Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05306769 |
| Other study ID # |
298515 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2022 |
| Est. completion date |
April 30, 2023 |
Study information
| Verified date |
March 2022 |
| Source |
Guy's and St Thomas' NHS Foundation Trust |
| Contact |
Cassie Fairhead |
| Phone |
020 7188 7188 |
| Email |
cassandra.fairhead[@]kcl.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Established recruitment methods will be used to recruit participants. The study will be
non-blinded. Eligibility will be checked and consent taken by a delegated study clinician.
Participants will attend a 30 minute virtual individual semi-structured interview.
Additionally, all patients attending an appointment within Harrison Wing will be invited to
complete an anonymous, self-administered survey on attitudes towards participation in HIV
clinical studies.
Description:
Study description and population to be studied:
Researchers will employ Implementation Science methodology to understand and act upon the
determinants of representation in HIV clinical studies in order to improve the diversity of
study recruitment at the central London clinic-embedded research unit such that it better
represents the clinic population. The setting is the Harrison Wing service: a specialist
outpatient service for over 3500 people living with HIV based at Guy's and St Thomas' NHS
Foundation Trust. This study will evaluate the extent and characteristics of study
underrepresentation in the context of our clinic; identify and engage key stakeholder
communities including both patients and clinicians, and collaboratively design a strategy to
facilitate uptake of diverse recruitment and diverse participation using participatory
methods.
Rationale and potential benefits of this study:
The demographic characteristics of participants in HIV clinical studies do not match those of
the wider population of people living with HIV (PLHIV), from clinic-level to global scales.
Women and ethnic minorities are chronically underrepresented. Those at the intersections
including ethnic minority or socially excluded women have particularly low participation
rates.
Underrepresentation in HIV clinical studies is well-recognized to seriously threaten
clinicians' and patients' ability to make informed decisions about treatment. Sub-group
analyses often lack statistical power, whereas studies that actively or exclusively target
underrepresented groups can reveal critical information about HIV treatment. Evidence is
accumulating of gender and ethnicity-based differences in the transmission, physiology,
course of infection, efficacy and safety of treatment, access to care and long-term wellbeing
for PLHIV. ViiV Healthcare recently highlighted this and called for targeted enrolment of
women in clinical trials.
There is also a clear ethical imperative regarding study recruitment: clinical studies may
represent a patient's best opportunity for life-saving or quality of life enhancing
therapies, particularly for individuals with poor access to services.37 Equitable trial
recruitment not only underpins the evidence behind equitable HIV care but often constitutes
that care itself. NIHR's equality, diversity and inclusion guidance emphasizes that every
eligible person should be offered equal opportunity to participate in research regardless of
demographics including ethnicity, sex, socioeconomic status or sexual orientation.
Underrepresentation in Covid-19 research has drawn recent attention to the importance of
diverse recruitment.
Despite this clear evidence that diverse and representative HIV clinical study recruitment is
critically important yet rarely achieved, implementing diverse recruitment is a complex
challenge. Participants' decisions to participate in research are multidimensional,
wide-ranging, culturally relevant and locally specific. Themes in considerations cited by
underrepresented groups include lack of knowledge about studies, mistrust of researchers,
concern for safety, altruism, and positive perceptions of medical care within studies.
Rationale for including both patients with excluded demographics and patients who participate
in HIV clinical studies:
Research into potential participants' locally relevant barriers reveals important nuance and
sometimes stark differences in prevailing trends in what drives study participation. For
example, in some areas distrust is a dominant barrier for men and medication concerns
dominant for women, yet elsewhere trust levels are similar regardless of gender.
benefits such as sociability motivate others. Stage of disease and psychological factors are
important. Interventions to increase representation have been efficacious where local factors
are appreciated. Interactions between patients and study providers may also be important:
study providers, such as clinicians, are gatekeepers to clinical study access. Biases in
referring to clinical trials disadvantages women, ethnic minorities and psychosocially
complex patients providers' perceptions of patients' recruitment barriers are not always
correct. Invitation to studies may be a dominant barrier to diverse recruitment. Ironically,
underrepresentation exists despite under-recruited populations desiring more representative
trial populations.
Justification for research methods to be used, including virtual semi-structured interviewing
and self-administered surveys:
Focus groups and semi-structured interviewing have been successfully utilized in a variety of
settings to identify barriers and enablers of trial recruitment through thematic analysis in
underrepresented groups. These strategies are frequently combined with baseline demographic
and social data, and surveys have proved a valuable resource in identifying and overcoming
barriers to diverse recruitment. The Investigators have chosen a virtual format for
convenience to participants and to minimise the risk of Covid-19 infection. Self-administered
surveys are effective and may be preferable through enabling anonymity of participants. Such
qualitative methods can successfully identify providers' biases and barriers as well as those
of patients. Assessing the representativeness of HIV patients in clinical studies using
electronic medical records and statistically evaluating differences has proved successful in
previous studies. Comparing patients in studies with the local clinic population from which
they are drawn, rather than from national or international statistics, will support the
implementation of representative recruitment.
Lessons learnt from such methods have enabled empowerment and facilitation of recruitment of
underrepresented groups. For the GRACE trial this included community involvement, enrolment
quotas and targeted public relations. The REPRIEVE study similarly co-developed recruitment
best practices aided by structured interviews. Effective strategies including culturally
sensitive information about clinical trials, practical assistance and peer support have been
identified through similar research into the barriers to recruitment.
As a highly active well-established research unit co-located and strongly embedded within a
large, diverse London clinic we are uniquely placed to put into practice lessons learned from
this project. If successful, this study and project will provide tools to increase the
diversity of the population in clinical trials in Harrison Wing to reach a position where the
demographics of trial participants reflects that of the local population living with HIV.
Direct benefits of this include increasing the generalizability of research results and
increasing equality of access to what may be a patient's best treatment option. Importantly,
Harrison Wing has a dynamic and established involvement in audit and Quality Improvement,
enabling successful strategies to be implemented and improved upon sustainably.
