Title: A comprehensive assessment of the cost-effectiveness of HIV prevention and testing strategies, including HIV self-testing, among men who have sex with men (MSM) in the UK
Funder: Department of Health and Social Care

Abstract: Background and Rationale The number of newly HIV diagnosed MSM is at an all-time high and the 3000 new infections/year are at significant cost to the NHS, accruing &pound;1 billion in future costs every year. Approximately 25% of all HIV positive MSM are unaware of their infection and disproportionately contribute to onward transmission (60% and 80% of transmissions) and late presentation with greatly increased risk of death. Reducing late HIV diagnosis remains a UK public health priority. Uptake and frequency of HIV testing among MSM remains low. Innovative strategies, such as HIV self-testing, which due to associated confidentiality and convenience could increase initial and repeat testing rates, and therefore diagnosis, needs to be evaluated. There are other HIV prevention initiatives in addition to self-testing, but it is unclear which offer greatest benefit for cost. In practice, assessing the cost-effectiveness of prevention interventions can only be done through modelling. We aim to reduce HIV incidence by determining the most cost effective HIV prevention and testing policies and directly working with policy makers to ensure their adoption Main Research Questions For MSM in the UK: Does provision of free HIV self-testing increase rates of HIV diagnosis? Which HIV prevention initiatives for reducing HIV incidence are most cost-effective? Research Plan Workstream 1: Feasibility Studies Aim: To increase understanding of acceptibility and feasibility of HIV self-sampling and self-testing among MSM, while collating evidence about the most appropriate intervention designs to directly inform RCT design and processes. Methods Study 1A: Systematic review to identify most up to date evidence concerning use and effectivness of HIV self-sampling and self-testing in MSM. Study 1B: Focus groups and interviews with MSM and HIV prevention and testing service providers to identify barriers and facilitators to HIV self-sampling and self-testing in a range of models and contexts. Study 1C: Study manual and material development to support RCT interventions and design of the RCT study website. Study 1D: Process Evaluation to assess the interventions in the RCT Workstream 2: Randomised Controlled Trial to assess Whether Free Availability of HIV Self-Testing Leads to Earlier Diagnosis of HIV Infection. Aim: To assess whether free self-testing for HIV with or without reminders to test results in earlier diagnosis of HIV infection compared with standard of care. Methods Study 2A: Randomised Control Trial - Internet-based, randomised, partial factorial trial. Randomisation A, all eligible men randomly allocated in 1:1 ratio to standard of care for HIV testing (Control arm), or standard of care plus unlimited free self-testing (Intervention arm). In Randomisation B, men that agree to be contacted will be randomly allocated in a 1:1 ratio to No reminder (control arm) or a Tailored reminder to test based on sexual behaviour provided 3 monthly through on-line questionnaires (intervention arm). The primary outcome of the trial is new confirmed HIV diagnosis, based on linkage to the PHE HIV Surveillance Database. This will be supplemented with test results in the Intervention arm for Randomisation B, and a brief on-line questionnaire sent to all at study closure. The RCT will be subjected to phased recruitment with review after the first 1000 respondents (10% saturation) to assess feasibility of enrolling 10,000, appropriateness of the partial factorial design, and to ensure that pathways for management of positive results, confirmatory testing and linkage with care are optimal. Study 2B: Qualitative Interview Study: 40 interviews with men from different arms of the study to explore testing pathways, practices and effects, self-care in the management of HIV health, and to gain a deeper understanding of perspectives on self-sampling and self-testing. Workstream 3: Modelling and Economic Evaluation to Assess Cost Effectiveness of Strategies for HIV Prevention in MSM in the UK. Aim: To assess the cost-effectiveness of strategies for preventing HIV in MSM, including free self-testing. Methods Study 3A: Assessing HIV incidence and risk behaviours in HIV negative MSM at the time of HIV infection and after diagnosis through web based longitudinal follow up of an already recruited sample (to provide key parameters for the cost effectiveness model) Study 3B: Identification of prevention strategies and characterisation of costs and effects Study 3C: Modelling the cost effectiveness of HIV prevention strategies, including HIV testing interventions, using a simulation model to determine the cost-effectiveness (from an NHS perspective with outcomes as Quality-Adjusted Life-Years) of strategies for preventing HIV transmission, alone and in combination. The evaluation will include assessment of different options for recommended frequency of testing. Anticipated Outcomes The main anticipated benefits within 3-5 years of programme end are more cost effective use of resources for prevention, higher rates of HIV diagnosis, more timely diagnosis of HIV infection and reduced late presentation with advanced disease which will ultimately reduce new HIV infections in MSM in the UK, thereby improving health and reducing the overall costs for the NHS.

Lay abstract: The number of new HIV diagnoses among men who have sex with men (MSM) in the UK continues to increase. HIV is now a treatable condition with good life expectancy, but at considerable cost to the NHS with 3000 new infections in MSM every year accruing almost &pound;1 billion in future NHS care costs. The cost to affected individuals of lifelong medication with potentially serious side effects, increased ill health and the social impact cannot be underestimated. In addition, estimates suggest that one quarter of HIV infected MSM are undiagnosed, which has significant implications of their increased risk of death and continued transmission. There is a national need for a renewed focus on preventing HIV infection in MSM and facilitating early diagnosis in those infected. There are multiple possible approaches to HIV prevention, but it is unclear to local and national policy makers which approach or combination of approaches offers the greatest benefit for the cost; to determine this is the overall aim of our research project. HIV prevention approaches have mainly focussed on condom use. This remains critically important, but additional approaches are needed, not least because while condom use is common, consistent condom use is rare. Other approaches include pre-exposure prophylaxis (HIV negative people take HIV drugs regularly to prevent infection) and offering earlier treatment after diagnosis, but neither of these are widely used or easily available. Increasing HIV testing is likely to have prevention benefits as people diagnosed with HIV may be more likely to use condoms and those in need can be treated. There are likely to be many different ways to have an HIV test in the near future including self-testing where you take the sample and do the test yourself, which takes about 5 minutes. There are no existing UK data on the effectiveness of offering self-testing for HIV in increasing HIV diagnosis rates in MSM despite its potential importance. Our research programme addresses these NHS priority areas by (i) assessing, through an randomised controlled trial design, the impact of HIV self-testing on HIV diagnosis rates in MSM and (ii) comparing the cost-effectiveness of different options for national (and local) prevention strategies. To conduct the cost effectiveness analysis we will further develop a detailed computer based model which will use data from previous studies and from longitudinal follow up of an existing cohort. The main anticipated benefits within 3-5 years of the programme end are a reduction in new HIV infections in MSM in the UK, avoiding future NHS drug costs, more cost efficient use of resources for prevention, higher rates of HIV diagnosis, and a reduction in late presentation with advanced disease which will improve health and reduce high cost NHS inpatient care.

Research activity codes: 3.2 INTERVENTIONS TO ALTER PHYSICAL AND BIOLOGICAL ENVIRONMENTAL RISKS
Health categories: INFECTION