Evaluating the Home-based Intervention Strategy (HIS-UK) to reduce new chlamydia infection among young men aged 16-25 years by promoting correct and consistent condom use: What is the cost effectiveness of two different delivery models (face-to-face and digital delivery)?
Trial acronym: HIS UK
Description
The reduction of sexually transmitted infections (STIs) is a priority area. Condoms remain the main protection against STIs when used correctly and consistently, yet there are many condom use barriers which reduce their usage, such as decreased sexual pleasure, fit-and-feel problems, lubrication issues and erection difficulties.
The UK Home-Based Intervention Strategy (HIS-UK) is a behaviour change condom promotion intervention for young men designed to enhance enjoyment of condom-protected intercourse, improve attitudes towards condoms, improve the correct and consistent use of condoms, and thereby reduce the risk of STIs. The programme gives out a kit containing different types of condoms and lubricants and asks men to experiment with the contents at home by themselves following condom use education and training. HIS-UK has two delivery models; digital delivery using an interactive website (eHIS), and face-to-face delivered by a trained health professional (proHIS).
To compare the effectiveness of HIS-UK delivered by proHIS and eHIS-UK to improve condom use experiences and reduce STI incidence, as compared to usual care, we will recruit 2231 men aged 16-25 years who are at STI risk through the non-use of condoms during sex with casual and/or new partners. Men will be recruited from sexual health (SH)/Genitourinary (GUM) services and linked community SH/GUM outreach facilities within each site across England and Wales.
Participants will be assigned at random to receive either proHIS, eHIS or usual condom care and will be followed up for 12 months during which they will be asked at regular intervals about their sexual behaviour, condom use experiences and to take Chlamydia tests. We will also collect health economic data to compare the resource use and cost-effectiveness of delivering HIS-UK by the two models to that of usual condom distribution care.
Study design: Multicentre, randomised controlled, qualitative, observational trial
Disease area: Sexual health/ infection
Trial status: In follow up
Chief Investigator: Prof Cynthia Graham
Sponsor: University of Southampton
Funder: National Institute for Health Research (NIHR), Public Health Research (PHR) Programme.
Start date: Nov 2019
End date: Aug 2024
Recruitment target: 2231
Summary of study results: N/A
For further information contact:
E: y.to@bsms.ac.uk