Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04901728 |
| Other study ID # |
PEDALstudy |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2021 |
| Est. completion date |
July 30, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
University of Sussex |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
The investigators propose a three-phase comparative study with a control population (i.e.,
people living with HIV on other dual therapy regimens and triple ART) and the target
population (i.e., people living with HIV on dual DTG/3TC regimen). The 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, the investigators 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). The target population will include patients on DTG/3TC. The addition of the control
group of patients on other dual therapies will allow the investigators to tease out the
particular characteristics of the dual DTG/3TC beyond the mere reduction of molecules
employed for the treatment.
The investigators suggest that a comparative study including the target and control
populations will allow to better understand patient perceptions and needs as related to the
variables of (i) safety, (ii) effectiveness, (iii) tolerability, and (iv) unmet needs. This
is because DTG/3TC will not be experienced and perceived in isolation from the patients'
previous drug regimens or from other patients on different drug regimens. When a participant
on DTG/3TC describes their experiences and perceptions, they will be making a comparison to a
'time before' or to 'an other'. For example, the investigators anticipate patients to
describe current experiences of DTG/3TC effectiveness in comparison to a time they were on
another drug regimen or in comparison to a friend/known person on another drug regimen (e.g.
'DTG/3TC is more effective than my previous treatment' or 'DTG/3TC seems to be less tolerable
because my friend is on a different regimen and has fewer side-effects'). This supports the
need to explore other drug regimens through a control group so that comparisons that arise in
the data will have a reference point rooted in the data. In short, if a patient says 'DTG/3TC
is safer than my previous treatment' the investigators can understand not only experiences on
DTG/3TC, but also how it compares to other treatments.
Additionally, the subjective nature of these variables means that each person will have a
different understanding, meaning, perception, and experience of the study variables. ViiV
Healthcare, the researchers, and health care providers will have one, or more, ways of
defining the variables, but there is added value in exploring what they mean to patients. By
widening our participant population to not just include the target population, but to also
include the control groups the investigators will gain a more in-depth understanding of what
these variables mean to patients. This will ensure conceptual and operational alignment of
the variables between patients and researchers.
This study's 'phases' refer to the order in which specific methods will be deployed and
findings preliminarily analysed. In Phase I the investigators will deploy Cultural Domain
Analysis (CDA), a type of structured interview aimed at understanding how people in a group
think about lists of things that somehow go together. CDA will help the investigators to
better understand patient unmet needs. After data collection, the investigators will conduct
a preliminary analysis to refine and improve our Focus Group Discussion (FGD) questions and
approach. In Phase II the investigators will conduct FGDs to gain a deeper knowledge of
patient unmet needs and to begin exploring the variables safety, efficacy, and tolerability.
The investigators will conduct a preliminary analysis of the FGDs to refine the questions and
approach the subsequent In-Depth Interviews (IDI). In Phase III the investigators will
conduct IDIs to gain expert knowledge and understanding of the variables safety, efficacy,
and tolerability. The investigators will conduct a preliminary analysis of the data. Finally,
the investigators will analyse all data sets, prepare journal articles, conference papers,
and share findings through public engagement with both the Brighton and Sussex Medical School
and the Sussex Beacon.
The investigators will ask the control population to draw on their knowledge of the DTG/3TC
regimen, and the target population to share their experiences on DTG/3TC; both in relation to
the above-mentioned variables. By asking the control population about the DTG/3TC regimen (as
opposed to their current care plan) the investigators will illuminate potential gaps in
knowledge and understanding about the DTG/3TC regimen, as well as potential misconceptions
among HIV patients in treatment about the 2-drug therapy.
The investigators will also ask the control population about their current dual and triple
therapy regimens and the target population about their previous experiences on triple therapy
or alternative dual therapy combinations before switching to the DTG/3TC regimen; both in
relation to the above-mentioned variables. By including exploration of different treatments,
the investigators will gain an understanding of whether patients perceive the new regimen to
be safer, effective, and more tolerable, as well as if they feel previously unmet needs are
now met on the new treatment plan. The investigators can also gauge the potential interest
and/or concern/worry/fear that patients on triple and alternative dual therapies may feel
about the future direction of HIV treatment.
This data will enable the investigators to provide recommendations for improved
doctor-patient communication and health education about the 2-drug and DTG/3TC regimen. It
may also allow identifying psycho-social concerns that support teams should be aware of or
anticipate as patient treatment plans change.
