• 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
    • 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.
    • 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.
    • 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
    • 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.
    • Mental health literacy of internally displaced Syrian young people and their parents in Syria: paving the way for mental health education and promotion in vulnerable communities.

      Hitchman, Eleanor; Slewa-Younan, Shameran; Cramond, Vanessa; White, Kate; Carrion-Martin, Isidro; Jorm, Anthony F.; MSF-OCA (2018-07)
      4. Objectives 4.1 Primary objective To determine levels of MHL relating to trauma related mental health disorders, namely posttraumatic stress disorder (PTSD) and depression among the displaced Syrian young people in northern Syria (see study population) . 4.2 Specific objectives 1. To estimate MHL relating to PTSD (and Depression) in a group of displaced Syrian young people (13-17 years old) and the parents of children (age 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 i. 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 and quality of life 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.
    • Morbidity, healthcare needs and barriers to access medical care amongst local and displaced populations in west Dar’a and Quneitra, Southern Syria.

      Homan, Tobias; Shoaib, Muhammad; de Rosa, Allan; Alfadel, Imad Aldin; Stein, Susan; Khalaileh, Fadi; Al-Khalouf, Nahed; Bil, Karla; MSF-OCA (2018-07)
      Objectives 2.1 Primary objective To determine the health care needs for local population and IDP’s in west Dar’a and Quneitra by estimating the prevalence of underlying morbidities, vaccination coverage and identifying barriers to access to health care, in order to obtain a baseline that can guide MSF and actor response. 2.2 Secondary objectives The relevance of subjects for the (secondary) objective(s) has been informed by insights from reports of, and explorative meetings with MSF and medical NGOs active in southern Syria (section 3.2.3). Of the secondary objectives identified, similar objectives are reflected in MSF-ERB approved protocols for surveys conducted in the region. We formulated the objectives (and related indicators on page 15) as much as possible on basis of these approved secondary objectives . I. To describe the socio-demographic characteristics of the surveyed population including age, gender and household characteristics. II. To estimate the prevalence of self-reported morbidities in previous two weeks, an estimate of the prevalence of non-communicable diseases, and the main reasons for requiring medical care. III. To estimate the vaccination coverage for key vaccine preventable diseases in children aged 6-59 months. IV. To characterise health care utilisation, the degree of access to healthcare for common morbidities in the population (health seeking behviour) and determine the most common barriers to access to health care. V. To estimate the global acute malnutrition [GAM] rate of in children aged 6-59 months. VI. To estimate the prevalence of conflict-related trauma experienced during the recall period. VII. To what extent maternal and reproductive health services are utilized by assessed crisis-affected women of 15-49 years of age in this area. VIII. To estimate the retrospective mortality and cause of mortality, over the past 6 months (since Ramadan 2017). IX. To better understand the configuration of the health system following the crisis, the characteristics of care-seeking and the quality of the services.
    • 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.
    • 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.
    • 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 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.