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NCT ID: NCT05658614 Recruiting - Clinical trials for Vaccination; Infection

Anti-Schistosomiasis Sm14-vaccine in Senegal

Start date: July 1, 2022
Phase: Phase 2
Study type: Interventional

Previous clinical trials have already demonstrated the safety of the candidate vaccine in adults as well as in children, in good health or infected with schistosomiasis. Regarding the induced immune response, more than 80% of vaccinated subjects were seroconverted after three vaccine injections. The induced immune response was substantial but transient. In order to obtain a more lasting immune response, the investigator will experiment with a new vaccination schedule (2 injections 1-month interval and the 3rd injection 5 months after the first dose), versus the vaccine schedule initially used (3 injections at 1-month interval). This trial will be the last phase 2 before testing the efficacy of the rSm14 vaccine candidate.

NCT ID: NCT05608928 Not yet recruiting - Clinical trials for Environmental Enteropathy

Ability of the Probiotic Vivomixx to Improve Environmental Enteropathy in Pregnant Women: a Proof of Concept Trial in Bangladesh, Pakistan, Senegal and Zambia

EMP
Start date: December 1, 2022
Phase: Phase 2
Study type: Interventional

This trial will determine if a well-established probiotic, Vivomixx, can modulate the maternal microbiota and ameliorate the maternal environmental enteropathy which compromises growth in the first 1000 days. The probiotic Vivomixx has been used in many thousands of people including pregnant women, both within and outside a research context. This trial is the first in a proposed series of proof-of-concept intervention studies which are intended to provide data to enable a rational selection of interventions to be evaluated at scale in future large scale phase 2 trial in which birth outcomes and postnatal growth will be key endpoints.

NCT ID: NCT05604248 Not yet recruiting - Vitamin A Clinical Trials

Kinetics of Retinol and TBS Among Lactating Senegalese Women Living in an Urban Setting and the Relationship Between Their TBS and Those of Their Infants

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

Vitamin A deficiency (VAD) is still a serious public health problem in most developing countries. Several strategies are used to prevent and address the consequences of this deficiency and to reduce its prevalence, particularly in Africa. In Senegal, the prevalence of VAD, although low among women of reproductive age, is quite worrying among children under 5 years old. In 2009, the fortification of refined oil with vitamin A was made mandatory in addition to the strategies already in place. The study of the impact of these strategies on the vitamin A status of women and children, showed relatively stable prevalences between 2010 and 2018. However, this study used plasma retinol concentration as an indicator. It is known that evaluation of vitamin A status is relatively insensitive when based on changes in plasma retinol concentrations, which are homeostatically controlled and negatively affected by subclinical infections. Incremental studies in the Dakar region using the modified relative dose response (MRDR) test in children under 2 years of age have indicated adequate vitamin A stores and a low prevalence of vitamin A deficiency in these children. The various strategies to prevent and control vitamin A deficiency have reportedly improved and even increased vitamin A stores in women and children, particularly in the Dakar region. Indeed, the latter benefit from substantial intakes of preformed retinol through the fortification program, and the majority of children under 2 years of age are breastfed. The aim of this study is to use a more sensitive method than plasma retinol, the retinol isotope dilution (RID) test, to assess the actual status of subjects following these different strategies and to better orient the policies implemented in Senegal.

NCT ID: NCT05544084 Not yet recruiting - Cervical Cancer Clinical Trials

Adaptation and Implementation of a Patient Navigation Program for Cervical Cancer Screening Across Contexts in Senegal

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

The goal of this project is to prevent unnecessary deaths due to cervical cancer in Senegal. This mixed methods research responds to identified intrapersonal- and community-level barriers to early cervical cancer screening uptake, follow-up, and treatment among women there. Investigators will apply the Dynamic Adaptation Process1 (DAP) as integrated into the Exploration, Preparation, Implementation, Sustainment (EPIS) framework1 to study the adaptation of an evidence-based cervical cancer patient navigation program in urban and rural contexts in Senegal, measure the intervention effectiveness, and evaluate programmatic implementation outcomes. By studying the process of adaptation of a patient navigation program in a low- and middle-income country (LMIC), investigators will build new knowledge while addressing an important public health issue. Our project demonstrates innovation by advancing both adaptation and implementation process knowledge of an evidence-based patient navigation intervention in various contexts within a LMIC with a particular focus on how the adaptation responds to cancer-related stigma, misinformation, and women's autonomy in healthcare decision-making. Investigators will build knowledge through local learning which will further our long-term goal to inform the national cervical cancer prevention and control programs in two areas of Senegal and other similar LMICs.

NCT ID: NCT05501470 Not yet recruiting - Clinical trials for Environmental Enteric Dysfunction

Probiotic For the Improvement of Environmental Enteropathy in Pregnant Women in Senegal

PROFE-Sen
Start date: December 2022
Phase: Phase 2
Study type: Interventional

Stunting in young children refers to attenuated linear growth. In the year 2020, 149.2 million children under the age of 5 were stunted, accounting for 22% of stunting globally. Stunting has short- and long-term consequences of increased morbidity and mortality, impairment of neurocognitive development , impaired responses to oral vaccines, and increased risk of non-communicable diseases. Stunting is partly driven by Environmental Enteric Dysfunction (EED), an enteropathic condition characterised by altered gut permeability, infiltration of immune cells and changes in villous architecture and cell differentiation. EED may help explain why nutritional supplementation either during pregnancy or early childhood has minimal value in correcting childhood stunting. Probiotics may serve to overcome the problem of EED through all mechanisms of pathogenicity, by providing additional bacteria that may help in intestinal decolonization of pathogenic microorganisms (changing the microbiological niche), promoting epithelial healing, improving nutrient absorption, and restoration of an appropriate immune balance between tolerance and responsiveness. This trial will explore the conceptual framework, that a well known probiotic, that can improve the composition of the gut microbiota, can reduce biomarkers of intestinal inflammation and gut health. This will restore healthy microbial signalling to the host epithelium, ameliorate barrier function through secretion of mucus and antimicrobial factors, and improve nutrient availability.

NCT ID: NCT05405322 Recruiting - HIV Infections Clinical Trials

Improving Care and Community Representation for Adolescents and Young Adults Living With HIV in West Africa

TRANSITIONS
Start date: April 7, 2021
Phase:
Study type: Observational

Context: HIV-positive young people aged 15 to 24 are a heterogeneous population in terms of gender, age, mode of transmission, sexual orientation and risk-taking. This most vulnerable age group is at greater risk of disruption of medical care and poor compliance, and has greater needs for psychosocial support and differentiated health services. It remains highly invisible in West African countries, both in the definition of care policies and in the allocation of resources and community representation. Objectives: The overall objective of the project is to contribute to the improvement of retention in care, health and well-being of adolescents and young adults living with HIV (AYAHIV) and to support their integration into the community space. SO1: Support the operationalisation of the transition of HIV-infected adolescents from paediatrics to adult medical services in a stakeholder inclusive, participatory and responsive approach SO2: Contribute to the empowerment and autonomy of adolescents and young adults living with HIV in the project environment SO3: Contribute to the generation and dissemination of evidence-based information and recommendations on the situation and needs of adolescents and young adults, including key populations, living with HIV Target: Approximately 67 caregivers∙e∙s ≥ 25 years old, of which 64%F, 30 peer-referent associations of 20-24 years old (ratio F/H= 1:1), 700 AYAHIV ≥ 15 years old, of which 47%F, in paediatrics and 500-600 AYAHIV aged 15-24 years old in adult medicine, of which 41%F, and including AYAHIV associations Summary of activities: Based on the capitalisation and pooling of experiences of partner teams, the project proposes to support the implementation of transition in a pragmatic approach, adapted to the needs of adolescents and inclusive of carers, adolescents and community peers. More globally, it contributes to improving the health, empowerment and autonomy of HIV-positive youth, including key populations, in particular through support to training, structuring and community representation of youth associations, documentation of the conditions of entry into care and their specific needs, including digital health, production and availability of evidence and recommendations in this West African context and advocacy building. A multidisciplinary and participatory research-action project, carried out by the IRD in Senegal and financed by Sidaction, accompanies the three specific objectives of the project.

NCT ID: NCT05374837 Recruiting - Anemia Clinical Trials

Mobile Messaging for Improved Nutrition

IIMAANJE
Start date: June 10, 2022
Phase: N/A
Study type: Interventional

This project will examine the impact of an infant and young child feeding (IYCF) voice messaging intervention delivered to mothers and fathers in Senegal on the consumption of a minimum acceptable diet and anemia prevalence in their children.

NCT ID: NCT05354258 Active, not recruiting - Malaria Clinical Trials

Feasibility and Safety of Combining Anti-malarial With Deworming Drugs in African Children

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

Malaria remains a major health problem, especially in sub-Saharan Africa where more than 90% of the disease and deaths occur in children. Adding to this high burden among the children is the co-existence of intestinal and genito-urinary worms. Prominent among these are soil-transmitted helminths and schistosomiasis. Existing control programmes for the worms are operating below the expected level, despite the commitments and support that followed the 2012 London Declaration of achieving 75% treatment coverage by 2020. On the other hand, a malaria prevention programme, called Seasonal Malaria Chemoprevention (SMC), introduced in the same year 2012 has achieved more than 75% treatment coverage and prevented 75-85% cases of uncomplicated and severe malaria in children. This encouraging development supports the need to explore the strategies involving the integration of worm control with successful platforms such as SMC. This would align worm and malaria control with the WHO road map for Neglected Tropical Diseases (NTD) of ending the neglect to attain Sustainable Development Goals by eradicating diseases of poverty and promoting health and well-being for those at risk. Given this context, it is important to develop a treatment approach that combines malaria and helminth control in an integrated framework that will be safe, effective and easy to deliver. This study will, therefore, investigate the feasibility and effectiveness of co-administration of anthelminthic and SMC drugs in a high-risk paediatric population living in a malaria-helminth co-endemic setting in Senegal, West Africa. This study is designed to test the hypothesis that co-administration of SMC and anthelminthic drugs will be safe and tolerated among children aged 1-14 years and that the incidence of side effects will not be significant. The objectives of this study are to assess the safety, tolerability, and effects of co-administration of SMC and anthelminthic drugs among the children

NCT ID: NCT05291390 Recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

Pyronaridine in Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML)

Start date: November 21, 2022
Phase: Phase 2
Study type: Interventional

A Phase 2a clinical trial on up to n=200 male and female subjects 18 years and over who were diagnosed with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL). Subjects are randomised in approximately a 1:1 ratio to receive standard of care treatment plus either pyronaridine (PND) or placebo. Quality of life parameters are measured. Visits include physical examinations, and blood draws for complete blood count with differential (CBC) and complete metabolic panel (CMP). Survival of subjects is tracked in Year 2.

NCT ID: NCT05065320 Recruiting - Pneumonia Clinical Trials

Tools for the Integrated Management of Childhood Illness: Evaluation of Pulse Oximetry and Clinical Decision Support Algorithms in Primary Care. Longitudinal Observational Study, With Embedded Mixed Methods Studies, Cost and Modelled Cost-effectiveness in Kenya, Myanmar and Senegal

TIMCI
Start date: August 16, 2021
Phase:
Study type: Observational [Patient Registry]

The overall goal of the Tools for the Management of Childhood Illness (TIMCI) project is to reduce morbidity and mortality in sick children attending primary care facilities, while supporting the rational and efficient use of diagnostics and medicines by healthcare providers. The evaluation component of the project seeks to generate evidence on the health impact, operational priorities, cost and modelled cost-effectiveness of introducing pulse oximetry, embedded into a Clinical Decision Support Algorithm (CDSA), at primary care level in LMICs, for children 0 - 59 months of age, to facilitate national and international decision-making on scale-up. For the longitudinal observational studies conducted in Kenya, Myanmar and Senegal, the health impact will be assessed through a quasi-experimental study design. It will compare the clinical care of children in a three-month pre-intervention period (Q1) with four sequential three-month periods (Q2-Q5). Additionally, mixed-method studies will be conducted to evaluate the key components of quality of care and to learn more about the implementation processes and mechanisms. Included will be a service provision assessment (SPA) which has been modified for the TIMCI study. Further a facility-based process mapping and time-flow study, as well as qualitative studies with caregivers, healthcare provediers and key stakeholders will be conducted. The study will take place in primary care level facilities in Kenya (Kakamega, Kitui and Uasin Gishu county), Myanmar (Ayeyarwady and Southern Shan) and Senegal (Thiès). In Kenya, facilities of Level 2 (dispensaries) and Level 3 (health-centres/sub-county hospitals are included; in Myanmar sub-centers and rural health centers and in Senegal health posts. The interventions that will be introduced and assessed are pulse oximetry, incorporated into Clinical Decision Support Algorithms. The criteria for pulse oximetry are a.) all children under 2 months of age, b.) Children 2-59 months of age presenting with cough/difficulty breathing, and c.) Children 2-59 months of age with IMCI signs of moderate/severe disease (yellow or red classification). The sample size for the longitudinal observational study is calculated separately for each country, based on comparison between Q1 and Q5, however the same sample size will also be collected in each of the intervening quarters (Q2, Q3 and Q4) where logistically feasible, for the purposes of secondary analysis over time. The sample size was calculated to detect a difference in referral from primary care from 3% to at least 4.5%, with 80% power. With the calculated sample size, we would expect to record a minimum detectable reduction of 18% in Kenya and Senegal and of 16% in Myanmar for the antibiotic prescription primary outcome. Service provision assessments and process mapping will be conducted in 8 - 10 longitudinal study facilities per country, stratified by rural / urban location and facility type, at 5 time points (once per quarter in each facility). At each facility at each time point, 10 - 30 children per facility will be included, resulting in an estimated sample size of 800 - 1000 clinical observations, time-flow observations and exit interviews per country over the study period.