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      Measuring the burden of SARS-CoV-2 infection among persons living with HIV and healthcare workers and its impact on service delivery in Mozambique: protocol of a prospective cohort study

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          Abstract

          Introduction

          As COVID-19 continues to spread globally and within Mozambique, its impact among immunosuppressed persons, specifically persons living with HIV (PLHIV), and on the health system is unknown in the country. The ‘ COVid and h IV’ (COVIV) study aims to investigate: (1) the seroprevalence and seroincidence of SARS-CoV-2 among PLHIV and healthcare workers providing HIV services; (2) knowledge, attitudes, practices and perceptions regarding SARS-CoV-2 infection; (3) the pandemic’s impact on HIV care continuum outcomes and (4) facility level compliance with national COVID-19 guidelines.

          Methods and analysis

          A multimethod study will be conducted in a maximum of 11 health facilities across Mozambique, comprising four components: (1) a cohort study among PLHIV and healthcare workers providing HIV services to determine the seroprevalence and seroincidence of SARS-CoV-2, (2) a structured survey to assess knowledge, attitudes, perceptions and practices regarding COVID-19 disease, (3) analysis of aggregated patient data to evaluate retention in HIV services among PLHIV, (4) an assessment of facility implementation of infection prevention and control measures.

          Ethics and dissemination

          Ethical approval was obtained from the National Health Bioethics Committee, and institutional review boards of implementing partners. Study findings will be discussed with local and national health authorities and key stakeholders and will be disseminated in clinical and scientific forums.

          Trial registration number

          NCT05022407.

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          Most cited references23

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          Using thematic analysis in psychology

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            Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.

            Research electronic data capture (REDCap) is a novel workflow methodology and software solution designed for rapid development and deployment of electronic data capture tools to support clinical and translational research. We present: (1) a brief description of the REDCap metadata-driven software toolset; (2) detail concerning the capture and use of study-related metadata from scientific research teams; (3) measures of impact for REDCap; (4) details concerning a consortium network of domestic and international institutions collaborating on the project; and (5) strengths and limitations of the REDCap system. REDCap is currently supporting 286 translational research projects in a growing collaborative network including 27 active partner institutions.
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              The REDCap consortium: Building an international community of software platform partners

              The Research Electronic Data Capture (REDCap) data management platform was developed in 2004 to address an institutional need at Vanderbilt University, then shared with a limited number of adopting sites beginning in 2006. Given bi-directional benefit in early sharing experiments, we created a broader consortium sharing and support model for any academic, non-profit, or government partner wishing to adopt the software. Our sharing framework and consortium-based support model have evolved over time along with the size of the consortium (currently more than 3200 REDCap partners across 128 countries). While the "REDCap Consortium" model represents only one example of how to build and disseminate a software platform, lessons learned from our approach may assist other research institutions seeking to build and disseminate innovative technologies.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2023
                6 June 2023
                6 June 2023
                : 13
                : 6
                : e068988
                Affiliations
                [1 ] departmentEvaluations Department , Ringgold_637151Friends in Global Health Mozambique Office , Maputo, Mozambique
                [2 ] departmentDelegation Maputo City , Ringgold_586683Instituto Nacional de Saúde , Maputo, Mozambique
                [3 ] departmentDivision of Science , US Centers for Disease Control and Prevention , Maputo, Mozambique
                [4 ] departmentResearch Department , Ringgold_158348Elizabeth Glaser Pediatric AIDS Foundation , Washington, District of Columbia, USA
                [5 ] departmentResearch Department , Ringgold_158348Elizabeth Glaser Pediatric AIDS Foundation , Maputo, Mozambique
                [6 ] departmentSenior Leadership , Ringgold_560848ICAP at Columbia University , Maputo, Mozambique
                [7 ] departmentDepartment of Monitoring & Evaluation , Jhpiego , Maputo, Mozambique
                [8 ] departmentEvaluation Department , Fundação Ariel Glaser contra o SIDA Pediátrico , Maputo, Mozambique
                [9 ] departmentSenior Leadership , Abt Associates (at time of protocol writing) , Maputo, Mozambique
                [10 ] departmentDepartment of Strategic Information , Ringgold_560775Centro de Colaboração em Saúde , Maputo, Mozambique
                [11 ] departmentDepartment of Biostatistics , Ringgold_12328Vanderbilt University Medical Center , Nashville, Tennessee, USA
                Author notes
                [Correspondence to ] Dr Caroline De Schacht; caroline.deschacht@ 123456fgh.org.mz
                Author information
                http://orcid.org/0000-0001-5384-2410
                Article
                bmjopen-2022-068988
                10.1136/bmjopen-2022-068988
                10254687
                37280029
                556d0c52-ffcb-4c0d-886d-f0794e478a06
                © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 07 October 2022
                : 15 May 2023
                Funding
                Funded by: Agency for International Development (USAID);
                Award ID: NA
                Funded by: United States Centers for Disease Control and Prevention (CDC);
                Award ID: NU2GGH001309/NU2GGH002368
                Award ID: NU2GGH001915
                Award ID: NU2GGH001943/NU2GGH002367
                Award ID: NU2GGH002369
                Award ID: NU2GGH002372
                Categories
                Epidemiology
                1506
                2474
                1692
                Protocol
                Custom metadata
                unlocked
                free

                Medicine
                hiv & aids,covid-19,epidemiology
                Medicine
                hiv & aids, covid-19, epidemiology

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