Participant recruitment for a clinical trial is often the most challenging part of completing a study. Adding to this difficulty is the stigma associated with certain health conditions that can leave potential participants hesitant to engage in research.
Stigma related to health and disease is pervasive and acts as a deterrent not only for clinical trial participation but for individuals to seek health care in the first place. The lack of health care leaves these individuals at a significant disadvantage, directly impacting their health throughout their lifetime.
Mental health conditions like Post-traumatic Stress Disorder (PTSD), schizophrenia, bipolar disorder, ADHD, substance use, and personality disorders carry a particularly heavy burden because of the social perceptions of each illness. Physical health conditions can also be stigmatized and include diabetes, HIV/AIDS, obesity, sexually transmitted infections, and skin conditions like acne and psoriasis.
There are a variety of factors that influence how others perceive a specific disease and the individual living with the condition, especially in health care settings. These include social stigma, internalized self-stigma, and stigmas held by health care professionals.
Clinical trial teams need to be aware of how stigma impacts participants, and ultimately can impact the results of a clinical trial by delaying or slowing recruitment.
By being mindful of the sources of stigma, study teams can improve the experience for participants, which can result in easier recruitment, reduce no-shows, and improve adherence to treatment protocols.
Social Stigma and How it Influences Disease
Social stigma related to health and illness is not a new phenomenon, nor is it unique to any one particular culture. It’s often viewed as an indicator of a person’s social status, and it can have a direct impact on how the larger population views and treats those with the condition.
Stigma is defined as stereotypes or negative views attributed to a person when their characteristics or behaviors are thought to be different from social norms. Highly visible health conditions, like obesity or psoriasis, or ones that influence behavior, like ADHD, or schizophrenia, carry heavy social stigma. Other conditions may be invisible like sexual dysfunction, or gastrointestinal disorders, but still have a significant social stigma because they impact what’s considered “normal” bodily function.
The social stigma associated with disease can make people hesitant to identify themselves as having a particular condition. Their feelings might be because they’re embarrassed or have experienced negative feedback from others when their health status is disclosed.
According to the Lancet, individuals with serious mental health issues often die years earlier than they should because of poor physical health. These early deaths are a consequence of their physical health conditions not being taken seriously because of the stigma surrounding their preexisting mental health issues.
Another example is the social stigma related to the HIV/AIDS epidemic since the disease first appeared in the 1970s. Individuals who contracted the disease were often ostracized from their families and communities, and treated as social outcasts. As late as 2009, individuals who were HIV positive were not allowed entry into the United States because of stigma related to disease transmission.
The Impact of Self-Stigma on Individual Health
Self-stigma is another concept to explore as it directly impacts a person’s willingness to self-identify as having a particular condition. Consequently, it can also influence their desire to engage in health care or to volunteer as a participant in a clinical trial.
When an individual with a particular health condition internalizes the social stigma related to their illness, they may feel guilty or inadequate about their condition. Often the fear of being labelled or judged can lead people to respond emotionally with embarrassment, isolation and anger.
This was a concern of Adrianne Monsef, Associate Director of Strategic Product Development at Strategic Science and Technologies, LLC, who led a study on Female Sexual Arousal Disorder (FSAD). FSAD is a highly sensitive condition and the self-stigma associated with the condition can prevent many women from self-identifying.
Trialfacts assuaged Ms. Monsef’s worries by creating effective ads that appealed to the study’s audience. A prescreening questionnaire was also created, which gave the research site some much-needed relief in the way of time and resources.
According to Monsef, “…I didn’t think women would be comfortable clicking a Facebook ad about sexual dysfunction. It’s a sensitive indication. That was my biggest concern—I didn’t think women would take it seriously. [I wondered if it was] credible enough for someone to want to participate in a clinical trial.”
These concerns are legitimate and can have an impact on the ability to recruit qualified participants for a clinical trial. By understanding how self-stigma can prevent individuals from engaging in research, study teams can address stigma as part of their initial protocol design, and throughout the study. This can include careful consideration given to the choice of recruitment strategies, the design of advertising campaigns, or designing how a particular procedure is done to reduce embarrassment.
Stigma and Bias in Health Care Settings
The third dimension of stigma related to health and disease is that held by physicians and other health care providers. It’s thought that a combination of social stigma, along with personal and professional experience, all contribute to the attitudes held by these professionals towards individuals with certain conditions.
These beliefs can directly impact the quality and type of care offered to individuals. For example, in some cases where pharmacy students wanted to distance themselves from individuals with Schizophrenia, they have been reported as being less willing to provide medication consultations.
There are other instances where individuals with mental illnesses may not receive equivalent care (compared to non-mentally ill patients) in general health settings once health professionals become aware of their mental health conditions.
Unconscious beliefs held by study teams in clinical trial settings about the participants they’re working with may impact study recruitment, retention and protocol adherence. For example, if it’s commonly believed that individuals with obesity are lazy or unmotivated, this may impact how staff interact with a participant. It can change what expectations staff have of that individual with adherence to a treatment protocol or their ability to attend site visits.
Awareness of stigma and its potential to create bias is an important first step in addressing the real-world implications for a clinical trial. Additionally, there are other ways that sites and study teams can create the conditions for success from the start.
Overcoming Stigma to Improve Clinical Trials
While stigma is pervasive and can impact the success of a clinical trial, it doesn’t need to be a show stopper.
There are general strategies that can be used to not only boost recruitment but also reduce no-shows and encourage retention including:
- Ensuring the safeguarding of personal health information and other private details that participants may be asked to provide.
- Communicating the safeguards undertaken to protect clinical trial participants and their personal health information, even if routine by industry standards.
- Seeking feedback on protocol design from target participants.
- Involving physicians early on to speak to the risks and benefits of the clinical trial.
- Establishing the potential value of a clinical trial for the participant and others in the future with the condition under study.
- Setting and consistently meeting expectations to ensure there are no surprises for participants.
- Developing the participant-researcher relationship.
- Providing detailed information about the study in advertising and on study websites so potential participants can privately assess whether the study may be relevant for them.
- Providing detailed online prescreening so that potential participants can assess their eligibility before divulging their identity.
- Creating simple, easy to follow processes that encourage participation.
The importance of privacy and confidentiality increases when a disease is highly stigmatized. It can also play an active role in how participants respond before and during their involvement with the study. Disclosure of certain stigmatized conditions can also have real-world consequences, like the ability of someone with PTSD to continue to serve in the military should their health status be disclosed to their employer.
Based on our experience, developing a good relationship between the site staff and participants is the most important factor in success. Effective relationships are built off of trust and communication and there are strategies that can be used to help nurture both including:
- Providing participants with information about the clinical trial including details about why the study is important, who it may help, and detailed information about what’s involved.
- Providing biographical information about the Principal Investigator and other key staff.
- Making time to answer participant questions and concerns whenever they come up.
- Focusing on creating a warm, welcoming environment at the site that encourages conversation between participants and staff (scheduling an initial meet and greet is a great way to do this).
- Acknowledging and showing gratitude for participants’ time and commitment to your study.
- Making things personal by ensuring all interactions are with the same site staff, making the effort to understand each person’s motivation to participate, and regularly taking the time to have casual conversations with participants.
Stigmatized conditions are in need of clinical research just as much as other diseases. While stigma may influence participants’ willingness to volunteer for a study, it isn’t a barrier that can’t be overcome. With awareness of the impact of stigma on participants and study staff you can proactively address these concerns before your trial begins.
Even though stigma can make recruitment more challenging, it shouldn’t be a factor that influences the success or failure of a clinical trial. Employing carefully thought-out strategies to overcome stigma can have a dramatic impact on enrollment; regardless of whether a condition carries a stigma, recruitment for clinical trials can be made more predictable and reliable by using a proven, data-driven process that guarantees results. Contact us if you’d like a review of your current recruitment strategy or would like to know which best practices will ensure on-time and in-budget recruitment for your study.