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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: 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.

NCT ID: NCT05050825 Recruiting - Malaria Clinical Trials

Validation of a CDSA Strategy to Reduce Antibiotic Prescription in Senegal

Start date: May 3, 2021
Phase: N/A
Study type: Interventional

This trial aims to validate a novel clinical care strategy based on a electronic clinical decision support algorithm (CDSA) combined with point of care rapid diagnostic tests by evaluating its impact on antibiotic prescription and clinical outcome of children and adolescent presenting at primary healthcare facilities with non-severe acute illness compared to routine practice. The trial also aims to assess the usability of the CDSA strategy. The study will be conducted in primary healthcare facilities across different epidemiological regions of Senegal.

NCT ID: NCT05016635 Completed - Clinical trials for Disability Adjusted Life Years of Sub-arachnoid Hemorrhage in Senegalese Cohort

Disability-adjusted Life Years in a Senegalese Cohort of Patients With Subarachnoid Hemorrhage

Start date: April 26, 2021
Phase:
Study type: Observational [Patient Registry]

Subarachnoid hemorrhage (SAH) is the extravasation of blood into the subarachnoid space from traumatic or nontraumatic origin. There is a paucity of data on the burden of SAH in African countries. In this study, we analyzed data from patients in the largest neurovascular center in Senegal to determine the sex- and age-adjusted burden of SAH in Senegal.

NCT ID: NCT04941209 Completed - Covid19 Clinical Trials

imPulse™ Una Infrasound-to-ultrasound E-stethoscope

Start date: June 11, 2021
Phase:
Study type: Observational

This study generates robust, uniform clinical data across emerging COVID-19 strains to train ML/AI algorithms of the Sponsor's imPulse™ Una infrasound-to-ultrasound e-stethoscope for digital diagnostic feature synthesis of asymptomatic and symptomatic COVID-19 digital biosignatures for rapid and accurate adult and child mass screening.

NCT ID: NCT04912284 Completed - Covid19 Clinical Trials

Africa COVID-19 Vaccine Hesitancy

ACHES
Start date: May 5, 2021
Phase:
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: NCT04902768 Recruiting - Clinical trials for Congenital Heart Disease

Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II

APPROACH-IS II
Start date: August 1, 2019
Phase:
Study type: Observational

This is an international, cross-sectional and descriptive study that aims to investigate differences in patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) and that aims to explore the profile and healthcare needs of adults with congenital heart diseases.

NCT ID: NCT04864444 Recruiting - Malaria Clinical Trials

Mass Drug Administration of Dihydroartemisinin-piperaquine + Single Low-dose Primaquine to Accelerate Toward Elimination Activities

Start date: June 19, 2021
Phase: N/A
Study type: Interventional

This community-based cluster randomized controlled trial aims to evaluate the effectiveness of time-limited, community-wide mass drug administration (MDA) with dihydroartemisinin-piperaquine (DHA-PPQ) and single low-dose primaquine (SLD-PQ) on Plasmodium falciparum transmission compared to standard-of-care seasonal malaria chemoprevention (SMC). The study will be conducted in a moderate-to-low malaria transmission setting of Senegal with optimized malaria control measures (e.g., proactive community case management and piperonyl butoxide pyrethroid long-lasting insecticidal nets (PBO LLINS)).

NCT ID: NCT04794660 Recruiting - HPV Infection Clinical Trials

The Study for the "Cervical Cancer Screening and Treatment Algorithms Study Using HPV Testing in Africa"

CESTA
Start date: October 1, 2019
Phase: Phase 3
Study type: Interventional

The main objectives of CESTA are (1) to compare the efficacy of two cervical cancer screening algorithms: HPV test followed by visual inspection with acetic acid (VIA) and treatment (HPV + VIA + treat) and HPV test followed by immediate treatment (HPV + treat). The study will be conducted to address its objectives in women living with HIV (from now on called HIV positive women); and 2) To evaluate the performance of other techniques for primary screening and as triage for HPV positives WLHIV. 1,500 women living with HIV WLHIV will be recruited from HIV care clinics, also called antiretrovirals (ARV) clinics in South Africa. After giving informed consent, women will be screened with HPV testing and those that have a HPV positive test will be randomized at a 4:1 ratio into HPV + VIA + treat (Arm 1) and HPV + treat (Arm 2). Women in Arm 1 will receive VIA and only positive for VIA will be treated. In Arm 2, all HPV positive women will be treated. Women that are eligible for ablative treatment will be randomized into treatment with TA or cryotherapy in both arms. Others will be referred to colposcopy. After VIA in Arm 1 or before treatment in Arm 2, the nurses will collect 2-4 biopsies on all HPV positive women. The biopsies will be used as gold standard for disease detection. Treated women will be called by telephone after 1 week and 1 month to assess side-effects and satisfaction with the procedures. Cervical samples from women will be tested with HPV DNA test and HPV mRNA test to evaluate different screening tests for WLHIV. All women with a positive HPV test (treated or not) will be called back after 1 year for a follow-up visit. At this visit, women will be screened with HPV testing and VIA and 2-4 colposcopy-directed biopsies will be taken from all HPV positive women. Women with remaining/recurrent CIN2+ disease will receive appropriate management.

NCT ID: NCT04794296 Recruiting - Childhood ALL Clinical Trials

Recommendations for the Treatment of Children With Acute Lymphoblastic Leukemia in the GFAOP

LALGFA2019
Start date: November 15, 2021
Phase:
Study type: Observational [Patient Registry]

The LALGFA2019 Recommendations redefine the standard risk criteria and propose to introduce anthracycline induction in so-called high-risk forms (LAL line T and LAL line B with leukocytosis greater than or equal to 50 G/L or in children less than 1 year of age or more than 10 years of age) as well as Endoxan and Methotrexate in high dose consolidation.