Title: Assessing the impact of introducing online postal self-sampling for sexually transmitted infections into sexual health provision within the UK on health inequalities, access to care and clinical outcomes. Short title: ASSIST
Funder: Department of Health and Social Care

Abstract: Aim of the research _x000D_ We want to determine if online postal self-sampling services for sexually transmitted infections (STIs) improves people’s access to sexual health care and benefits those most in need. We want to discover how people who use and provide these services feel about them, the economic impact of introducing these services, and determine the overall societal benefit, or otherwise, of this approach to sexual health care. Service commissioners and providers who have responsibility for delivery of sexual health will benefit through greater understanding of this model of care provision. The findings will also help develop national quality measures and standards of care for online sexual health services. _x000D_ _x000D_ Background _x000D_ Sexual health is important for building a healthy society, and treatment for STIs is costly to the NHS. Young people, those living in more deprived areas, gay men and those from black and minority ethnic groups are more affected by poor sexual health. Many STIs are rising and demand on services is increasing (new attendances rose from 1.6 million in 2011 to over 3.5 million in 2018), yet funding has reduced. As a result, services have had to find new ways to deliver care, including ordering testing kits online which can be used at home. The samples are sent to a laboratory, with negative results provided via text, and positive results delivered by phone with follow up in a clinic. The hope is that these online services are cost effective and increase access to testing, in particular amongst groups most at risk; if so, this would have the added benefit of reducing existing health inequalities. _x000D_ _x000D_ Design and methods _x000D_ We are focusing on three areas (London, Birmingham and Glasgow) which provide an excellent cross section of our population. Each area has used a different service model and introduced online postal self-sampling services at different times. The plan is to identify and understand all the parts involved in these services, and what is needed to introduce them in different settings. We will look at key documents, interview service users and staff, and consider national and clinic and online service level data. Alongside this we will also undertake an economic evaluation. Synthesising this data will enable us to understand the pros and cons of OPSS and the work required for implementing, integrating and embedding online postal self-sampling services into routine practices. This will help us understand which people access these services, whether it affects their care and clinical outcomes, how services have adapted to changes, and what works best, how and for whom. This research will assist future service planning and could help develop similar public health services. _x000D_ _x000D_ Patient and public involvement _x000D_ A lay member has helped to shape this proposal and will be involved throughout the project. The British Association of Sexual Health & HIV PPI research group is strongly supportive, and will also be involved in the design, planning and delivery. We will have community members within our advisory group and steering committee. _x000D_ _x000D_ Dissemination _x000D_ We will use our website, social media and scientific conferences to take our work to different audiences alongside publishing our findings in scientific journals. Our researchers have important health roles nationally which will help get our findings into NHS policy and practice. At the end of the project we will hold a (livestreamed) event to present our finding

Lay abstract: Research questions: _x000D_ 1.Does channelling to online postal self-sampling for sexually transmitted infections (STIs) and HIV: _x000D_ a. Impact on health inequalities _x000D_ b. Increase access to sexual health care, especially for those most at risk? _x000D_ c. Improve clinical and public health outcomes? _x000D_ d. Provide desired economic outcomes? _x000D_ 2.How are online services implemented and what affects their sustainability? _x000D_ 3.How do online implementation models affect the impact on health inequalities, clinical- and cost-effectiveness? _x000D_ _x000D_ Background: Sexual health is a UK public health priority. Over 3.6 million people attend sexual health services annually with significant morbidity and substantial costs. STI diagnoses and antibiotic resistance are increasing, yet funding has reduced and services are fragmented. Online services are seen as a means to address these challenges, yet their effectiveness and cost-effectiveness is unknown. _x000D_ _x000D_ Aims and objectives: To assess the impact of online postal self-sampling services on health inequalities, access to care, and clinical and economic outcomes, and to identify the factors that influence the implementation and sustainability of these services. _x000D_ _x000D_ Methods: A theoretically informed evaluation of 3 case study areas (Birmingham, London and Glasgow) implementing online services. Our proposed work uses realist methodology within 4 inter-linking work streams (WS): _x000D_ WS1 examines the impact of online services on health inequalities, access and clinical outcomes, using existing surveillance data, clinic/OPSS datasets, and qualitative interviews with service users and healthcare professionals. _x000D_ WS2 analyses the costs and outcomes associated with online services compared to clinic-based services, by undertaking an economic analysis based on the resource use, clinical outcomes and cost data collected from each case-study area. _x000D_ WS3 describes and evaluates how implementation processes and service delivery models contribute to observed variation in clinical and cost-effectiveness. It uses document analysis, in-depth and contextual observational interviews and normalisation process theory. _x000D_ WS4 ensures that the initial programme theories of impact and implementation of OPSS are iteratively refined into detailed realist programme theories using relevant data from across WSs. _x000D_ _x000D_ Timelines: _x000D_ Over 39 months (1/01/2021 – 31/03/2024): _x000D_ HRA approvals (Month (M) 0-6) _x000D_ WS1(M3-33), WS2(M3-36), WS3(M3-28), WS4(M3-36) Writing up and dissemination (M33-39), dissemination event (M39) _x000D_ _x000D_ Impact and dissemination: _x000D_ We will generate impact by providing: _x000D_ • Evidence of the impact on health inequalities, effectiveness, and cost effectiveness of online postal self-sampling _x000D_ • A description of the feasibility and acceptability of the different components of the intervention; unexpected adverse events; equity; and tested causal assumptions _x000D_ • An evidence base around what works best, how and for whom, to inform delivery of online services _x000D_ • Information highly relevant to other regions planning similar service transformation. Leadership, management and governance requirements for the successful implementation and scale up of online services_x000D_ • Evidence to develop national quality measures and standards of care for online services and inform sexual health policy._x000D_ A robust dissemination strategy, underpinned by strong patient and public involvement and engagement, will enable timely dissemination of findings and translation into practice

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: INFECTION;REPRODUCTIVE HEALTH AND CHILDBIRTH