Patients' Experiences and Perceptions of 3TC/DTG Dual Therapy (the PEDAL Study)
PEDAL
Lamivudine (3TC) Plus Dolutegravir (DTG) Dual Therapy: a Study on Patients' Experiences and Perceptions
1 other identifier
observational
118
1 country
1
Brief Summary
Improvements in health care and antiretroviral treatments have made it possible to turn HIV into a chronic disease leading to longer life expectancies and better quality of life among patients. Dual-drug combinations offer the advantage of a reduced exposure to antiretroviral agents, therefore leading to potential reductions in drug-associated side effects in the long-term. In light of this context, the primary aim of this qualitative study is to investigate patients' perceptions and experiences on the safety, effectiveness, tolerability, and unmet needs of the dolutegravir/lamivudine two-drug regimen. The secondary objective is to conduct a comparative analysis between patients on dolutegravir/lamivudine and patients on other two-drug and three-drug combinations. Lastly, the study aims to provide recommendations that 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2021
CompletedFirst Posted
Study publicly available on registry
May 25, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2022
CompletedMay 25, 2022
May 1, 2022
1.1 years
May 18, 2021
May 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Cultural Domain Analysis
Question to evaluate patients' unmet needs
June to September 2021 (up to a month after the study starts)
Focus Group Discussions
To investigate patients' perceptions and experiences on the safety, effectiveness, tolerability, and unmet needs of the DTG/3TC 2-drug regimen
Following completion of cultural domain analysis (October to November 2021, five months after the study starts)
In-depth interviews
To investigate patients' perceptions and experiences on the safety, effectiveness, tolerability, and unmet needs of the DTG/3TC 2-drug regimen
Two months after completing focus group discussions (January to March 2022, eight months after the study starts)
Study Arms (3)
Target Population
People living with HIV and following a DTG/3TC drug regimen
Control Group on Dual Regimens
The first control population will include a group on dual regimens other than DTG/3TC and a group on triple therapy. In the control group of patients receiving dual therapies, we will include patients (i) on Juluca (DTG/rilpivirine\[RPV\]), (ii) on boosted darunavir plus lamivudine (DRV/r or DRV/c + 3TC), and (iii) on boosted darunavir plus raltegravir (DRV/r or DRV/c + RAL).
Control Group on Triple Regimens
The second control population will include a group on triple regimens including: 2 NRTIs + 1 NNRTI; 2 NRTIs + 1 INSTI, and 2 NRTIs + 1 PI/b.
Interventions
80 and up to a maximum of 120 participants
At least 18 and up to a maximum of 60 participants
At least 18 and up to a maximum of 36 participants
Eligibility Criteria
Patient participants will consist of 18+ people living with HIV in the Brighton and Hove area, and receiving HIV care at the HIV Department of the Brighton and Sussex University Hospital (Lawson Unit/Elton John Centre).
You may qualify if:
- Adults (aged 18 years old or older)
- Able to consent
- Receive HIV care at the HIV Department of the Brighton and Sussex University Hospital (Lawson Unit/Elton John Centre)
- All genders, sexual orientations, and socio-economic groups are eligible for participation
- On one of the following therapies
- Control population
- Juluca (DTG/rilpivirine\[RPV\])
- Boosted darunavir plus lamivudine (DRV/r or DRV/c + 3TC)
- Boosted darunavir plus raltegravir (DRV/r or DRV/c + RAL)
- A triple regimen (2 nucleos(t)ide reverse transcriptase inhibitors \[NRTIs\] + 1 InSTI; 2 NRTIs + 1 non-nucleoside reverse transcriptase inhibitor \[NNRTI\]; 2 NRTIs + boosted protease inhibitor \[PI/b\])
- Target population
- DTG/3TC
You may not qualify if:
- Patients taking off-label drug combinations due to complex HIV resistance patterns.
- ART naïve or individuals declining ART will be excluded.
- Patients without access to the technology to participate in the online study will be given the option to participate in person (following COVID-19 guidance), and if this is not possible they will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Sussex County Hospital, Brighton, UK
Brighton, BN2 5BE, United Kingdom
Related Publications (1)
Villa G, Garcia Rodriguez D, Fray D, Clarke A, Ackley C. Qualitative study exploring the experiences and perceptions of dolutegravir/lamivudine dual antiretroviral therapy (the PEDAL study) in people living with HIV: protocol. BMJ Open. 2022 May 19;12(5):e056414. doi: 10.1136/bmjopen-2021-056414.
PMID: 35589352DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giovanni Villa
Brighton & Sussex Medical School
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2021
First Posted
May 25, 2021
Study Start
July 1, 2021
Primary Completion
July 30, 2022
Study Completion
July 30, 2022
Last Updated
May 25, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share