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      Todurujo na Kadurok (empowering youth): study protocol of an HIV self-testing and edutainment comic cluster randomised trial among refugee youth in a humanitarian setting in Uganda

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          Abstract

          Introduction

          Refugees experience HIV vulnerabilities due to the confluence of displacement, violence and poverty. HIV self-testing, understudied with refugees, is a promising method to increase testing uptake, yet challenges remain with linkages to confirmatory testing following a positive HIV self-test. This study aims to evaluate the effectiveness of HIV self-testing kits and ‘edutainment’ comics in increasing HIV testing and HIV status knowledge among refugee youth aged 16–24 years in Bidi Bidi Refugee Settlement, Uganda.

          Methods and analysis

          This study will be conducted in Bidi Bidi. We conducted a qualitative formative phase with focus groups (n=40) to generate knowledge of barriers and facilitators of HIV prevention, testing and care among refugee youth (aged 16–24) in Bidi Bidi. These findings were used to create comic scenarios aligning with edutainment approaches to health promotion and inform a four-arm cluster randomised controlled trial in Bidi Bidi using a 2×2 factorial design: (1) HIV self-testing alongside edutainment comics, (2) HIV self-testing alone, (3) edutainment comic alone and (4) standard of care. The target sample size will be 120 youth (30 per arm), who will be enrolled in the trial and followed for 3 months. Data will be collected at baseline and 3 months after enrolment. The primary outcomes (HIV testing frequency, HIV status knowledge) and secondary outcomes (linkage to confirmatory HIV testing, HIV care linkage, HIV self-test kit use, HIV-related stigma, HIV knowledge, safer sex efficacy, condom use, adolescent sexual and reproductive health (SRH) stigma, sexual relationship power, access to SRH services) will be evaluated using descriptive statistics and regression analyses.

          Ethics and dissemination

          This study was approved by the University of Toronto Research Ethics Board, Mildmay Uganda Research Ethics Committee and the Uganda National Council for Science and Technology. Results will be shared in peer-reviewed publications and community knowledge sharing.

          Trial registration number

          NCT05213689.

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          Most cited references60

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          G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences

          G*Power (Erdfelder, Faul, & Buchner, 1996) was designed as a general stand-alone power analysis program for statistical tests commonly used in social and behavioral research. G*Power 3 is a major extension of, and improvement over, the previous versions. It runs on widely used computer platforms (i.e., Windows XP, Windows Vista, and Mac OS X 10.4) and covers many different statistical tests of the t, F, and chi2 test families. In addition, it includes power analyses for z tests and some exact tests. G*Power 3 provides improved effect size calculators and graphic options, supports both distribution-based and design-based input modes, and offers all types of power analyses in which users might be interested. Like its predecessors, G*Power 3 is free.
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            SPIRIT 2013 statement: defining standard protocol items for clinical trials.

            The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.
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              SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

              High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.
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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
                2022
                23 November 2022
                : 12
                : 11
                : e065452
                Affiliations
                [1 ]departmentFactor-Inwentash Faculty of Social Work , University of Toronto , Toronto, Ontario, Canada
                [2 ]departmentWomen's College Research Institute , University of Toronto , Toronto, Ontario, Canada
                [3 ]United Nations University Institute for Water, Environment and Health (UNU-INWEH) , Hamilton, Ontario, Canada
                [4 ]Centre for Gender & Sexual Health Equity , Vancouver, British Columbia, Canada
                [5 ]departmentSchool of Social Work , University of Illinois-Champaign , Urbana, Illinois, USA
                [6 ]departmentSchool of Social Sciences , Uganda Christian University , Mukono, Uganda
                [7 ]departmentDalla Lana School of Public Health , University of Toronto , Toronto, Ontario, Canada
                [8 ]departmentDepartment of Sociology , University of Toronto , Toronto, Ontario, Canada
                [9 ]University of Cape Town , Rondebosch, South Africa
                [10 ]departmentSchool of Health Studies, Faculty of Health Sciences , Western University , London, ON, Canada
                [11 ]Uganda Refugee and Disaster Management Council , Yumbe, Uganda
                [12 ]Yumbe Regional Referral Hospital , Yumbe, Uganda
                [13 ]departmentMost at Risk Population Initiative , Mulago Hospital , Kampala, Uganda
                Author notes
                [Correspondence to ] Professor Carmen H Logie; carmen.logie@ 123456utoronto.ca
                Author information
                http://orcid.org/0000-0002-8035-433X
                Article
                bmjopen-2022-065452
                10.1136/bmjopen-2022-065452
                9685005
                36418143
                a4a99944-6865-4121-860f-2f26c2cfa301
                © Author(s) (or their employer(s)) 2022. 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
                : 09 June 2022
                : 26 October 2022
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100001804, Canada Research Chairs;
                Award ID: Tier 2
                Funded by: FundRef http://dx.doi.org/10.13039/501100000196, Canada Foundation for Innovation;
                Award ID: JELF
                Funded by: ViiV Healthcare Limited;
                Award ID: Grant#628520-1652450711
                Funded by: FundRef http://dx.doi.org/10.13039/501100003400, Ontario Ministry of Research, Innovation and Science;
                Award ID: ERA
                Categories
                HIV/AIDS
                1506
                Protocol
                Custom metadata
                unlocked

                Medicine
                hiv & aids,public health,preventive medicine
                Medicine
                hiv & aids, public health, preventive medicine

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