Title: Sexual risk reduction interventions for patients attending sexual health clinics; feasibility to conduct an effectiveness trial
Funder: Department of Health (England)

Abstract: Design: A literature review a mixed methods survey of existing sexual risk reduction practice and identification and refinement of a suite of behavioural interventions by intervention mapping. Interventions will be individualised to user’s needs and sexual risk. Front running interventions will be tested for practicability and acceptability in clinics. Finally we will design a RCT of the package of interventions and an economic analysis. Setting: Sexual health clinics - GUM sexual and reproductive health and integrated contraception and sexual health services. Strategy for reviewing the literature: A systematic review of sexual risk reduction interventions focussing on settings relevant to the UK and interventions that can be delivered in SH clinics or introduced in clinic and self-administered at home. This will update published reviews and focus on studies with well validated outcome measures. Target population: Among clinic attendees groups at increased sexual risk will be identified particularly identifying those sub-groups of men who have sex with men and young people. The definition of the groups will be differentiated by clinic type with ages and behavioural criteria informed by secondary analysis of the disease and behavioural surveillance data (GUMCAD) collected by Public Health England. This will provide the basis of a triage/sexual behaviour assessment that will be adapted to each clinic type. Health technologies assessed: The components of the intervention will be informed by evidence on effectiveness feasibility and acceptability and will use risk-reduction opportunities at several points in a clinical pathway. It will involve a triage step that stratifies individuals’ sexual risk and allows an individualised package of interventions to be offered. We expect that the package of interventions will include group delivered (e.g. waiting room videos) self-delivered (e.g. on-line interactive interventions) and clinician delivered (one-to-one motivational interviewing). Interventions will be adapted from existing components as required and selected for deliverability within existing resources and clinical pathways. Measurement of costs and outcomes: The costs of the intervention package will be determined during piloting in clinics. Acceptability will be measured through uptake rates of various components of the intervention and reasons for non-acceptance drop out or not being offered the intervention. Potential trial outcome measures include feasibility of active follow-up and STI infection and reinfection rates. Sample size: Survey of current clinic practice (n=570). Key informant (n=30) and semi-structured interviews (n=30). Discrete choice experiment to help select intervention elements (n=250). In the pilot of the interventions in 6 clinics (two large and two medium sized GUM clinics two CASH clinics and 3 control clinics (assuming a possible cluster RCT design). N=800 to estimate the proportion completing the intervention (50% 95% CI 46-54); n=400 in intervention clinics and n=300 in control clinics to provide an estimate of the follow-up rate at 60% (CI 56-64) with 80% power to detect a difference of 53 vs 67% in control and intervention clinics. Timetable: 24 monthsExpertise in the team: A multidisciplinary team with expertise in behaviour change clinical expertise in sexual health and STIs qualitative and quantitative research evidence synthesis service evaluation user involvement modelling epidemiology intervention design and evaluation health economics.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH;INFECTION