Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 19, 2022
Date Accepted: Feb 16, 2023
An Intervention to Increase Condom Use Among Users of STI Self-Sampling Websites (Wrapped): Protocol for a Randomized Controlled Feasibility Trial
ABSTRACT
Background:
Reducing the rates of Sexually Transmitted Infections (STIs) amongst young people is a public health priority. The best way 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 self-sampling kits for STIs via the internet. The potential of this opportunity is enhanced by the increasing numbers of young people being tested via this route every year in England.
Objective:
The present paper is a protocol for a feasibility randomised controlled trial (fRCT). The fRCT seeks to establish whether it is feasible to run an RCT to test the effectiveness and cost-effectiveness of Wrapped. Wrapped is 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.
Methods:
A two-arm parallel group randomised fRCT of Wrapped plus usual care, compared to usual care only (basic information on STIs and condom use), with a nested qualitative study. A minimum of 230 participants (aged 16-24 years) are recruited from an existing chlamydia self-sampling website. Participants are randomised into one of two parallel groups (1:1 allocation). Repeated measures are surveys at baseline (month (M) 0), M3, M6 and M12, and postal chlamydia screening at M0, M3 and M12. Nested qualitative interviews with trial participants are used to gain insight into factors affecting recruitment and attrition.
Results:
Recruitment to the fRCT began in March 2021 and was completed in October 2021. Data collection is likely to be completed by the end of December 2022.
Conclusions:
This feasibility study will provide data to inform the design of a future definitive trial. This work is timely given the rapid rise in the use of internet testing for STIs and the sustained high levels of STIs amongst young people. Clinical Trial: ISRCTN Registry ISRCTN17478654; http://www.isrctn.com/ISRCTN17478654
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