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Previous Versions BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay-per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email [email protected] BMJ Open Digital Health Literacy Intervention to Support Maternal, Child and Family Health in Primary Healthcare Settings of Pakistan during the Age of Coronavirus: Study Protocol for a Randomized Controlled Trial ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2020-045163 Article Type: Protocol Date Submitted by the 25-Sep-2020 Author: Complete List of Authors: Jafree, Sara; Forman Christian College, Department of Sociology Bukhari, Nadia; University College London, School of Pharmacy Muzamill, Anam; Forman Christian College, Department of Mass Communications Tasneem, Faiza; Forman Christian College, Department of Business Fischer, Florian; Charité Universitätsmedizin Berlin, Institute of Public Health; University of Applied Sciences Ravensburg-Weingarten, Doggenriedstraße Maternal medicine < OBSTETRICS, Community child health < Keywords: PAEDIATRICS, COVID-19, PRIMARY CARE For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 64 BMJ Open 1 2 3 4 5 6 7 8 9 I, the Submitting Author has the right to grant and does grant on behalf of all authors of the Work (as defined 10 in the below author licence), an exclusive licence and/or a non-exclusive licence for contributions from authors 11 who are: i) UK Crown employees; ii) where BMJ has agreed a CC-BY licence shall apply, and/or iii) in accordance 12 with the terms applicable for US Federal Government officers or employees acting as part of their official 13 duties; on a worldwide, perpetual, irrevocable, royalty-free basis to BMJ Publishing Group Ltd (“BMJ”) its 14 licensees and where the relevant Journal is co-owned by BMJ to the co-owners of the Journal, to publish the 15 Work in this journal and any other BMJ products and to exploit all rights, as set out in our licence. 16 17 The Submitting Author accepts and understands that any supply made under these terms is made by BMJ to 18 the Submitting Author Forunless you peer are acting as review an employee on behalf only of your employer or a postgraduate 19 student of an affiliated institution which is paying any applicable article publishing charge (“APC”) for Open 20 Access articles. Where the Submitting Author wishes to make the Work available on an Open Access basis (and 21 intends to pay the relevant APC), the terms of reuse of such Open Access shall be governed by a Creative 22 Commons licence – details of these licences and which Creative Commons licence will apply to this Work are set 23 out in our licence referred to above. 24 25 Other than as permitted in any relevant BMJ Author’s Self Archiving Policies, I confirm this Work has not been 26 accepted for publication elsewhere, is not being considered for publication elsewhere and does not duplicate 27 material already published. I confirm all authors consent to publication of this Work and authorise the granting 28 of this licence. 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 64 786 1 2 3 Digital Health Literacy Intervention to Support Maternal, Child and Family Health in 4 5 Primary Healthcare Settings of Pakistan during the Age of Coronavirus: Study Protocol 6 for a Randomized Controlled Trial 7 8 9 Sara Rizvi Jafree, Nadia Bukhari, Anam Muzammil, Faiza Tasneem, Florian Fischer 10 11 Dr. Sara Rizvi Jafree 12 13 Department of Sociology, Forman Christian College University, Lahore, Pakistan 14 [email protected] 15 16 For peer review only 17 Nadia Bukhari 18 School of Pharmacy, University College London, London, United Kingdom 19 [email protected] 20 21 22 Anam Muzammil 23 Department of Mass Communications, Forman Christian College University, Lahore, Pakistan 24 [email protected] 25 26 27 Faiza Tasneem 28 Department of Business, Forman Christian College University, Lahore, Pakistan 29 30 [email protected] 31 32 Dr. Florian Fischer 33 34 1) Institute of Public Health, Charité – Universitätsmedizin Berlin, Berlin, Germany 35 2) Institute of Gerontological Health Services and Nursing Research, Ravensburg- 36 Weingarten University of Applied Sciences, Weingarten, Germany 37 38 [email protected] 39 40 Corresponding author: 41 42 Dr. Florian Fischer 43 Charité – Universitätsmedizin Berlin 44 Institute of Public Health 45 46 Charitéplatz 1 47 10117 Berlin 48 E-Mail: [email protected] 49 50 51 52 Word count: 3,592 53 54 55 56 57 58 - 1 - 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 64 BMJ Open 786 1 2 3 1 Abstract 4 5 6 2 Introduction: There is a need to continue primary healthcare services through digital 7 8 3 communication for disadvantaged women living in underdeveloped areas of Pakistan, especially 9 10 4 in the age of the coronavirus pandemic, social distancing, and lockdown of communities. This 11 12 5 project will be the first of its kind in aiming to provide women with a smartphone and access for 13 14 15 6 a digital health literacy intervention through community healthcare workers. The majority of poor 16 For peer review only 17 7 women in Pakistan is dependent on primary health services, because 1) they suffer more from 18 19 8 health challenges compared to men due to multiple social and structural disadvantages, 2) they are 20 21 22 9 the dominant care-providers and nurturers in the home, and 3) they need support in understanding 23 24 10 public health messages during health crises due to low health literacy and awareness. 25 26 11 Methods and analysis: The digital health literacy intervention will be delivered in two target areas: 27 28 29 12 (i) hygiene and sanitation, and (ii) awareness and prevention related to the coronavirus. Women 30 31 13 will be sampled from disadvantaged areas across the four provinces of Pakistan (Baluchistan, 32 33 14 KPK, Punjab, and Sindh) and the autonomous territory Gilgit-Baltistan. A target of 1,000 women 34 35 15 will comprise the sample with 500 women each assigned randomly to the intervention and control 36 37 38 16 group. ANOVA will be used for analyzing the intervention’s effects compared to the control 39 40 17 group. 41 42 18 Dissemination: Results will be disseminated to the international scientific community and 43 44 45 19 stakeholders in Pakistan. 46 47 20 48 49 21 Keywords: digital health literacy, primary healthcare, community healthcare workers, maternal 50 51 52 22 and child health, COVID-19, RCT 53 54 23 Trial Registration: Registered at clinicaltrials.gov (NCT04603092) 55 56 57 58 - 2 - 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 64 786 1 2 3 24 Ethics Committee Approval: Internal Review Board of the Forman Christian College University; 4 5 6 25 Approval reference number: IRB-252/06-2020 7 8 26 9 10 27 Strengths and limitations of the study 11 12 13 28 This is the first randomized controlled trial investigating the effects of a digital health 14 15 29 literacy intervention in Pakistan. 16 For peer review only 17 30 Using a two-step approach of pre-testing, we aim to establish an intervention tailored to 18 19 20 31 the needs of study participants. 21 22 32 The study results are not only relevant for digital interventions in general, but particularly 23 24 33 in times of the coronavirus pandemic, where social distancing hinders the provision of 25 26 27 34 health interventions personally. 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 - 3 - 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 5 of 64 BMJ Open 786 1 2 3 35 Introduction 4 5 6 36 South Asia is home to 25% of the world population, the majority of them is poor and without 7 8 37 universal health coverage. Research has estimated that 1 in 10 South Asians face health challenges, 9 10 38 multimorbidity, and risk of infectious disease; with each additional morbidity carrying greater risk 11 12 39 of mortality [1, 2]. Pakistan’s healthcare sector is known to be under-resourced and inefficient, 13 14 15 40 with health budget allocation standing at less than 1.5% of gross domestic product [3]. Primary 16 For peer review only 17 41 healthcare services in Pakistan are not adequate or well planned, contributing to the infectious 18 19 42 disease burden in the country [4].
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