Protocol for a qualitative study exploring the experiences and perceptions of dolutegravir/lamivudine dual antiretroviral therapy (the PEDAL Study) in people living with HIV

Abstract

INTRODUCTION Antiretroviral treatment turned HIV infection into a chronic disease and improved quality of life for people living with HIV. Dual-drug combinations can potentially reduce long-term drug-associated toxicities. We aim to investigate patients' perceptions and experiences on the safety, effectiveness, tolerability, and unmet needs of the dual-drug combination dolutegravir/lamivudine focusing on patients receiving care in Brighton, United Kingdom. In addition, we will conduct a comparative analysis between patients on dolutegravir/lamivudine and patients on other dual-drug and three-drug combinations. Lastly, the study aims to provide recommendations to improve doctor-patient communication, knowledge and understanding of the treatment plan, and additional care that ought to be considered in patient-centred, holistic care plans. METHODS AND ANALYSIS Our qualitative methodological framework is based on three main methods: cultural domain analysis, focus group discussions, and in-depth interviews. Cultural domain analysis employs a range of techniques (free listing, pile sorts, and rankings) to elicit terms from informants regarding specific cultural domains (i.e., groups of items that are perceived to be of the same kind). This framework has been co-designed with a patient representative to ensure relevance, suitability, and co-production of knowledge. All methods have been tested to take place online via Zoom®, Skype®, or Microsoft Teams® should participants prefer to participate digitally rather than in person. Padlet®, an application to create online boards, will be used during the cultural domain analysis session. Data collected will be analysed following the completion of each method embracing an iterative approach through applied thematic analysis. ETHICS AND DISSEMINATION Ethical approval was obtained from the Health Research Authority (Reference 21/NW/0070). Findings will be used to produce recommendations to improve doctor and patient communication by identifying patients' fears, worries, misconceptions, and general concerns of their drug regimen. Conclusions will be disseminated via journal articles, conference papers, and discussions through public engagement events.