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Evaluating mHealth technology in HIV to improve Empowerment and healthcare utilisation: Research and innovation to Generate Evidence for personalised care

Periodic Reporting for period 4 - EmERGE (Evaluating mHealth technology in HIV to improve Empowerment and healthcare utilisation: Research and innovation to Generate Evidence for personalised care)

Reporting period: 2019-05-01 to 2020-04-30

HIV is now considered as a chronic health condition with the life expectancy of people living with HIV being similar to the general population, providing that individuals know their HIV status, have access to antiretroviral therapy and are linked to treatment and care. European guidelines recommend follow up by a health care professional every 3-6 months with routine blood monitoring including an HIV viral load: most individuals are seen by a clinician every 6 months.
The majority of individuals have undetectable HIV viral loads (the aim of treatment) on antiretrovirals and are seeking to reduce at the impact of HIV on their lives; at the same time the number of people living with HIV continues to increase and the population is ageing.
The EmERGE project is a five year Horizon 2020 funded project which started in May 2015 and completed in April 2020. Within the project we have successfully co-designed, integrated and evaluated a digital health pathway for people living with medically stable HIV.
Within the EmERGE pathway individuals are seen once a year face-to-face by their clinician with an interim visit carried out using the EmERGE platform. People attend for their bloods; results are checked by a clinician and are then encrypted and pushed securely through to the persons’ mobile phone with a message from the clinician and other information.
The EmERGE pathway has been evaluated in a study which enrolled 2251 people living with HIV across five diverse clinical sites in Europe - the digital health platform having been successfully integrated and operational at sites since 2017.
The results of the evaluation study have been analysed and are being prepared for publication; they have been presented & are due to be presented at National and European conferences.
EmERGE has been distinctive in the high degree of community involvement throughout the project.
The EmERGE project consortium has chosen to take a values-based not-for-profit strategy to ensure that the EmERGE platform can be provided sustainably to existing clinics and new sites beyond the project. In so doing it aims to ensure that the Horizon 2020 funding & the efforts of all partners can continue to bring benefit to citizens of the member states, working towards a digital single market.
In the first year of the project we undertook a detailed background assessment and situational analysis to understand how people living with HIV are followed up in the five participating clinics. This included an assessment of clinical pathways; ICT infrastructure and security requirements; information governance; and ethical-legal frameworks at each of the clinical sites.
A series of ‘co-design’ workshops and interviews were carried out at three stages within the project with community groups; clinicians; and participants in the study – these have fed into the development of the platform and the co-designed digital health pathway in an iterative fashion.
Our IT partners within the project consortium developed the GDPR complaint EmERGE platform; and integrated it into the ICT systems at each site.
An evaluation of the platform and reduced visit digital health pathway started in April 2017. 2251 people living with medically stable HIV were enrolled into the study and were followed up for a minimum of 12 months (12-30 months depending on date of enrolment).
Follow up using the EmERGE pathway is safe – 99% of individuals maintained an undetectable viral load whilst under follow up [intention to treat analysis]; no serious adverse events related to the platform or pathway were reported across the five sites. There were no data breaches reported during 3891patient years of follow-up.
Patient activation was high in this population; qualitative data collected as part of the sociotechnical evaluation demonstrated the positive impact on empowerment for communities and for individuals.
The project has captured learning about the feasibility and acceptability of introducing such a digital health pathway for individuals living with medically stable HIV; including the challenges and barriers. Uptake at sites was good with a mean of 23.1% of the clinic cohort at each site accepting the invitation to take part (range 8.2%-47.7%).
Cost effectiveness has been demonstrated via a detailed health economics analysis. Cost reductions increase the fiscal space of the clinic, enabling resources to be provided in a more targeted manner, to cater for additional patients and / or to increase resources for those with more complex needs.
Dissemination of the project findings is underway with presentations at national and international conferences; and at local, regional and national meetings (a list of publications and public presentations is available on the project website).
The EmERGE project has influenced the European AIDS Clinical Society (EACS) HIV guidelines which have been updated to incorporate new guidance on the use of digital modalities in routine HIV care.
The EmERGE consortium has opted to adopt a not-for-profit strategy to commercialisation and value generation (exploitation). This will ensure that the innovative digital health solutions produced by the project remain accessible to HIV and sexual health clinics in and beyond Europe. The not-for-profit company will continue to work closely with its stakeholders in product development, service provision and research activities.
The EmERGE project has demonstrated that a digital health pathway is an effective option in the routine management of people living with medically stable HIV. The EmERGE platform has been successfully integrated at five diverse clinical sites and has been used by >2000 people living with HIV as part of a novel pathway of care within the EmERGE study. The EmERGE pathway facilitates remote access to patient data including test results, appointments and medication information and allows people living with HIV to reduce the number of times that they need to visit the clinic; also allowing the service provider to better manage capacity.
The EmERGE pathway takes HIV care and digital health / mHealth in HIV beyond the current start-of-the-art, even five years after project start – providing access to data & choice for individuals who would like to reduce the number of visits needed to clinic.

As the project was drawing to a close, the world experienced an unprecedented COVID-19 pandemic forcing many countries into lockdown and disrupting (amongst many things) the provision of face-2-face health services. Many services have turned to telephone & are re-evaluating digital health provision. The co-designed EmERGE platform & pathway provide a solution which is truly beyond the state of the art: evidence from this project can give providers & communities’ confidence in moving to digital health pathways – shared learning from our experience is invaluable; the EmERGE platform provides a secure and trusted option for which evidence has been generated in a ‘real world setting’ which is now available for sites to implement via the not-for-profit EmERGE mHealth Ltd.