Increasing representation of LGBTQIA+ patients in clinical trials: A source of pride

By Gabrielle Platt, Content Marketing Manager

As Pride Month comes to a close, we honor the contributions of the LGBTQIA+ community in advocating for better access to, and participation in clinical trials, and outline the progress still to be made to ensure truly inclusive clinical trials and improved health outcomes for the LGBTQIA+ community.

The LGBTQIA+ community has played a pioneering role in the history of clinical trials and the resultant advances in medical progress. Historically, it has not been easy, with LGBTQIA+ people facing higher barriers to participation in clinical trials, due to the overlapping disadvantages of discrimination and stigmatization, increasing the psychological and financial barriers to participation. However, the LGBTQIA+ community has not allowed these barriers to become a blockade.

Despite many LGBTQIA+ people experiencing past discrimination in institutional and medical environments, a recent survey we ran of over 4,000 participants across 9 countries, showed that LGBTQIA+ respondents had a very high willingness to participate in clinical trials that may benefit the health of their community. Historically, we have seen the impact of this push for representation and willingness to participate in landmark trials that have bettered the outcomes for those living with HIV and other conditions that disproportionately impact the LGBTQI+ community.

Clariness has experience in finding patients of all backgrounds for studies in indications that disproportionally impact LGBTQI+ communities, including major depressive disorder, PTSD, breast cancer and obesity. It is up to trial managers, sponsors and recruiters to create an inclusive trial environment to ensure a continued increase in the participation of LGBTQIA+ people in clinical trials, ultimately improving health outcomes for the community.

LGBTQIA+ health, conditions that matter

LGBTQIA+ people often face health challenges that are compounded by societal stigma and discrimination resulting in unequal access to healthcare. The discrimination that LGBTQIA+ people face creates a heightened risk of poor health outcomes, ranging from mental health concerns to obesity, HIV, HPV and delayed cancer diagnoses. Further clinical research including LGBTQIA+ people is vital to improving these outcomes.  

Additionally, LGBTQIA+ people are at a higher risk of experiencing mental health issues, and are 1.5 times more likely to experience mood, anxiety and substance use disorders than heterosexual people1.  Some research suggests that lesbian and bisexual women have a higher risk of developing obesity2 and breast cancer than heterosexual women. Increased substance abuse and stress among lesbian and bisexual women compared to the general population has been thought to potentially contribute to breast cancer risk3.   

These disparities in health outcomes begin at a young age, with LGBTQIA+ youth facing unique issues compared to their peers such as increased stigmatization, social stress, peer victimization and family rejection. Healthcare providers often lack the right training to provide the best individualistic care for LGBTQIA+ youth4, leading to negative associations and relationships with medical institutions starting early.  

Promisingly, working with clinical trial sponsors, we are now seeing more clinical trials on mental health interventions tailored for LGBTQIA+ individuals and the effectiveness of various therapies. 

Late and delayed cancer screenings are another issue faced by the LGBTQIA+ community. A lack of cervical cancer screenings has been shown to potentially lead to higher rates of cervical cancer1. Transgender people are more likely to receive later stage cancer diagnosis, are less likely to receive care and may have lower survival rates5. Gay and bisexual men are more likely to develop anal cancer than heterosexual counterparts6. These examples show a clear need to better include the LGBTQIA+ community in oncology clinical trials. 

The history of HIV research: the impact of LGBTQIA+ advocacy

One of the most significant intersections of clinical trials, medicine, and the LGBTQIA+ community is the history of HIV/AIDS research. In 2018, adolescent and adult gay and bisexual men made up 68% of new HIV diagnoses in the United States7.  

During the early years of the HIV/AIDS epidemic in the 1980s and 1990s, the LGBTQIA+ community, particularly gay men, were disproportionately affected. Activist groups like ACT UP (AIDS Coalition to Unleash Power) played a crucial role in advocating for faster drug approval processes and more inclusive clinical trials. This activism led to significant changes in how clinical trials are conducted and has had a lasting impact on drug development and approval processes ever since8.

Pre-Exposure Prophylaxis (PrEP) is one example of a groundbreaking HIV prevention strategy that involves taking a daily pill (Truvada or Descovy) to prevent HIV infection. Clinical trials for PrEP, such as the iPrEx trial, specifically included gay and bisexual men and transgender women, populations that are historically at higher risk for HIV. The successes of these trials has led to the widespread use of PrEP, significantly reducing new HIV infections within these communities9.

Recent studies have also trialed novel acceptance based behavioral therapy (ABBT) intervention in people living with HIV to improve social support and mental health concerns10.  

Advancements in HIV diagnostics have significantly improved early detection and treatment outcomes. Rapid HIV tests, which can deliver results in as little as 20 minutes, have become a cornerstone in combating the spread of the virus. Furthermore, the advent of at-home HIV testing kits has revolutionized access to diagnostics, allowing individuals to perform tests privately and conveniently. These kits, which include both oral swab and finger-prick blood tests, have increased testing rates among populations who may be hesitant to visit a clinic due to stigma or privacy concerns. By making testing more accessible and discreet, at-home diagnostics play a crucial role in early detection and the ongoing effort to reduce HIV transmission.

Drivers and barriers to LGBTQIA+ clinical trial participation: financial and psychological barriers

In our recent international diversity survey, 73% of LGBTQIA+ participants showed willingness to participate in clinical trials, a higher response than non-LGBTQI+ respondents. So, what is standing in their way? Our survey found that financial and psychological barriers are the strongest deterrants to participating in a clinical trial, and for LGBTQI+ people, these barriers unfortunately loom larger.  

The more financially insecure a survey respondent was, the more the potential travel costs of attending a trial center impacted their willingness to participate. As with all marginalized groups, cycles of discrimination and oppression lead to heightened financial insecurity. 34.7% of bisexual and pansexual people and 44.6% of gay people we spoke to cited a lack of financial compensation as a barrier, compared to 28% of straight individuals.  

A history of negative experiences with doctors and healthcare systems disproportionally affects the LGBTQI+ community. 6.5% of non-binary respondents struggled finding doctors that fit their requirements, 50% reported that their doctors were insensitive to them, 37% felt their doctors did not listen to them and 54.3% said they were afraid to visit doctors or hospitals.  

How can we make clinical trials more inclusive to the LGBTQI+ community?

Due to the ongoing work of advocacy groups, we have seen a greater inclusion of LGBTQIA+ people in clinical trials. Led by advocacy groups, policymakers and sponsors have followed suit. For instance, the National Institutes of Health (NIH) established the Sexual and Gender Minority Research Office (SGMRO), which has led to increased funding and support for studies that include sexual and gender minorities11.

Centering trust and community has been shown to increase participation among transgender individuals in clinical trials.  Research suggests that transgender individuals are motivated to participate in trials that are led or staffed by transgender researchers, benefit transgender communities and are recommended by trusted clinicians12.  

It is important to improve the visibility of transgender people in all research that involves them and to ensure the data collected in clinical trials accurately reflects a transgender person’s identity. The medical language and reporting practices used in clinical trials are an opportunity to foster inclusion rather than exclusion of transgender participants13. Progress has been made to unlink presumptive links based on gender to certain types of cancer and pregnancy, and to allow trial participants more choice of gender and sexual identity categories to accurately describe themselves and provide more nuanced data14.  

Understanding that barriers to trial participation can be further compounded by intersectional factors, particularly for LGBTQIA+ people of color is the key to improving greater inclusion in clinical trials. Read here to learn more about increasing the representation of Black/African American people in clinical trials.  

Clariness is committed to increasing the engagement of all underrepresented groups in clinical trials, and in turn improving patients’ lives by accelerating the development of new medical therapies. If you wish to discuss creating more inclusive clinical trials, and patient recruitment, please contact us here.  

Recommended Reading

  1. Gillespie C. 7 Major Health Disparities Affecting the LGBTQ+ Community. Health. Published 23 November 2022. Accessed 20 June 2024. Health Disparities Affecting the LGBTQ+ Community 
  1. Specter M. How Act Up Changed America. The New Yorker. Published 7 June 2021. Accessed 20 June 2024.  
  1. National Institute of Allergy and Infectious Diseases. Pre-Exposure Prophylaxis (PrEP) to Prevent HIV. Published 1 March 2024. Accessed 20 June 2024. Pre-Exposure Prophylaxis (PrEP) to Prevent HIV | NIAID: National Institute of Allergy and Infectious Diseases ( 
  1. Moitra E, Brick LA, Cancilliere MK, et al. A randomized trial of acceptance-based behavioral therapy to improve mental health outcomes for LGBTQ+ persons: Study protocol. Contemp Clin Trials. 2023;130:107211. doi:10.1016/j.cct.2023.107211 
  1. Gmelin JH, De Vries YA, Baams L, et al. Increased risks for mental disorders among LGB individuals: cross-national evidence from the World Mental Health Surveys. Soc Psychiatry Psychiatr Epidemiol. 2022;57(11):2319-2332. doi:10.1007/s00127-022-02320-z 
  1. Azagba S, Shan L, Latham K. Overweight and Obesity among Sexual Minority Adults in the United States. Int J Environ Res Public Health. 2019;16(10):1828. Published 2019 May 23. doi:10.3390/ijerph16101828 
  1. Meads C, Moore D. Breast cancer in lesbians and bisexual women: systematic review of incidence, prevalence and risk studies. BMC Public Health. 2013;13:1127. Published 2013 Dec 5. doi:10.1186/1471-2458-13-1127 
  1. Hafeez H, Zeshan M, Tahir MA, Jahan N, Naveed S. Health Care Disparities Among Lesbian, Gay, Bisexual, and Transgender Youth: A Literature Review. Cureus. 2017;9(4):e1184. Published 2017 Apr 20. doi:10.7759/cureus.1184 
  1. Jackson SS, Han X, Mao Z, et al. Cancer Stage, Treatment, and Survival Among Transgender Patients in the United States. J Natl Cancer Inst. 2021;113(9):1221-1227. doi:10.1093/jnci/djab028 
  1. Patel, P.; Bush, T.; Kojic, E.; Conley, L.; Unger, E.; Darragh, T., et al. (2018). Prevalence, Incidence, and Clearance of Anal High-Risk Human Papillomavirus Infection Among HIV-Infected Men in the SUN Study. The Journal of Infectious Diseases, 217(6), 953-963. 
  1. National Institutes of Health Sexual & Gender Minority Research Office. Published 20 May 2024. Accessed 20 June 2024. Sexual & Gender Minority Research Office | DPCPSI ( 
  1. Asquith A, Sava L, Harris AB, et al: Patient-centered practices for engaging transgender and gender diverse patients in clinical research studies. BMC Med Res Methodol 21:202, 2021 
  1. Ash B. Alpert et al., Addressing Barriers to Clinical Trial Participation for Transgender People With Cancer to Improve Access and Generate Data. JCO 41, 1825-1829(2023).DOI:10.1200/JCO.22.01174 
  1. Stroumsa D, Wu JP: Welcoming transgender and nonbinary patients: Expanding the language of “women’s health”. Am J Obstet Gynecol 219:585.e1-585.e5, 2018  

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