MSF Ethics Review Board > Templates & procedures
Gerstl S, Grandesso F, Siddiqui R, Greig J, du Cros PAK, et al.
25 October 2022
MSF Ethics Review Board > Templates & procedures
Grandesso F, Gerstl S, Siddiqui R, Greig J, du Cros PAK, et al.
25 October 2022
Mortality Survey Protocol - standardised, MSF ERB approved, intersectional
This collection of files includes an overview of the whole process of conducting a mortality survey and templates for concept papers, the protocol, questionnaires and consent and other related forms. Surveys that use this standardised intersectional protocol do not require MSF Ethics Review Board (ERB) review if the Medical Director of the relevant section takes responsibility for addressing the ethics issues. The exemption criteria of the MSF ERB for standardised intersectional survey protocols must be followed.
This collection of files includes an overview of the whole process of conducting a mortality survey and templates for concept papers, the protocol, questionnaires and consent and other related forms. Surveys that use this standardised intersectional protocol do not require MSF Ethics Review Board (ERB) review if the Medical Director of the relevant section takes responsibility for addressing the ethics issues. The exemption criteria of the MSF ERB for standardised intersectional survey protocols must be followed.
Protocol > Survey Protocol
Gerstl S, Siddiqui R, Greig J, Lenglet AD, du Cros PAK, et al.
24 August 2017
Vaccination coverage survey protocol - standardised, MSF ERB approved, intersectional
This collection of files includes an overview of the whole process of conducting a vaccination coverage survey and templates for concept papers, the protocol, questionnaires and consent and other related forms. Surveys that use this standardised intersectional protocol do not require MSF Ethics Review Board (ERB) review if the Medical Director of the relevant section takes responsibility for addressing the ethics issues. The exemption criteria of the MSF ERB for standardised intersectional survey protocols must be followed.
This collection of files includes an overview of the whole process of conducting a vaccination coverage survey and templates for concept papers, the protocol, questionnaires and consent and other related forms. Surveys that use this standardised intersectional protocol do not require MSF Ethics Review Board (ERB) review if the Medical Director of the relevant section takes responsibility for addressing the ethics issues. The exemption criteria of the MSF ERB for standardised intersectional survey protocols must be followed.
Protocol > Research Protocol
Verputten M, Siddiqui R, Gray NSB, Casimir CF, Finaldi P, et al.
1 July 2018
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 Port-au-Prince, Haiti
2.2 Primary objective
To understand how to improve utilization of SGBV services for the population in MSF catchment area Port-au-Prince, Haiti
2.3 Specific objectives
1. To understand community knowledge related to SGBV, including its causes, consequences, treatment and services
2. To understand attitudes towards 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 uptake of SGBV services
5. To understand which strategies/activities people consider would be effective in preventing SGBV
2.1 Research question
To identify factors that could improve SGBV service utilisation and acceptance amongst MSF’s catchment population in Port-au-Prince, Haiti
2.2 Primary objective
To understand how to improve utilization of SGBV services for the population in MSF catchment area Port-au-Prince, Haiti
2.3 Specific objectives
1. To understand community knowledge related to SGBV, including its causes, consequences, treatment and services
2. To understand attitudes towards 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 uptake of SGBV services
5. To understand which strategies/activities people consider would be effective in preventing SGBV
Research & Publication Guidance > Guidelines/How-Tos
McConnell R, Roll S, van der Kam S, Shanks L, Venis S, et al.
1 February 2012
Journal Article > ResearchAbstract
Sex Transm Infect. 12 February 2012; Volume 18 (Issue 5); DOI:10.3201/eid1801.110850
Chacko L, Ford NP, Sabaiti M, Siddiqui R
Sex Transm Infect. 12 February 2012; Volume 18 (Issue 5); DOI:10.3201/eid1801.110850
ObjectiveTo assess adherence to post-exposure prophylaxis (PEP) for the prevention of HIV infection in victims of sexual assault.MethodsThe authors carried out a systematic review, random effects meta-analysis and meta-regression of studies reporting adherence to PEP among victims of sexual violence. Seven electronic databases were searched. Our primary outcome was adherence; secondary outcomes included defaulting, refusal and side effects.Results2159 titles were screened, and 24 studies matching the inclusion criteria were taken through to analysis. The overall proportion of patients adhering to PEP (23 cohort studies, 2166 patients) was 40.3% (95% CI 32.5% to 48.1%), and the overall proportion of patients defaulting from care (18 cohorts, 1972 patients) was 41.2% (95% CI 31.1% to 51.4%). Adherence appeared to be higher in developing countries compared with developed countries.ConclusionsAdherence to PEP is poor in all settings. Interventions are needed to support adherence.
Protocol > Research Protocol
Siddiqui R, White K, Guzek J
1 July 2018
2.1. PRIMARY OBJECTIVES
To estimate the scale of the emergency through measurement of crude mortality rate for the total population and for children under five years of age
2.2. SECONDARY OBJECTIVES
To describe the population in terms of age, sex and household composition;
To determine the coverage of measles, polio, MenACWY, DPT-Hib-HepB (Pentavalent), cholera (OCV) and pneumococcal virus (PCV) vaccination in 6-59 month olds;
To determine the rate of severe and global acute malnutrition in 6-59 month olds;
To identify the most prevalent morbidities in the population in the two weeks preceding the survey;
To describe the health seeking behaviour in terms of access to primary and secondary care;
To estimate crude mortality rate for the total population and for children under five years of age before and after the SPLA advance into Equatoria, South Sudan;
To identify major causes of death, by age group and sex;
To gain knowledge of violence-related events
2.1. PRIMARY OBJECTIVES
To estimate the scale of the emergency through measurement of crude mortality rate for the total population and for children under five years of age
2.2. SECONDARY OBJECTIVES
To describe the population in terms of age, sex and household composition;
To determine the coverage of measles, polio, MenACWY, DPT-Hib-HepB (Pentavalent), cholera (OCV) and pneumococcal virus (PCV) vaccination in 6-59 month olds;
To determine the rate of severe and global acute malnutrition in 6-59 month olds;
To identify the most prevalent morbidities in the population in the two weeks preceding the survey;
To describe the health seeking behaviour in terms of access to primary and secondary care;
To estimate crude mortality rate for the total population and for children under five years of age before and after the SPLA advance into Equatoria, South Sudan;
To identify major causes of death, by age group and sex;
To gain knowledge of violence-related events
To estimate the scale of the emergency through measurement of crude mortality rate for the total population and for children under five years of age
2.2. SECONDARY OBJECTIVES
To describe the population in terms of age, sex and household composition;
To determine the coverage of measles, polio, MenACWY, DPT-Hib-HepB (Pentavalent), cholera (OCV) and pneumococcal virus (PCV) vaccination in 6-59 month olds;
To determine the rate of severe and global acute malnutrition in 6-59 month olds;
To identify the most prevalent morbidities in the population in the two weeks preceding the survey;
To describe the health seeking behaviour in terms of access to primary and secondary care;
To estimate crude mortality rate for the total population and for children under five years of age before and after the SPLA advance into Equatoria, South Sudan;
To identify major causes of death, by age group and sex;
To gain knowledge of violence-related events
2.1. PRIMARY OBJECTIVES
To estimate the scale of the emergency through measurement of crude mortality rate for the total population and for children under five years of age
2.2. SECONDARY OBJECTIVES
To describe the population in terms of age, sex and household composition;
To determine the coverage of measles, polio, MenACWY, DPT-Hib-HepB (Pentavalent), cholera (OCV) and pneumococcal virus (PCV) vaccination in 6-59 month olds;
To determine the rate of severe and global acute malnutrition in 6-59 month olds;
To identify the most prevalent morbidities in the population in the two weeks preceding the survey;
To describe the health seeking behaviour in terms of access to primary and secondary care;
To estimate crude mortality rate for the total population and for children under five years of age before and after the SPLA advance into Equatoria, South Sudan;
To identify major causes of death, by age group and sex;
To gain knowledge of violence-related events
Journal Article > ResearchFull Text
Malar J. 6 September 2016; Volume 15 (Issue 1); 455.; DOI:10.1186/s12936-016-1444-x
de Wit MBK, Funk A, Moussally K, Nkuba DA, Siddiqui R, et al.
Malar J. 6 September 2016; Volume 15 (Issue 1); 455.; DOI:10.1186/s12936-016-1444-x
BACKGROUND
Between 2009 and 2012, malaria cases diagnosed in a Médecins sans Frontières programme have increased fivefold in Baraka, South Kivu, Democratic Republic of the Congo (DRC). The cause of this increase is not known. An in vivo drug efficacy trial was conducted to determine whether increased treatment failure rates may have contributed to the apparent increase in malaria diagnoses.
METHODS
In an open-randomized non-inferiority trial, the efficacy of artesunate-amodiaquine (ASAQ) was compared to artemether-lumefantrine (AL) for the treatment of uncomplicated falciparum malaria in 288 children aged 6-59 months. Included children had directly supervised treatment and were then followed for 42 days with weekly clinical and parasitological evaluations. The blood samples of children found to have recurring parasitaemia within 42 days were checked by PCR to confirm whether or not this was due to reinfection or recrudescence (i.e. treatment failure).
RESULTS
Out of 873 children screened, 585 (67%) were excluded and 288 children were randomized to either ASAQ or AL. At day 42 of follow up, the treatment efficacy of ASAQ was 78% before and 95% after PCR correction for re-infections. In the AL-arm, treatment efficacy was 84% before and 99.0% after PCR correction. Treatment efficacy after PCR correction was within the margin of non-inferiority as set for this study. Fewer children in the AL arm reported adverse reactions.
CONCLUSIONS
ASAQ is still effective as a treatment for uncomplicated malaria in Baraka, South Kivu, DRC. In this region, AL may have higher efficacy but additional trials are required to draw this conclusion with confidence. The high re-infection rate in South-Kivu indicates intense malaria transmission.
Trial registration NCT02741024.
Between 2009 and 2012, malaria cases diagnosed in a Médecins sans Frontières programme have increased fivefold in Baraka, South Kivu, Democratic Republic of the Congo (DRC). The cause of this increase is not known. An in vivo drug efficacy trial was conducted to determine whether increased treatment failure rates may have contributed to the apparent increase in malaria diagnoses.
METHODS
In an open-randomized non-inferiority trial, the efficacy of artesunate-amodiaquine (ASAQ) was compared to artemether-lumefantrine (AL) for the treatment of uncomplicated falciparum malaria in 288 children aged 6-59 months. Included children had directly supervised treatment and were then followed for 42 days with weekly clinical and parasitological evaluations. The blood samples of children found to have recurring parasitaemia within 42 days were checked by PCR to confirm whether or not this was due to reinfection or recrudescence (i.e. treatment failure).
RESULTS
Out of 873 children screened, 585 (67%) were excluded and 288 children were randomized to either ASAQ or AL. At day 42 of follow up, the treatment efficacy of ASAQ was 78% before and 95% after PCR correction for re-infections. In the AL-arm, treatment efficacy was 84% before and 99.0% after PCR correction. Treatment efficacy after PCR correction was within the margin of non-inferiority as set for this study. Fewer children in the AL arm reported adverse reactions.
CONCLUSIONS
ASAQ is still effective as a treatment for uncomplicated malaria in Baraka, South Kivu, DRC. In this region, AL may have higher efficacy but additional trials are required to draw this conclusion with confidence. The high re-infection rate in South-Kivu indicates intense malaria transmission.
Trial registration NCT02741024.
Conference Material > Abstract
Verputten M, Gray NSB, Siddiqui R, Mohan H, Borgundvaag E, et al.
MSF Scientific Days International 2020: Research. 20 May 2020
INTRODUCTION
An estimated one in three women globally experience sexual violence (SV) and intimate partner violence. MSF has provided comprehensive medical and psychosocial care for SV and IPV survivors in Port-au-Prince, Haiti, and Delhi, India, since 2015. We aimed to understand the knowledge, attitudes, and practices (KAP) surrounding SV and care-seeking pathways, to improve access to and uptake of services.
METHODS
We conducted two sequential mixed-methods studies between March and October 2018. Quantitative data were collected using a KAP survey in randomly selected households. Qualitative data were collected using in-depth interviews (IDI’s) with key stakeholders and focus group discussions (FGD’s) with community members; in Haiti FGD’s with young people and IDI’s with survivors of SV were also done.
ETHICS
These studies were approved by the ethics committee of the Dr. B.R. Ambedkar Medical College in India (for Delhi), the Comité National de Bioéthique in Haiti (for Port-au-Prince), and the MSF Ethics Review Board (for both).
RESULTS
2340 people participated in household surveys: 1083 in Haiti and 1257 in India. Qualitative data were collated for 382 individuals: 289 in Haiti (24 adult FGD’s, eight youth FGD’s, 15 IDI’s with key stakeholders and eight IDI’s with SV survivors during their follow-up visit) and 93 in India (14 adult FGD’s and 12 IDI’s with health workers). We found an almost universal perceived need for medical care for SV survivors, mostly for injury treatment. However, in both contexts, participants described numerous issues perceived to hinder or prevent survivors seeking and accessing care. Shame, fear of stigma, and social consequences were the most significant barriers reported, compounded by major service-level barriers. There were also context-specific factors. In India, lower knowledge of health consequences and available treatment, combined with media-influenced perceptions of rape as a physically violent event and a 'police issue' were major barriers, compounded by mandatory police reporting and a lack of confidentiality in health facilities. In Haiti, knowledge of medical consequences and care needs was higher than in India, but perceived lack of services, their inaccessibility, and high costs impeded access to care. Participants in both studies explained that most survivors were likely to stay silent. Those who would seek medical help would do so only should physical consequences (eg injuries) arise. A key factor facilitating access to care was support from trusted confidants; improving access would require enhancing social support and facilitating community referral networks, combined with ensuring provision and awareness of quality, comprehensive, confidential care.
CONCLUSION
Sociocultural conceptualisations and structural responses to SV influence perceived and lived consequences for survivors, shaping engagement with support and available services. These findings inform MSF's SV response, supporting adaptation of modalities of care provision and augmenting local knowledge and networks to improve access. We propose a model for understanding context-specific factors affecting access to survivor-centred care in different settings, to better inform development of strategies and activities to improve access and service utilisation.
CONFLICTS OF INTEREST
None declared.
An estimated one in three women globally experience sexual violence (SV) and intimate partner violence. MSF has provided comprehensive medical and psychosocial care for SV and IPV survivors in Port-au-Prince, Haiti, and Delhi, India, since 2015. We aimed to understand the knowledge, attitudes, and practices (KAP) surrounding SV and care-seeking pathways, to improve access to and uptake of services.
METHODS
We conducted two sequential mixed-methods studies between March and October 2018. Quantitative data were collected using a KAP survey in randomly selected households. Qualitative data were collected using in-depth interviews (IDI’s) with key stakeholders and focus group discussions (FGD’s) with community members; in Haiti FGD’s with young people and IDI’s with survivors of SV were also done.
ETHICS
These studies were approved by the ethics committee of the Dr. B.R. Ambedkar Medical College in India (for Delhi), the Comité National de Bioéthique in Haiti (for Port-au-Prince), and the MSF Ethics Review Board (for both).
RESULTS
2340 people participated in household surveys: 1083 in Haiti and 1257 in India. Qualitative data were collated for 382 individuals: 289 in Haiti (24 adult FGD’s, eight youth FGD’s, 15 IDI’s with key stakeholders and eight IDI’s with SV survivors during their follow-up visit) and 93 in India (14 adult FGD’s and 12 IDI’s with health workers). We found an almost universal perceived need for medical care for SV survivors, mostly for injury treatment. However, in both contexts, participants described numerous issues perceived to hinder or prevent survivors seeking and accessing care. Shame, fear of stigma, and social consequences were the most significant barriers reported, compounded by major service-level barriers. There were also context-specific factors. In India, lower knowledge of health consequences and available treatment, combined with media-influenced perceptions of rape as a physically violent event and a 'police issue' were major barriers, compounded by mandatory police reporting and a lack of confidentiality in health facilities. In Haiti, knowledge of medical consequences and care needs was higher than in India, but perceived lack of services, their inaccessibility, and high costs impeded access to care. Participants in both studies explained that most survivors were likely to stay silent. Those who would seek medical help would do so only should physical consequences (eg injuries) arise. A key factor facilitating access to care was support from trusted confidants; improving access would require enhancing social support and facilitating community referral networks, combined with ensuring provision and awareness of quality, comprehensive, confidential care.
CONCLUSION
Sociocultural conceptualisations and structural responses to SV influence perceived and lived consequences for survivors, shaping engagement with support and available services. These findings inform MSF's SV response, supporting adaptation of modalities of care provision and augmenting local knowledge and networks to improve access. We propose a model for understanding context-specific factors affecting access to survivor-centred care in different settings, to better inform development of strategies and activities to improve access and service utilisation.
CONFLICTS OF INTEREST
None declared.
Journal Article > ResearchFull Text
Confl Health. 16 September 2013; Volume 7 (Issue 1); DOI:10.1186/1752-1505-7-19
de Jong K, Shanks L, Ariti C, Denault M, Siddiqui R, et al.
Confl Health. 16 September 2013; Volume 7 (Issue 1); DOI:10.1186/1752-1505-7-19
Medecins Sans Frontieres (MSF) provides individual counselling interventions in medical humanitarian programmes in contexts affected by conflict and violence. Although mental health and psychosocial interventions are a common part of the humanitarian response, little is known about how the profile and outcomes for individuals seeking care differs across contexts. We did a retrospective analysis of routine programme data to determine who accessed MSF counselling services and why, and the individual and programmatic risk factors for poor outcomes.