Reducing sexually transmitted infections amongst those at highest risk: The Wrapped randomised controlled trial

Background

Reducing the rates of Sexually Transmitted Infections (STIs) amongst young people is a public health priority. The best way for sexually active people to avoid STIs from penetrative sex is to use a condom but young people report inconsistent use.

A missed opportunity to intervene to increase condom use is when they access web-based STI self-sampling kits. Young people are increasingly being tested via this route every year in England.

With young people and other stakeholders, we have developed Wrapped, a multi-component digital intervention aiming to reduce STI positivity through increasing correct and consistent condom use. It has been developed for 16-24-year olds and is intended to sit within the web-based STI testing pathway.

Research question

Is Wrapped plus usual care (usual STI prevention information provided by STI testing websites) effective and cost-effective in reducing STI positivity amongst 16–24-year-olds at 12 months in comparison to usual care only? Primary Objective: To determine whether adding Wrapped to usual care reduces chlamydia positivity at 12 months.

Methods

Design: a two-arm parallel group randomised controlled trial (RCT) of Wrapped compared to usual care, with nested intervention uptake and qualitative studies.

For the RCT, we will recruit a minimum of 3,576 participants (aged 16-24-years) over 18 months from web-based STI self-sampling websites. Participants will be randomised into one of two parallel groups (1:1 allocation). Measures will be surveys at baseline (M0) and at M3, M6 and M12, and chlamydia screening at M0, M3 and M12. We will collect health economic data to compare the resource costs and cost effectiveness of delivering Wrapped compared to usual care.

The nested intervention uptake study will estimate future levels of Wrapped uptake and use. For this, up to 300 users of web-based STI self-sampling services will be given access to Wrapped for three months (outside the confines of the RCT) and usage tracked using data analytics.

The nested qualitative study will be used to understand different patterns of engagement with Wrapped, and young people’s perceptions on whether and how Wrapped works. For this, up to 30 participants will be sampled from users of Wrapped in the intervention uptake study. Semi-structured interviews will be recorded and transcribed prior to reflexive thematic analysis.

Timelines for delivery 0-6 months – study set-up, ethics approval 9-14 months – nested intervention study data collection and analysis 9-26 months – recruitment to RCT 9-38 months – RCT data collection 33-39 months – nested qualitative interviews and analysis 39-44 months – RCT data analysis

43-48 months – report writing, dissemination Anticipated impact and dissemination

We will assess the readiness and ability of web-based STI self-sampling providers to implement Wrapped using an implementation tool designed for e-health interventions (e-HIT). Should Wrapped be established as cost-effective, an in-person implementation stakeholder meeting will be held to reflect on current commissioning and service delivery, discuss current implementation issues, and generate a road map for implementation.

Potential impact includes reduced STI positivity and improved sexual health and quality of life, reduced costs of STI treatment, and reduced health inequality.

We have a robust plan for project dissemination including multi-media communication with stakeholders, academics and the public.