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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 model the comparative cost-effectiveness of the two screening and treatment strategies. 2,000 HIV positive women 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 are HPV positive 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. All women who were HPV-positive (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: NCT04667767 Recruiting - Clinical trials for Severe Acute Malnutrition

The TISA Trial - Senegal

TISA
Start date: December 22, 2020
Phase: N/A
Study type: Interventional

This study evaluates the addition of a simple, scalable "WASH kit", including household water treatment products, a safe water storage container, and hygiene promotion, to the standard national protocol for outpatient treatment of uncomplicated severe acute malnutrition among children aged 6-59 months of age in northern Senegal.

NCT ID: NCT04635553 Recruiting - Schistosomiasis Clinical Trials

Monitoring Schistosome Hybrids Under Under Praziquantel Pressure

Sen_hybrids
Start date: August 11, 2020
Phase:
Study type: Observational

The overall objective of this project is to examine and quantify the potential existence and impact on Praziquantel (PZQ) efficacy, of naturally occurring S. haematobium and S. bovis hybrid populations in northern Senegal. Schistosome hybrids may present vigor compared to their pure parental forms and hence, may be less sensitive to PZQ. We hypothesise that PZQ repeated treatment selects the hybrid schistosome populations.

NCT ID: NCT04390594 Recruiting - COVID-19 Clinical Trials

Efficacy and Safety Evaluation of Treatment Regimens in Adult COVID-19 Patients in Senegal

SEN-CoV-Fadj
Start date: August 13, 2020
Phase: Phase 3
Study type: Interventional

COVID-19 is an emerging pandemic disease affecting most countries including Senegal, caused by the new coronavirus (SARS-CoV-2) which was first detected in the city of Wuhan in China in December 2019. A rapid spread of the disease has occurred at a global scale, associated with a mortality rate of 3.4%. The first case in Africa was declared on February 15, 2020 in Egypt and the first case in Senegal was declared on March 2nd, 2020. In this context, the SEN-CoV-Fadj clinical trial aims to evaluate efficacy and safety, among adults, of different therapeutic regimens considered optimal according to current knowledge, as well as available and adapted to Sub-Saharan Africa. This trial is nested into a cohort of confirmed cases of COVID-19 in Senegal aiming to understand the main clinical, biological, virologic and immunological characteristics of the infection. The protocol of the cohort is based and adapted from the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) / World Health Organization (WHO) Clinical Characterisation Protocol (CCP). The Nafamostat mesilate, whose antiviral, anticoagulant an anti-inflammatory activities have been shown, has been eligible for SEN-CoV-Fadj for the treatment of moderate to severe COVID-19 cases.

NCT ID: NCT04235361 Not yet recruiting - Malaria Clinical Trials

Mobile Point of Care Diagnostic Testing for Ebola Virus Disease in DRC

MobEboDRC
Start date: January 15, 2021
Phase:
Study type: Observational

A mobile suitcase laboratory for EBOV point-of-care (POC) detection at Ebola treatment centers was successfully implemented in Guinea during the large Ebola virus disease (EVD) outbreak in West-Africa 2014-2015. It was shown that isothermal amplification (Recombinase Polymerase Amplification (RPA)) could be efficiently used to test suspect EVD cases and local teams were trained in and successfully deployed with this fast method. In the frame of this project we want to train teams in DRC and expand RPA testing capacity to the differentials recommended by the WHO. Existing RPA assays for all parameters will be included into a multistrip for simultaneous use. This will be integrated with a simple biosafe extraction method. Implementing this approach and testing in the ongoing EVD outbreak will provide teams in DRC with response capacity for future EVD outbreaks.

NCT ID: NCT04177654 Recruiting - Clinical trials for Soil-transmitted Helminth Infections

Monitoring Drug Efficacy and Anthelmintic Resistance in Soil-transmitted Helminth Programs

StarwormsWP2
Start date: May 15, 2019
Phase:
Study type: Observational

Soil-transmitted helminths (STHs) are a group of parasitic worms that infect millions of children in sub-tropical and tropical countries, resulting in malnutrition, growth stunting, intellectual retardation and cognitive deficits. To control the morbidity due to these worms, school-based deworming programs are implemented, in which anthelminthic drugs are administered to children without prior diagnosis. The continued fight against these worms is aided by the London declaration on neglected tropical diseases, which helps sustain and expand global drug donation program, resulting in an unprecedented growth of deworming programs. However, the high degree of drug pressure makes deworming programs vulnerable to the development of anthelmintic resistance because they only rely on one drug with sometimes suboptimal efficacy and there is no availability of alternative drugs. Moreover, at present, there is no surveillance system to monitor the emergence and spread of anthelmintic resistance. It remains unclear to what extent the efficacy of drugs may have dropped and whether anthelmintic resistance is already present. This project aims to strengthen the monitoring and surveillance of drug efficacy and anthelmintic resistance in STH programs. As such, it will support deworming programs in their quest to eliminate STHs as a public health problem. The overall aim of this study is to pilot a surveillance system to assess anthelmintic drug efficacy and the emergence of AR in 9 countries were drug pressure has been high over a long period of time. The specific objectives are to: 1. Assess the prevalence of moderate/heavy intensity infections of the different STH 2. Assess the drug efficacy of a single dose of BZ drugs against STH infections in these countries 3. Assess the frequency of the ß-tubulin SNPs linked to BZ resistance 4. Identify implementation-related barriers and opportunities for monitoring drug efficacy and AR in national PC programs for STH. 5. Expand the Starworms repository of STH field samples

NCT ID: NCT04065529 Completed - Diarrhea Clinical Trials

Clinical Trial in Children Between 3 Months and 14 Years Old to Evaluate the Efficacy and Safety of Gelatin Tannate in the Treatment of Acute Diarrhea (INDIGO)

INDIGO
Start date: September 11, 2019
Phase: Phase 3
Study type: Interventional

To evaluate the safety, global efficacy and rapidity of action of GT in children with acute gastroenteritis taking ORS solution.

NCT ID: NCT03893097 Completed - Schistosoma Mansoni Clinical Trials

Evaluation of Artesunate-mefloquine as a Novel Alternative Treatment for Schistosomiasis in African Children

SchistoSAM
Start date: October 14, 2019
Phase: Phase 3
Study type: Interventional

The SchistoSAM study is an open label, two-arm, individually-randomized controlled trial with a non-inferiority design, conducted in northern Senegal. The study aims at determining if the efficacy of one and of repeated courses of artesunate-mefloquine (AM) is respectively similar to or higher than that of a standard praziquantel (PZQ) treatment. Secondly, the study will assess if novel DNA- and antigen-based diagnostics are more accurate than microscopy in assessing antischistosomal treatment response.

NCT ID: NCT03880006 Recruiting - HIV/AIDS Clinical Trials

Universal Coverage of Antiretroviral Treatment in Senegal

Start date: June 5, 2017
Phase: N/A
Study type: Interventional

Senegal plans a rapid scale up of HIV treatment for all people living with HIV, regardless of cluster of differentiation 4 (CD4) count or viral suppression. However, limited data exist on how to achieve sustained viral suppression outside of a controlled setting, and with significant barriers to effective antiretroviral therapy delivery, uptake, and adherence. The purpose of this study is to develop and assess the feasibility, fidelity, and cost-effectiveness of a universal coverage of Antiretroviral Treatment (ART) intervention among people living with HIV who are not virally suppressed in Dakar and Ziguinchor, Senegal.

NCT ID: NCT03799510 Completed - Schistosomiasis Clinical Trials

Anti-Schistosomiasis Vaccine: Sm14 Phase 2b-Sn in School Children

Start date: December 13, 2018
Phase: Phase 2
Study type: Interventional

The clinical trial phase 2b is designed to assess the safety and the specific immune response of the active ingredient (protein + adjuvant) in healthy and then in infected school children from 8 to 11 years of age with intestinal and/or urinary schistosomiasis, living in the Valley of the Senegal River, a highly endemic area for schistosomiasis.