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Keep up to date with Wrapped with our quarterly newsletters.

Issue 1 - September 2020

Who are we?

We are a group of researchers based at University of Hertfordshire, University of Birmingham, University of Sussex, Maastricht University, and University College London with expertise in sexual health research and conducting clinical trial and analysis.

What is the study about?

The Wrapped Project is a feasibility randomised controlled trial of an interactive digital behaviour change intervention (Wrapped) to decrease incidence of sexually transmitted infections (STIs) amongst users of STI self-sampling websites. Research Question: Is it feasible to run an RCT to test the effectiveness and cost- effectiveness of Wrapped (a fully automated, multi-component and interactive digital behaviour change intervention that aims to reduce the incidence of STIs through increasing correct and consistent condom use amongst users of STI self-sampling websites aged 16-24 years old)?

When did we start?

The Wrapped Project officially launched on 1 May 2020 and will run until August 2022.

What have we done so far?

  • set up Study Steering Committee and Data Monitoring and Ethics Committee meetings
  • Patient and Public Involvement (PPI) group formed and workshops held to develop the recruitment and retention strategy
  • completed preceding qualitative study
  • recruitment and retention strategy finalised
  • instructed our software developers to make updates to the Wrapped website.

What will we be doing over the next three months?

  • finish all updates on intervention and control websites
  • complete protocol paper for publication
  • user testing of all trial procedures.

Disclaimer: This output is the result of independent research funded by the National Institute for Health Research (NIHR Public Health Research, NIHR128148 - An interactive digital behaviour change intervention (Wrapped) to decrease incidence of sexually transmitted infections (STIs) amongst users of STI self-sampling websites: A randomised controlled feasibility trial). The views expressed are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care.

Issue 2 - December 2020

Achievements

  • we have received NHS ethics approval and sponsorship arrangements are in place
  • our study is now registered on the ISRCTN
  • we have held our first meeting of the Wrapped Study Steering Committee and Data Monitoring and Ethics Committee
  • our software developers have been busy making updates to the Wrapped Website, and it’s very nearly complete
  • our Patient and Participant Involvement (PPI) group have been busy reviewing and providing feedback on our study materials, working on the development of our recruitment and retention strategy, and testing out our trial procedures.

What are we working towards?

  • finalising our data sharing and safeguarding procedures
  • testing, testing, and more testing of our data collection procedures!
  • launching our trial – planned start in January
  • then monitoring recruitment/retention and supporting intervention delivery.

Issue 3 - March 2021

Achievements

  • all data sharing and safeguarding procedures have been finalised
  • the Wrapped website is now live
  • rigorous testing was carried out on all of our online data collection and intervention systems ready for the launch of recruitment
  • we started recruiting participants this month and have 13 signed up so far.

What are we working towards?

  • monitoring recruitment/retention and supporting intervention delivery
  • publishing the protocol paper
  • setting up the qualitative nested study, ready to interview a sample of the participants and their sexual partners.

Issue 4 - June 2021

Achievements

  • a total of 86 young people (16-24 year olds) have been recruited to the study so far. That’s over a third of our recruitment target!
  • an ethics amendment was submitted and approved, to increase the incentive amount and add some additional local authority partner sites
  • the nested study is set up on REDCap ready to start recruiting participants and their sexual partners later this month
  • this month marks the three month point for some of our participants. They will be receiving their second digital survey and an STI test kit in the post very soon!

What are we working towards?

  • getting the additional local authority sites set up ready for recruitment
  • continuing to monitor recruitment/retention and support intervention delivery
  • preparing to send out month three surveys and STI test kits
  • publishing the protocol paper.

Issue 5 - September 2021

Achievements

  • a total of 156 16–24-year old's have been recruited to the study so far (68% of our recruitment target)
  • so far, we have interviewed five of our target 10 young people about their experience of being involved in the early stages of the trial – we are aiming to speak to a further 10 around month six and a further 10 around month 12
  • we are well into month three activities for a proportion of our participants, a large percentage of whom have completed their month three survey and sent back the month three chlamydia test kit we’ve sent them.

What are we working towards?

  • continuing to recruit young people to the project, until we reach our target of 230
  • continuing to monitor recruitment/retention and support intervention delivery
  • publishing the protocol paper.