Benjumea-Bedoya, Dione http://orcid.org/0000-0002-4004-2219
Villegas Arbeláez, Esteban
Martínez-Peñaloza, Daniela
Beltrán-Arroyave, Claudia Patricia
Restrepo Gouzy, Andrea Victoria
Marín, Diana
Cadavid Álvarez, Lina Marcela
Molinares, Beatriz
Montes Zuluaga, Fernando Nicolás
Pulido Duarte, Henry
Suárez Parra, Pedro Mauricio
Alzate Ángel, Juan Carlos
Vélez-Parra, Guillermo
Realpe, Teresa
Vásquez Villa, Marisol
Ríos Buitrago, Stefani Yamile
Puerta Zapata, Jenifer
Arango García, Lisandra María
Perea Torres, Yesenia
Pérez Doncel, Natalia
Arbeláez Montoya, María Patricia
Robledo, Jaime
Funding for this research was provided by:
Ministerio de Ciencia Tecnología e Innovación de Colombia (902-2019, 088-2021)
Article History
Received: 19 September 2022
Accepted: 12 December 2022
First Online: 19 January 2023
Declarations
:
: The present work follows the guidelines according to the 8430 of 1993 resolution of the Ministry of Health of Colombia and the Declaration of Helsinki, and it has the Research Ethics Committee approval of <i>Corporación para Investigaciones Biológicas</i> (Record June 10<sup>th</sup>, 2019) and <i>Universidad Pontificia Bolivariana</i> (Record N° 24 from November 30<sup>th</sup>, 2020).During the first field visit, parents or guardians are socialized about the project to obtain authorization to be contacted by the research team. Once this authorization is given, during the initial phone call, children with their parents are invited to participate in the study, highlighting the voluntary nature of the project and the importance of ruling out an infection. When they manage to assist to the first meeting, the informed consent is read to participate in the study of diagnostic tests, which involves collecting biological samples. The identification of the child, as well as the information provided throughout the investigation, is protected and encrypted to preserve the privacy of the participants, which is kept even if they later decide not to continue. Subsequently, there is an informed assent, where the process that is going to be conducted is explained to the child in plain language for their age. If the child continues in the integrated care strategy, a new informed consent process is conducted for the activity. The activities to do, the potential risks and the measures taken to minimize them are also explained.Following the research requirements, this study has a civil liability insurance policy to benefit participants with health damage caused by the integrated care strategy.The Principal Investigator has access to the final trial dataset and is responsible for providing access to staff members who require it for research purposes.The plan for disseminating the results include socialization to the regional health authorities, a description of the results to participants either during the last assessment, by telephone contact or in group socialization, a presentation at a scientific event, and a scientific publication. The authorship of the scientific publication of the results will be defined according to the standards of the International Committee of Medical Journal Editors (ICMJE).This study was registered at ClinicalTrials.gov and identified as NCT04331262 “Implementation of an Integrated Care Strategy for Children Contacts of Patients with Tuberculosis”.This study is funded through a call from the <i>Ministerio de Ciencia, Tecnología e Innovación of Colombia</i> (Minciencias), which has no role in conducting the study. Research group members from different institutions and staff members are responsible for data collection, ensuring data accuracy, and reporting adverse events and protocol deviations to the Research Ethics Committee. There is no independent data monitoring committee.
: Not applicable.
: The authors declare that they have no competing interests.