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NCT ID: NCT05632237 Active, not recruiting - Parenting Clinical Trials

Evaluation of a Family Strengthening Program Evaluation in Sierra Leone to Prevent Family Separation

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

In Sierra Leone, poverty and challenges with family functioning can lead to family separation, and children may go to live on the street or enter residential care institutions/orphanages. Helping Children Worldwide (HCW), a non-profit organization with over 20 years of experience in Sierra Leone, has developed a two-part Family Strengthening Program delivered by their program partners in Sierra Leone, the Child Reintegration Centre, to improve families financial literacy and attachment between caregivers and children, with the ultimate goal of preventing family separation. The hypothesis of this study is that the Family Strengthening Program program is effective at (1) changing parenting behaviors, (2) improving emotional regulation, (3) improving caregiver-child attachment, and (4) improving financial literacy in dyads consisting of children ages 9-13 and their caregivers.

NCT ID: NCT05284097 Recruiting - Infections Clinical Trials

Ad26.ZEBOV, MVA-BN-Filo Vaccination in Children and Adults Previously Vaccinated With Control in the EBOVAC-Salone Study

Start date: September 19, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2, open-label, study evaluating the safety and immunogenicity of the 2-dose vaccination regimen, Ad26.ZEBOV, MVA-BN-Filo, in adults and children originally enrolled in the control arm of the EBOVAC-Salone study

NCT ID: NCT05085340 Recruiting - Malaria Clinical Trials

MULTIple Doses of IPTi Proposal: a Lifesaving High Yield Intervention

Start date: February 14, 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.

NCT ID: NCT05067166 Available - Clinical trials for Hemorrhagic Fever, Ebola

Open-Label Expanded Access for Ebola-Infected Patients to Receive Human mAb Ansuvimab as Therapeutic or for HR PEP

Start date: n/a
Study type: Expanded Access

The human monoclonal antibody (mAb), ansuvimab (mAb114), will be provided to Ebola-infected patients as either a treatment or as PEP under expanded access. Ansuvimab is administered at 50 mg/kg as a single intravenous (IV) infusion

NCT ID: NCT04912284 Completed - Covid19 Clinical Trials

Africa COVID-19 Vaccine Hesitancy

Start date: May 5, 2021
Study type: Observational

Vaccine hesitancy is defined by the WHO's Strategic Advisory Group of Experts on Immunization as a 'delay in acceptance or refusal of vaccination despite availability of vaccination services'. This varies in form and intensity based on when and where it occurs and what vaccine is involved. Several prophylactic vaccines against COVID-19 are currently available. As the world is beginning the roll-out the first approved vaccines, little is known about people's potential acceptance of a COVID-19 vaccine in most of the African countries. ACHES (African COVID -19Vaccine Hesitancy) is an observational study aimed at measuring COVID-19 vaccine hesitancy in five west African countries and exploring causes behind the hesitancy with the main objective of informing guidelines for the proficient roll-out of the vaccines in the region.

NCT ID: NCT04711356 Completed - Ebola Virus Disease Clinical Trials

Ad26.ZEBOV Booster in Children Previously Vaccinated With Ad26.ZEBOV and MVA-BN-Filo (EBOVAC Booster Study)

Start date: July 8, 2021
Phase: Phase 2
Study type: Interventional

This is an open-label study evaluating the safety and immunogenicity of a booster dose of Ad26.ZEBOV administered to children who were previously vaccinated with Ad26.ZEBOV followed by MVA-BN-Filo 56 days later.

NCT ID: NCT04481399 Active, not recruiting - Child Development Clinical Trials

Mobile Health (mHealth) Tools to Improve Delivery Quality of a Family Home Visiting Intervention

Start date: August 5, 2021
Phase: N/A
Study type: Interventional

The proposed exploratory research will pilot a family-focused, behavioral health intervention while also developing and piloting innovative and cost-effective mHealth tools to support Community Health Workers (CHWs) in Sierra Leone. This dual focus will help build capacity both for delivery of evidence-based mental health services to reduce family violence and harsh parenting practices, and for effective use of mHealth strategies to improve healthcare delivery and quality. This study will leverage Government of Sierra Leone investments in community health initiatives and mHealth innovations as a strategy to address critical healthcare workforce limitations that plague delivery of evidence-based interventions to vulnerable families in post-conflict Sierra Leone. The study will pilot mHealth-supported delivery of a culturally adapted version of the Family Strengthening Intervention for Early Childhood Development (FSI-ECD). The FSI-ECD has demonstrated effectiveness in improving parental emotion regulation and reducing family violence and harsh parenting practices among high-risk families with children aged 6-36 months in Rwanda. Study aims are to: Aim 1. Employ a five-phase user-centered design approach to develop and test mHealth tools to improve training, supervision, and fidelity monitoring of Community Health Workers. Study investigators hypothesize that mHealth tools will be feasible, acceptable, and user-friendly. Aim 2. Conduct a Randomized Controlled Pilot Study to assess feasibility, acceptability, and preliminary effects of the mHealth-supported delivery of FSI-ECD on parent mental health, emotion regulation, and familial violence in high risk families with children aged 6-36 months (n=40) in comparison to control families (n=40) who receive standard care. Parental mental health, emotion regulation, household violence, and parenting practices will be assessed at baseline, post-intervention and 6-month follow-up. The pilot study will also integrate a cost-effectiveness analysis to assess the economic value of the mHealth-supported delivery of the FSI-ECD vs. standard care. Study investigators hypothesize that (a) the effects of the FSI-ECD will be comparable to results observed with vulnerable families in Rwanda; (b) digital tools will be feasible and acceptable to CHWs and supervisors; and (c) mHealth-enhanced supervision and fidelity monitoring will increase supervisor engagement and support CHW quality improvement cycles. Aim 3. Leverage well-established relationships and government partners to strengthen capacity for mHealth research and quality healthcare delivery in Sierra Leone. Partners include the University of Makeni, the Directorate of Science, Technology and Innovation, and the Ministry of Health and Sanitation.

NCT ID: NCT04334538 Completed - Malnutrition, Child Clinical Trials

Effect of an Alternative RUTF on Intestinal Permeability in Children With Severe Acute Malnutrition

Start date: March 2, 2021
Phase: N/A
Study type: Interventional

Ready-to-use therapeutic food (RUTF) is the standard of care for the treatment of SAM. UNICEF requires that there be no oil separation in these products necessitating the use of emulsifiers. The effect of emulsifiers on gut health and integrity in children receiving an exclusive diet of RUTF is unknown. The PIs have recently completed a randomized, triple-blind, controlled, clinical equivalency trial in Sierra Leone comparing the alternative oat RUTF (oat-RUTF) to standard RUTF on recovery rates in children with SAM. This study demonstrated higher rates of recovery among children receiving the oat-RUTF. The investigators hypothesize that this benefit may be due to the lack of emulsifier in the oat-RUTF resulting in improved intestinal health.This research project is a double-blind, randomized, controlled clinical effectiveness trial comparing a novel RUTF containing oats and no emulsifier and standard RUTF on recovery from severe acute malnutrition (SAM) and effects on intestinal health. The trial will be conducted in up to 40 PHUs in Western Rural and Pujehun Districts where supplementary feeding programs (SFP) are not currently available.

NCT ID: NCT04235816 Recruiting - Child Mortality Clinical Trials

Improving Care Through Azithromycin Research for Infants in Africa

Start date: March 15, 2021
Phase: Phase 3
Study type: Interventional

Infectious diseases are among the most common causes of mortality in the over 2.5 million children under 5 years of age (U5) who died in 2018 in sub-Saharan Africa (SSA). New approaches to treatment and prevention of these diseases are needed to increase child survival. Sierra Leone has one of the highest rates of under-five child mortality in the world. It is estimated that 32,000 children die each year, the leading causes being neonatal conditions, malaria, pneumonia and diarrhea. In Sierra Leone, the available information on malaria indicates that it accounts for 38% of deaths among under-five children. Reducing the prevalence and impact of the disease among the general population is a major priority of the Ministry of Health and Sanitation (MoHS) of Sierra Leone . Intermittent Preventative Treatment in infants (IPTi) - the administration of a full course antimalarial treatment to infants at individual timepoints regardless of infection status- has been shown to reduce clinical malaria and anemia in infants in the first year of life . When delivered alongside the Expanded Program on Immunization (EPI), IPTi with Sulphadoxine-pyrimethamine (SP) is a highly cost-effective intervention. . Sierra Leone is currently the only country that implements nationwide the World Health Organization's (WHO) IPTi guideline, which is administered within the first year of life. However, its benefit when expanded into the second year of life remains unknown. Taking the advantage of the inclusion in the EPI program of a booster dose of measles vaccine at 15 months of age, the ICARIA trial will also assess the efficacy of adding a dose of IPTi-SP at this age. Recent studies show that azithromycin (AZi) - a macrolide antibiotic with some antimalarial effect- is associated with a significant reduction in childhood mortality when used in mass drug administration (MDA) for trachoma elimination in areas of sub-Saharan Africa (SSA) with child mortality rates far beyond Sustainable Development Goals , . However, despite the potential benefit of the intervention several fundamental scientific questions need to be answered before it can be recommended for large-scale implementation.

NCT ID: NCT04216043 Completed - Malnutrition, Child Clinical Trials

Milk Matters in Malnutrition, is it the Lactose or Dairy Protein?

Start date: September 16, 2020
Phase: N/A
Study type: Interventional

This study is to look at the types of sugar and protein composition in the treatment of moderate acute malnutrition and its effects on gut health. The study will use 4 different types of ready to use supplementary foods to see which one if any has better recovery rate along with looking into the gut health. Children will be treated using one food for up to 12 weeks. A subset of about 400 will be tested for intestinal permeability using the dual sugar test.