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NCT ID: NCT03231449 Active, not recruiting - Stroke Clinical Trials

A Survey of Hospitalizations in Cardiology Units in Sub-Saharan Africa

FEVRIER
Start date: February 1, 2017
Phase: N/A
Study type: Observational

FEVRIER study is an observatory of hospitalizations in cardiology units in sub-Saharan Africa.

NCT ID: NCT03044899 Completed - Surgery Clinical Trials

African Surgical Outcomes Study (ASOS)

ASOS
Start date: February 1, 2016
Phase: N/A
Study type: Observational [Patient Registry]

STUDY OBJECTIVE To confirm the incidence of in-hospital postoperative complications in adult surgical patients in Africa. STUDY DESIGN Seven day, African national multi-centre prospective observational cohort study of adult (≥18 years) patients undergoing surgery. Patients will be followed up for a maximum of 30 days. We will follow the original International Surgical Outcomes Study (ISOS) study design. The primary outcome is in-hospital postoperative complications in adult surgical patients in Africa. Secondary outcomes include in-hospital mortality and the relationship between postoperative complications and postoperative mortality. The intention is to present a representative sample of surgical outcomes across all African countries. This study will run between February and March 2016.

NCT ID: NCT03014167 Not yet recruiting - Helminthiasis Clinical Trials

Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH)

Start date: March 2017
Phase: Phase 4
Study type: Interventional

Over 1.5 billion people are infected with soil-transmitted helminths (STH). Global STH guidelines recommend MDA (mass drug administration) of albendazole or mebendazole to targeted populations, including pre-school age children and school-age children. However mathematical models suggests that current MDA strategies are not sufficient for interrupting disease transmission in most areas. Meanwhile many lymphatic filariasis (LF) programs have successfully treated entire populations with albendazole (in combination with ivermectin or diethylcarbamazine) and are transitioning to a state of post-MDA surveillance. This project will conduct a series of community-based cluster randomized trials in India, Malawi, and Benin to determine if maintaining three years of MDA with albendazole to entire communities following the cessation of LF programs can interrupt STH transmission in focal geographic areas. Additionally, this study aims to compare the efficacy of community-wide MDA versus targeted MDA of children in interrupting the transmission of STH. Nested implementation science research will be used to optimize the intervention, identify contextual factors influencing trial efficacy, and evaluate the feasibility of sustaining and scaling community-wide MDA for STH. These data will provide evidence necessary to inform future guidelines, policies, and operational plans as country partners engage in intensified approaches to eliminate these disabling diseases.

NCT ID: NCT02810678 Not yet recruiting - Clinical trials for Latent Tuberculosis Infection

Enhancing the Public Health Impact of Latent Tuberculosis (TB) Infection Diagnosis and Treatment

ACT4
Start date: July 2016
Phase: N/A
Study type: Interventional

The study is a pragmatic cluster randomized trial that is being conducted in 6 countries, with sites in 4 cities in Canada, Benin, Brazil, Ghana, Indonesia and Vietnam. The trial tests a complex intervention-a two phase programmatic public health package which includes a standardized public health evaluation and analysis, to identify problems and barriers limiting Latent Tuberculosis Infection diagnosis and treatment among close contacts of active Tuberculosis cases. This will be followed by implementation of appropriate solutions. The primary objective of the study is to increase the proportion starting Latent Tuberculosis Infection treatment among household contacts of patients with active pulmonary. A secondary objective is to evaluate the cost effectiveness of this two phase intervention. If successful, this approach can be expanded throughout these countries. After initial preparations, including administrative and ethical review, all participating sites will be randomized to intervention or control. Immediately after this, Phase 1 will begin in intervention sties with the standardized public health evaluation to identify barriers to LTBI diagnosis and treatment initiation and the selection of solutions to be used in Phase 2. To ensure standardization of data gathering research staff will use (i) current indicators of the Latent Tuberculosis Infection cascade of care in intervention facilities (number of contacts per index case registered, investigated, started on treatment and completing treatment) and (ii) interviewer administered questionnaires for patients with active pulmonary Tuberculosis, adult and child household contacts and clinic staff. These questionnaires will assess latent Tuberculosis-related knowledge, attitudes and beliefs from the perspective of these different participants. Results from intervention sites in Phase 1 will be analyzed, and used by the investigators, together with local public health officials, to decide on appropriate corrective solutions in each sites. In Phase 2, solutions for problems identified will be selected and implemented at the intervention sites. Study outcomes and costs will be measured at all intervention and control sites throughout Phase 1 & 2. Results will be disseminated within each country through existing links with national Tuberculosis programs, and through international organizations such as the World Health Organization.

NCT ID: NCT02744469 Recruiting - Tuberculosis Clinical Trials

Benin Population Diversity of Tuberculosis and Implications

BeniDiT
Start date: April 2016
Phase: N/A
Study type: Observational

Tuberculosis is a public health problem caused by a microbe. This microbe may differ from one patient to another. The purpose of this study is to know to which extent, each of these various microbes is involved in tuberculosis disease in Benin. This study will also find out whether the type that affects a patient, depends on patient characteristics and whether the difference affects the outcome of the treatment. Finally the study will also help to find out whether diagnostic tests are reliable for all types of the microbe. This information will be used after the study to inform decision making in order to improve tuberculosis control.

NCT ID: NCT02647489 Recruiting - Malaria, Antepartum Clinical Trials

Safety and Immunogenicity of the Placental Malaria Vaccine Candidate PAMVAC Variously Adjuvanted

PAMVAC
Start date: May 2016
Phase: Phase 1
Study type: Interventional

Despite having developed robust acquired immunity against complications of malaria, women can return to a susceptible state during their first pregnancies and contribute significantly to the burden of severe malaria in highly endemic areas. Naturally acquired protection against placental malaria correlates with the presence of high concentration of immunoglobulin G molecules (IgGs) against VAR2CSA, a parasite protein of the var gene family that is essential for the binding of infected erythrocytes to CSA in the placenta. To induce high concentrations of specific IgGs, subjects will receive escalating doses of PAMVAC vaccine antigen adjuvanted with Alhydrogel, Glucopyranosyl Lipid Adjuvant-Stable Emulsion (GLA-SE) or Glucopyranosyl Lipid Adjuvant-Liposome-QS-21 Formulation (GLA-LSQ). Three injections with the same dosage and adjuvant will be done, each 28 days apart (Day 0, 28 and 56). Control subjects will receive physiological saline instead of the vaccine and dose escalation will be staggered to ensure safety during the trial.

NCT ID: NCT02237027 Completed - Clinical trials for Adherence to Medication Regime

Early Antiretroviral Therapy and Pre-exposure Prophylaxis for HIV Prevention Among Female Sex Workers in Cotonou, Benin

TasP/PrEP
Start date: October 2014
Phase: Phase 4
Study type: Interventional

In the last few years, early treatment of HIV-infected individuals, or "treatment as prevention (TasP), and pre-exposure prophylaxis with antiretroviral drugs among HIV-negative people at very high-risk of acquiring the infection (PrEP) have emerged as highly promising biological preventive interventions to tackle the HIV pandemic within the framework of combination prevention, a multi-component strategy that has been promoted for the last five years. In West Africa, the evidence strongly suggests that female sex workers (FSWs) contribute very disproportionally to the HIV spread. This is why the investigators propose this TasP and PrEP demonstration project in Benin, where our group has been involved in HIV prevention research in the sex work milieu for the last two decades. After a run-in phase for community preparedness and the development of a specific education program on adherence, the investigators plan to recruit 100 HIV-infected FSWs in the TasP component of the project (these women will receive a first-line antiretroviral treatment (ART) regimen as per the Benin guidelines) and 250 HIV-negative FSWs in the PrEP component (these women will receive Truvada®). The recruitment period will last for one year, followed by an additional one year of follow-up, for a total follow-up period varying between 12 and 24 months, depending on when a given woman is recruited in the study. During follow-up visits every three months, the investigators will closely monitor treatment adherence and changes in sexual behaviour, including the use of viral load testing among TasP participants and Truvada® plasma level testing for PrEP participants, as well as detection of prostate-specific antigen (PSA) and Y-chromosome DNA in vaginal fluids in all participants. The investigators will evaluate the feasibility of TasP and PrEP through a set of indicators, including uptake, coverage, adherence, condom migration, occurrence of side effects and development of drug resistance, whereas mathematical modeling will be used to predict the potential impact of both interventions in the sex work milieu and the general population, based on the actual set of indicators observed. The study will be completed by an economic evaluation of the interventions and a cost-effectiveness analysis. Finally, the investigators will disseminate the results to the study population and to the Beninese health authorities and ensure the broad implementation of these interventions in Benin if the demonstration project shows that they are feasible and relevant.

NCT ID: NCT02083380 Completed - Clinical trials for Uncomplicated Plasmodium Falciparum Malaria

Phase IIb Study to Investigate the Efficacy of OZ439 & Piperaquine Phosphate Co-administered to Adults & Children With Uncomplicated Plasmodium Falciparum.

Start date: July 2014
Phase: Phase 2/Phase 3
Study type: Interventional

A randomised, double-blind single-dose (loose combination) study in patients with uncomplicated Plasmodium falciparum malaria. The study will test for efficacy/futility through analyses, using Bayesian methodology. Adults and children will be included through progressive step-down in age following safety analyses. This study investigates the efficacy exposure-response of OZ439/PQP combination in the target populations and if it meets its efficacy objectives, will inform dose setting for Phase III studies.

NCT ID: NCT01941264 Completed - Malaria, Antepartum Clinical Trials

Community-based Screening and Treatment of Malaria in Pregnancy: a Cluster-randomized Trial

COSMIC
Start date: October 2013
Phase: N/A
Study type: Interventional

Malaria is a common disease in Africa and a major health problem. Pregnant women are also at risk of malaria. Malaria in pregnancy is life threatening to both the mother and the baby she is carrying. It can result in the destruction of the mother's blood and in babies with a lower birth weight than normal, making them less healthy in their first years of life. These risks are even higher in women having their first pregnancy. When a woman is pregnant she should go to the Antenatal clinic (ANC) for care. Usually the ANC health staff gives the woman intermittent preventable treatment (IPTp-SP) against malaria. This drug helps protect the woman against getting malaria. Each pregnant woman should receive at least 2 doses of this drug during their pregnancy; thus, they should go the ANC at least 2 times during their pregnancy. However, many women still do not go often to the ANC for health care during their pregnancy. This study would like to see whether community health workers (CHW) can work with pregnant women to encourage them to attend ANC more often. Also, the CHW will test a pregnant woman every month for malaria with a rapid test. If a woman has malaria, the CHW will treat her in her home instead of the woman having to go a health clinic for treatment. The woman will be treated with a different drug than the drug that is given at the ANC visits. Our hypothesis is that this will improve the care and management of malaria during pregnancy and this will improve the health of women and their newborns. To see whether this strategy improved the health of women and their newborns, we will take a small piece of the placenta at delivery to test for malaria and we will weigh the baby. We will test this strategy in multiple communities. We will compare this to pregnant women in communities where this strategy was not followed, thus where pregnant women received standard care. Participants will be pregnant women. There are no direct benefits for participating in the study, except the outcome of our research question that is possible health benefits in the intervention group. The drugs involved are tested safe in pregnant women from second trimester on.

NCT ID: NCT01790321 Completed - Zinc Deficiency Clinical Trials

Water-based Zinc Efficacy Trial in Beninese Shool Children

Start date: February 2013
Phase: N/A
Study type: Interventional

The general objective of this study is to determine the effect of the daily consumption of zinc-fortified water provided by the LSF-filter on zinc status and diarrhea rates in school age children from rural areas characterized by a high risk of zinc deficiency and by elevated stunting prevalence.