Title: Applying the MRC framework to the development of interventions to facilitate informed choice and optimise treatment-related behaviour in HIV
Funder: Department of Health and Social Care

Abstract: Aims and Objectives 1. 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. Background ART 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 Plans Workstream (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 WS3 WS3 will evaluate the efficacy of the interventions in two randomised controlled trials, running in parallel, with ART uptake and adherence as the respective primary outcomes WS4 will model the costs and cost-effectiveness of the interventions over the short- and long-term WS5 will begin implementation within the NHS and communicate the wider implications for other long-term conditions The 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 to the NHS include improved standard of care for HIV, less expensive treatment regimens, fewer consultations, referrals, investigations and hospital admissions. Public involvement The applicants include two HIV community representatives. The programme was designed and will be delivered with full involvement of service users. A Patient/Public Advisory Group of ten HIV service users, representing UK HIV community organisations, will guide the programme, with representation on the Steering Group. Ethical implications The research will conform to ethical and legal guidelines for consent, confidentiality and storage of data and each study will be approved by the National Research Ethics Service. Resources are needed for a programme manager, research assistants, coapplicants’ time, patient/public involvement, development, delivery and implementation of the interventions, transcribing, translating, and dissemination.???

Lay abstract: Current treatment for HIV (antiretroviral therapy) is extremely effective however many patients in the UK may not be getting the best from this treatment. Research suggests over a quarter of patients delay accepting treatment when it is recommended and a third do not take treatment as prescribed. Both these behaviours reduce the benefits of treatment. Reasons for delaying treatment and low adherence may be intentional (where the individual decides not to take treatment or to take it in a way that differs from their doctor’s recommendations) or unintentional (where the person wants to take treatment as recommended but is prevented from doing so by circumstances beyond their control). We have conducted studies to improve our understanding of how people make decisions about treatment. These studies show the importance of common-sense beliefs which often differ from the medical view and although logical, may be based on misconceptions about HIV and antiretroviral therapy. Many people refused treatment or missed doses because they had doubts about their personal need for it (often because they felt well) or strong concerns about potential adverse effects (such as fears about side effects). The goals of this programme are to: 1) Increase our knowledge of barriers to starting treatment and low adherence among men who have sex with men and people from black African communities in the UK. 2) Combine the knowledge and expertise of HIV positive people, academics and NHS clinicians to develop support (interventions) to address barriers to starting treatment and support people who are experiencing problems taking their treatment as prescribed. These interventions will be aimed at addressing misconceptions and concerns about treatment, helping people to manage side-effects, providing accessible information, support and practical advice. 3) Determine whether these interventions are acceptable to patients and are effective (i.e. whether they improve rates of uptake and adherence). 4) Develop training programmes and recommendations for the delivery of these interventions in NHS HIV services by HIV-specialist nurses and pharmacists. The outcomes will be interventions to support people facing decisions about treatment and experiencing problems with adherence, improving the standard of NHS HIV care for UK patients. Benefits to patients include better self-management of HIV, improved quality of life and a lower risk of HIV-related infections.?

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