Article Text

Qualitative study exploring the experiences and perceptions of dolutegravir/lamivudine dual antiretroviral therapy (the PEDAL study) in people living with HIV: protocol
  1. Giovanni Villa1,2,
  2. Diego Garcia Rodriguez1,
  3. David Fray3,
  4. Amanda Clarke1,2,
  5. Caroline Ackley1
  1. 1 Department of Global Health and Infection, Brighton and Sussex Medical School, Brighton, East Sussex, UK
  2. 2 The Lawson Unit, University Hospitals Sussex NHS Foundation Trust, Brighton, East Sussex, UK
  3. 3 Service User Forum, The Sussex Beacon, Brighton, East Sussex, UK
  1. Correspondence to Dr Giovanni Villa; g.villa{at}


Introduction Antiretroviral treatment turned HIV infection into a chronic disease and improved quality of life for people living with HIV. Dual-drug combinations have been shown to be effective in suppressing viral replication and 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 in Brighton and Hove, UK. In addition, we will conduct a comparative analysis between patients on dolutegravir/lamivudine and patients on other dual-drug and three-drug combinations. Finally, 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 (ie, groups of items that are perceived to be of the same kind). This framework has been codesigned with a patient representative to ensure relevance, suitability and coproduction of knowledge. All methods have been tested to take place online, as an option, via Zoom, Skype or Microsoft Teams. 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.

Project registration number IRAS number: 286277. NCT04901728.

  • hiv & aids
  • therapeutics
  • qualitative research
  • anthropology

Data availability statement

No data are available.

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Data availability statement

No data are available.

View Full Text

Supplementary materials


  • Twitter @GvillaDr, @__diegogarcia__

  • Contributors GV is the chief and principal investigator of the study, he conceptualised the study and wrote the protocol with CA; DGR is a research assistant, he converted the protocol into its publishable format and coauthored the protocol; DF and AC are coinvestigators and coauthored the protocol; CA is the coprincipal investigator of the study, she conceptualised the study and wrote the protocol with GV. All authors supported the development and critical review of the protocol and of this manuscript.

  • Funding This work was supported by ViiV Healthcare; grant number 214249.

  • Competing interests GV declares a research grant from ViiV Healthcare to his Institution to run the study presented in the manuscript; AC declares direct payments from Gilead Sciences, ViiV Healthcare, MSD, Theratechnologies for participation in advisory boards; a sponsorship from Gilead Sciences for conference attendance; research grants from Gilead Sciences, ViiV Healthcare, MSD to her Institution for running clinical trials. All the other authors have no competing interests to declare.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting or dissemination plans of this research. Refer to the Methods section for further details.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.