This section contains MSF research protocols and their ethics reviews. These materials can be used, adapted and copied as long as citation of the source is given including the direct URL to the material. This work is licensed under a Creative Commons Attribution 4.0 International License: http://creativecommons.org/licenses/by/4.0/ https://i.creativecommons.org/l/by/4.0/88x31.png, Where pdf files have been uploaded, Word versions of these files may be available on request from the primary investigator - contact details are included in each protocol.

Recent Submissions

  • Health Seeking Behaviour in Kamrangirchar

    Jeroen van der Heijden; OCA (2018-09-28)
  • Retrospective mortality survey in the MSF catchment area in Fizi health zone, South Kivu, Democratic Republic of Congo

    Lenglet, Annick; Bil, Karla; Mandelkow, Jantina; MSF-OCA (2018-07-31)
    . OBJECTIVES 2.1. PRIMARY OBJECTIVES To estimate the crude mortality rate for the total population (host and IDP) and for children under five years of age in the health zone of Fizi, South Kivu, DRC, in order to understand the current health status of the population in this catchment area. 2.2. SECONDARY OBJECTIVES  To determine the prevalence of self-reported morbidities in the two weeks preceding the survey in household members;  To determine the frequency and reasons for displacement;  To assess access to health care;  To determine the main causes of deaths during the recall period;  To measure the incidence and types of direct violence experienced by the civilian population;  To evaluate household ownership of basic non-food items;
  • Predicting Visceral Leishmaniasis in HIV Infected Patients (PreLeisH)

    Griensven, JV; Diro, Ermias; MSF-OCA (2018-07)
    Aim To study the asymptomatic period preceding the onset of active VL in HIV‐infected individuals from VL endemic regions in Ethiopia as an avenue to develop an evidence‐based screen and treat strategy to prevent progression to active VL.Primary: 1. To estimate the prevalence of asymptomatic Leishmania infection . 2. To estimate the incidence rate of asymptomatic Leishmania infection. 3. To describe the evolution of Leishmania infection markers over time. 4. To estimate the incidence rate of active VL. 5. To identify risk factors associated with the development of active VL. 6. To translate these risk factors into a clinical prognostic tool to identify individuals at high risk to develop active VL within 12 months . Secondary: 1. To identify patterns in host immune markers that are associated with asymptomatic Leishmania infection. 2. To describe the evolution of host immune markers over time. 3. To identify patterns in host immune markers that are associated with treatment failure. 4. To identify patterns in host immune markers that are associated with VL relapse.
  • Determination of the most accurate diagnostic approach for the diagnosis of human brucellosis in Lankien, South-Sudan

    Kosack, Cara; Page, Anne-Laure; Moriyon, Ignacio; Zuniga, Amaia; Conde, Raquel; Laku, Richard; MSF-OCA (2018-07)
    3. Objectives 3.1 Primary objective To estimate the diagnostic accuracy (sensitivity, specificity, positive and negative predicative values and likelihood ratios) of the modified RBT method and the rapid diagnostic test developed by the KIT tests performed (if commercially available) at Institute for Tropical Health (ITH), the University of Navarra, Pamplona, Spain for the diagnosis of brucellosis. Specimens collected in an endemic region (South Sudan) will be used and characterized at the ITH at the University of Navarra, Pamplona, Spain with undiluted RBT, SAT, Coombs test, Brucellacapt and when necessary an indirect ELISA used as the reference tests. 3.2 Secondary objectives • To assess the diagnostic accuracy (sensitivity, specificity, positive and negative predicative values and likelihood ratios) of the Rose Bengal test (Spinreact, Spain) at the study site. • To assess inter-user agreement of the RB test performed on site and at ITH. • To optimize the buffer used in the RBT using characterized sera available at ITH and evaluate the diagnostic performance of the modified method with serum dilution using specimens collected in this study. To date the buffer conditions are those used for diagnosis in cattle and they have not been optimized for diagnosis in humans. In fact, the conditions used in the Brucellacapt (i.e. a special buffer at pH 5.0) also render all antibodies agglutinating. Therefore, some simple modifications of the RBT conditions (i.e. pH and ionic strength) may improve the performance of RBT and produce a similarly simple but better test. • To estimate the diagnostic performance of an ‘in-house’ latex-agglutination test against Brucella-specific cytosoluble proteins. • To describe the clinical characteristics of brucellosis suspects and confirmed cases • To assess/identify risk factors for brucellosis in the study population
  • Risk factors for diagnosed Noma in North West Nigeria, 2017

    Lenglet, Annick; Farley, Elise; Trienekens, Suzan; Amirtharajah, Mohana; Bil, Karla; van der Kam, Saskia; Jiya, Nma M.; Huisman, Geke; Adetunji, Adeniyi Semiyu; Stringer, Beverley; MSF-OCA (2018-07)
    Background 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. Aims and objectives Aim 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. Specific objectives 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; 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; 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; 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. Methods 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. 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. 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. Outcomes • Initiate the MSF operational research agenda around Noma in Nigeria; • Improved understanding of local beliefs, traditions and language used to describe Noma; • Improved understanding of Noma patients at the Sokoto Children’s hospital; • Identification of preventable risk factors for Noma development in our patients; • 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.  
  • The Impact of digital X-ray with Teleradiology on Case Management in Mweso, Democratic Republic of Congo

    Kosack, Cara; Halton, Jarred; Greig, Jane; Shanks, Leslie; Spijker, Saskia; MSF-OCA (2018-07)
    Study objectives 3.1 Primary objective To demonstrate the extent of change in patient management through the availability of digital X-ray with teleradiology consultation. 3.2 Secondary objectives a) To demonstrate the extent of change in patient diagnosis through the availability of digital X-ray with teleradiology consultation. b) To demonstrate the extent of change in patient diagnosis and management in the subgroup of patients with chest pathologies through the availability of digital X-ray with teleradiology consultation. c) To estimate if the extent of change in diagnosis and management is different in patients < 5 years of age versus ≥5 years of age.
  • Malnutrition, morbidity and vaccination coverage in Bokoro District, Chad, 2016 (Final Survey) 1613C

    Lenglet, Annick; Vernier, Larissa; Monge, Susana; White, Kate; Sang, Sibylle; MSF-OCA (2018-07)
    3 OBJECTIVES 3.1 PRIMARY OBJECTIVES To estimate the impact of an integrated program targeted at preventing malnutrition on children under 5 years of age in Bokoro district. 3.2 SECONDARY OBJECTIVES - To describe the population in terms of age breakdown, sex, household composition etc. - To estimate overall mortality rate and under 5 mortality rate - To estimate the prevalence of severe and global acute malnutrition (SAM and GAM) in the under 5 year age group and in children between 6 and 23 months that are the specific target of MSF prevention activities; - To estimate the coverage of insecticide treated bednets in the community; - To estimate the coverage of soap and hygiene practices in the community - To estimate coverage of plumpydoz (nutritional food) in children between 6 months and 2 years of age and to investigate practices around plumpydoz.
  • Review of maternal mortality cases in MSF-OCA projects 2015 (a capture-recapture study)

    Price, Debbie; Lenglet, Annick; Thoulass, Janine; Willrich, Niklas; MSF-OCA (2018-07)
    Aim To identify the best method to monitor maternal mortality in MSF-OCA facilities prospectively. Objectives/Research questions  Evaluate the current surveillance system for maternal mortality in MSF-OCA facilities  Estimate maternal mortality in MSF-OCA facilities for 2015  Identify contributing factors to maternal mortality in MSF-OCA facilities for 2015
  • Prevalence of depression, anxiety and posttraumatic stress related symptoms in the Kashmir Valley – a cross sectional study, 2015.

    Housen, Tambri; Shah, Showkat; Janes, Simon; Pintaldi, Govanni; Lenglet, Annick; Ariti, Cono; MSF-OCA (2018-07)
    Objectives 1.5 Primary objective To estimate prevalence of mental health related problems, specifically depression/anxiety and posttraumatic stress symptoms in the Kashmir Valley and to determine the accessibility to mental health services. 1.6 Specific objectives • Using validated screening tools determine the percentage of people with depression, anxiety and PTSD symptoms in Kashmir; • To correlate scores obtained on validated mental health screening tools with individual psychiatric evaluations using the mini international neuropsychiatric interview (MINI); • To explore local knowledge and perceptions of mental illness in Kashmir; • To determine the level of access to mental heath services across Kashmir; • To identify mental health service needs perceived by the Kashmiri community. 1.7 Goal To provide an updated insight into current mental health needs in Kashmir, which will help MSF to increase relevance and impact of current activities in Kashmir and to advocate for supportive programming and policy review.
  • Health and developmental outcomes of low-birth-weight infants born at the Centre de Référence d’Urgences Obstétricales (CRUO), Port-au-Prince, Haiti.

    Hillaire, Marjorie; Lenglet, Annick; Ariti, Cono; Ledger, Elizabeth; Reilly, Liam; Berthet, Marine; Faniyan, Olu; MSF-OCA (2018-07)
    Summary Title A prospective cohort study investigating health and developmental outcomes of low birth weight infants born at the Centre de Reference d’Urgences Obstretricales (CRUO), Port-au-Prince, Haiti. Primary objective: To describe and compare health and developmental outcomes between low birthweight (LBW) and normal weight infants up to 24 months post-partum, corrected for gestational age. Secondary objective To identify risk factors associated with negative health and developmental outcomes in LBW infants.
  • Evaluating the effectiveness and burden of diabetes care in a complex humanitarian emergency setting in Mweso, North Kivu, Democratic Republic of the Congo (DRC), 2015

    Caleo, Grazia; Ngadjo, Cyril; Roberts, Bayard; Kitembo, Augustin Wika; Jobanputra, Kiran; Perel, Pablo; de la Croix, Jean; Sadique, Zia; de Wit, Marit; MSF-OCA (2018-07)
    Executive summary Background: Since 2008 Médecins Sans Frontières-Operational Centre Amsterdam (MSF-OCA) has been working in Mweso health zone, North Kivu, Democratic Republic of the Congo (DRC). In collaboration with the local Ministry of Health (MoH), MSF-OCA supports the Hospital in Mweso and 4 out of 23 Primary Health Care clinics. Mweso Hospital routinely treats diabetic patients presenting with acute complications and in need of treatment (insulin and/or oral treatment). Since 2011, this has been extended to the out-patient clinic, but without clinical guidance or standard operating procedures (SOP), nor specifically trained staff. The Mweso project reports increasing numbers of patients with diabetes and diabetes-related complications, and requested from MSF-OCA to implement a formal diabetes service to improve quality of care for Diabetics. Rationale: A new model of diabetes care was implemented by MSF-OCA in Mweso in March 2015. The model (Integrated Diabetic Clinic within an Outpatient Department (IDC-OPD)) is based on simplified context-adapted clinical guidelines, clinical SOPs, adapted patient counselling & support materials, medications from World Health Organization(WHO) Essential Medicines list, and one-off staff training by a Diabetologist. This represents an opportunity to evaluate and refine this model of diabetes care to support its application in comparable settings. Furthermore there is an opportunity to benchmark diabetes burden in the MSF Catchment area and measure its diabetes care coverage in the area. Overall aim: To evaluate IDC-OPD in Mweso health zone, North Kivu, DRC. The specific objectives are to examine: • The reach (coverage) of the diabetes service to the intended target population. • The effectiveness of IDC-OPD in improving diabetes outcomes (fasting blood glucose and complications) • Adoption / acceptance of IDC-OPD by staff and patients • Implementation of IDC-OPD in terms of consistency/fidelity, adaptation and costs • Maintenance of IDC-OPD in patients and programme over time.
  • Determining sero-prevalence of antibodies against Hepatitis E during an acute outbreak scenario.

    Lenglet, Annick; Kamau, Charity; Boris, Hogema; MSF-OCA (2018-07)
    OBJECTIVES 3.1 PRIMARY OBJECTIVES To estimate sero prevalence of anti-HEV antibodies (IgG and IgM) in different age groups in Am Timam, Chad 3.2 SECONDARY OBJECTIVES • To determine individual risk factors associated with different anti-HEV antibody status during an acute outbreak; • To determine household level risk factors associated with different anti-HEV antibody status during an acute outbreak; • To compare the sero prevalence of anti-HEV antibodies (IgG and IgM) in different age groups at two different time periods during an acute HEV outbreak to inform our understanding of viral transmission dynamics in a population in this context; • To determine sero prevalence in different age groups of other jaundice causing agents (malaria, hepatitis A, B and C, leptospirosis and arboviral diseases such as yellow fever, viral haemorrhagic fever, Dengue and Rift valley fever; • To compare dried blood spots (DBS) with blood samples for detection of HEV IgM and IgG and HEV RNA through PCR; • To compare oral swabs with blood samples for the detection of HEV IgM and IgG and HEV RNA through PCR.
  • A prospective, randomized, controlled trial of negative-pressure wound therapy use in conflict-related extremity wounds

    Alga, Andreas; Bashaireh, Khaldoon; Wong, Sidney; Lundgren, Kalle; von Schreeb, Johan; MSF-OCA (2018-07)
    Extremity wounds and fractures constitute the majority of conflict-related traumatic injuries, both for civilians (1) and combatants (2). Conflict-related injuries often result in soft and boney tissue being contaminated with foreign material, generally leading to secondary infection (3,4). Negative-pressure wound therapy (NPWT) is widely used in the treatment of wounds and is considered to promote wound healing and prevent infectious complications. The technique involves the application of a wound dressing through which a negative pressure is applied. Any wound and tissue fluid is drawn away from the area and collected into a canister. Due to a plastic film overlaying the wound the risk of wound contamination is reduced. NPWT is supported for use in a range of surgical applications, including after or in between debridements as a bridge to definite closure of soft tissue wounds (5). The technique has previously been used in the treatment of acute conflict-related wounds with satisfactory results (6–8). Cochrane reviews of NPWT for the treatment of chronic wounds (9) and surgical wounds (10) were inconclusive due to the lack of suitably powered, high-quality trials. A recent systematic review of randomized, controlled trials (RCTs) of NPWT for the treatment of acute and chronic wounds concluded there is a lack of evidence and that good RCTs are needed (11). For the use in limb trauma, NPWT is considered suitable for complex soft tissue injuries (12). NPWT appears to be an effective and safe adjunctive treatment of high-energy combat wounds but existing results are retrospective and lack follow-up (13). The support of RCTs is needed to establish best treatment strategies. Summary of potential risks and benefits Both treatment methods (NPWT and conventional dressings) are well established and used in Jordan for the treatment of acute and chronic wounds. As neither of the two treatment modalities are known to be better in terms of outcome neither patient group may be regarded as receiving preferential treatment. NPWT is generally considered a safe treatment method. Potential benefits are shortened healing time and fewer infectious complications. Potential risks are pain, mainly associated with dressing changes (14) and bleeding, predominantly minor bleeding from granulation tissue (15). Conventional wound dressing has the potential benefit of being a safe treatment method used for many years. Since this method permits air into the wound there is a potential risk of contamination and the development of wound infection. Objectives We aim to evaluate the efficacy and safety of NPWT in the treatment of traumatic extremity wounds in a context associated with a high level of contamination and infection.
  • Evaluation of Second Line Antiretroviral Treatment Outcomes and Determinants in Epworth, MSF-OCA HIV Cohort, Zimbabwe

    Zizhou, Simukai; Gashu, Tadele; Ahmad, Bilal; Dhliwayo, Rumbidzai; Aluma, Theresa; Gonzalez, Lucia; Sang, Sibylle; Mesic, Anita; Otiato, Alice Ayuma; Belaye, Abi Kebra; Greig, Jane; Casas, Esther C; MSF-OCA (2018-07)
    Summary 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. 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. 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. 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.
  • Case-study: A retrospective assessment of transmission of Ebola virus disease (EVD) through a rural Sierra Leonean community and the impact on mortality and health seeking behaviours.

    Duncombe, Jennifer; Caleo, Grazia; Mills, Clair; Passmore, Charlotte; Kremer, Ronald; Lokuge, Kamalini; Greig, Jane; Lamin, Manjo; MSF-OCA (2018-07)
    OBJECTIVES 2.1. PRIMARY OBJECTIVES  To provide a comprehensive description of mortality and transmission of EVD and the community response to EVD in one rural Sierra Leonean community in Kailahun District throughout the course of an outbreak. 2.2. SECONDARY OBJECTIVES 1. Describe the transmission and associated morbidity and mortality of EVD within the village throughout the course of the outbreak, with particular attention to the period prior to the MSF Ebola Management Centre (EMC) opening in Kailahun district (May-June 2014) and the period during which it was receiving cases from the village under study (July-November 2014). 2. Estimate overall and cause-specific mortality (EVD and non-EVD) in under-5 and 5 and older populations within the study village 3. Estimate the secondary cases due to Ebola in quarantined and non-quarantined households. 4. Document the broader impact of the Ebola virus outbreak on health-seeking behaviours and disease outcomes in general, including changes in access to healthcare, illness beliefs and perceptions of healthcare providers. 5. Determine level and factors associated with access and uptake of MSF EMC services within affected households.
  • Exploring the experiences of returned Ebola Virus Disease workers from the United Kingdom

    Cooper, Jane; Falade, Bankole; Mannell, Jenevieve; MSF-OCA (2018-07)
    A brief summary of MSF EVD programmes & workers MSF has been running EVD programmes including Treatment Centres in affected countries since early 2014, and currently employs 325 international and around 4150 national staff . MSF protocols to deliver care and control transmission, and to ensure and monitor the health of workers, were available, based on experience in previous outbreaks over many years. In the latter part of 2014, other organisations and national governments established programmes in, and/or sent volunteer workers to, affected countries. In parallel, national protocols for the monitoring of returned workers, and the screening of travellers, have been established in many countries. MSF international workers have, to date, numbered some [insert] in total. Infection of MSF workers has been relatively rare, being reported in [insert] international workers, and [insert] national workers; [insert] of the latter have died. Most cases in national workers have been attributed to exposures in the community. No cases of infection due to secondary transmission from infected MSF international workers have been identified. [check]. To date, [insert] MSF international workers have returned to the UK; [insert] of these have undertaken more than one mission. No UK returnees have been infected [check] Overall aim: To describe and explore the experiences of UK EVD workers during the period following their return Specific objectives: 1. To explore experiences, perceptions, and views of interactions with family and friends 2. To explore experiences, perceptions, and views of interactions with the general public 3. To explore experiences, perceptions, and views of interactions with colleagues and managers in returning to work 4. To explore experiences, perceptions, and views of public opinion and media coverage 5. To explore experiences, perceptions, and views of policy implementation 6. To identify potential lessons, and areas for potential future research, relevant to the management of staff and programmes
  • Malnutrition, morbidity and vaccination coverage in Bokoro District, Chad, 2016 (Mid Term Survey).

    Lenglet, Annick; Monge, Susana; Ndumbi, Patricia; Nyarwangu, Justin; Hamdan, Musa; Cramond, Vanessa; Sang, Sibylle; MSF-OCA (2018-07)
    3 OBJECTIVES 3.1 PRIMARY OBJECTIVES To estimate the impact of an integrated program targeted at preventing malnutrition on children under 5 years of age in Bokoro district. 3.2 SECONDARY OBJECTIVES - To describe the population in terms of age breakdown, sex, household composition etc. - To estimate overall mortality rate and under 5 mortality rate - To estimate the prevalence of severe and global acute malnutrition (SAM and GAM) in the under 5 year age group and in children between 6 and 23 months that are the specific target of MSF prevention activities; - To estimate the coverage of insecticide treated bednets in the community; - To estimate the coverage of soap and hygiene practices in the community - To estimate coverage of plumpydoz (nutritional food) in children between 6 months and 2 years of age and to investigate practices around plumpydoz.
  • Longitudinal cohort to evaluate Hepatitis C treatment effectiveness in HIV co-infected patients: Manipur, India

    Himanshu, M; Singh, Karam Romeo; Shougrakpam, Jeetesh; MSF-OCA (2018-07)
    4. OBJECTIVES Primary objective The primary objective of this study is to assess the effectiveness of HCV curative treatments in patients with chronic hepatitis C (CHC), co-infected with HIV in Manipur, India. Secondary objectives a. To describe the demographic, clinical and biological characteristics of patients with chronic hepatitis C and HIV co-infection b. To assess the effectiveness of HCV curative strategies in patients with chronic HCV, co-infected with HIV stratified by regimen and by site c. To identify risk factors associated with differing virological responses d. To assess the safety of HCV treatment e. To monitor the safety of HCV treatment in HIV co-infected patients f. To document the clinical and biological tolerance of the HCV treatment g. To assess the feasibility of HCV treatment h. To assess comparative performance of elastography (Fibroscan®) and APRI (AST to Platelet Ration Index), to evaluate liver fibrosis among HIV/HCV co-infected individuals i. To describe causes of non-eligibility for treatment j. To describe the clinical and biological evolution of co-infected patients, not eligible for HCV treatment k. To assess treatment adherence
  • Field evaluation of the performance of HCV Serological Rapid Diagnostic Tests among HCV/HIV co-infected patients

    Gupta, Ekta; Carnimeo, Valentina; Samukcham, Inao; Loarec, Anne; Mahajan, Supriya; Choudhary, Manish; Bastard, Mathieu; Maman, David; Page, Anne Laure; MSF-OCA (2018-07)
    P R O T O C O L S U M M A R Y  Title: Field evaluation of the performance of HCV Serological Rapid Diagnostic Tests among HCV/HIV co-infected patients.  Aim: To evaluate the performance of serological HCV Rapid Diagnostic Tests (RDTs) to identify tests adapted to resource-limited settings, reliable for HIV-infected patients.  Study design: Prospective evaluation of the performance of serological RDTs for HCV screening.  Primary objective: o To evaluate the performance of serological HCV RDTs under field conditions using as reference standard a combination of enzyme immunoassay (EIA) and recombinant immunoblot assay (RIBA) for the detection of antibodies anti-HCV in HIV infected patients.  Secondary objectives: o To describe the accuracy (sensitivity, specificity) of the RDTs as screening tests o To describe the performance of the RDTs according to the HCV genotype and HCV VL o To describe the performance of the RDTs according to the CD4 counts and HIV VL o To describe the performance of the RDTs in presence of HBV co-infection (presence of antigen anti-HBs (HBsAg)) o To describe the operational characteristics of the tests including ease of use, technical complexity and inter-reader variability. o To evaluate predictive values of each HCV RDT based on the prevalence of the testing center.
  • Severe acute malnutrition and retrospective all-cause mortality in children under 5 years of age in target areas of Zamfara State, Nigeria: a SMART survey.

    Hadera, Amdom; Huisman, Geke; Kaur, Gurpreet; Oluyide, Bukola; Greig, Jane E.; Bil, Karla; Roggeveen, Harriet; van der Kam, Saskia; MSF-OCA (2018-07)
    2. OBJECTIVES 2.1. PRIMARY OBJECTIVES To estimate the all-cause mortality rate and proportion of SAM in children under 5 years of age in target areas in Zamfara State. 2.2. SECONDARY OBJECTIVES  To determine causes of death  To assess morbidity  To assess health seeking behaviour  To assess food security and nutritional practices  Estimate the prevalence of gingivitis in children <5 years of age

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