiscus sabdarifa for consumption and income by empowering women during the dry/lean season in northern Ghana. • Aims 1: To develop dietary screening tools that are validated by biomarkers for early detection of deficiencies among children 6-23 months and their mothers H1.1: Dietary diversity score can predict iron deficiency among children 6-23 months and their mothers. H1.2: Dietary diversity score can predict iodine status deficiency among children 6-23 months and their mothers. - Aims 2: Indigenous nutrient-rich meals of hibiscus sabdarifa improves iron and iodine status of dyads H2.1: Indigenous nutrient-rich meals of hibiscus sabdarifa improves iron status of dyads H2.2: Indigenous nutrient-rich meals of hibiscus sabdarifa improves iodine status of dyads - Aims 3: to demonstrate that container gardening can provide sustainable and scalable improvement of food systems for iron-rich Hibiscus sabdarifa for consumption and income during the dry/lean season in northern Ghana H3.1: Container gardening can provide adequate amounts of vegetables for mother and child dyad during the dry season H3.2: Container gardening can provide adequate income to purchase iodized salt and Amani for mother and child dyad during the dry season SIGNIFICANCE This project addresses the gap in our knowledge and practices pertaining to serious and persisting trace mineral deficiencies that result in stunting and cognitive impairment in northern Ghana. Early detection of iron and iodine deficiencies with validated non-invasive dietary screening tools (aim 1), effective indigenous nutrient-rich meal-based programs (aim 2) and sustainable/scalable and women-led community-based food-system changing agricultural project (aim 3) are expected to be the most creative approach to counteract iron and iodine deficiencies in northern Ghana. This project will utilize science and education to change practices, environments and policies to reduce the prevalence of trace mineral deficiencies at the local, regional, national and global levels.