London, 18 November 2020?? ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (?GSK?), with Pfizer Inc. and Shionogi Limited as shareholders, today announced positive initial findings from the PROgress study, which was designed to evaluate how the introduction of patient reported outcomes (PROs) could improve the care of people living with HIV by increasing their healthcare providers? awareness of their unmet needs. The PROgress study also explored the value of introducing PROs to healthcare providers and clinic staff, and how to best integrate the survey information into routine care.

During the study, conducted over 15 months at two North American community-based HIV outpatient clinics (St. Michael?s Hospital, Toronto, ON and Midway Specialty Care Clinic, Ft. Pierce, FL), 1761 sessions were conducted in which people living with HIV self-administered a brief electronic tablet survey after arriving for their clinic visit. The survey assessed PROs covering a range of measures, including treatment adherence, mental health, substance abuse, and intimate partner violence. The summary results of the tablet survey were instantly made available to the healthcare provider and used to guide their visit and discussion. Following the pre-visit survey, 200 people living with HIV and 17 healthcare providers and clinic staff were asked to review the process.

The study showed that across all people living with HIV and healthcare providers, 82% agreed that the pre-visit survey of PROs was valuable for HIV clinical practice. People living with HIV found the pre-visit survey improved communication with their healthcare provider by prioritising discussion topics, it also helped initiate discussion on sensitive issues like personal drug use, and improved comprehensiveness of and satisfaction with care. Healthcare providers found the pre-visit survey to be both useful and incorporated into routine care with minimal disruption to clinic flow.

Jean Bacon, Executive Director of the Ontario HIV Treatment Network and Member of the PROgress Study Steering Committee,?said: ?Incredible improvements in HIV treatment and care have significantly increased the life span of people living with HIV, which has allowed us to expand our focus beyond viral suppression to also examine how we can improve our patients? wellbeing and quality of life. As shown by the results of the PROgress study, through the incorporation of a simple but focused pre-visit survey, we can look beyond the clinical lab markers of HIV status and can begin to re-define long-term treatment success more holistically to improve care for people living with HIV.?

Perspectives of People Living with HIV from PROgress To evaluate the perceptions of people living with HIV in the PROgress study, 200 patient participants were surveyed about the usefulness of the pre-visit survey on their HIV care. The perspectives of these participants were positive, with a large proportion (82%) indicating they agreed that the inclusion of the pre-visit survey made their visit better overall. In addition, people living with HIV agreed that the survey helped them consider their overall health (89%), reminded them of health concerns to raise (81%), helped them discuss topics that might not have otherwise arisen (76%), helped them discuss issues difficult to speak frankly about (71%), and helped them in general to decide what to talk about with their healthcare provider (67%).

The survey findings were reinforced by individual one-on-one interviews with 30 patient participants who were able to elaborate further and noted that by being asked about mental health and quality of life-related needs they felt more ?cared about.? In the study, people living with HIV reported that the inclusion of their pre-visit survey added value to their care as it improved recall and preparation for areas to address, removed barriers to honest responses, enriched patient-provider communication, promoted self-evaluation in behavioral areas, and improved the comprehensiveness of their care.

Jeff Berry, Member of the PROgress Study Steering Committee, Director of Publications at TPAN, Editor of Positively Aware Magazine, Co-Founder of the Reunion Project and a long-term survivor of HIV said: ?The PROgress study has shown how it can be difficult to come to a clinic visit prepared to talk about sensitive issues such as mental health challenges or substance use. Individuals can be afraid or find it very difficult to be open and disclose certain things in person to their healthcare provider, even when they have known them for a long time or if they have a good relationship. Patients have shown how they are much more comfortable and likely to answer some of the more personal questions about their health and wellbeing through a simple survey conducted before a visit, which helps both the individual and their doctor ensure they receive the best care and support.?

Perspectives of Healthcare Providers from PROgress Similar to people living with HIV, the perspectives of 11 healthcare providers in the PROgress study were evaluated with a post-visit survey and one-on-one interviews that asked them about the usefulness and acceptability of the pre-visit survey. The PROgress study showed that 82% of healthcare providers agreed or strongly agreed that the inclusion of the pre-visit survey added value to the visit overall, made the consultation easier, helped prioritise discussion topics with patients, and led to more discussions on potentially sensitive topics.

Forty-five percent of healthcare providers agreed that the pre-visit survey saved time during their consultation. Furthermore, one-on-one interviews revealed that in instances where the pre-visit survey impacted workflow, healthcare providers noted it was manageable and worth the tradeoff for the ability to better identify issues and increase the comprehensiveness of care. Sentiment from the one-on-one interviews supported this finding, noting that the inclusion of the pre-visit survey allowed them to address sensitive issues that may otherwise have been missed, such as depression and suicidality.

Heidi M. Crane, MD, MPH, PROgress co-Principal Investigator, Professor of Medicine and Associate Director Clinical Cohort and Comorbidity Research Core, Center for AIDS Research, University of Washington, said: ?Physicians described how the inclusion of PROs into their practice was like ?looking behind a curtain? into some of the more complex and personal issues their patients hadn?t proactively raised before. I?ve personally encountered this in my practice, where a patient who had a prior history of?substance usage experienced relapse and didn?t bring up his new challenges during our visits. Then a pre-visit survey picked up on his new relapse and we were able to work together to find him the help and support he needed. Uncovering these personal issues that might have otherwise been missed, perfectly encapsulates how valuable incorporating PROs into clinical practice can be for both people living with HIV and their healthcare providers.?

Implementing patient reported outcomes into clinical practice In addition to these initial findings, the 15-member PROgress study steering committee of people living with HIV, HIV care providers, clinic directors, and healthcare researchers jointly developed a toolkit and supporting resources to assist healthcare clinics with the adoption of PROs into their clinical practice. This PRO implementation toolkit provides practical advice to support the introduction of pre-visit surveys, including a summary sheet to help both people living with HIV and healthcare providers initiate, structure conversations, and prioritise what is discussed during consultation. Also included in the toolkit is an evidence summary that is designed to raise awareness of the published literature characterising the impact of PROs in routine clinical care for patients with chronic comorbidities. This toolkit and resources are available at?https://progresshivcare.org/.

Duncan Short, PhD, Director, Global Implementation Science at ViiV Healthcare,?said: ?The PROgress study program is important because it confirmed how a short pre-visit survey focused on PROs could improve communication and HIV care, while also providing the foundation for our joint steering committee to develop tools and resources that could support clinics in adopting these measures. This implementation toolkit will provide invaluable information to help integrate PROs into clinical practice and has the potential to improve how people living with HIV receive care and how their healthcare providers deliver it.?

The PROgress study is part of ViiV Healthcare?s pioneering Implementation Science programme, focusing on improving the real-world delivery of HIV treatment and care outside the structured environment of clinical trials. Implementation science trials led by ViiV Healthcare are ongoing globally to study a variety of issues including improving access to testing, clinical care and effective treatment.

About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of acquiring HIV. Shionogi joined as a shareholder in October 2012. The company?s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

For more information on the company, its management, portfolio, pipeline and commitment, please visit?www.viivhealthcare.com.

About GSK GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit?http://www.gsk.com/en-gb/about-us.