Monrovia, Liberia
Health Systems and Policy Contexts of Medical Oxygen
The investigators will use a concurrent mixed-methods design, with an overarching comparative case study methodology. The investigators will adopt an iterative approach, using co-design to adapt the study methodology to the specific context of each country and annual learning team meetings with stakeholders to refine the final case study topics (sub-study 3) and methodology. Three embedded sub-studies are planned: Sub-study 1 (Stakeholder Analysis) aims to understand the policy environment for medical oxygen services across different country contexts. This will be informed by the MOXY baseline survey, which includes data on oxygen-related facility readiness and clinical practices across the MOXY program areas. Data sources will include stakeholder interviews with participants from different levels (national, provincial, local) and policy perspectives (government, implementing/advising partners, practitioners, beneficiaries). Results will inform sub-study 2 and MOXY program implementation. Sub-study 2 (Policy-Implementation Gap Analysis) aims to critically analyse the gap between policy intentions and actual implementation. This will be informed by the baseline facility readiness and clinical practice data. Data sources will include a desk review of oxygen-related policies, stakeholder in-depth interviews, and program administrative data. Results will inform implementation of country oxygen strategies and feed into prioritization of focus areas for sub-study 3. Sub-study 3 (Comparative Country Case Studies) aims to compare oxygen programs across countries, focusing on particular challenges or unique solutions identified in sub-study 1 and 2. Data sources will include repeated desk review of oxygen-related policies and program administrative data, follow-up stakeholder interviews, and triangulation with quantitative survey results on facility readiness and clinical practices. This research will also draw on national stakeholder dialogues - both to review, refine, and validate preliminary findings of the study team and to draw out feasible solutions/alternatives for both policy and practice and oxygen eco-system. In year 1 the investigators will generate key evidence about how the current strategies and polices are being translated into action, identifying key opportunities for implementing partners to focus support. Over years 2 and 3, the investigators will learn how these activities have affected medical oxygen service coverage, drawing lessons across country contexts and across different implementation approaches.
Phase
N/ASpan
179 weeksSponsor
Murdoch Childrens Research InstituteMonrovia
Recruiting
Evaluation of a Multi-country Medical Oxygen Program
Medical oxygen is an essential medicine. Hypoxaemia is deadly, and increases the risk of death by 5-8 fold, requiring prompt recognition and oxygen therapy. Oxygen services are currently inequitable within and between countries, and this has been exacerbated by the COVID19 pandemic. Children are especially vulnerable: in many contexts, fewer than 20% of children admitted to district hospitals with severe hypoxaemia receive oxygen. There are many barriers, at all levels, to ensuring that people who need oxygen will receive it- from delayed care-seeking and referral barriers to facility under-preparedness and over-burdened healthcare workers, to deficiencies in maintenance services, and community misconceptions and fears. Reliable access in rural and remote facilities poses even more challenges. The Clinton Health Access Initiatives (CHAI), on the back of pre-existing close collaborations with Ministries of Health (MoH) has supported countries in tackling the oxygen access crises of the pandemic. Emerging from this, CHAI and MoH in 9 countries have amalgamated these efforts into a program targeted at improved access to oxygen in each country (the 'MOXY' program). The specific approaches are different in each country but broadly include efforts to: (1) strengthening policies, strategies, and governance of medical oxygen production, distribution, maintenance, and use; (2) building capacity of healthcare workers and technicians to use and maintain oxygen well, and (3) strengthening oxygen-related data acquisition and use for forecasting, budgeting, and monitoring. MOXY provides the first opportunity to learn from interventions specifically directed at addressing the oxygen problem at large scale, and across different settings (between and within countries). REAL-MOXY is a series of embedded mixed methods studies that aim to better understand the contexts into which oxygen interventions are being introduced; identify and interrogate mechanisms of how these systems work (or not work) to improve health outcomes, and their interaction with different contexts; and synthesise these findings to test and develop theories that can guide policy makers and clinicians in delivering more effective approaches to improve oxygen access. We will adopt a mixed methods design, with an iterative approach, and co-design to adapt the study methodology to the specific context of each country and facility. We have planned for 5 embedded sub-studies: The findings of sub-study 1 identifies the facilities that will contribute data (i.e., sequential); and then data collection and integration is concurrent in sub-studies 2-5. Sub-study 1 aims to identify facilities with high and low functioning oxygen systems, based on current pulse oximetry and oxygen-related clinical practices and facility oxygen readiness. We will use the results of a cross-sectional study already being conducted involving all health facilities in the MOXY catchment areas (part of the MOXY baseline assessment for which ethical approval is already in place). Results will inform facility selection for the subsequent mixed-methods studies. Sub-study 2 aims to map care pathways (as they are intended) for children (<15 years) with 4 hypothetical clinical scenarios in each participating facility. Data sources include direct observation of patient and equipment flow, and discussions with senior clinicians and managers. Maps to study questions i, ii, and iv. Sub-study 3 aims to follow patient journeys from arrival through the first 4 hours of care, to understand the sequence of care for acutely unwell children, including how pulse oximetry and oxygen are integrated with other aspects of emergency care. Data sources include direct observation of patients and health workers, patient/caregiver interviews and medical documentation. This sub-study is based in the initial assessment areas of facilities (e.g., emergency or outpatient units). Maps to study questions i, ii, and iv. Sub-study 4 aims to understand how pulse oximetry and oxygen are used by nurses and medical officers, why, and how this impacts on patient care. Data sources include direct observation of nursing practice, ward rounds, and medical documentation. This sub-study is based in an inpatient unit caring for children. Maps to study questions i, ii and iii. Sub-study 5 aims to understand the perspectives of a) patients/caregivers, b) healthcare workers, managers and biomedical engineers/technicians. Data sources include focus group discussions and in-depth interviews. Maps to study questions i, ii, iii and iv.
Phase
N/ASpan
214 weeksSponsor
Murdoch Childrens Research InstituteMonrovia
Recruiting
A Lassa Fever Vaccine Trial in Adults and Children Residing in West Africa
rVSVΔG-LASV-GPC is a candidate vaccine that has been shown to be safe and protects against LF disease in animals. The vaccine was studied studied in a Phase 1 trial and has been well tolerated and immunogenic. This Phase 2 trial will add to data from the Phase 1 trial to establish a broader profile of safety and immunogenicity in adults and expand the population to include a subset of adults with HIV infection as well as older adults and healthy children, in preparation for an efficacy trial in West Africa. Primary Objective: • To evaluate the safety and tolerability of rVSVΔG-LASV-GPC vaccine at 2 different dosage levels in adults, including PLWH, and in children Secondary Objectives: • To determine binding LASV-GPC-specific antibody responses induced by rVSVΔG-LASV-GPC vaccine • To determine neutralizing LASV-GPC-specific antibody responses induced by rVSVΔG-LASV-GPC vaccine in a subset of participants in each group • To evaluate the magnitude and duration of the rVSVΔG-LASV-GPC vaccine viremia in plasma in a subset of participants. • To evaluate the magnitude and duration of the rVSVΔG-LASV-GPC vaccine shedding in saliva and urine, and possibly semen and cervicovaginal fluid, in a subset of participants Exploratory Objective • To explore the characteristics of the immune responses induced by rVSVΔG-LASV-GPC vaccine in a subset of participants
Phase
2Span
165 weeksSponsor
International AIDS Vaccine InitiativeMonrovia
Recruiting
Healthy Volunteers
Girl Empower: Studying the Impact of Mentorship, Asset Building, Caregiver Discussion Groups, and Cash Transfers on Reducing Girl's Vulnerability to Sexual Exploitation and Abuse
The GE program is unique in its approach because it addresses girls' needs holistically. The girls' activities will take place in girl-only safe spaces located in their communities and contains the following components: Mentorship: girls have access to older female mentors. Mentors both provide weekly group-based and one-to-one interaction with girls as well as teach them critical skills; Asset building: Girls will have access to life skills and financial literacy training. This includes setting up savings accounts so girls practice their financial literacy skills, Monthly caregiver discussion groups among guardians of program girls, Capacity building and training of local health and psychosocial service providers to provide quality services to survivors of gender-based violence Intervention communities will either receive the GE program alone or the GE program with the plus small cash transfers to the girls' families as an incentive to attendance in weekly sessions (GE+).
Phase
N/ASpan
77 weeksSponsor
Population CouncilMonrovia
Recruiting
Healthy Volunteers
Long-Term Neurologic and Neurocognitive Sequelae Following Pediatric Ebola Virus in Liberia
Study Description: The long-term neurological sequelae of Ebola virus disease (EVD) are not well-described, particularly in survivors infected during pediatric age. The 2015 west Africa EVD epidemic had dramatic effect on adults and children and by one year following infection, concerns for neurologic sequelae became apparent. The PREVAIL III (PIII) Ebola Natural History Study in Monrovia, Liberia had a number of substudies, including both an adult Neurology and pediatric Neurology Substudy which were undertaken to better understand the long-term neurologic sequelae of EVD. The adult Neurology Substudy had over five years of follow up visits whereas the original Pediatric Neurology Substudy cohort was composed of a small sample of children seen in 2015 one time under PIII with no subsequent follow ups. Although this pediatric cohort was small, pilot data from this assessment revealed lower cognitive scores in the pediatric EVD survivors compared to controls, as well as worse executive function scores, more complaints of neuropsychiatric symptoms, and worse disability on modified Rankin Scale, among other findings. PIII subsequently closed out between 2020 and 2021. Here we propose a new protocol to observe and study the neurologic and neurocognitive sequelae following Ebola virus exposure at an age below 18. We propose conducting a single in-person neurologic visit including neurologic exam, neurocognitive assessment, and neurologic history and symptom questionnaire to be given to participants at greater than 5-years following exposure. We also plan to do a single blood draw at time of visit to assess for Ebola Virus antibody titers in survivors and close contacts (controls). The participants included in this study will include Ebola survivors and close contacts (controls) that were enrolled in PIII at age less than 18. We hypothesize that some pediatric Ebola survivors will have longterm neurologic sequelae at greater than 5 years post exposure that may be subtle in nature. Included in this study will be one embedded substudy. Longitudinal Pediatric Neuro EVD Substudy: We propose to see the original small cohort of pediatric participants seen in 2015 for a second visit as a longitudinal sub study. In evaluating our longitudinal cohort, we expect that some of the sequelae noted during their initial evaluation may have improved over time, but these survivors still may have persistent neurological sequelae even after over 5 years convalescence from EVD. Objectives: Primary Objective: 1. Pediatric EVD Neuro Follow up Study: To observe and describe the range of neurologic and neurocognitive findings that are present in EVD survivors at greater than 5 years following infection as compared to controls. 2. Longitudinal Pediatric Neuro EVD Substudy (Subset of population): To compare neurologic and neurocognitive findings found in EVD survivors and controls at greater than 5 years following infection to that of the same participants at first visit about 1 year post infection. Secondary Objectives 1. Pediatric EVD Neuro Follow up Study: To characterize serum Zaire Ebola virus (EBOV) specific antibodies in pediatric EVD survivors at greater than 5 years following infection compared to that of controls. 2. Longitudinal Pediatric Neuro EVD Substudy: To characterize serum EBOV specific antibodies in pediatric EVD survivors at greater than 5 years following infection to that of the same participant at first visit about 1 year post infection. Exploratory Objective: Pediatric EVD Neuro Follow up Study 1. To compare EBOV specific antibodies in pediatric EVD survivors with and without neurologic and neurocognitive sequelae. 2. To compare neurologic and neurocognitive findings in pediatric EVD survivors and controls at greater than 5 years post infection to that of adult participants from the PIII adult Neurology sub study. 3. To explore the presence of other serologic markers in pediatric EVD survivors compared to close-contacts (control). Outcomes: Primary Endpoint: 1. Pediatric EVD Neuro Follow up Study: In comparison of EVD survivors at greater than 5 years following infection with close contacts (controls), the prevalence of: - neurological symptoms (as asked on neurologic symptom questionnaire CRF) - physical disability (as assessed through MRS score) - executive function dysfunction (as assessed through executive function assessment questions) - neuropsychiatric symptoms (as indicated on neuropsychiatric symptom portion of CRF) - neurologic exam abnormalities (as found on full neurologic physical exam performed by licensed neurologist during visit) - neurocognitive deficits (as determined by cognitive exam scores on NIH Toolbox exam and ICA-P assessment) 2. Longitudinal Pediatric Neuro EVD Substudy: In comparison of EVD survivors at greater than 5 years following infection to that at first visit about 1 year after infection, the change in: - number of neurological symptoms (as asked on neurologic symptom questionnaire CRF) - Physical disability (as assessed through MRS score) - Executive function dysfunction (as assessed through executive function assessment questions). - number of neuropsychiatric symptoms (as indicated on neuropsychiatric symptom portion of CRF. - persistence of neurologic exam abnormalities (as found on full neurologic physical exam performed by licensed neurologist during visit). - neurocognitive deficits (as determined by cognitive exam scores on NIH Toolbox exam and ICA-P assessment). Secondary Endpoints: 1. Pediatric EVD Neuro Follow up Study: The degree of antibody response in pediatric EVD survivors at greater than 5 years following infection compared to that of close contacts (controls). 2. Longitudinal Pediatric Neuro EVD Substudy: The degree of antibody response in pediatric EVD survivors at greater than 5 years following infection compared to that at about 1 year following infection. Exploratory Endpoints: Pediatric EVD Neuro Follow up Study: 1. In EVD survivors at greater than 5 years post infection, the correlation between serum EBOV specific antibody presence and: - presence of neurological symptoms (as asked on neurologic symptom questionnaire CRF). - presence of physical disability (as assessed through MRS score). - presence of executive function dysfunction (as assessed through executive function assessment questions) - presence of neuropsychiatric symptoms (as indicated on neuropsychiatric symptom portion of CRF) - presence of neurologic exam abnormalities (as found on full neurologic physical exam performed by licensed neurologist during visit). - presence of neurocognitive deficits (as determined by cognitive exam scores on NIH Toolbox exam) 2. In pediatric versus adult EVD survivors at greater than 5 years following infection, the prevalence of: - neurological symptoms (as asked on neurologic symptom questionnaire CRF). - physical disability (as assessed through MRS score) - neuropsychiatric symptoms (as indicated on neuropsychiatric symptom portion of CRF) - neurologic exam abnormalities (as found on full neurologic physical exam performed by licensed neurologist during visit) - neurocognitive deficits (as determined by cognitive exam scores on NIH Toolbox exam). 3. The profile of serologic immune markers in pediatric EVD survivors at greater than 5 years following infection.
Phase
N/ASpan
16 weeksSponsor
National Institute of Neurological Disorders and Stroke (NINDS)Monrovia
Recruiting