Applying the MRC framework to the development of interventions to facilitate informed choice and optimise treatment-related behaviour in HIV

Aims and Objectives1. Apply Medical Research Council (MRC) guidance to develop and evaluate theory-based interventions to support antiretroviral therapy (ART) uptake and adherence by addressing the salient behavioural determinants identified in empirical studies.2. Conduct staged testing and continued development of the interventions with feasibility studies informing subsequent trials of their efficacy on ART uptake and adherence.3. Assess and model the short and long-term costs and cost-effectiveness of the interventions.4. Prepare for implementation within the NHS and communicate the implications for other long-term conditions.BackgroundART has dramatically reduced HIV morbidity and mortality but its success is impeded by delay to initiate treatment (25% of patients) and low adherence (30%), with serious implications for individuals, public health and the NHS. There are no interventions for improving ART uptake. ART adherence interventions have had limited success, partly because they have not been systematically developed. We have developed a theory of nonadherence, empirically tested across long-term conditions, and applied it to identify the salient perceptual factors (e.g. beliefs about HIV and ART) and practical factors (limitations in capacity and resources) influencing motivation and ability to start and continue ART among men who have sex with men (MSM). Subsequent studies involving people from black African communities in the UK (BAUK) were confirmatory. We have identified targets for intervention in the two groups representing over 90% of UK cases. Studies in other illnesses suggest that these targets are amenable to change. We are now ready to develop interventions to support ART uptake and adherence informed by our theoretical model and developmental studies.Research PlansWorkstream (WS) 1 comprises three linked studies to: identify culturally-specific determinants of ART uptake and adherence that have not emerged in previous research (Study 1), refine our validated measures of perceptual and practical determinants of ART behaviour (Study 2) and to inform the design of ART Uptake and ART Adherence interventions (Study 3)In WS2 pilot studies will determine the feasibility and acceptability of the Uptake and Adherence interventions and their effects on perceptual and practical barriers to ART (process variables) with a pilot economic evaluation in parallel. The results will determine effect sizes for the evaluative studies (WS3) and inform the Independent Advisory Group’s decision on progression to WS3WS3 will evaluate the efficacy of the interventions in two randomised controlled trials, running in parallel, with ART uptake and adherence as the respective primary outcomesWS4 will model the costs and cost-effectiveness of the interventions over the short- and long-termWS5 will begin implementation within the NHS and communicate the wider implications for other long-term conditionsThe research team is a world-class partnership of academics, clinicians, HIV service users, NHS commissioners and managers, able to ensure that high quality, pragmatic interventions are developed, evaluated and implemented into the NHS.The research environment comprises leading academic and NHS institutions with a track record of delivering and implementing health services research.Outputs are intervention manuals and other materials to support ART uptake and adherence, data on efficacy and cost-effectiveness of the interventions, with recommendations, training materials and audit tools to facilitate implementation.Outcomes will be an evidence base for supporting best use of ART within the NHS, with theoretically derived, pragmatic interventions to increase uptake and adherence, and preparation for implementation. Benefits to patients and public include support with treatment decisions and self-management of HIV, less chance of morbidity and mortality, drug resistance and cross-resistance and a lower chance of transmitting HIV. Benefits t