• MSF ERB Ethics Review Research Template

      MSF Ethics Review Board (2016)
    • MSF Ethics Review Board Standard Operating Procedures

      Describes the mechanisms of operation of the MSF Ethics Review Board including the different types of review required eg for emergency research or retrospective analyses of routine data
    • Multi-site evaluation of HIV testing algorithms

      Kosack, Cara; Page, Anne-Laure; Shanks, Leslie; Chaillet, Pascale; Beelaert, Greet; Fransen, Katrien; Benson, Tumwesigye T.; Savane, Aboubacar; Nganga, Anne; MSF-OCA (2018-07)
      Objectives 3.1 Primary objective  To evaluate the overall and site-specific performance of the diagnostic algorithm performed at 6 MSF African program sites (i.e. using RDT results from the program sites) comparing using the diagnostic algorithm with ELISA, LIA, EIA-Ag and DNA-PCR as gold standard. 3.2 Secondary objectives  To evaluate the accuracy (sensitivity, specificity and predictive values) of Orgenics ImmunoComb® II HIV 1&2 Combfirm as an HIV confirmatory test.  To model different HIV RDT testing algorithms in order to define acceptable testing algorithm in each study setting (i.e. using RDT results from reference laboratory).  To determine the inter-user reliability of RDT testing (i.e. program sites vs. reference laboratory)  To evaluate accuracy of each HIV RDT measured by the sensitivity (SN), specificity (SP) and predictive values based on the prevalence of each testing centre.  To evaluate the accuracy of HIV testing using DPS samples for quality control purpose in HIV testing.  To assess whether additional confirmatory testing (i.e. Orgenics ImmunoComb® II HIV 1&2 Combfirm) improves the accuracy of the diagnostic algorithm used at the different study sites.  To perform a descriptive analysis on the differentiation between HIV 1 and 2 of the discriminative RDTs.
    • Operational Research Policy and Practice OCB 2013

      Operational Research Unit OCB; Medical Department, OCB (2013)
    • The perceptions and experiences of health and health seeking behaviour for the community living in the slum areas of Kamrangirchar and Hazaribag, Dhaka, Bangladesh: a qualitative study

      van der Heijden, Jeroen; Stringer, Beverly; Gray, Nell; Kalon, Stobdan; Dada, Martins; Shaheen, Aminur; Akhter, Sadika; Hussian, Enayet; Bishwash, Animesh; MSF-OCA (2018-07)
      Objectives This study aims to provide a better understanding of community perceptions toward health and health services in order to inform programme strategies: • Describe community and local-level perspectives and opinions on health care provision; • Document gaps, barriers and influences that impact access and acceptance of health care; • Contribute to best practice and development of health policy for this population
    • 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.
    • 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.
    • 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.
    • Randomised Controlled Trials: how to do them in MSF

      McConnell, Rebecca; Roll, Stephanie; van der Kam, Saskia; Shanks, Leslie; Venis, Sarah; du Cros, Philipp; Siddiqui, Ruby; Greig, Jane; Manson Unit, MSF UK (2012-02)
    • 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
    • Research Ethics Governance in Times of Ebola

      Schopper, D; Ravinetto, R; Schwartz, L; Kamaara, E; Sheel, S; Segelid, MJ; Ahmad, A; Dawson, A; Singh, J; Jesani, A; et al. (Oxford University Press, 2016-11-01)
    • Research Protocol - Health and developmental outcomes of low-birth-weight infants born at the Centre de Référence d’Urgences Obstétricales (CRUO), Port-au-Prince, Haiti.

      Bryson, Lindsay; Hillaire, Marjorie; Roggeveen, Harriet; Lenglet, Annick; Ariti, Cono; Ledger, Elizabeth; Reilly, Liam; MSF OCA, Haiti; Ministry of Health, Haiti; MSF OCA, Amsterdam; MSF OCA, Amsterdam; MSF OCA, London, MSF OCA, Haiti; MSF OCA Haiti (2015-04)
      Primary objective: To describe and compare health and developmental outcomes between low birthweight (LBW) and normal weight infants up to 1 year post-partum, corrected for gestational age. Secondary objective To identify risk factors associated with negative health and developmental outcomes in LBW infants.
    • Research Protocol - 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; Saffa, Gbessay; Manson Unit, MSF UK, London; MSF OCA, Sierra Leone; MSF OCA, Bo, Sierra Leone; MSF OCA, Amsterdam; Manson Unit, MSF UK, London; Manson Unit, MSF UK, London; Ministry of Health, Sierra Leone; Ministry of Health, Sierra Leone (2015-07-02)
      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.
    • Research Protocol - A prospective, randomized, controlled trial of negative-pressure wound therapy use in conflict-related extremity wounds

      Älgå, Andreas; Bashaireh, Khaldoon; Wong, Sidney; Lundgren, Kalle; Schreeb, Johan von;; Karolinska Institutet, Stockholm, Sweden; Jordan University of Science and Technology, Ar Ramtha, Jordan; MSF OCA, Amsterdam; Karolinska Institutet, Stockholm, Sweden; Karolinska Institutet, Stockholm, Sweden; (2015-05)
      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.