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      Trials and tribulations of conducting interventional studies in urban slums of a developing country: Experiences from Kolkata, India

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          Abstract

          Experimental studies involving human subjects provide most internally valid evidences in epidemiological research due to their robust methodology. While conducting population-based interventional studies, to achieve external validity, inclusion of information from vulnerable groups like urban slum-dwellers of the developing world, in the epidemiological estimates is of paramount importance. The challenges faced while conducting 2 consecutive large-scale, community-based vaccine trials in urban slums of Kolkata, India are presented in this article. Interventions in these communities often get constrained by issues pertaining to human rights and benefits, socio-cultural factors, political environment, methodological shortcomings in addition to the challenges in ensuring community participation. While conducting these trials although we intermittently faced obstacles, by virtue of having a long term and robust surveillance system and developing a trusted relationship between the researchers, community leaders and residents we were able to come up with a commendable community participation which culminated into the success of the interventions. Bridging the gap between research and field operations by incorporating knowledge gathered from interventional studies and making strategies to improve health conditions of these informal settlers is a major unfulfilled agenda. We believe the lessons learnt during our research will help researchers while developing efficient interventions in similar setting.

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          Most cited references18

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          Community-based participatory research contributions to intervention research: the intersection of science and practice to improve health equity.

          Community-based participatory research (CBPR) has emerged in the last decades as a transformative research paradigm that bridges the gap between science and practice through community engagement and social action to increase health equity. CBPR expands the potential for the translational sciences to develop, implement, and disseminate effective interventions across diverse communities through strategies to redress power imbalances; facilitate mutual benefit among community and academic partners; and promote reciprocal knowledge translation, incorporating community theories into the research. We identify the barriers and challenges within the intervention and implementation sciences, discuss how CBPR can address these challenges, provide an illustrative research example, and discuss next steps to advance the translational science of CBPR.
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            Barriers to participation in randomised controlled trials: a systematic review.

            A systematic review of three bibliographic databases from 1986 to 1996 identified 78 papers reporting barriers to recruitment of clinicians and patients to randomised controlled trials. Clinician barriers included: time constraints, lack of staff and training, worry about the impact on the doctor-patient relationship, concern for patients, loss of professional autonomy, difficulty with the consent procedure, lack of rewards and recognition, and an insufficiently interesting question. Patient barriers included: additional demands of the trial, patient preferences, worry caused by uncertainty, and concerns about information and consent. To overcome barriers to clinician recruitment, the trial should address an important research question and the protocol and data collection should be as straightforward as possible. The demands on clinicians and patients should be kept to a minimum. Dedicated research staff may be required to support clinical staff and patients. The recruitment aspects of a randomised controlled trial should be carefully planned and piloted. Further work is needed to quantify the extent of problems associated with clinician and patient participation, and proper evaluation is required of strategies to overcome barriers.
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              Reconsidering community-based health promotion: promise, performance, and potential.

              Contemporary public health emphasizes a community-based approach to health promotion and disease prevention. The evidence from the past 20 years indicates, however, that many community-based programs have had only modest impact, with the notable exception of a number of HIV prevention programs. To better understand the reasons for these outcomes, we conducted a systematic literature review of 32 community-based prevention programs. Reasons for poor performance include methodological challenges to study design and evaluation, concurrent secular trends, smaller-than-expected effect sizes, limitations of the interventions, and limitations of theories used. The effectiveness of HIV programs appears to be related in part to extensive formative research and an emphasis on changing social norms.
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                Author and article information

                Journal
                Hum Vaccin Immunother
                Hum Vaccin Immunother
                KHVI
                khvi20
                Human Vaccines & Immunotherapeutics
                Taylor & Francis
                2164-5515
                2164-554X
                January 2016
                29 July 2015
                29 July 2015
                : 12
                : 1
                : 182-186
                Affiliations
                [1 ]National Institute of Cholera and Enteric Diseases ; Kolkata, India
                [2 ]University of the Philippines; National Institutes of Health ; Manila, Philippines
                [3 ]International Vaccine Institute ; Seoul, Republic of Korea
                [4 ]The National Academy of Sciences ; Allahabad, Uttar Pradesh, India
                Author notes
                [* ]Correspondence to: Suman Kanungo; Email: sumankanungo@ 123456gmail.com
                Article
                1066052
                10.1080/21645515.2015.1066052
                4962717
                26224251
                70d4ae42-2b58-48b4-82ee-e0e331600380
                © 2015 The Author(s). Published with license by Taylor & Francis Group, LLC

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-Non-Commercial License ( http://creativecommons.org/licenses/by-nc/3.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. The moral rights of the named author(s) have been asserted.

                History
                : 4 June 2015
                : 21 June 2015
                Page count
                Figures: 0, Tables: 0, References: 26, Pages: 5
                Categories
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                Molecular medicine
                conducting vaccine trials,lessons from interventional studies,randomized control trial,trials and tribulations,urban slums

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