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NCT ID: NCT06219109 Recruiting - Eclampsia Clinical Trials

Pulmonary Edema Resolution in Severe Preeclampsia and Eclampsia

TiPER
Start date: May 8, 2023
Phase:
Study type: Observational

Patients with severe preeclampsia or eclampsia suffer from pulmonary complications. Accurate assessment of patients with pulmonary involvement using lung ultrasound (LUS) and echocardiography could lead to earlier detection of pre eclampsia and eclampsia associated pulmonary oedema, ARDS (acute respiratory distress syndrome) and other pulmonary complications. here is currently limited evidence regarding the features, severity, aetiology and history of pulmonary oedema in this group of patients Data from this prospective observational study will facilitate the early recognition of pre-eclamptic and eclamptic patients with pulmonary involvement to implement optimal triage and early therapeutic choices in a limited resource setting (diuretics, escalation to non invasive or invasive ventilation, referral to HDU (High dependency unit) or ICU, dialysis) and potentially reduce unfavorable outcomes.

NCT ID: NCT06065631 Recruiting - Refractive Errors Clinical Trials

Seeing to Learn in Sierra Leone

SLII
Start date: October 25, 2023
Phase: N/A
Study type: Interventional

The main objective of the Sierra Leone Sees to Learn (SL2) trial is to assess the educational impact of providing free eyeglasses to students aged 12-15 years with uncorrected refractive error in Sierra Leone. The procedures include baseline questionnaires and educational assessments to collect data on students and schools, and then the provision of free eyeglasses to students who have uncorrected (or undercorrected) refractive error (URE). The questionnaires and student assessments will take 1-2 hours. The duration of the study timeframe is one school year. The end-line questionnaires and student assessments will be administered at the end of the school year.

NCT ID: NCT06007105 Recruiting - Schizophrenia Clinical Trials

SUCCEED Africa: Support, Comprehensive Care and Empowerment of People With Psychosocial Disabilities

SUCCEED
Start date: July 18, 2023
Phase: N/A
Study type: Interventional

Although psychotic disorders typically affect less than 1% of the population, they are a significant cause of disability worldwide. Psychotic symptoms such as hallucinations, delusions and suicidal ideation can be profoundly disturbing, and negatively impact daily living. However, the social consequences of psychosis are often even more troubling than the symptoms. For example, people with psychosis have a high risk of experiencing violence, poverty, homelessness, incarceration, and unemployment, among other adverse outcomes. There is a need for a range of accessible, appropriate interventions for people with psychosis to be delivered to those in the most vulnerable situations, including in low-resource settings in sub-Saharan Africa. A systematic review recently carried out as part of the formative research for SUCCEED identified 10 studies evaluating the impact of interventions for people with psychosis in Africa, most of which had a strongly clinical focus. The review concluded that there was a need for further research involving people with lived experience of psychosis in designing and evaluating holistic interventions that meet their diverse needs, within and beyond the health sector. SUCCEED Africa is a six-year Health Research Programme Consortium (RPC) that has brought together people with lived experience of psychosis and people with professional experience (researchers, clinicians) from four African countries (Malawi, Nigeria, Sierra Leone, Zimbabwe) to co-produce a community-based intervention for psychosis, using a Theory of Change-driven approach. The SUCCEED intervention takes the World Health Organisation's (WHO's) CBR Matrix as a point of departure to consider the multifaceted needs of people living with psychosis and other psychosocial disabilities, and how best to meet these needs by mobilising the resources of individuals and families affected, as well as their broader communities. This protocol describes a pilot study in which the SUCCEED intervention will be delivered and evaluated on a small scale, in preparation for a larger multi-country research evaluation using more rigorous methods, including randomised controlled trials in Nigeria and Zimbabwe and observational studies in Malawi and Sierra Leone, respectively. The main outcome of interest is change in subjective quality of life among participants with lived experience of psychosis who are offered the intervention over a four-month follow up period.

NCT ID: NCT06002438 Recruiting - Stunting Clinical Trials

Eggs for Gut Health

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

The goal of this clinical trial is to test egg powder supplementation in children with moderate acute malnutrition in Sierra Leone. The main question it aims to answer is: - Will provision of 15g of whole egg powder per day during and after treatment for moderate acute malnutrition (for 24 weeks total) improve small intestinal permeability and linear growth among 6-30 month old Sierra Leonean children compared with daily corn powder supplementation?

NCT ID: NCT05949190 Recruiting - Preterm Birth Clinical Trials

Improving Cognition and Gestational Duration With Targeted Nutrition

COGENT
Start date: August 18, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test (1) a novel maternal ready-to-use supplementary food and (2) a novel cognitive behavioral therapy intervention in undernourished Sierra Leonean women. The main questions it aims to answer are: - Will the addition of omega-3 long-chain polyunsaturated fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), as well as choline, to a maternal ready-to-use supplementary food (M-RUSF+) prolong gestation when compared with a similar supplementary food except that it lacks DHA, EPA, and choline (M-RUSF)? - Will M-RUSF+ improve infant cognitive development at 9 months of age when compared with M-RUSF? - Will the novel CBT program improve ante- and post-partum depression?

NCT ID: NCT05909917 Recruiting - Trauma Clinical Trials

Deploying Emergency Bystander Internet Training

DEBIT
Start date: July 15, 2023
Phase: N/A
Study type: Interventional

The primary aim of this study is to evaluate the efficacy of a massive open online course (MOOC) for training lay first responders in sub-Saharan Africa. The research team will assess educational outcomes of first responder training implemented at program locations in Nigeria, Sierra Leone, Uganda, and Kenya, through previously validated pre- and post-course survey instruments, standardized patient assessments, and incident reporting. The research team will investigate efficacy of MOOC training amongst diverse populations with variable technology literacy and utilize data gathered to develop more efficient means of disseminating basic first aid training information.

NCT ID: NCT05737667 Recruiting - Mental Health Clinical Trials

Advancing mHealth-supported Adoption and Sustainment of an Evidence-based Mental Health Intervention in Sierra Leone

Start date: February 15, 2023
Phase: N/A
Study type: Interventional

This study will examine a new implementation strategy for the Youth Readiness Intervention (YRI), an evidence-based mental health intervention. The strategy will (a) leverage a delivery setting (schools) and workforce (teachers) used effectively in low- and middle- income countries; and (b) innovate with technology and mHealth tools to enhance mental health service delivery quality. The YRI will be implemented as an extracurricular resilience-building after school activity in Sierra Leone. Teachers will deliver the YRI and receive either mobile phone-supported supervision or standard in-person supervision. Mobile-based supervision will integrate WhatsApp, a free cross-platform messaging and voice service used widely throughout Africa, with mHealth digital tools. The mHealth tools will support supervision through key features, including voice activated content, fillable forms (i.e., YRI fidelity checklist), and visual dashboards to monitor fidelity. A hybrid type 3 implementation-effectiveness design will allow for evaluation of both mobile phone-based supervision as a new implementation strategy, and clinical effectiveness of the YRI on youth mental and behavioral health as secondary outcomes.

NCT ID: NCT05580666 Recruiting - Clinical trials for HIV Disease Progression

Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)

REVIVE
Start date: May 8, 2023
Phase: Phase 3
Study type: Interventional

A double blinded, placebo-controlled, multicenter trial to evaluate effectiveness of azithromycin prophylaxis on mortality in advanced HIV.

NCT ID: NCT05085340 Recruiting - Malaria Clinical Trials

MULTIple Doses of IPTi Proposal: a Lifesaving High Yield Intervention

MULTIPLY
Start date: February 14, 2022
Phase:
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: NCT04235816 Recruiting - Child Mortality Clinical Trials

Improving Care Through Azithromycin Research for Infants in Africa

ICARIA
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.