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NCT ID: NCT05478954 Active, not recruiting - Malaria Clinical Trials

Chemoprevention Efficacy Study in Burkina Faso

Start date: July 15, 2022
Phase: Phase 4
Study type: Interventional

The aim of this study is to determine whether Seasonal Malaria Chemoprevention (SMC) remains effective in the health district of Nanoro in the Centre-Ouest region or Boussé in the Plateau Central region. It also aims to assess the protective efficacy of the antimalarial drugs used in SMC in the target population and to investigate levels of parasite resistance in the study districts. According to the results, this trial should provide the evidence needed to change the drugs used in SMC. A Type II hybrid effectiveness-implementation study design will be used to evaluate the effects of a clinical intervention on relevant outcomes whilst collecting information on implementation. It is designed to determine feasibility and effectiveness of an innovative intervention, as well as the protective efficacy of the antimalarial drugs used. The study consists of two components: 1) Conducting a prospective cohort study to determine the protective efficacy of the drug combination Sulfadoxine-Pyrimethamine and Amodiaquine (SPAQ) (if SPAQ provides 28 days of protection from infection) and whether drug concentrations and/or resistance influence the duration of protection; 2) Conducting a resistance markers study in symptomatic patients in the research district.

NCT ID: NCT05405322 Active, not 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: NCT04657640 Active, not recruiting - Anemia Clinical Trials

School-Based Assessment of Micronutrient Interventions in Adolescents in Burkina Faso

SAMIA
Start date: December 11, 2020
Phase: Phase 3
Study type: Interventional

This purpose of this study is to assess effects of iron and folic acid supplementation and multiple micronutrient supplementation on anemia status, school performance/attendance and development outcomes among adolescents in Burkina Faso.

NCT ID: NCT04650815 Active, not recruiting - Malaria Clinical Trials

Malaria Transmission in Humans and Mosquitoes at the Area of Sabou, Burkina Faso

Start date: June 10, 2021
Phase:
Study type: Observational

Background: Malaria is a disease that affects many people in Burkina Faso. It is caused by germs that are spread by mosquito bites. A vaccine that blocks the spread of malaria is important to get rid of the disease. To see if a vaccine works, researchers need to find out how many malaria infections are happening in the community. Objective: To learn how often people of all ages who live in Sabou, Burkina Faso, get malaria. Eligibility: Healthy people ages 6 months to 65 years who reside in Sabou in a household with adults and children. Design: Participants will be screened with questions about their health. They will have a physical exam. Participants will be asked about any malaria symptoms they are having. They will be asked about the use of bed nets. Their vital signs, like blood pressure and temperature, will be measured. They will have blood taken from their arm with a needle. Participants who have a fever will have a malaria test. Those who test positive for malaria will be referred to the local health facility for treatment. Participants will have monthly study visits. Blood will be taken from a finger. Participants may be invited to take part in 2 mosquito feeding experiments. Mosquitos that do not carry malaria will bite their arm. And a small amount of blood will be fed to mosquitos in a laboratory. Participants' homes will be examined for mosquitoes. Researchers will remove all mosquitoes they collect. Participants' homes will be sprayed with a chemical to kill mosquitoes and other insects. Participation will last for 12 months.

NCT ID: NCT04300309 Active, not recruiting - Clinical trials for Plasmodium Falciparum Malaria

Pharmacokinetics, Safety, Tolerability and Efficacy of a New Artemether-lumefantrine Dispersible Tablet in Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria

CALINA
Start date: December 21, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This study aims to evaluate PK, safety, tolerability and efficacy of a new formulation of artemether-lumefantrine dispersible tablet in neonates and infants <5 kg body weight with acute uncomplicated Plasmodium falciparum malaria.

NCT ID: NCT04238845 Active, not recruiting - Malaria Clinical Trials

Assessment of a Combined Strategy of SMC + Nutrients Supplementation to Tackle Malaria and Malnutrition

SMC-NUT
Start date: July 13, 2020
Phase: N/A
Study type: Interventional

Malaria and malnutrition represent major public health concerns worldwide especially in Sub-Sahara Africa. Despite implementation of Seasonal Malaria Chemoprophylaxis (SMC), an intervention aimed at reducing malaria prevalence among children aged 6- 59 months, the burden of malaria and associated mortality among children below age 5 years remains high in Burkina Faso. This raises the question of what hiding factors may negatively affect the responsiveness of SMC intervention. Malnutrition, in particular micronutrient deficiency, is one of these potential factors that can negatively affect the effectiveness of SMC. Treating micronutrient deficiencies is known to reduce the prevalence of malaria mortality in highly prevalent malaria zone such as rural settings. Therefore, the hypothesis that a combined strategy of SMC together with a daily oral nutrients supplement (Vitamin A-Zinc OR fortified peanut butter-like paste-Plumpy'Doz) will enhance the immune response and decrease the incidence of malaria in this population and at the same time reduce the burden of malnutrition among children under SMC coverage was postulated. Prior to the SMC implementation by the National Malaria Control Program (NMCP), children under SMC coverage will be identified through the Health and Demographic Surveillance System (HDSS). Children will be randomly assigned to one of the three groups (a) SMC + Vitamin A alone, (b) SMC + Vitamin A+ Zinc, or (c) SMC+Vitamin A + Plumpy'Doz. After each SMC monthly distribution, children will be visited at home to confirm drug administration and follow-up for one year. Anthropometric indicators will be recorded at each visit. Blood samples will be collected for thick and thin film and hemoglobin measurement and spotted onto filter paper for further PCR analyses. This project will serve as a pilot of an integrated strategy in order to mutualize resources for best impact. By relying on existing strategies, the policy implementation of this joint intervention will be scalable at country and regional levels.

NCT ID: NCT04136405 Active, not recruiting - Chronic Hepatitis c Clinical Trials

Cross Sectional Survey on the Burden, Impacts and Causes of Hepatitis C Virus (HCV) Outbreak in South West Region in Burkina Faso

REVERSO
Start date: July 14, 2020
Phase:
Study type: Observational

This study investigates hepatitis C virus (HCV) outbreak in South West general population in Burkina Faso with three specific objectives: estimate HCV prevalence in South West Region general population in 2019; identify factors associated with recent HCV infection (in subjects younger than 20 years); and evaluate the pilot treatment strategy implemented by the national program for diagnosed cases during investigation.

NCT ID: NCT04022967 Active, not recruiting - HIV-1-infection Clinical Trials

ANRS 12372 MODERATO Study

MODERATO
Start date: September 21, 2020
Phase: Phase 3
Study type: Interventional

MODERATO is a phase III, open-label, randomized, multicenter, non-inferiority trial conducted in West and Central Africa (Cameroon, Côte d'Ivoire, Burkina Faso). HIV-1 infected adults receiving first line ART with TDF+XTC+EFV or DTG+XTC+TDF virologically suppressed will be recruited and followed during 100 weeks. The objective is to assess the non-inferiority of a strategy consisting of switching to a dual maintenance therapy (DTG+3TC or ATV/r+3TC), comparing to WHO standard first line regimen (TDF+3TC+EFV or DTG+3TC+TDF), in terms of virological success at 96 weeks

NCT ID: NCT03967054 Active, not recruiting - Malaria Clinical Trials

Repeat Ivermectin Mass Drug Administrations for MALaria Control II

RIMDAMAL II
Start date: July 13, 2019
Phase: Phase 3
Study type: Interventional

RIMDAMAL II is a double-blind, cluster randomized trial in Burkina Faso designed to test whether repeated ivermectin mass drug administrations, integrated into a monthly delivery platform with standard malaria control measures of seasonal malaria chemoprevention and insecticide-treated bed net distribution in the Sahel, will reduce childhood malaria incidence.

NCT ID: NCT03869944 Active, not recruiting - HIV-1 Clinical Trials

Preventing Childhood HIV: Rescue Intervention. ANRS 12388 PREVENIR-PEV

PREVENIR-PEV
Start date: December 4, 2019
Phase: Phase 2
Study type: Interventional

The second visit of the Expanded Programme of Immunization when the child is 2 months old (EPI-2) represents a unique opportunity to link the EPI and PMTCT programmes and to introduce preventive and therapeutic rescue interventions in order to 1) Assess the efficacy of the PMTCT cascade up to 2 months postpartum; 2) Allow at least 80% of HIV-1-infected infants identified at the second EPI visit who were not involved in HIV care to initiate ARVs at the earliest, but no later than 2 months after confirmation of HIV diagnosis; 3) Reduce HIV-1 transmission to less than 3% between 2 and 12 months among exposed children who completed the second EPI visit