Title: Comprehensive Assessment of the Prevention Role of Antiretroviral therapy (CAPRA)
Funder: Department of Health (England)

Abstract: AIMS AND OBJECTIVES We aim to reduce the transmission of HIV in the UK by assessing the acceptability, effectiveness and cost-effectiveness of a policy of initiating antiretroviral therapy (ART) in all people in the UK diagnosed with HIV. BACKGROUND Around 3500 new HIV infections occur each year in the UK and this continues to increase despite intensive prevention efforts. Effective ART means that death rates are low, but HIV care is resource intensive for the NHS with 3500 new infections representing around £1.75 billion in future drug costs accruing every year at today’s prices. People on ART with low viral load have markedly reduced infectiousness but the extent of this is currently uncertain. Currently 30% of patients seen for care are not on ART. Research in several areas is needed before a policy of treating all people with HIV diagnosed can be implemented. We will assess the acceptability of such an intervention, the patterns of sexual risk behaviour in individuals on early ART and the transmission risk for individuals with very low viral load, all of which are currently unknown. We will use this information in our existing stochastic computer model which models sexual risk behaviour, HIV infection and details of HIV progression to make the first detailed assessment of the effectiveness and cost effectiveness of the proposed policy of widespread ART use in the UK. Our programme arises as a result of several streams of work involving the applicants which have previously led to important service developments. RESEARCH PLANS We propose a series of interconnected projects to evaluate a policy of early treatment in HIV to reduce numbers of new infections. Study 1: Cross sectional survey in 5 UK HIV centres in year 1 and 3.5 of the programme to assess sexual behaviours, beliefs about HIV transmission risk, and attitudes to use of early ART, in patients with HIV under care within the UK, and to investigate trends over time in these factors. Study 2: Randomized trial to assess the extent to which people starting very early ART have increases in high risk sexual behaviour, compared with those not starting ART. This trial is a substudy within a separately funded larger trial (START). Study 3: To estimate the rate of transmission of HIV to unprotected HIV negative sex partners of patients with plasma viral load Study 4: Transmission modelling study to assess whether a policy of providing ART to all people diagnosed with HIV will lead to a reduction in the number of people becoming infected and be cost-effective RESEARCH TEAM Our multidisciplinary team consists of international leaders in HIV epidemiology, clinical trials and studies of sexual risk behaviour who have led major collaborative research and health service developments. Our work has improved patient care by changing clinical practice and informing guideline development. PROGRAMME MANAGEMENT Each study within the programme will be led by one or two of the applicants with a small core team. Overall co-ordination will be through a Steering Committee, which will include all the applicants, the Project manager and statistician employed. RESEARCH ENVIRONMENT There is considerable expertise in epidemiological, clinical, statistical, sociological and behavioural aspects of HIV within the Department of Infection & Population Health at UCL. The START trial is being conducted within the INSIGHT network, which has previously successfully conducted two large international treatment trials, SMART and ESPRIT. The Copenhagen HIV Programme (CHIP) has over 15 years experience in conducting international multi-centre studies. We have expertise in modelling, and have a long standing collaboration on HIV health economics with the London School of Hygiene and Tropical Medicine. ANTICIPATED OUTPUTS Our work will evaluate the effectiveness and cost effectiveness of a policy of early treatment in HIV to reduce numbers of new infections of HIV in the UK. The policy has potential to have significant impact not just to individual patients in terms of HIV infections avoided, but also in terms of future cost saving to the NHS. The findings will be generalisable globally. PATIENT AND PUBLIC INVOLVEMENT We have active involvement from members of the HIV community in the core team for all studies. Applicant SC is an HIV patient who has written widely appreciated patient-oriented material for i-Base for several years. We will have representation from the HIV community on the Independent Advisory Board and on the Steering Committee. ETHICAL IMPLICATIONS Studies will be submitted for MREC approval. Intensive prevention advice on the appropriate use of condoms will be given to all study participants at each contact. JUSTIFICATION FOR RESOURCES Resources primarily relate to recruitment and follow up of study participants and staff costs, statistical analysis and modelling.??


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: INFECTION