Title: Multicentre RCT and economic evaluation of a psychological intervention to reduce risk behaviour amongst MSM prescribed post-exposure prophylaxis for HIV following sexual exposure (PEPSE)
Funder: Department of Health (England)

Abstract: Background Sexual risk taking behaviour of men who have sex with men (MSM) is reported to be increasing. MSM are the group most affected by the HIV epidemic and one to one behavioural interventions, such as motivational interviewing (MI) have been recommended to reduce HIV. NICE guidance recommends one to one interventions within current STI/HIV service provision and advises that these interventions are integral to the modernisation of sexual health services. We suggest that patients who present for post-exposure prophylaxis for HIV following sexual exposure (PEPSE) could be targeted for risk reduction interventions, thus potentially lowering the likelihood of further risk behaviour, detrimental health outcomes and costs. Aims To evaluate the impact of motivational interviewing (MI) augmented with information and behavioural skills building (informed by the Information-Motivation-Behavioral Skills Model), over and above usual care, on risky sexual behaviour in men who have sex with men prescribed PEPSE. A secondary aim is to examine the impact of MI over and above usual care, on adherence to PEPSE. We hypothesize that compared with usual care, those in the intervention arm will: 1) Report a reduction in risky sexual practices 2) Have greater levels of adherence to PEPSE treatment; 3) Have lower rates of subsequent use of PEPSE; 4)Have greater motivation to avoid risky sexual behaviours; 5) Have greater risk reduction knowledge; 6) Have greater risk reduction behavioural skills. Plan of Investigation A parallel group randomised controlled trial is proposed. Participants will be MSM prescribed PEP after sexual exposure recruited from Brighton and London. The intervention will consist of two telephone sessions based on motivational interviewing (MI) and augmented by knowledge-enhancing and skill development techniques recommended by the Information-Motivation-Behavioural Skills (IMB) model of behaviour change. The intervention group will be compared to a ‘treatment as usual’ control group. Primary and secondary outcomes will be collected at 3, 6 and 12 months after the end of treatment to estimate intervention sustainability. An economic evaluation comparing the cost-effectiveness of the intervention to treatment as usual, using a decision model of HIV transmission is also proposed. Potential Impact The proposed RCT is both novel and timely. HIV is a condition affecting both length and quality of life, even with highly effective treatments. Health-related quality of life is at least 20% lower in people with HIV compared to the general population. Moreover, the lifetime NHS cost of a single HIV infection is estimated to be about £0.35 million. Taken together, along with the relatively low costs of the proposed intervention, it is clear that the intervention needs only to be moderately effective for it to be cost-effective and cost-saving. Findings will influence the nature and content of future consultations between staff and those requiring PEPSE and so have a direct bearing on the quality of care of patients.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: INFECTION