Patients’ experiences and perceptions of 3TC/DTG dual therapy_v1.0
Research type
Research Study
Full title
Lamivudine (3TC) plus dolutegravir (DTG) dual therapy: a study on patients’ experiences and perceptions (the PEDAL Study)
IRAS ID
286277
Contact name
Giovanni Villa
Contact email
Sponsor organisation
University of Sussex
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Antiretroviral treatment (ART) - the combination of medicines or ‘drugs’ used to treat HIV infection - has been effective in controlling the disease since three different active medicines have been combined together in the late Nighties (triple therapy). However, now the future of ART includes treatment options with fewer combined medicines that still have sufficient power to control the replication of the virus and control the disease. The goal of combining fewer medicines in treatment is to limit drug toxicity, long-term side effects, and the need of frequent changes in medications. We aim to study patients' experiences and perceptions of the 2-drug ART combination dolutegravir/lamivudine (DTG/3TC) and to compare them with other 2-drug combinations and triple-drug ART. The study will explore the themes of efficacy, tolerability, safety, and patients' unmet needs. We will interview participants using 1) structured interviews, in the format of Cultural Domain Analysis, 2) in-depth interviews, and 3) Focus Groups Discussions. We will recruit adults undergoing treatment at the HIV Departments of the Royal Sussex County Hospital and of the Western Sussex Integrated Sexual Health. We will compare the data collected from patients receiving DTG/3TC with patients' experiences on current and previous alternative treatment combinations. The study will follow a process whereby data analysis from one method will inform and refine the next one. The data that we will obtain from the three different methods will generate a dataset that will allow us to have an in-depth understanding of patients' experiences and perceptions of their treatment combinations. The methods will be conducted either online or in-person, depending on both participants' preferences and COVID-19 guidance on physical distancing. The findings will inform and guide recommendations on doctor-patient communication, knowledge, and understanding of treatment plan, and additional care that ought to be considered in patient-centred, holistic care.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
21/NW/0070
Date of REC Opinion
28 Apr 2021
REC opinion
Further Information Favourable Opinion