• 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.
    • Research Protocol - 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; van Griensven, Johan; Zijlstra, Ed; Dorlo, Thomas; Addis Ababa University, Addis Ababa, Ethiopia; University of Gondar, Gondar, Ethiopia; Médecins Sans Frontières, London, UK; Médecins Sans Frontières, Amsterdam, The Netherlands; University of Gondar, Gondar, Ethiopia; Institute of Tropical Medicine, Antwerp, Belgium; Drugs for Neglected Diseases initiative, Geneva, Switzerland; Slotervaart Hospital, Amsterdam, The Netherlands (2014-10)
      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 protocol - Addressing water and sanitation needs of displaced women in emergencies

      de Lange, Rink; Fisher, Julie; Fesselet, Jean Francois; Shanks, Leslie; MSF & WEDC Loughborough University, Loughborough, UK; WEDC Loughborough University, Loughborough, UK; MSF-OCA, Amsterdam, The Netherlands; MSF-OCA, Amsterdam, The Netherlands (2014-09)
    • Research Protocol - An Evaluation of False Positive HIV Results due to Testing Errors

      Maparo, Tatenda; Mungofa, Stanley; Bara, Hilda T.; Chirisa, Florence; MSF-OCA; Harare City Council, Harare, Zimbabwe; Harare City Council, Harare, Zimbabwe (2014-06)
      An unacceptably high frequency of false positive HIV test results has been reported in various settings. Given the severity and implications of an HIV+ diagnosis, a false positive result is likely to be psychologically traumatic and may result in inappropriate and potentially harmful treatment. The current HIV testing algorithm being used in Zimbabwe does not include repeat testing for HIV positive results, and it is not currently known whether testing errors are leading to false positive diagnoses at a significant rate. WHO recommends that an additional specimen for testing be collected at some point after the initial diagnosis is made. This procedure aims to rule out possible technical or clerical errors including specimen mislabelling and transcription errors. STUDY OBJECTIVE: To evaluate the number of false positive HIV results due to testing errors, using the WHO retesting recommendations, in 6 clinics in Harare, Zimbabwe.
    • Research Protocol - Assessing barriers and enablers to reproductive health care in Dollo zone, Somali Regional State: a qualitative study

      Stringer, B;; Balayneh, AB;; Bryson, L;; Price, D;; Bil, K;; Farah, A;; Hussein, R; Médecins Sans Frontières, London, UK; The Ethiopian Public Health Institute, Addis Ababa, Ethiopia; Médecins Sans Frontières; Médecins Sans Frontières; Médecins Sans Frontières; Somali Regional Health Bureau; Médecins Sans Frontières (2017-06)
      A deeper understanding of the perspectives, knowledge and awareness of women living in the region with regard to pregnancy and child birth is essential to learn lessons and increase acceptability and effectiveness for reproductive health care services offered in the area. How do women and men perceive the options for reproductive health care? What are the gaps and needs? What are the barriers? And what may facilitate care? In addition, inquiry with adult men with regard to their knowledge and awareness will help analyse the consistency of main findings through gathering opinions and suggestions at community level. This study therefore aims to describe the population’s everyday experiences in Somali Regional State (SRS) by exploring the enablers and barriers women face in accessing reproductive health care. Key objective:  To understand the reasons behind low utilisation of reproductive health care services in SRS from the perspectives of the local population. Secondary objectives:  To identify gaps and barriers for uptake of reproductive health services.  To identify what may help facilitate use of reproductive health services.
    • Research Protocol - Assessing home based treatment and care of MDR-TB patients in northern Uganda

      Horter, Shona; Collins, Beverley; Du Cros, Philipp; Casas, Esther; Amin, Shoaib; Kasozi, Samuel; London School of Hygiene and Tropical Medicine (LSHTM), London, UK; MSF-UK, London, UK; MSF-UK, London, UK; MSF-Holland, Amsterdam, The Netherlands; MSF, Uganda; National TB and Leprosy Programme, Uganda (2014-09)
    • Research Protocol - Cholera and pregnancy in Haiti: description of pregnant patients presenting to MSF OCA cholera treatment centers, September 2011-December 2013.

      Schillberg, Erin; Bryson, Lindsay; Pierre, Grand; Lenglet, Annick; MSF OCA, Haiti; MSF OCA, Haiti; Ministry of Health Haiti (MSPP), Haiti; MSF OCA, Amsterdam, Netherlands (2015-06)
      Principal objective To understand the demographic, clinical and outcome profiles of pregnant patients that presented with cholera infection to Figaro CTC and CRUO CTU between September 2011 and December 2013. Specific objectives 1. To determine the clinical presentation, treatment regimens and outcomes of pregnant patients with cholera seen at Figaro CTC and CRUO CTU between September 2011 and December 2014; 2. To identify factors related to age, clinical presentation or treatment that favour positive outcomes in pregnant patients with cholera presenting to Figaro CTC and CRUO CTU between September 2011 and December 2014; 3. To describe the evolution of patient profiles of pregnant cholera cases at Figaro CTC and CRUO CTU between September 2011 and December 2014 over time; 4. To describe the evolution of patient profiles of pregnant cholera cases at Figaro CTC and CRUO CTU between September 2011 and December 2014 in terms of spatial characteristics. 5. To identify differences in outcomes of patients presenting to a CTC (Figaro CTC) compared to a specialized maternal CTU (CRUO CTU). 6. To identify differences in outcomes after the implementation of new, more aggressive, maternal rehydration guidelines in June 2013.
    • Research Protocol - Effectiveness and safety of a simplified short regimen for Multidrug Resistant Tuberculosis treatment in Manzini Region, Swaziland

      Casas, Esther; Dlamini, Themba; Dietrich, Sebastian; Keus, Kees; Gashu, Tadele; Greig, Jane; Hepple, Pamela; Shanks, Leslie; Médecins Sans Frontières, Operational Center Amsterdam; National TB Program, Ministry of Health, Swaziland; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam (2014-07)
      Multidrug resistant tuberculosis (MDR TB) is a growing problem and few people have access to adequate diagnosis and treatment. The current recommended treatment regimen for MDR TB has a minimum of 20 months duration. Evidence from Bangladesh in 2010 showed that a 9-month short-course regimen could achieve a relapse free-cure rate of 88%. Several countries in West Africa started implementing similar regimens with similar outcomes. Evidence of effectiveness of this shortened regimen amongst HIV co-infected population is still limited. We propose an observational study to evaluate the effectiveness of a shortened course MDR TB regimen in the high HIV prevalence and high MDR TB prevalence setting of Manzini Region, Swaziland. Main objective To describe outcomes at end of treatment and relapse rate at 1 year and safety following treatment completion of a short course (9-12 month) MDR TB treatment in HIV co-infected patients in programmatic conditions in Manzini region, Swaziland. Secondary objectives 1. To describe sputum smear microscopy and culture conversion rates at 6 months and time to sputum conversion in both: HIV/MDR TB co-infected patients and MDR TB/HIV negative patients. 2. To describe outcomes at end of treatment and relapse after 1 year of treatment completion of MDR TB treatment in HIV negative patients. 3. To describe the adverse events of the treatment regimen in both: HIV/MDR TB co-infected patients and MDR TB/HIV negative patients. 4. To evaluate risk factors for unfavorable outcomes (death, lost-to-follow up and failure) and relapse as a combined cohort. 5. To describe proportion of inhA and katG mutations for H and correlation with DST for high dose at MIC 1.0 mg/ml amongst MDR TB cases and examine whether genetic mutations for H are risk factors for favorable or unfavorable outcomes (including description of outcomes 10 per baseline level of resistance to H), to increase understanding of the role of high dose H in the regimen. 6. To describe the proportion of relapse and re-infection amongst the patients developing TB at 1 year after treatment completion by genotyping. 7. To describe the correlation of smear microscopy with culture to assess the safety of a simplified monitoring with smear microscopy for MDR TB treatment. 8. To describe the rate of resistance amplification amongst patients with outcome failure.