HIS-UK RCT
A study to test whether HIS-UK is effective and cost-effective
Role: Co-investigator (research lead: Prof Cindy Graham, Kinsey Institute, USA)
Funder: National Institute for Health and Care Research (NIHR), Public Health Research Programme
Dates: January 2019 to December 2023
Background
Our earlier work in this area involved the adaptation of an existing intervention (the Kinsey Institute® Homework Intervention Strategy (KIHIS)) targeting condom skills, enjoyment and self-efficacy for a UK audience (HIS-UK). Subseqeuntly we conducted a study which demonstrated intervention acceptability and the feasibility of conducting a main trial. See HIS-UK feasibility study for further information. This project reports on a study which aimed to test the effectiveness and cost-effectiveness of HIS-UK in comparison to usual care.
What did we do?
Participants (men aged 16-25 years at risk of STIs) recruited through targeted advertisements and opportunistic direct approaches at selected healthcare settings were randomly allocated to 1 of 3 trial arms: “e-HIS” (HIS-UK delivered digitally), “ProHIS” (HIS-UK delivered face-to-face), and control condition (usual NHS care). Participants were asked to complete surveys at baseline and on a monthly basis for 12 months, as well as complete three chlamydia screening tests (baseline, 6, and 12 months). Outcomes measures included the extent to which correct and consistent condom use was increased, improvement of condom use experiences (pleasure as well as fit and feel); and decrease in chlamydia test positivity. A sub-sample of participants were also interviewed to explore issues related to implementation, fidelity, and dose, and to assist in
interpretation of outcome data.
What did we find?
Recruitment commenced in March 2020. Due to the COVID-19 pandemic however, the study had to be halted. Whilst recruitment reopened in Summer 2021, we were asked by the funder to cease enrollment of new participants (February 2023) before our target sample size was reached due to cost concerns. We are continuing to collect data from those who are already enrolled.
Next steps
We are currently preparing to analyse our data and planning dissemination activities.
Publications