Médecins Sans Frontières

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    Leishmania Antigenuria to Predict Initial Treatment Failure and Relapse in Visceral Leishmaniasis/HIV Coinfected Patients: An Exploratory Study Nested Within a Clinical Trial in Ethiopia

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    Background: Biomarkers predicting the risk of VL treatment failure and relapse in VL/HIV coinfected patients are needed. Nested within a two-site clinical trial in Ethiopia (2011-2015), we conducted an exploratory study to assess whether (1) levels of Leishmania antigenuria measured at VL diagnosis were associated with initial treatment failure and (2) levels of Leishmania antigenuria at the end of treatment (parasitologically-confirmed cure) were associated with subsequent relapse. Methods:Leishmania antigenuria at VL diagnosis and cure was determined using KAtex urine antigen test and graded as negative (0), weak/moderate (grade 1+/2+) or strongly-positive (3+). Logistic regression and Kaplan-Meier methods were used to assess the association between antigenuria and (1) initial treatment failure, and (2) relapse over the 12 months after cure, respectively. Results: The analysis to predict initial treatment failure included sixty-three coinfected adults [median age: 30 years interquartile range (IQR) 27-35], median CD4 count: 56 cells/μL (IQR 38-113). KAtex results at VL diagnosis were negative in 11 (17%), weak/moderate in 17 (27%) and strongly-positive in 35 (36%). Twenty (32%) patients had parasitologically-confirmed treatment failure, with a risk of failure of 9% (1/11) with KAtex-negative results, 0% (0/17) for KAtex 1+/2+ and 54% (19/35) for KAtex 3+ results. Compared to KAtex-negative patients, KAtex 3+ patients were at increased risk of treatment failure [odds ratio 11.9 (95% CI 1.4-103.0); P: 0.025]. Forty-four patients were included in the analysis to predict relapse [median age: 31 years (IQR 28-35), median CD4 count: 116 cells/μL (IQR 95-181)]. When achieving VL cure, KAtex results were negative in 19 (43%), weak/moderate (1+/2+) in 10 (23%), and strongly positive (3+) in 15 patients (34%). Over the subsequent 12 months, eight out of 44 patients (18%) relapsed. The predicted 1-year relapse risk was 6% for KAtex-negative results, 14% for KAtex 1+/2+ and 42% for KAtex 3+ results [hazard ratio of 2.2 (95% CI 0.1-34.9) for KAtex 1+/2+ and 9.8 (95% CI 1.8-82.1) for KAtex 3+, compared to KAtex negative patients; P: 0.03]. Conclusion: A simple field-deployable Leishmania urine antigen test can be used for risk stratification of initial treatment failure and VL relapse in HIV-patients. A dipstick-format would facilitate field implementation

    Field evaluation of the performance of HCV Serological Rapid Diagnostic Tests among HCV/HIV co-infected patients

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    Research ProtocolP R O T O C O L S U M M A R Y\ud  Title: Field evaluation of the performance of HCV Serological Rapid Diagnostic Tests among\ud HCV/HIV co-infected patients.\ud  Aim: To evaluate the performance of serological HCV Rapid Diagnostic Tests (RDTs) to identify tests\ud adapted to resource-limited settings, reliable for HIV-infected patients.\ud  Study design: Prospective evaluation of the performance of serological RDTs for HCV screening.\ud  Primary objective:\ud o To evaluate the performance of serological HCV RDTs under field conditions using as reference\ud standard a combination of enzyme immunoassay (EIA) and recombinant immunoblot assay\ud (RIBA) for the detection of antibodies anti-HCV in HIV infected patients.\ud  Secondary objectives:\ud o To describe the accuracy (sensitivity, specificity) of the RDTs as screening tests\ud o To describe the performance of the RDTs according to the HCV genotype and HCV VL\ud o To describe the performance of the RDTs according to the CD4 counts and HIV VL\ud o To describe the performance of the RDTs in presence of HBV co-infection (presence of antigen\ud anti-HBs (HBsAg))\ud o To describe the operational characteristics of the tests including ease of use, technical\ud complexity and inter-reader variability.\ud o To evaluate predictive values of each HCV RDT based on the prevalence of the testing center

    Evaluation of Second Line Antiretroviral Treatment Outcomes and Determinants in Epworth, MSF-OCA HIV Cohort, Zimbabwe

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    Research protocolSummary\ud \ud Epworth poly-clinic is found in Epworth district, Harare. It is a clinic jointly run by Epworth local board (on behalf of the Ministry of Health and Child Care) and Médecins sans Frontiers (MSF). One of the major MSF activities in the clinic is early detection and management of patients who fail first line ART. Patients with elevated viral load (VL), HIV RNA greater than 1000 copies/ml, undergo five to six sessions of two weekly enhanced adherence counseling (EAC) support. After enhanced adherence counseling sessions, those with elevated repeat VL test result are then switched to second line ART. Since the number of patients on second line ART is growing, there is an increased need to know the outcomes of second line ART and predictors of treatment failure.\ud The main objective of this study is to evaluate the prognosis and determinants of second line ART regimen for cohort of HIV patients in Epworth MoH/MSF poly-clinic, Zimbabwe. The study will also identify cumulative incidence of SL ART treatment failure through clinical, immunological or virological criteria at 6, 12, 24 and 36 months of second line ART initiation for a cohort of patients enrolled from March 2009 to January 2016 in Epworth poly-clinic. \ud This is a retrospective cohort study of patients on second line ART in Epworth poly-clinic enrolled since 2009. We describe baseline characteristics and outcomes of treatment using descriptive analysis. Multivariate cox proportional hazard modeling is used to model predictors of time to treatment failure. Kaplan–Meier curve is used to calculate cumulative incidence of treatment failure at 6, 12, 24 and 36 months of second line ART initiation.\ud The study is expected to be finished and communicated to relevant stakeholders in December 2016. The report will be published on peer reviewed journals in January 2017. All the costs needed for this study will be covered by MSF OCA

    Risk factors for diagnosed Noma in North West Nigeria, 2017

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    Research ProtocolBackground\ud Noma is an orofacial gangrene that rapidly eats away at the hard and soft tissue as well as the bones in the face. Noma has a 90% mortality rate, and the disease affects mostly children under the age of 5. Little is known about Noma as the majority of cases live in underserved, difficult to reach locations. MSF runs projects at the Noma Children’s Hospital in Sokoto, northern Nigeria and currently assists with surgical interventions for the patients who have survived and sought care at the hospital. Community outreach and active case finding are also taking place. These projects place MSF in a unique position to study Noma, and to add to the scant body of knowledge around the disease.\ud \ud Aims and objectives\ud Aim\ud To identify risk factors for Noma in north west Nigeria in terms of epidemiological (demographic characteristics, medical history), socio-economic-behavioural aspects and access to health care in order to better guide existing prevention strategies.\ud Specific objectives\ud 1. To understand concepts and perceptions of Noma within the population of northwestern Nigeria, specifically those affected (caretakers of Noma cases) by the disease, and controls matching these cases. To describe the epidemiological profile of all cases of Noma that have been treated at the MSF Noma Children’s Hospital from August 2015 until June 2016;\ud 2. To describe the current Noma patient’s clinical history before the onset of the disease, the start of the disease and the care/treatment sought as well as the impact of Noma on the patient; \ud 3. To assess Noma risk factors by comparing cases enrolled at the Noma Children’s Hospital and controls matched to cases by sex, age, and village of residence;\ud \ud All of these objectives are in order to assess if there are intervention opportunities in the unique Nigerian setting that could prevent further Noma case development.\ud \ud Methods\ud 1) Qualitative phase: focus groups will take place with care takers (guardians or parents) of cases as well as key informant interviews with health care workers to better understand the local concepts, vocabulary and expressions used to describe Noma in this part of Nigeria.\ud 2) Descriptive epidemiology: description of all available medical, nutritional and mental health data associated with the Noma patients operated on at the Noma Children’s Hospital over the last year. \ud 3) Case control study: assessing risk factors for Noma using care takers of cases recruited from the Noma Children’s Hospital and care takers of controls that are recruited from cases village of residence and matched by age and sex.\ud \ud Outcomes\ud • Initiate the MSF operational research agenda around Noma in Nigeria;\ud • Improved understanding of local beliefs, traditions and language used to describe Noma;\ud • Improved understanding of Noma patients at the Sokoto Children’s hospital;\ud • Identification of preventable risk factors for Noma development in our patients;\ud • Integration of information obtained into outreach programming, improved community engagements, options for preventative campaigns and overall improved clinical and mental health care of Noma patients and caretakers in the MSF project.\ud

    The impact of lay counselors on HIV testing rates: Quasi-experimental evidence from lay counselor redeployment in KwaZulu-Natal, South Africa

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    This study aimed to determine the causal effect of the number of lay counselors employed at a primary care clinic in rural South Africa on the number of clinic-based HIV tests performed

    How has the Zimbabwe mycobacterial culture and drug sensitivity testing system among re-treatment tuberculosis patients functioned during the scale-up of the Xpert MTB/RIF assay?

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    In Zimbabwe, while the Xpert MTB/RIF assay is being used for diagnosing tuberculosis and rifampicin-resistance, re-treatment tuberculosis (TB) patients are still expected to have culture and drug sensitivity testing (CDST) performed at national reference laboratories for confirmation. The study aim was to document the Xpert MTB/RIF assay scale-up and assess how the CDST system functioned for re-treatment TB patients

    MSF Ethics Review Board Members

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    Delayed access to emergency obstetrical care among preeclamptic and non-preeclamptic women in Port-Au-Prince, Haiti

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    The primary objective of this comparative, cross-sectional study was to identify factors affecting delays in accessing emergency obstetric care and clinical consequences of delays among preeclamptic and non-preeclamptic women in Port-au-Prince, Haiti

    Health Seeking Behaviour in Kamrangirchar

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    The perceptions and experiences of health and health seeking behaviour for the community living in the slum areas of Kamrangirchar and Hazaribagh, Dhaka, Bangladesh: a qualitative stud

    Retention on ART and predictors of disengagement from care in several alternative community-centred ART refill models in rural Swaziland

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    A broad range of community-centred care models for patients stable on anti-retroviral therapy (ART) have been proposed by the World Health Organization to better respond to patient needs and alleviate pressure on health systems caused by rapidly growing patient numbers. Where available, often a single alternative care model is offered in addition to routine clinical care. We operationalized several community-centred ART delivery care models in one public sector setting. Here, we compare retention in care and on ART and identify predictors of disengagement with care

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