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

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 £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