Wrapped Randomised Controlled Feasibility Trial
Research type
Research Study
Full title
An interactive digital behaviour change intervention (Wrapped) to decrease incidence of sexually transmitted infections (STIs) amongst users of STI self-sampling websites: Study protocol for a randomised controlled feasibility trial
IRAS ID
285542
Contact name
Katie Newby
Contact email
Sponsor organisation
University of Hertfordshire
ISRCTN Number
ISRCTN17478654
Duration of Study in the UK
1 years, 9 months, 31 days
Research summary
Last year in England, 210,000 15-24 year olds were diagnosed with a Sexually Transmitted Infection
(STI), half of all total diagnoses. The only way for sexually active people to avoid STIs is to use a condom, but young people report inconsistent use. It is important that we look for ways to reach young people at risk of future STIs and identify what will help them to increase their condom use.
Together with young people and stakeholders, we have developed a website called ‘Wrapped’. Wrapped is a fully automated, multi-component and interactive digital intervention that aims to reduce future STIs through increasing correct and consistent condom use amongst users of STI self-sampling websites.
What we want to know is whether Wrapped works. To find this out, we need to run a type of
experiment called a Randomised Controlled Trial (RCT). RCTs are time consuming and expensive,
often involving thousands of participants. In line with good practice, to prepare for this we are going to run a feasibility trial. The primary aim is to identify whether we can recruit and retain the numbers of participants required for an RCT. We will work with users of a chlamydia self-sampling website (our Patient and Public Involvement (PPI) group) on development of a recruitment and retention strategy for this future trial.
We will then test these strategies out by running a mini version of a full RCT (feasibility trial). Throughout, we will carefully monitor engagement and interview participants, including those who drop-out, to see what we can learn about what it is like to be a participant in our study. We will use this evidence to adapt our materials and procedures so that we are ready to carry out a full RCT. Conducting this future trial will enable us to determine whether Wrapped is cost-effective.
Lay summary of study results: Sexually transmitted infections (STIs) such as chlamydia are common amongst young people. Without treatment, they can cause serious health problems including infertility. Condoms are recommended to prevent STIs but young people often report not using them for penetrative sex. Face-to-face sexual health services are available for STI testing but more and more people are using STI testing websites and demand for this service is rising rapidly. Young people most at risk of STIs are using these sites but they do not offer much support or advice on how to prevent future infections.Together with young people and health professionals, we developed a website called ‘Wrapped’. Wrapped aims to reduce future STI diagnoses amongst users of web-based STI testing services by increasing their condom use. Users can order a free condom sample pack and carrier, access a free monthly condom ordering service, and watch videos that demonstrate condom use, give tips on communicating about condoms, and of real couples discussing and using condoms.
What we want to know is whether Wrapped works to reduce STIs. To find this out, we need to run a type of experiment called a Randomised Controlled Trial (RCT). We conducted a feasibility study to see if it was possible to carry out this type of study. Uptake was slow but given the large numbers of young people who use these sites, we estimate that this will still be high enough to run the RCT. Over 12 months, high numbers of young people completed all our surveys and used STI self-sampling kits to provide us with accurate information on whether they had an STI. Young people liked Wrapped, said that it made them feel differently about condoms, and described taking part in the study as easy. We have successfully secured funding from the National Institute for Health and Care Research (NIHR) to run the required RCT. The RCT work began on 1st November 2024
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
20/EM/0275
Date of REC Opinion
12 Nov 2020
REC opinion
Favourable Opinion