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      Pilot phase of an internet-based RCT of HIVST targeting MSM and transgender people in England and Wales: advertising strategies and acceptability of the intervention

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          Abstract

          Background

          The SELPHI study (An HIV Self-Testing Public Health Intervention) is an online randomised controlled trial (RCT) of HIV self-testing (HIVST). The aim of this study was to assess the feasibility of recruiting UK men who have sex with men (cis and trans) and trans women who have sex with men to the SELPHI pilot, and the acceptability of the HIVST intervention used among those randomised to receive a kit.

          Methods

          A mixed-methods approach to assessing trial feasibility and intervention acceptability was taken, using quantitative data from advertising sources and RCT surveys alongside qualitative data from a nested sub-study.

          Results

          Online recruitment and intervention delivery was feasible. The recruitment strategy led to the registration of 1370 participants of whom 76% (1035) successfully enrolled and were randomised 60/40 to baseline testing vs no baseline testing. Advertising platforms performed variably. Reported HIVST kit use increased from 83% at two weeks to 96% at three months. Acceptability was very high across all quantitative measures. Participants described the instructions as easy to use, and the testing process as simple. The support structures in SELPHI were felt to be adequate. Described emotional responses to HIVST varied.

          Conclusions

          Recruiting to a modest sized HIVST pilot RCT is feasible, and the recruitment, intervention and HIVST kit were acceptable. Research on support needs of individuals with reactive results is warranted.

          Electronic supplementary material

          The online version of this article (10.1186/s12879-019-4247-1) contains supplementary material, which is available to authorized users.

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          Most cited references37

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          The behaviour change wheel: A new method for characterising and designing behaviour change interventions

          Background Improving the design and implementation of evidence-based practice depends on successful behaviour change interventions. This requires an appropriate method for characterising interventions and linking them to an analysis of the targeted behaviour. There exists a plethora of frameworks of behaviour change interventions, but it is not clear how well they serve this purpose. This paper evaluates these frameworks, and develops and evaluates a new framework aimed at overcoming their limitations. Methods A systematic search of electronic databases and consultation with behaviour change experts were used to identify frameworks of behaviour change interventions. These were evaluated according to three criteria: comprehensiveness, coherence, and a clear link to an overarching model of behaviour. A new framework was developed to meet these criteria. The reliability with which it could be applied was examined in two domains of behaviour change: tobacco control and obesity. Results Nineteen frameworks were identified covering nine intervention functions and seven policy categories that could enable those interventions. None of the frameworks reviewed covered the full range of intervention functions or policies, and only a minority met the criteria of coherence or linkage to a model of behaviour. At the centre of a proposed new framework is a 'behaviour system' involving three essential conditions: capability, opportunity, and motivation (what we term the 'COM-B system'). This forms the hub of a 'behaviour change wheel' (BCW) around which are positioned the nine intervention functions aimed at addressing deficits in one or more of these conditions; around this are placed seven categories of policy that could enable those interventions to occur. The BCW was used reliably to characterise interventions within the English Department of Health's 2010 tobacco control strategy and the National Institute of Health and Clinical Excellence's guidance on reducing obesity. Conclusions Interventions and policies to change behaviour can be usefully characterised by means of a BCW comprising: a 'behaviour system' at the hub, encircled by intervention functions and then by policy categories. Research is needed to establish how far the BCW can lead to more efficient design of effective interventions.
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            Validation of the theoretical domains framework for use in behaviour change and implementation research

            Background An integrative theoretical framework, developed for cross-disciplinary implementation and other behaviour change research, has been applied across a wide range of clinical situations. This study tests the validity of this framework. Methods Validity was investigated by behavioural experts sorting 112 unique theoretical constructs using closed and open sort tasks. The extent of replication was tested by Discriminant Content Validation and Fuzzy Cluster Analysis. Results There was good support for a refinement of the framework comprising 14 domains of theoretical constructs (average silhouette value 0.29): ‘Knowledge’, ‘Skills’, ‘Social/Professional Role and Identity’, ‘Beliefs about Capabilities’, ‘Optimism’, ‘Beliefs about Consequences’, ‘Reinforcement’, ‘Intentions’, ‘Goals’, ‘Memory, Attention and Decision Processes’, ‘Environmental Context and Resources’, ‘Social Influences’, ‘Emotions’, and ‘Behavioural Regulation’. Conclusions The refined Theoretical Domains Framework has a strengthened empirical base and provides a method for theoretically assessing implementation problems, as well as professional and other health-related behaviours as a basis for intervention development.
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              Qualitative data analysis for applied policy research

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                Author and article information

                Contributors
                020 7927 2800 , Charles.Witzel@lshtm.ac.uk
                m.gabriel@ucl.ac.uk
                leanne.mccabe@ucl.ac.uk
                Peter.Weatherburn@lshtm.ac.uk
                mitzy.gafos@lshtm.ac.uk
                a.speakman@ucl.ac.uk
                roger@nam.org.uk
                f.burns@ucl.ac.uk
                chris.bonell@lshtm.ac.uk
                f.lampe@ucl.ac.uk
                d.dunn@ucl.ac.uk
                denise.ward@ucl.ac.uk
                justin@sh24.org.uk
                andrew.phillips@ucl.ac.uk
                s.mccormack@ucl.ac.uk
                alison.rodger@ucl.ac.uk
                Journal
                BMC Infect Dis
                BMC Infect. Dis
                BMC Infectious Diseases
                BioMed Central (London )
                1471-2334
                8 August 2019
                8 August 2019
                2019
                : 19
                : 699
                Affiliations
                [1 ]ISNI 0000 0004 0425 469X, GRID grid.8991.9, Sigma Research, Department of Public Health, Environments & Society, , London School of Hygiene and Tropical Medicine, ; 15-17 Tavistock Place, London, WC1H 9SH UK
                [2 ]ISNI 0000 0004 0606 323X, GRID grid.415052.7, MRC Clinical Trials Unit at UCL, ; London, UK
                [3 ]ISNI 0000 0004 0425 469X, GRID grid.8991.9, Department of Global Health and Development, , London School of Hygiene and Tropical Medicine, ; London, UK
                [4 ]ISNI 0000000121901201, GRID grid.83440.3b, Institute for Global Health, , UCL, ; London, UK
                [5 ]NAM Aidsmap, London, UK
                [6 ]ISNI 0000 0001 0439 3380, GRID grid.437485.9, Royal Free London NHS Foundation Trust, ; London, UK
                [7 ]ISNI 0000 0004 0425 469X, GRID grid.8991.9, Department of Public Health, Environments & Society, , London School of Hygiene and Tropical Medicine, ; London, UK
                [8 ]SH:24, London, UK
                Article
                4247
                10.1186/s12879-019-4247-1
                6686516
                31391003
                440a302f-b4fe-435e-847d-ef65c8019605
                © The Author(s). 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 21 January 2019
                : 1 July 2019
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100007602, Programme Grants for Applied Research;
                Award ID: PG-1212-20006
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2019

                Infectious disease & Microbiology
                hiv self-testing,men who have sex with men,transgender people,randomised controlled trial,online service delivery,implementation science,process evaluation

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