Protocol for a qualitative study exploring the experiences and perceptions of dolutegravir/lamivudine dual antiretroviral therapy (the PEDAL Study) in people living with HIV
Authors: Villa Giovanni , Rodriguez Diego Garcia , Fray David , Clarke Amanda , Ackley Caroline 
Published: August 2021

ABSTRACTINTRODUCTIONAntiretroviral 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 ANALYSISOur 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 DISSEMINATIONEthical 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.PROJECT REGISTRATION NUMBERIRAS Number: 286277SPONSOR Number: 076 VIL/ 286277FUNDER Number: 214249ClinicalTrials.orgRegistration Number:NCT04901728STRENGHTS AND LIMITATIONS OF THE STUDYStrengths▸This study will gather qualitative data through three research methods (cultural domain analysis, focus group discussions, and in-depth interviews) to triangulate the findings emerging from patients’ experiences and perceptions of the dolutegravir/lamivudine (DTG/3TC) dual-drug combination▸This study is the first of its kind to provide patient-centred insight into DTG/3TC treatment combination to improve clinical care through an in-depth qualitative, iterative, and comparative approach (against previous survey studies on patients’ reported outcomes)▸The study’s protocol has been co-designed with a representative of people living with HIV in Brighton and Hove to ensure co-production of knowledge▸Data gathered will be analysed through applied thematic analysis to produce recommendations to improve doctor and patient communication after identifying patients’ concerns of their drug regimen▸The possibility of taking part in research both in-person and online will allow for increased anonymity and flexibility for patients to participate while simultaneously ensuring that they are safe in the COVID-19 environment by reducing in-person meetingsLimitations▸The cohort in Brighton might not be representative of the whole country and groups like women living with HIV, ethnic minorities, and transgender individuals might be underrepresented▸Potential participants who might not feel comfortable meeting in person and who lack the digital skills required might be unable to take part in the study▸Patients with complex ARV regimens will not be included given their limited treatment options