Contributions of authors
Katie Newby (https://orcid.org/0000-0002-9348-0116) (Associate Professor, Health Psychology) conceived the idea for the Wrapped intervention, led the application for fRCT funding, led study delivery and co-wrote this monograph.
Kayleigh Kwah (https://orcid.org/0000-0003-2307-1285) (Senior Research Assistant, Health Psychology) undertook day-to-day management of the study, ran the qualitative data collection and analysis, led on PPI input, led on data management and co-wrote this monograph.
Lauren Schumacher (https://orcid.org/0000-0003-3430-1816) (Senior Research Assistant, Health Psychology) undertook day-to-day management of the study, ran the qualitative data collection and analysis, led on PPI input, led on data management and co-wrote this monograph.
Rik Crutzen (https://orcid.org/0000-0002-3731-6610) (Professor of Behaviour Change and Technology, Health Psychology) supported development of the recruitment and retention strategy and supported study delivery.
Julia V Bailey (https://orcid.org/0000-0002-5001-0122) (Associate Professor, Primary Care) supported measure development and study delivery.
Louise J Jackson (https://orcid.org/0000-0001-8492-0020) (Senior Lecturer, Health Economics) led on the health economic assessment, led on the Wrapped implementation assessment, supported study delivery and co-wrote this monograph.
Stephen Bremner (https://orcid.org/0000-0003-0790-7070) (Professor of Medical Statistics, Statistics) advised on all statistical analysis and reporting of statistics and supported study delivery.
Katherine E Brown (https://orcid.org/0000-0003-2472-5754) (Professor of Behaviour Change in Health, Health Psychology) led on measures development, contributed to the Wrapped implementation assessment, supported study decision-making throughout, provided mentoring to KN and co-wrote this monograph.
Acknowledgements
We would like to thank all participants for their time and commitment to this study and the PPI group for their invaluable contributions. We would also like to thank Preventx Ltd for their support with recruitment and supplying data on the sampling pool, all NHS trusts and associated local authority public health departments who gave permission to us to recruit from their areas and supported study delivery, and all organisations that supported focus group recruitment. Finally, we would like to thank our DMEC and SSC members for their time and expert guidance.
Patient data statement
This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety, and plan NHS services. Patient data should be kept safe and secure, to protect everyone’s privacy, and it’s important that there are safeguards to make sure that they are stored and used responsibly. Everyone should be able to find out about how patient data are used. #datasaveslives You can find out more about the background to this citation here: https://understandingpatientdata.org.uk/data-citation.
Data-sharing statement
All data requests should be submitted to the corresponding author for consideration. Access to anonymised data may be granted following review.
Ethics statement
All participants provided informed consent prior to data collection. Ethics approval for the fRCT and nested qualitative study granted on 16 November 2020 by NHS East Midlands – Leicester Central Research Ethics Committee (reference 20/EM/0275). Ethics approval for the qualitative study embedded within work to develop the recruitment and retention strategy, granted on 4 February 2020 by Health, Science, Engineering and Technology Ethics Committee with Delegated Authority (ECDA) at the University of Hertfordshire (reference LMS/SF/UH/04061). This study was conducted according to the principles expressed in the Declaration of Helsinki.
Information governance statement
The University of Hertfordshire is committed to handling all personal information in line with the UK Data Protection Act (2018) and the General Data Protection Regulation (EU GDPR) 2016/679. Under the Data Protection legislation, the University of Hertfordshire is the Data Controller, and you can find out more about how we handle personal data, including how to exercise your individual rights, and the contact details for our Data Protection Officer here www.herts.ac.uk/about-us/legal/freedom-of-information-data-protection/data-protection.
Disclosure of interests
Full disclosure of interests: Completed ICMJE forms for all authors, including all related interests, are available in the toolkit on the NIHR Journals Library report publication page at https://doi.org/10.3310/LKOT7404.
Primary conflicts of interest: Co-authors Katie Newby, Rik Crutzen, Julia V Bailey, Louise J Jackson, Stephen Bremner and Katherine E Brown received funding from the National Institute for Health and Care Research (NIHR) Public Health Research (PHR) programme to conduct this research (NIHR award NIHR128148) and have since been awarded funding, also from NIHR PHR, to undertake a full trial of the same intervention (NIHR award NIHR157903).
At the time of conducting this study, Wrapped (the intervention under examination) was the Intellectual Property of Coventry University. A license was granted by Coventry University to the University of Hertfordshire to use Wrapped for research purposes for a period of 10 years (26 March 2020–26 March 2030).
Katie Newby was an unpaid committee member of the European Health Psychology Society Specialist Interest Group (SIG) in Digital Health and Computer Tailoring between 2019 and 2023. She is a review panel member for the World Health Organization (WHO) Sexual and Reproductive Health Research Project (unpaid) and a member of the Health and Care Research Wales Integrated Funding Scheme (unpaid).
Kayleigh Kwah has been a committee member of the European Health Psychology Society Specialist Interest Group (SIG) in Digital Health and Computer Tailoring since 2023 (unpaid) and has been a hub coordinator (paid) for the Behavioural Science and Public Health Network (BSPHN) since 2022.
Lauren Schumacher was a hub coordinator (paid) for the Behavioural Science and Public Health Network (BSPHN) between 2021 and 2023.
Stephen Bremner holds the following awards from the National Institute for Health and Care Research: NIHR133889, NIHR203241, 16/31/87, PB-PG-1217-20024, NIHR158476, NIHR156442, 17/54/06, PB-PG-0317-20029.
Copyright and credit statement
Every effort has been made to obtain the necessary permissions for reproduction, to credit original sources appropriately and to respect copyright requirements. However, despite our diligence, we acknowledge the possibility of unintentional omissions or errors and we welcome notifications of any concerns regarding copyright or permissions.
Publications
Newby K, Kwah K, Schumacher L, Crutzen R, Jackson L, Bremner S, et al. Intervention to increase condom use among users of sexually transmitted infection (STI) self-sampling websites (Wrapped): feasibility randomized controlled trial. J Med Internet Res 2025;27:e71611. https://doi.org/10.2196/71611 Schumacher L, Crutzen R, Kwah K, Brown K, Bailey JV, Bremner S, et al. Planning for successful participant recruitment and retention in trials of behavioural interventions: Feasibility randomised controlled trial of the Wrapped intervention. PLOS Digit Health 2025;4:e0000875. https://doi.org/10.1371/journal.pdig.0000875 Schumacher L, Kwah K, Crutzen R, Brown K, Bremner S, Jackson LJ, Newby K. Mixed-methods assessment of engagement with a digital intervention: the Wrapped feasibility randomised controlled trial. medRxiv 2025.09.16.25335892. https://doi.org/10.1101/2025.09.16.25335892
Disclaimers
This article presents independent research funded by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, the PHR programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, the PHR programme or the Department of Health and Social Care.