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

  • Exploring the perceptions of communities toward the impact novel Coronavirus-2 (SARS-CoV-2), COVID-19 outbreak and response can have on their lives and security

    Stringer, B; Alcayna, T; Caleo, G; Carrion-Martin, I; Froud, A; Gray, N; Keating, P; Kuehne, A; Lenglet, A; Stellmach, D; et al. (2020-06)
  • Research Protocol - Exploring Menstrual Hygiene Management (MHM) Systems, Practices and Perceptions in Selected MSF Health Structures: A Mixed Method Study

    Scott Moncrieff, Izzy; Fesselet, Jeff; Stringer, Beverley; Lenglet, Annick; MSF OCA (2019-05)
    To establish the degree to which sanitation and hygiene facilities at MSF heath structures meet the requirements of menstruating women.
  • 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;
  • The Impact of a Tick-Sheet in Improving Interpretation Accuracy of Chest Radiographs by Non-Specialists in an HIV positive cohort

    Kosack, Cara; Mesic, Anita; Spijker, Saskia; Bonnet, Maryline; Joekes, Elizabeth; MSF-OCA (2018-07)
    Study objective 3.1 Primary objective To determine if the application of a tick-sheet after four hour training on its use and on CXR interpretation, improves the interpretation accuracy of CXRs for active TB, by nonspecialists, in an HIV-positive cohort. 3.2 Secondary objective To determine whether the application of a tick-sheet reduces the inter-reader variability of CXR interpretation in a group of non-specialists by comparing the inter-reader agreement before and after intervention.
  • Retrospective population-based mortality survey in an urban and rural area of Sierra Leone, 2015

    Caleo, Grazia; Kardamanidis, Katina; Broeder, Rob; Belava, Jaroslava; Kremer, Ronald; Lokuge, Kamalini; Greig, Jane; Turay; Saffa, Gbessay; MSF-OCA (2018-07)
    2. Objectives 2.1. Primary objectives The Primary objective of the survey is to:  Estimate mortality in a sample of the population in the urban and rural area of Bo District from the approximate start of the Ebola outbreak in Sierra Leone (mid May 2014) until the day of the survey. 2.2. Secondary objectives  Estimate overall and cause-specific mortality (EVD and non-EVD) in children under the age of 5 years, and the population aged 5 years and older within the study area, with particular attention to the period prior to the MSF Ebola Management Centre (EMC) opening in Bo district (19 September 2014) and the period during which it was receiving cases from the district (last confirmed case exited 26 January 2015);  Estimate overall and cause-specific mortality (EVD and non-EVD) in quarantined and non-quarantined households; and contact-traced and non-contact-traced households;  Describe health seeking behaviour in terms of whether health care was sought, where health care was sought and whether access to health care was possible.
  • Maternal and child health care seeking behaviour: a household survey and interview study in an urban and rural area of Sierra Leone, 2016

    Elston, James; Snag, Sibylle; Kazungu, Donald Sonne; Jimissa, A; Caleo, Grazia; Danis, Kostas; Lokuge, Kamalini; Black, Benjamin; Gray, Nell; MSF-OCA (2018-07)
    To describe health seeking behaviour during pregnancy, for childbirth and in children under the age of five years, and to identify barriers to accessing and receiving healthcare services at the time of the study and since the start of the Ebola outbreak in an urban and rural area of Tonkolili District. 2.2 PRIMARY OBJECTIVES 1. To estimate utilisation of health facilities by women for childbirth in Magburaka town and Yoni chiefdom since the start of the Ebola outbreak ; 2. To estimate utilisation of healthcare services by children aged <5 years in Magburaka town and Yoni chiefdom during their most recent febrile illness within the three month period preceding the day of the survey. 3. To identify and describe factors influencing utilisation of health services and delays in seeking and receiving adequate healthcare during pregnancy and for childbirth 4. To identify and describe factors influencing utilisation of health services and delays in seeking and receiving adequate healthcare for febrile illness in children aged <5 years
  • Health Service Access Survey among Non-camp Syrian Refugees in Irbid Governorate, Jordan

    Rehr, Manuela; Shoaib, Muhammad; Deprade, Anais; Lenglet, Annick; Ait-Bouziad, Idriss; Altarawneh, Mohammad; Alshafee, Abdel Razzaq; Gabashneh, Sadeq; MSF-OCA (2018-07)
    2. OBJECTIVES 2.1. PRIMARY OBJECTIVES • To determine the level of access to health care services for Syrian refugees living out-of-camp in Irbid governorate, Jordan. 2.2. SECONDARY OBJECTIVES • To describe the socio-demographic characteristics of the surveyed population including age, gender, disabilities, time living in Jordan, living conditions, and legal status • To describe the economic situation of the surveyed households with regards to income & income sources, dependency on humanitarian assistance, household expenditures and direct and indirect expenditures on health • To characterize health care utilization of non-camp Syrian refugees including frequency & type of services used as well as the main reasons for requiring medical care • To estimate coverage with the most crucial health services such as vaccination coverage of under 5-year-old children, coverage with services for non-communicable diseases and maternal health coverage. • To estimate the coverage of MSF services including specifically NCD care as well as ANC and child health care • To estimate health service needs by estimating the household- prevalence of NCDs as well as the birth rate. • To identify barriers to accessing general-, as well as specialized health care services with regards to economic constraints, barriers resulting from knowledge gaps as well as limitations in accessibility and/or acceptability of existing services. • To identify risk factors for not accessing general and specialized health services as needed. • To estimate retrospectively the crude mortality rate (CMR) and specific mortality rates for the total population and for children under five years of age (U5MR).
  • Knowledge, Attitudes and Practice (KAP) survey of Long-Lasting Insecticide-treated bedNets (LLITNs) in the refugee camps of Kule, Tierkidi and Nguenyyiel, in Gambela, Ethiopia, MSF-OCA catchment area.

    Doyle, Kate; Isidro Carrion Martin, Antonio; Piening, Turid; Ramirez, Angela; Fesselet, Jeff; Loonen, Jeanine; Rao, V Bhargavi; Brechard, Raphael; MSF-OCA (2018-07)
    Ethiopia is a land locked country in east Africa, known for its deep culture and history as well as its struggle with disease outbreaks, drought, malnutrition and major refugee inflex’s. According to UNDP Ethiopia is ranked at 174 in the human development index. Life expectancy at birth is 64.6 years, infant mortality rate is 41.4 (per 1,000 live births), under 5 mortality rate is 59.2 (per 1,000 live births) and deaths from Malaria are 106 (per 100, 000 people). Historically, Gambella region and Itang woreda area are places of ethnic tension between original Agnuak population, Nuers who have arrived in earlier refugee movements 20+ years back, and new Nuer refugees, and Highlanders. All incomers to the area are not refugees, and movement to/from both sides of the South Sudanese border is frequent. Tribal clashes and single incidents take place often; of late the bigger fighting has been less frequent. In Gambella region there are currently 6 camps and 5 reception centers. MSF activities are focused across 3 camps (Kule, Tierkidi and Nguenyyiel) and 1 reception center (Pamdong). While the current refuges crises has been present since early 2014, over the last 18 months more than 130,000 new arrivals have entered Ethiopia, leading to the creation of the latest camp, Nguenyyiel. As of 31st March 2018, official UNHCR data indicates a total South Sudanese population in the region to be 419,259, which now exceeds the local/host population. Key demographics include; 55% of population to be female; 64% to be under 18 years of age; 88% to be women and children. Within this total there are 3,076 unaccompanied minors (0.73%) and 23,238 are separated children (5.5%). It is assumed that also in 2018 the number of unregistered refugees will massively increase due to unwillingness for relocation to other regions creating the need for further extensions or new camps. As all people staying in Gambella camps are not registered with UNHCR, many who seek help with MSF are not officially entitled to it. ARRA health Centres in Tierkidi and Nguenyyiel refuse to treat those without ration card/registration. In case of need of further referral to Gambella hospital, MSF are forced to compromise with the treatment, as those patients are not granted a permit. Across the region, but specifically in the camps served by MSF, we see very high case load of malaria, with major spikes during the rainy season. In 2017, across Kule and Tierkidi camps, MSF treated more than 70,000 people for malaria. Prevention efforts in the camps have been very weak, with limited bed net distribution (last one in 2014) and poorly planned/executed IRS campaigns (Oct 2017—late rain season). MSF will now engage to take on a more active role in prevention and treatment mechanisms including mass bed net distribution, IRS campaigns, use of primaquine (decreased transmission); improved follow up of cases requiring re-treatment as well as participating in a study with the Ethiopian Public health institute looking into the presence of HRP2 gene deletion. PRIMARY OBJECTIVES  To estimate the Long-Lasting Insecticide-Treated bedNets (LLITN) coverage ratio for the total population in the MSF catchment area SECONDARY OBJECTIVES  To describe the population surveyed by sex and age  To measure the LLITN coverage ratio for children under five years of age and pregnant women  To estimate indoor residual spraying (IRS) coverage ratio for the total population in the MSF catchment area  To assess malaria knowledge, attitude and practices in the population including recognition of symptoms, and how to prevent malaria with special focus on LLITN.  To assess knowledge, attitude and practices about malaria treatment.
  • Understanding the health status and humanitarian impact of the recent events in the internally displaced population (IDPs) in Tal Abyad and Manbij districts, northern Syria, 2017

    Malaeb, Rami; Lenglet, Annick; Langlois, Celine; White, Kate; Hussein, Shajib; de Boever, Rieneke; Onus, Robert; Desoulieres, Sophie; MSF-OCA (2018-07)
    Aims and objectives 2.1. Primary objective To estimate the prevalence of current illnesses (self-reported), vaccination coverage, and mental health distress related symptoms in the IDP population in order to obtain a baseline that can guide MSF response activities in Raqqa as well as in Tal Abyad and Manbij districts. 2.2. Secondary objectives 1) To estimate the vaccination coverage for key vaccine preventable diseases in children aged 6-59 months among the new IDP population; 2) To describe the demographic characteristics of the IDP population; 3) To describe the displacement routes and experiences of the IDP population; 4) To estimate the prevalence of self-reported morbidities in the previous two weeks; 5) To estimate the global acute malnutrition (GAM) rate of in children aged 6-59 months and pregnant women; 6) To estimate the prevalence of self-reported major chronic diseases; 7) To estimate the prevalence of symptoms commonly associated with mental health distress; 8) To estimate the prevalence of conflict-related violence/trauma experienced during the recall period (365 days); 9) To estimate the retrospective mortality since the beginning of Ar-Raqqa offensive in northern Syria (12 June 2016); 10) To gain more understanding related to the concerns, challenges and priority needs of the IDPs in the community.
  • Vaccination coverage survey for diphtheria, Streptococcus pneumoniae, polio and tetanus in Rohingya refugee settlements in Ukhiya and Teknaf Upazilas, Cox’s Bazar, Bangladesh

    Pereboom, Monique; White, Kate; Van Leeuwen, Crystal; Siddiqui, Ruby; Guzek, John; Sangma, Mitchell; MSF-OCA (2018-07)
    OBJECTIVES PRIMARY OBJECTIVES a) To describe the vaccine coverage (penta / dT) in children aged 6 months to 14 years for diphtheria in the Rohingya Settlement Camps; SECONDARY OBJECTIVES To describe the vaccine coverage of pentavalent, bOPV and PCV vaccines in children aged 6 weeks to 6 years of age in the Rohingya Settlement Camps; To describe the vaccine coverage for diphtheria and tetanus vaccination among 7 - 14 year olds to assess vaccination rates in this age-group in the Rohingya Settlement Camps
  • Mental health literacy of internally displaced Iraqi young people and their parents in Iraq: paving the way for mental health education and promotion in vulnerable communities.

    Hitchman, Eleanor; Slewa-Younan, Shameran; Lunenborg, Norbert; Bil, Karla; Lenglet, Annick; Jorm, Anthony F.; MSF-OCA (2018-07)
    4. Objectives 4.1 Primary objectives To determine levels of MHL relating to trauma related mental health disorders, namely posttraumatic stress disorder (PTSD) and depression among the displaced Iraqi young people in northern Iraq (see study population). 4.2 Specific objectives 1. To estimate MHL relating to PTSD (and Depression) in a group of displaced Iraqi young people (13-17 years old) and the parents of children (8-12 years old) pertaining to: a. Problem recognition (including “self-recognition”) b. Beliefs about the severity of the problem described and its prevalence in the target population c. Beliefs about causes and risk factors d. Beliefs about how best to support someone with PTSD/depression e. Beliefs about the helpfulness of specific treatments and treatment providers f. Beliefs about likely outcome with and without treatment g. Beliefs about possible barriers to treatment h. Stigma and perceived discrimination towards someone with PTSD/depression 2. To determine associations between specific aspects of MHL as outlined above, and individuals’ demographic characteristics (age, gender, religion, ethnicity, lengthen of displacement etc.) and symptom levels. 3. To estimate the prevalence of mental health distress (major depression, anxiety disorders or suicidality ) using the Self Reporting Questionnaire (SRQ-20) in care takers of children 8-12 years old; 4. To estimate the prevalence of constructs of intrusion, avoidance and arousal in children 8-17 years of age in the study population; 5. To estimate the prevalence of self-reported depression in children 8-17 years old. The categories specified in objective 1 above were chosen because they were considered to be the aspects of MHL most likely to be of interest in informing the determinants of mental health in the proposed population. Objective 2 which seeks to examine the associations between specific aspects of MHL and individuals’ demographic characteristics and symptoms levels is important because associations of this kind can indicate specific targets for health promotion programs.
  • Evaluating the input of the nurse to quality of medical/or healthcare in humanitarian settings

    Gilday, Josie; Chatler, Tracey; Treacy-Wong, Vicky; Stringer, Beverley; MSF-OCA (2018-07)
    Key objective • Develop a basic framework to evaluate quality nursing care in humanitarian settings.
  • Assessing the feasibility of preventing injury risks and improving work safety amongst factory workers in an urban slum: a participatory before-and-after intervention study

    Caleo, Grazia; Dada, Martins; Gray, Nell; Sangma, Mitchell; Scoizzato, Luca; Bangs, Gary W.; Stringer, Beverley; Islam, Zahirul; Baset, Kamrun Ul; MSF-OCA (2018-07)
    Specific Objectives: 1. Explain dynamics of injury risk over time by: 1.1. Describing the circumstances of incidents leading to an injury (injury risks or dynamics of incident) 1.2. Describing the circumstances of near-miss incident where no injury or illness occurs (incident risks) 1.3. Measuring frequency and severity of injuries (burden) 1.4. Describe perceptions of risks amongst owner/manager/workers 2. Design acceptable interventions to reduce injury risks 3. Document intervention feasibility by: 3.1. Describing acceptability, capturing adherence to interventions and changes in risk perceptions 3.2. Describing practicality: 3.2.1. Documenting operational challenges and lessons learned 3.2.2. Capturing resources (human resources, time, materials and cost) of implementation 4. Describe any changes in worker safety behaviour and incident incidence rate
  • Improving utilisation of services for sexual and gender-based violence (SGBV): knowledge, attitudes, practices and perceptions (KAP) in Jahangipuri, Delhi India protocol

    Himanshu, M; Sharmin, Sabrina; Renjhen, Prachi; Saheb, Baba; Gupta, Vinita; MSF-OCA (2018-07)
    2 Research question and objectives 2.1 Research question To identify factors that could improve SGBV service utilisation and acceptance amongst MSF’s catchment population in Delhi, India 2.2 Primary objective To understand how to improve utilization of SGBV services for the population in MSF catchment area Delhi, India 2.3 Specific objectives 1. To understand community knowledge related to SGBV, including its consequences, treatment and clinical services 2. To understand attitudes towards health aspects of SGBV 3. To explore practices related to SGBV care seeking pathways, including barriers and enablers affecting service access and uptake 4. To understand which strategies/activities people consider would be effective in improving access and uptake of clinical services by survivors of SGBV
  • 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.
  • Secondary prophylaxis of visceral leishmaniasis relapses in HIV co-infected patients using pentamidine as a prophylactic agent: a prospective cohort study

    Diro, Ermias; Griensven, Johan van; Woldegebreal, Teklu; Belew, Zewdu; Taye, Melese; Yifru, Sisay; Davidson, Robert N.; Balasegaram, Manica; Lynen, Lut; Boelaert, Marleen; et al. (2018-07)
    2.1 OBJECTIVES 2.1.1 General objective: To document the effectiveness, safety and feasibility of monthly PM secondary prophylaxis (PSP) in VL/HIV co-infected patients that have documented parasite clearance after VL treatment when used for prevention of VL relapse. 2.1.2 Specific objectives of the primary study period 2.1.2.1 Primary objectives In VL/HIV co-infected patients that have documented parasite clearance after VL treatment: - to assess the effectiveness of PSP in terms of preventing relapse and death; - to assess the safety of PSP in terms of drug-related serious adverse events or permanent drug discontinuations due to adverse events; - to assess the feasibility of PSP in terms of number of patients compliant to therapy during the first year of monthly PM secondary prophylaxis. 2.1.2.2 Secondary objectives; In VL/HIV co-infected patients that have documented parasite clearance after VL treatment: - to assess the safety of PSP in terms of: - drug-related non-serious adverse events - serious adverse events (drug-related or not) - to assess the feasibility of PSP in terms of: - number of treatment interruptions/discontinuations, - number of therapeutic interventions needed to treat adverse drug reactions
  • A randomized trial of AmBisome monotherapy and combination of AmBisome and miltefosine for the treatment of VL in HIV positive patients in Ethiopia followed by secondary VL prophylactic treatment with pentamidine

    Hailu, Asrat; Diro, Ermias; Kolja, Stille; Ritmeijer, Koert; Yifru, Sisay; Griensven, Johan van; Zijstra, Ed; Dorlo, Thomas; Strub-Wougaft, Nathalie; Bardonneau, Clelia; et al. (2018-07)
    General Objectives The overall objective of this trial is to identify a safe and effective treatment for VL in HIV coinfected patients. Primary Objective: To evaluate at day 29 assessment the efficacy of a combination regimen of AmBisome® + miltefosine and AmBisome® monotherapy in Ethiopian co-infected HIV + VL patients. Secondary Objectives: 1. To evaluate relapse-free survival at day 390 (after initial cure at day 29 or cure at day 58 after extended treatment). 2. To assess safety of the regimens. Other objectives: 1.To evaluate of viral load and CD4 count in all patients 2. To evaluate the pharmacokinetics of ARV, Ambisome and miltefosine and immune function markers in a subset of patients
  • 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

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