There are about 42 clinical studies being (or have been) conducted in Niger. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
A national survey in Niger found that women and children are at risk of undernutrition and that many pregnant women don't visit health centers during pregnancy as often as is recommended. The aim is to assess the nutritional and health status of pregnant women in the Zinder region and to understand their knowledge, attitudes and practices related to health and nutrition during pregnancy. In collaboration with the Medical District of Zinder the prenatal care services will be optimized and the programmatic impact on gestational weight gain and anemia prevalence will be assessed.
Options for large-scale preventive distributions include fortified blended flours, ready-to-use foods and direct cash transfer either alone or in combination with family protective rations. Finding the most appropriate strategy is essential to prevent child malnutrition in countries like Niger with annual hunger gaps. Here, the investigators compare different preventive strategies on the incidence of acute malnutrition among children 6 to 23 months.
Each year, an estimated 230,000 HIV-infected women in need of services for prevention of mother-to-child transmission of HIV (PMTCT) give birth in Nigeria, more than in any other nation in the world. Vanderbilt University (VU), through its affiliate, Friends in Global Health (FGH), is currently supporting HIV/AIDS services in North-Central Nigeria. These sites are predominantly rural primary health centers (PHCs) where shortages of high-cadre health care providers and insufficient laboratory capacity to perform CD4+ cell count testing have been major barriers to effective PMTCT scale-up. A systematic reassignment of patient care responsibilities coupled with the adoption of point-of-care (POC) CD4+ cell count testing will facilitate the ability of lower-cadre health providers to manage PMTCT care, including the provision and scale-up of antiretroviral treatment (ART) to pregnant women in these rural, decentralized sites. A system wherein men are facilitated to accompany their wives to ANC appointments will create an important opportunity to address entrenched gender norms. The investigators therefore propose using community and facility-based measures to encourage male partners to accompany their spouses for ANC. As influential community members, male partners can assist their spouses to utilize culturally-sensitive, sustainable and integrated PMTCT care provided by lower-cadre providers in these resource-constrained settings. The investigators propose a parallel, cluster randomized trial to evaluate the impact of a family-focused PMTCT package that includes: 1) task-shifting to lower-cadre providers at PMTCT sites; 2) POC CD4+ cell count testing; (3) integrated mother-infant care; and (4)) a prominent role for influential family members (male partners), working in close partnership with community-based health workers/volunteers. The specific aims of this study are: 1. To evaluate whether implementation of the integrated PMTCT package in primary level antenatal clinics (ANC) increases the proportion of eligible pregnant women who initiate antiretroviral medications for the purposes of PMTCT. The investigators hypothesize that the provision of the PMTCT package in intervention clinics will improve PMTCT antiretroviral uptake rates among eligible women during pregnancy from 40% to 65%. 2. To determine whether implementation of the PMTCT package improves postpartum retention of mother-infant pairs at 6 and 12 weeks. The investigators hypothesize that postpartum retention rates among mother-infant pairs attending intervention sites will be >20% higher at 6 weeks when compared to mother-infant pairs receiving care in non-intervention sites. 3. Conduct a cost-effectiveness analysis (CEA) of the impact of this novel PMTCT intervention compared to the existing standard-of-care referral model. The investigators hypothesize that the proposed intervention will be more cost-effective than the existing model of care. In addition, two qualitative evaluations will be conducted in order to: 1. Assess client satisfaction with health services, comparing PMTCT services provided by lower level vs. higher level cadre health workers; and 2. Evaluate health care worker satisfaction with the new PMTCT service delivery model.
PRIMARY OBJECTIVE : To determine whether mothers, given minimal group training, are capable of using a MUAC (mid-upper arm circumference) bracelet to screen their children for malnutrition and categorise them into one of three groups : 'red' (SAM ; severe acute malnutrition), 'yellow' (MAM ; moderate acute malnutrition) or 'green' (normal nutritional status) SECONDARY OBJECTIVES : To establish whether there is a difference in the MUAC value if measured on the right arm as opposed to the left, in young children To determine whether there is a difference in the MUAC value if the mid upper arm position is determined visually as opposed to being measured in the 'classical' fashion
Study treatments: - Artemether-lumefantrine - Artesunate-amodiaquine - Dihydroartemisinin-piperaquine Location: Maradi, Niger Principal Objective: To measure the clinical and parasitological efficacy of the three artemisinin combination therapies over a period of 42 days from the start of treatment and with polymerase chain reaction assay (PCR) adjustment. Secondary objectives: - To determine the blood concentration of the non-artemisinin component of the treatment (lumefantrine, desethylamodiaquine or piperaquine) at day 7 - To assess the incidence of adverse events during the follow-up period; - To measure speed of parasite clearance Methods: In vivo non comparative study as for WHO standardised protocol. The study also measure the concentration of the non-artemisinin component. Target population: Children under 5 years of age consulting the integrated health centres of Andoumé and Dix-sept portes in Maradi. Sample size: 221 patients per study treatment; 663 patients in total. Treatment allocation: Random. Outcomes: - Early treatment failure, - Late clinical failure, - Late parasitological failure, - Adequate clinical and parasitological response. Analysis: - Cumulative success or failure rate (Kaplan-Meier analysis). - Proportions of early treatment failures, late clinical failures, late parasitological failures, and adequate clinical and parasitological response (called also Per-protocol analysis).
This study will be conducted as a randomized, double-blind, placebo-controlled trial to compare routine antibiotic prescription vs. no routine antibiotic prescription in the management of uncomplicated cases of severe acute malnutrition treated in the community in terms of nutritional recovery. The investigators hypothesize that there will be no significant difference in terms of the risk of nutritional recovery among children uncomplicated cases of severe acute malnutrition treated in the community that receive routine antibiotic prescription and those who receive no routine antibiotic prescription.
This facility-based, multi-center randomized controlled trial (RCT) will test the non-inferiority of short-term (7 day) urethral catheterization compared to longer-term (14 day) urethral catheterization in terms of predicting fistula repair breakdown three months following urinary fistula repair surgery. The study will be conducted among 507 women with simple fistula presenting at 8 study sites in Sub-Saharan Africa for fistula repair surgery.
Major epidemics of meningococcal meningitis occur in countries of the African Sahel and sub-Sahel every few years. Most of these epidemics are caused by meningococci belonging to serogroup A. Until recently there has been no serogroup A conjugate vaccine available to prevent epidemics in Africa because none of the major pharmaceutical companies wanted to develop such a vaccine for commercial reasons. For this reason a public private partnership was established in 2001, the Meningitis Vaccine Project (MVP), with support from the Bill and Melinda Gates Foundation, to develop an affordable new serogroup A meningococcal conjugate vaccine for Africa. The new vaccine, MenAfriVac™, received WHO pre-qualification in 2010 and mass campaigns started in Burkina Faso, Mali and Niger in 2010. It is expected that full coverage through mass vaccination campaigns will be achieved by the end of 2011 in these three countries. A case-control study will be conducted in Mali and Niger during the epidemic seasons of 2012 and 2013 to assess the efficacy of MenAfriVac™.
The purpose of the study is to determine whether the artesunate-amodiaquine combination is effective in treating uncomplicated Plasmodium falciparum malaria in children with severe acute malnutrition. Infection with Plasmodium falciparum malaria remains a significant cause of morbidity and mortality in malnourished children. Malnutrition is known to have a modulating effect on the incidence of malaria infections, its severity and effectiveness of treatments. However, little data exists on antimalarial drug efficacy in malnourished children. Artesunate-amodiaquine combination is the first line treatment used in Médecins Sans Frontières programmes in Niger. The assumption of current efficacy of artesunate-amodiaquine is based on non malnourished children. The aim of this study is to measure the clinical and parasitological efficacy in severely malnourished children. The study is consistent with the standard WHO protocol for monitoring antimalarial drug efficacy (WHO: Methods for surveillance of antimalarial drug efficacy. Geneva; 2009), except for one inclusion criterion. Severe acute malnutrition is an inclusion criteria, instead of being an exclusion criteria. The study will encompass a pharmacokinetic part that will provide important information on the absorption of the drug.
Meningococcal disease occurs throughout the world but attack rates in the Sahelian and sub-Sahelian regions of Africa - the African meningitis belt - are many times higher than those seen in any other part of the world. During 2009, over 70,000 meningitis cases and 3,200 deaths were reported in Nigeria, Niger, and Chad alone. In 2001, a public private partnership between WHO and PATH was created, the Meningitis Vaccine Project (MVP). The MVP set out to develop an affordable meningococcal serogroup A conjugate vaccine (MenAfriVac™) for use in the African meningitis belt. This was successfully achieved, and the new vaccine, produced by the Serum Institute of India (SII), was granted a licence in 2009 for international export. The vaccine dossier was submitted to WHO for prequalification at the beginning of 2010. Introduction through mass vaccination is planned in three African Meningitis belt countries in 2010 (Burkina Faso, Mali and Niger). The implementation of MenAfriVac will be the responsibility of the local Ministry of Health, with the support of the World Health Organization. It is anticipated that this vaccine will be deployed in other countries of the meningitis belt in 2011. This vaccine should provide high levels of direct protection to immunised individuals but, as for serogroup C conjugate vaccines in the United Kingdom, a greater public health impact will be achieved if carriage and transmission of the infection are also prevented. The London School of Hygiene & Tropical Medicine (LSTHM) is coordinating the African Meningococcal Carriage Consortium (MenAfriCar). One of the primary objectives of the MenAfriCar project is to evaluate the impact of the new conjugate vaccine on meningococcal carriage and transmission of serogroup A meningococci in Mali, Niger and Chad. A community-based prospective, pre- and post intervention, observational study will be conducted. MenAfriCar will also help to develop research capacity in the participating African countries.