Updates

Achievements

• Data analysis is now complete. For the Month 12, 75.7% returned a valid chlamydia self-sample
• Our sample was representative of young people in our sampling pool (those using an online STI self-sampling service) in terms of gender and levels of deprivation. We did however under-represent those age 19 years old, and over-represented those of Black ethnicity
• Chlamydia positivity at Month 12 was 2.3% (1.2% intervention group, 3.4% control group)
• Qualitative analysis indicated that:
  • Young people found joining the study, and completing the surveys and test kits, a straightforward process
  • Young people found communication from the research team was pitched right; it made them feel engaged in the study and connected to the research team but without being excessive
  • The intervention was acceptable to young people and reportedly changed their condom related beliefs and behaviours.

What are we working towards?

• Preparing the final report, due May 2023
• Preparing a funding application to proceed to full trial.

NB The data in this report relates to all those known to be absent of chlamydia at baseline i.e. self-reported their STI test result and if positive, that the full course of treatment was taken.

Achievements

• All participants have reached the end of the trial and we are in the final stages of data collection
• Approximately 85% of all participants (or 92% of the closed population*), so far have completed the month twelve survey
• For the surveys at months 3, 6, and 12: 76% of all participants (or 85% of the closed population) have completed all three surveys
• For the Month 12 test kits 65% of all participants (or 75% of the closed population) have completed the test kits so far
• Nested study interviews are complete: of 30 planned interviews, 10 were completed at Month 3, 10 were completed at Month 6, and 10 were completed at Month 12.

What are we working towards?

• Analysing data from the feasibility trial as well as the nested qualitative study
• Preparing the final report, due May 2023.

*All those known to be chlamydia negative at baseline

Achievements

• All participants have passed the month six stage, with approximately 78% of all participants (or 85% of the closed population*), completing the month six survey.
• Month 12 chlamydia test kits and surveys are ongoing, with around half of participants reaching the end of the trial. For the surveys 76% of all participants (or 73% of the closed population) have completed all three surveys (months 3, 6, and 12).
• For the Month 12 test kits 65% of all participants (or 74% of the closed population) have completed the test kits.
• Nested study interviews are nearly complete: of 30 planned interviews, 10 were completed at Month 3, 10 were completed at Month 6, and 6 have been completed so far at Month 12, with a remaining 4 to be completed.

What are we working towards?

• Continuing to send out month 12 chlamydia test kits and surveys and conduct interviews with participants to find out about their experience of being in the trial.
• Preparing to present, along with five other European researchers, at a symposium to be held at the EHPS annual conference (eHealth and mHealth track): “Considerations for Development and Evaluation of Digital Health Projects.”
• Continuing to monitor recruitment/retention and support intervention delivery.

*All those known to be chlamydia negative at baseline

Achievements

• Almost all participants have passed the month six stage, with approximately 80% of all participants (or 88% of the closed population*), completing the month six survey.
• Month 12 chlamydia test kits and surveys have started to becompleted. These are the final activitiesof the trial.
• 100 orders have been placed on the Wrapped website. We expect more orders to be placed up until the end of the trial.
• A webinar, hosted by a Specialist Interest Group (SIG) of the European Health Psychology Society (EHPS; Digital Health and Computer Tailoring), was delivered in April. This focussed on how our recruitment and retention strategy was developed.

What are we working towards?

• Continuing to send out month 12 chlamydia test kits and surveys and conduct interviews with participants to find out about their experience of being in the trial.
• Preparing to present,along with five other European researchers, at a symposium to be held at the EHPS annual conference (eHealth and mHealth track): “Considerations for Development and Evaluation of Digital Health Projects.”
• Continuing to monitor recruitment/retention and support intervention delivery.

*All those known to be chlamydia negative at baseline

Achievements

• All participants have now passed the month three stage. Of the closed population (all those who self-reported their chlamydia test result at baseline), 72% have completed the month three chlamydia test kit, and 91% have completed the survey.
• Around 66% of our participants have reached the six-month stage, with around 85% of participants in the closed population completing the survey.
• We have reached our target to interview 10 participants about their experience of being involved in the early stages of the trial. We will be speaking to a further 20 as the trial progresses.

What are we working towards?

• We are preparing to send out month 12 chlamydia test kits and surveys.
• Delivering a webinar hosted by a Specialist Interest Group (SIG) of the European Health Psychology Society (EHPS; Digital Health and Computer Tailoring) about how the recruitment and retention strategy was developed.
• Working with five European researchers on a symposium submission for the EHPS annual conference (eHealth and mHealth track): “Considerations for Development and Evaluation of Digital Health Projects”.
• Continuing to monitor recruitment/retention and support intervention delivery.

Achievements

• We successfully reached our recruitment target of 230 participants on October 18 2021.
• So far, we have interviewed 9 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 (to reach 30 in total by project end).
• Around 70% of our participants have reached their month three activities and around 40% have reached month six, the majority of whom are returning their chlamydia test kit (month three) and completing the surveys (both time points).

What are we working towards?

• Continuing to monitor recruitment/retention and support intervention delivery.
• Beginning to look at the analytics data from the intervention.
• Publishing the protocol paper.

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.

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.

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.

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.

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.