A targeted literature review exploring solutions for inclusivity of transgender and non-binary patients in clinical research

Rosamund Rounda, Nichola Gokoolb, Georgiana Manicac, Liam Paschalld, Simon Foulcerb

aParexel International, Uxbridge, Middlesex, UK; bParexel International, Worthing, West Sussex, UK; cParexel International, Bucharest, Romania; dParexel International, Durham, NC, USA

KEY FINDINGS

  • Barriers impeding wider inclusivity of transgender patients in clinical research are multifaceted and include practical, medical, scientific, regulatory, and ethical considerations
  • There is an intersectionality between barriers to healthcare access for transgender and non-binary patients and their low inclusivity in clinical research

CONCLUSIONS

  • This literature review brings together disparate research and recommendations to support greater inclusivity in clinical research for transgender and non-binary patients
  • Further research and regulatory guidance are required to improve representation in clinical studies from the transgender and non-binary community
  • In the past, regulatory guidance facilitated industry development; clear direction from agencies is likely required if sustained and meaningful change is to be achieved

Why does this research matter?

  • To date, clinical trials are not fully representative of the wider patient population and often exclude representation from the transgender and non‑binary community, impacting an increasing number of patients
  • Careful consideration is required to balance fair and equitable access to potential new medications with safety concerns. Further research is needed on dosing and drug interactions with hormonal treatments
  • This review of the literature identified several articles providing best-practice recommendations on clinical trial conduct and participation

Introduction

  • In recent years, progress has been made in improving the rights of lesbian, gay, bisexual, transgender, queer, intersex, asexual, and two-spirit (LGBTQIA2S+) people1,2
  • However, LGBTQIA2S+ individuals still suffer from stigmatization, discrimination, and marginalization and face barriers to accessing inclusive healthcare3,4
  • There is also a lack of guidance on legal and ethical issues regarding transgender and non-binary individuals’ participation in clinical research5
  • This study reviewed the current research on the inclusivity of transgender and non-binary patients in clinical trials to help inform future practices in clinical research

Click the numbered list icon above to view the references

Methods

  • The PubMed database was searched between July 2018 and February 2022 to identify articles reporting results from randomized, interventional clinical trials that included transgender and non-binary patients
  • A targeted search was performed from July 2018 to August 2021 to identify any article reporting on the barriers contributing to the limited transgender and nonbinary patient representation in clinical studies
  • MEDLINE, Biosis Previews, EMBASE, SciSearch®: a Cited Reference Science Database, and International Pharmaceutical Abstracts databases were searched between July 2018 and February 2022 to assess the challenges faced by transgender and non-binary individuals when accessing healthcare services

Results

Transgender and non-binary patient representation in clinical studies

  • Between July 2018 and February 2022, 116,057 articles were published reporting clinical trial results. Among these, 78 (0.06%) studies reported participation of transgender patients

Figure 1

Summary of interventional clinical trials

7 studies
Reported transgender patients as a specific patient population

Additional reading
  1. Gillard S, Bremner S, Patel A, et al. Peer support for discharge from inpatient mental health care versus care as usual in England (ENRICH): a parallel, two-group, individually randomised controlled trial. Lancet Psychiatry. 2022;9(2):125-136. https://doi.org/10.1016/S2215-0366(21)00398-9
  2. Huang Y, Naidoo L, Zhang L, et al. Pharmacokinetics and predicted neutralisation coverage of VRC01 in HIV-uninfected participants of the Antibody Mediated Prevention (AMP) trials. EBioMedicine. 2021;64:103203. https://doi.org/10.1016/j.ebiom.2020.103203
  3. Kapadia SN, Wu C, Mayer KH, et al. No change in health-related quality of life for at-risk U.S. women and men starting HIV pre-exposure prophylaxis (PrEP): Findings from HPTN 069/ACTG A5305. PLoS One. 2018;13(12):e0206577. https://doi.org/10.1371/journal.pone.0206577
  4. Mujugira A, Nakyanzi A, Kasiita V, et al. HIV self-testing and oral pre-exposure prophylaxis are empowering for sex workers and their intimate partners: a qualitative study in Uganda. J Int AIDS Soc. 2021;24(9):e25782. https://doi.org/10.1002/jia2.25782
  5. Uhrig Castonguay BJ, Cressman AE, Kuo I, et al. The implementation of a text messaging intervention to improve HIV continuum of care outcomes among persons recently released from correctional facilities: randomized controlled trial. JMIR Mhealth Uhealth. 2020;8(2):e16220. doi: 10.2196/16220
  6. Waldock KAM, Hayes M, Watt PW, Maxwell NS. Physiological and perceptual responses in the elderly to simulated daily living activities in UK summer climatic conditions. Public Health. 2018;161:163-170. https://doi.org/10.1016/j.puhe.2018.04.012
  7. Wiley DJ, Hsu HK, Ganser MA, et al. Cholinergic modulation of exposure disrupts hippocampal processes and augments extinction: proof-of-concept study with social anxiety disorder. Biol Psychiatry. 2019;86(9):703-711. https://doi.org/10.1016/j.biopsych.2019.04.012

50 studies
Grouped transgender and non-binary patients with MSM and other sexual minorities

Additional reading
  1. Anand T, Nitpolprasert C, Jantarapakde J, et al. Implementation and impact of a technology-based HIV risk-reduction intervention among Thai men who have sex with men using “Vialogues”: a randomized controlled trial. AIDS Care. 2020;32(3):394-405. doi: 10.1080/09540121.2019.1622638
  2. Carballo-Diéguez A, Giguere R, Balán IC, et al. Few aggressive or violent incidents are associated with the use of HIV self-tests to screen sexual partners among key populations. AIDS Behav. 2020;24(7):2220-2226. doi: 10.1007/s10461-020-02809-1
  3. Coffin PO, Santos GM, Hern J, et al. Effects of mirtazapine for methamphetamine use disorder among cisgender men and transgender women who have sex with men: a placebo-controlled randomized clinical trial. JAMA Psychiatry. 2020;77(3):246-255. doi: 10.1001/jamapsychiatry.2019.3655
  4. Colson PW, Franks J, Wu Y, et al. Adherence to pre-exposure prophylaxis in Black men who have sex with men and transgender women in a community setting in Harlem, NY. AIDS Behav. 2020;24(12):3436-3455. doi: 10.1007/s10461-020-02901-6
  5. Corey L, Gilbert PB, Juraska M, et al. Two randomized trials of neutralizing antibodies to prevent HIV-1 acquisition. N Engl J Med. 2021;384(11):1003-1014. doi: 10.1056/NEJMoa2031738
  6. Edupuganti S, Mgodi N, Karuna ST, et al. Feasibility and successful enrollment in a proof-of-concept HIV prevention trial of VRC01, a broadly neutralizing HIV-1 monoclonal antibody. J Acquir Immune Defic Syndr. 2021;87(1):671-679. doi: 10.1097/QAI.0000000000002639
  7. Egan JE, Corey SL, Henderson ER, et al. Feasibility of a web-accessible game-based intervention aimed at improving help seeking and coping among sexual and gender minority youth: results from a randomized controlled trial. J Adolesc Health. 2021;69(4):604-614. doi: 10.1016/j.jadohealth.2021.03.027
  8. Frye V, Nandi V, Hirshfield S, et al. Brief report: randomized controlled trial of an intervention to match young Black men and transwomen who have sex with men or transwomen to HIV testing options in New York City (All About Me). J Acquir Immune Defic Syndr. 2020;83(1):31-36. doi: 10.1097/QAI.0000000000002223
  9. Glidden DV, Das M, Dunn DT, et al. Using the adherence-efficacy relationship of emtricitabine and tenofovir disoproxil fumarate to calculate background HIV incidence: a secondary analysis of a randomized, controlled trial. J Int AIDS Soc. 2021;24(5):e25744. doi: 10.1002/jia2.25744
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  11. Goldwirt L, Bauer R, Liegeon G, et al. Estimated pill intake with on-demand PrEP with oral TDF/FTC using TFV-DP concentration in dried blood spots in the ANRS IPERGAY trial. J Antimicrob Chemother. 2021;76(10):2675-2680. doi: 10.1093/jac/dkab253
  12. Gonzales P, Grieco A, White E, et al. Safety of oral naltrexone in HIV-positive men who have sex with men and transgender women with alcohol use disorder and initiating antiretroviral therapy. PLoS One. 2020;15(3):e0228433. doi: 10.1371/journal.pone.0228433
  13. Grant RM, Pellegrini M, Defechereux PA, et al. Sex hormone therapy and tenofovir diphosphate concentration in dried blood spots: primary results of the interactions between antiretrovirals and transgender hormones study. Clin Infect Dis. 2021;73(7):e2117-e2123. doi: 10.1093/cid/ciaa1160
  14. Hakim AJ, Coy K, Patnaik P, et al. An urgent need for HIV testing among men who have sex with men and transgender women in Bamako, Mali: low awareness of HIV infection and viral suppression among those living with HIV. PLoS One. 2018;13(11):e0207363. doi: 10.1371/journal.pone.0207363
  15. Hassan A, Wertheim JO, Blumenthal JS, et al. Characteristics of a cohort of high-risk men who have sex with men on pre-exposure prophylaxis reporting transgender sexual partners. Medicine (Baltimore). 2019;98(50):e18232. doi: 10.1097/MD.0000000000018232
  16. Holtz TH, Chitwarakorn A, Hughes JP, et al. HPTN 067/ADAPT: correlates of sex-related pre-exposure prophylaxis adherence, Thai men who have sex with men, and transgender women, 2012-2013. J Acquir Immune Defic Syndr. 2019;82(2):e18-e26. doi: 10.1097/QAI.0000000000002131
  17. Iribarren S, Lentz C, Sheinfil AZ, et al. Using an HIV self-test kit to test a partner: attitudes and preferences among high-risk populations. AIDS Behav. 2020;24(11):3232-3243. doi: 10.1007/s10461-020-02885-3
  18. Kuhns LM, Karnik N, Hotton A, et al. A randomized controlled efficacy trial of an electronic screening and brief intervention for alcohol misuse in adolescents and young adults vulnerable to HIV infection: step up, test up study protocol. BMC Public Health. 2020;20(1):30. doi: 10.1186/s12889-020-8154-6
  19. Kuo I, Liu T, Patrick R, et al. Use of an mHealth intervention to improve engagement in HIV community-based care among persons recently released from a correctional facility in Washington, DC: a pilot study. AIDS Behav. 2019;23(4):1016-1031. doi: 10.1007/s10461-018-02389-1
  20. Lama JR, Brezak A, Dobbins JG, et al. Design strategy of the sabes study: diagnosis and treatment of early HIV infection among men who have sex with men and transgender women in Lima, Peru, 2013-2017. Am J Epidemiol. 2018;187(8):1577-1585. doi: 10.1093/aje/kwy030
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  22. Landovitz RJ, Donnell D, Clement ME, et al. Cabotegravir for HIV prevention in cisgender men and transgender women. N Engl J Med. 2021;385(7):595-608. doi: 10.1056/NEJMoa2101016
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  25. Liu AY, Norwood A, Gundacker H, et al. Brief report: routine use of oral PrEP in a phase 2 rectal microbicide study of tenofovir reduced-glycerin 1% gel (MTN-017). J Acquir Immune Defic Syndr. 2019;81(5):516-520. doi: 10.1097/QAI.0000000000002066
  26. Lee JGL, Blanchflower TM, O'Brien KF, et al. Assessing the potential impact of cigarette packs designed for lesbian, gay, bisexual, and transgender adults: a randomized experiment to inform U.S. regulation, 2018. Health Promot Pract. 2020;21(1_suppl):157S-164S. doi: 10.1177/1524839919879923
  27. Lemos MP, Nandi V, Dragavon J, et al. HIV-1 nucleic acids identify rectal HIV exposures in self-collected rectal swabs, whereas Y-chromosome single tandem repeat mixtures are not reliable biomarkers of condomless receptive anal intercourse. J Acquir Immune Defic Syndr. 2021;88(2):138-148. doi: 10.1097/QAI.0000000000002748
  28. Leu CS, Giguere R, Bauermeister JA, et al. Trajectory of use over time of an oral tablet and a rectal gel for HIV prevention among transgender women and men who have sex with men. AIDS Care. 2019;31(3):379-387. doi: 10.1080/09540121.2018.1533223
  29. MacCarthy S, Izenberg M, Barreras JL, et al. Rapid mixed-methods assessment of COVID-19 impact on Latinx sexual minority men and Latinx transgender women. PLoS One. 2020;15(12):e0244421. doi: 10.1371/journal.pone.0244421
  30. Marins LMS, Torres TS, Leite IDC, et al. Performance of HIV pre-exposure prophylaxis indirect adherence measures among men who have sex with men and transgender women: results from the PrEP Brasil study. PLoS One. 2019;14(8):e0221281. doi: 10.1371/journal.pone.0221281
  31. Matthews AK, Steffen AD, Kuhns LM, et al. Evaluation of a randomized clinical trial comparing the effectiveness of a culturally targeted and nontargeted smoking cessation intervention for lesbian, gay, bisexual, and transgender smokers. Nicotine Tob Res. 2019;21(11):1506-1516. doi: 10.1093/ntr/nty184
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21 studies
Transgender-only interventions

Additional reading
  1. Andrasik M, Grove D, Broder G, et al. Efficacy of an empowerment-based, group-delivered HIV prevention intervention for young transgender women: the Project LifeSkills randomized clinical trial. Vaccine. 2019;37(29):3911-3917. doi: 10.1016/j.vaccine.2019.05.016
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  5. Clark J, Reisner S, Perez-Brumer A, et al. TransPrEP: results from the pilot study of a social network-based intervention to support PrEP adherence among transgender women in Lima, Peru. AIDS Behav. 2021;25(6):1873-1883. doi: 10.1007/s10461-020-03117-4
  6. Damanpak-Rizi M, Farnam F, Khodakhah P. Effect of cognitive-behavioral therapy on domestic violence and its consequences in transgender youth: a randomized clinical trial, parallel group study. BMC Psychiatry. 2021;21(1):210. doi: 10.1186/s12888-021-03224-z
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  8. Garofalo R, Kuhns LM, Reisner SL, et al. A descriptive analysis of transgender participants in phase 1-2a trials of the HIV Vaccine Trials Network (HVTN) in the United States and Peru. JAMA Pediatr. 2018;172(10):916-923. doi.org/10.1016/j.vaccine.2019.05.016
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  10. Lacombe-Duncan A, Logie CH, Persad Y, et al. 'Transgender Education for Affirmative and Competent HIV and Healthcare (TEACHH)': protocol of community-based intervention development and a non-randomised multisite pilot study with pre-post test design in Canada. BMJ Open. 2020;10(7):e034144. doi: 10.1136/bmjopen-2019-034144
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  13. Perl L, Elkon-Tamir E, Segev-Becker A, et al. Blood pressure dynamics after pubertal suppression with gonadotropin-releasing hormone analogs followed by estradiol treatment in transgender female adolescents: a pilot study. J Pediatr Endocrinol Metab. 2021;34(6):741-745. doi.org/10.1515/jpem-2021-0172
  14. Restar AJ, Jin H, Ogunbajo A, et al. Prevalence and risk factors on nonmedical prescription opioid use among transgender girls and young women. JAMA Netw Open. 2020;3(3):e201015. doi: 10.1001/jamanetworkopen.2020.1015
  15. Saul H, Gursul D. Self-testing for HIV could increase diagnoses in the trans community. BMJ. 2021;375:n2633. doi.org/10.1136/bmj.n2633
  16. Schlosshauer T, Kiehlmann M, Riener MO, et al. Effect of low-thermal dissection device versus conventional electrocautery in mastectomy for female-to-male transgender patients. Int Wound J. 2020;17(5):1239-1245. doi.org/10.1111/iwj.13382
  17. Smeaton LM, Kileel EM, Grinsztejn B, et al. Characteristics of REPRIEVE trial participants identifying across the transgender spectrum. J Infect Dis. 2020;222(suppl 1):S31-S40. doi.org/10.1093/infdis/jiaa213
  18. Stephenson R, Todd K, Kahle E, et al. Project Moxie: results of a feasibility study of a telehealth intervention to increase HIV testing among binary and nonbinary transgender youth. AIDS Behav. 2020;24(5):1517-1530. doi: 10.1007/s10461-019-02741-z
  19. Timmermans FW, Mokken SE, Smit JM, et al. Within-patient randomized clinical trial comparing incisional negative-pressure wound therapy with suction drains in gender-affirming mastectomies. Br J Surg. 2021;108(8):925-933. doi.org/10.1093/bjs/znab204
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  21. Vlot MC, Wiepjes CM, de Jongh RT, et al. Gender-affirming hormone treatment decreases bone turnover in transwomen and older transmen. J Bone Miner Res. 2019;34(10):1862-1872. doi.org/10.1002/jbmr.3762

MSM, men having sex with men.

Additional reading
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  12. Marshall Z, Welch V, Minichiello A, et al. Documenting research with transgender, nonbinary, and other gender diverse (trans) individuals and communities: introducing the global trans research evidence map. Transgender Health. 2019;4(1):68-80. doi.org/10.1089/trgh.2018.0020
  13. Moseson H, Zazanis N, Goldberg E, et al. The imperative for transgender and gender nonbinary inclusion: beyond women's health. Obstet Gynecol. 2020;135(5):1059-1068. doi.org/10.1097/AOG.0000000000003816
  14. Poteat T, Aqil A, Corbett D, et al. "I would really want to know that they had my back": transgender women's perceptions of HIV cure-related research in the United States. PloS One. 2020;15(12):e0244490. doi.org/10.1371/journal.pone.0244490
  15. Reardon S. The largest study involving transgender people is providing long-sought insights about their health. Nature. 2019;568(7753):446-449. doi.org/10.1038/d41586-019-01237-z
  16. Rich AJ, Poteat T, Koehoorn M, et al. Development of a computable phenotype to identify a transgender sample for health research purposes: a feasibility study in a large linked provincial healthcare administrative cohort in British Columbia, Canada. BMJ Open. 2021;11(3):e040928. doi.org/10.1136/bmjopen-2020-040928
  17. Safer JD. Research gaps in medical treatment of transgender/nonbinary people. J Clin Invest. 2021;131(4):e142029. doi.org/10.1172/JCI142029
  18. Salk RH, Thoma BC, Choukas-Bradley S. The gender minority youth study: overview of methods and social media recruitment of a nationwide sample of U.S. cisgender and transgender adolescents. Arch Sex Behav. 2020;49(7):2601-2610. doi.org/10.1007/s10508-020-01695-x
  19. Siskind R, Collins C, Campbell R, et al. Fostering transgender inclusion in HIV prevention research. J Int AIDS Soc. 2021;24(suppl. 1):PU05.01. https://programme.hivr4p.org/Abstract/Abstract/376?msclkid=33b9fbfccd3311ecadf36e3012cba1d9
  20. Staples JM, Bird ER, Masters TN, et al. Considerations for culturally sensitive research with transgender adults: a qualitative analysis. J Sex Res. 2018;55(8):1065-1076. doi.org/10.1080/00224499.2017.1292419
  21. Theisen JG, Amarillo IE. Creating affirmative and inclusive practices when providing genetic and genomic diagnostic and research services to gender-expansive and transgender patients. JALM. 2021;6(1):142-154. doi.org/10.1093/jalm/jfaa165
  22. Ware J. Research topics inhibited by transgender paradigm. Arch Sex Behav. 2020;49(7):2237-2238. doi.org/10.1007/s10508-020-01758-z
  23. Xie F, Getahun D, Quinn VP, et al. An automated algorithm using free-text clinical notes to improve identification of transgender people. Inform Health Soc Care. 2021;46(1):18-28. doi.org/10.1080/17538157.2020.1828890

Barriers contributing to limited transgender and non-binary patient representation in clinical studies

  • A targeted search identified 23 studies reporting specific barriers that limit inclusion of transgender and non-binary patients in clinical studies

Figure 2

Clinical trial overview and barriers to inclusion for transgender and non-binary patients

Barriers to healthcare access for transgender and non-binary patients

  • Due to the limited results, the search was extended to understand some of the barriers and facilitators to trans healthcare access, as these likely are applicable to the clinical research setting. Following removal of duplicate and irrelevant articles, we identified 365 articles

Figure 3

Barriers, perspectives, and strategies impacting healthcare access

Additional reading
  1. Cahill SR, Keatley J, Wade TS, et al. "Some of us, we don't know where we're going to be tomorrow." Contextual factors affecting PrEP use and adherence among a diverse sample of transgender women in San Francisco. AIDS Care. 2020;32(5):585-593. doi.org/10.1080/09540121.2019.1659912
  2. DeJonckheere M, Zhao A, Lane J, et al. Results of a national text message poll of youth: perspectives on primary care. J Adolesc Health. 2020;67(6):814-820. doi.org/10.1016/j.jadohealth.2020.04.017
  3. Feldman JL, Luhur WE, Herman JL, et al. Health and health care access in the US transgender population health (TransPop) survey. Andrology. 2021;9(6):1707-1718. doi.org/10.1111/andr.13052
  4. Kattari SK, Atteberry-Ash B, Kinney MK, et al. One size does not fit all: differential transgender health experiences. Health Soc Work. 2019;58(9):899-917. doi.org/10.1080/00981389.2019.1677279
  5. Kearns S, Kroll T, O'Shea D, et al. Experiences of transgender and non-binary youth accessing gender-affirming care: a systematic review and meta-ethnography. PloS One. 2021;16(9):e0257194. doi.org/10.1371/journal.pone.0257194
  6. Rahman M, Li DH, Moskowitz DA. Comparing the healthcare utilization and engagement in a sample of transgender and cisgender bisexual+ persons. Arch Sex Behav. 2019;48(1):255-260. doi: 10.1007/s10508-018-1164-0
  7. Renner J, Täuber L, Nieder TO. Need for inclusive consideration of transgender and gender diverse people in e-health services: a systematic review. J Clin Med. 2020;11(4):1090. doi.org/10.3390/jcm11041090
  8. Romanelli M, Lindsey MA. Patterns of healthcare discrimination among transgender help-seekers. Am J Prev Med. 2020;58(4):e123-e131. doi.org/10.1016/j.amepre.2019.11.002
  9. Uhrig JD, Stryker JE, Bresee S, et al. HIV information needs of transgender people and their healthcare providers. AIDS Care. 2019;31(3):357-363. doi.org/10.1080/09540121.2018.1499862
  10. Warner DM, Mehta AH. Identifying and addressing barriers to transgender healthcare: where we are and what we need to do about it. J Gen Intern Med. 2021;36(11):3559-3561. doi: 10.1007/s11606-021-07001-2

Studies discussing barriers to healthcare access for transgender and non-binary patients and healthcare disparities

  • Stigma, discrimination, and lack of respect (from verbal harassment to inappropriate curiosity and being refused necessary medical care)
  • Challenges with denied coverage for any transition-related services by healthcare insurance providers
  • Lack of trust in the medical profession (incorrect pronoun usage, insufficient knowledge of hormone therapy or gender-affirming surgery)
Additional reading
  1. Chen D, Kolbuck VD, Sutter ME, et al. Knowledge, practice behaviors, and perceived barriers to fertility care among providers of transgender healthcare. J Adolesc Health. 2019;64(2):226-234. doi: 10.1016/j.jadohealth.2018.08.025
  2. Dutton S, Cimino AN, Lombardo MJ, et al. Assessing knowledge, attitudes and beliefs of nurses about LGBTQ older adults using a documentary video. Nurse Educ. 2022;108:105177. https://doi.org/10.1016/j.nedt.2021.105177
  3. Eickhoff C. Identifying gaps in LGBTQ health education in baccalaureate undergraduate nursing programs. J Nurs Educ. 2021;60(10):552-558. https://doi.org/10.3928/01484834-20210729-01
  4. Greene MZ, France K, Kreider EF, et al. Comparing medical, dental, and nursing students’ preparedness to address lesbian, gay, bisexual, transgender, and queer health. PloS One. 2018;13(9):e0204104. doi: 10.1371/journal.pone.0204104
  5. Guerrero-Hall KD, Muscanell R, Garg N, et al. Obstetrics and gynecology resident physician experiences with lesbian, gay, bisexual, transgender and queer healthcare training. Med Sci Educ. 2021;31(2):599-606. doi: 10.1007/s40670-021-01227-9
  6. Levy A, Prasad S, Griffin DP, et al. Attitudes and knowledge of medical students towards healthcare for lesbian, gay, bisexual, and transgender seniors: impact of a case-based discussion with facilitators from the community. Cureus. 2021;13(8):e17425. doi: 10.7759/cureus.17425
  7. Loo S, Almazan AN, Vedilago V, et al. Understanding community member and health care professional perspectives on gender-affirming care - a qualitative study. PloS One. 2021;16(8):e0255568. doi.org/10.1371/journal.pone.0255568
  8. Shires DA, Prieto L, Woodford MR, et al. Gynecologic health care providers' willingness to provide routine care and Papanicolaou tests for transmasculine individuals. J Women's Health. 2019;28(11):1487-1492. doi: 10.1089/jwh.2018.7384
  9. Taneja A, Stark S, Chokshi B, et al. A knowledge, attitudes and practices survey for medical trainees about cancer in the LGBTQ community. J Clin Oncol. 2020;38(15):e19073. doi: 10.1200/JCO.2020.38.15_suppl.e19073
  10. VanDerKolk K, McKinney V, Graves L, et al. Transgender education in North American family medicine clerkships: a CERA study. Fam Med. 2021;53(8):676-683. doi: 10.22454/FamMed.2021.509974

Studies investigating HCPs’ perspectives, knowledge, and attitudes toward transgender care

  • Insufficient training for HCPs on both transgender non-medical and medical care (lack of hormone dosing guidance or reference ranges for laboratory tests)
Additional reading
  1. Crapanzano A, Mixon L. The state of affirmative mental health care for transgender and gender non-confirming people: an analysis of current research, debates, and standards of care. Riv Psichiatr. 2022;57(1):44-54. doi 10.1708/3749.37327
  2. Medina-Martínez J, Saus-Ortega C, Sánchez-Lorente MM, et al. Health inequities in LGBT people and nursing interventions to reduce them: a systematic review. Int J Environ. 2021;18(22):11801. doi.org/10.3390/ijerph182211801
  3. Ziegler E, Luctkar-Flude M, Carroll B, et al. Development of an online educational toolkit for sexual orientation and gender identity minority nursing care. Rev Lat Am Enfermagem. 2021;29:e3470. doi.org/10.1590/1518-8345.4712.3470
  4. Klein A, Golub SA. Enhancing gender-affirming provider communication to increase health care access and utilization among transgender men and trans-masculine non-binary individuals. LGBT Health. 2020;7(6):292-304. doi.org/10.1089/lgbt.2019.0294
  5. Grundmann O, Segal R, Pullo J, et al. The pharmacist as an LGBTQ ally. Am J Pharm Educ. 2020;84(7):ajpe7835. doi.org/10.5688/ajpe7835
  6. Ding JM, Ehrenfeld JM, Edmiston EK, et al. A model for improving health care quality for transgender and gender nonconforming patients. Jt Comm J Qual Patient Saf. 2020;46(1):37-43. doi.org/10.1016/j.jcjq.2019.09.005
  7. Stryker SD, Pallerla H, Pickle S. Considerations on medical training for gender-affirming care: motivations and perspectives. Int J Trans Health. 2019;21(1):79-88. https://doi.org/10.1080/15532739.2019.1689880
  8. Stevenson MO, Sineath RC, Haw JS, et al. Use of standardized patients in endocrinology fellowship programs to teach competent transgender care. J Endo Soc. 2019;4(1):bvz007. https://doi.org/10.1210/jendso/bvz007
  9. Jadwin-Cakmak L, Reisner SL, Hughto JMW, et al. HIV prevention and HIV care among transgender and gender diverse youth: design and implementation of a multisite mixed-methods study protocol in the U.S. BMC Public Health. 2019;19(1):1531. doi: 10.1186/s12889-019-7605-4
  10. Klein P, Narasimhan S, Safer JD. The Boston Medical Center experience: an achievable model for the delivery of transgender medical care at an academic medical center. Trans Health. 2018;3(1):136-140. https://doi.org/10.1089/trgh.2017.0054

Studies reporting current or future strategies to improve healthcare access for transgender and non-binary patients

  • Multidisciplinary care may be optimal but is not universally available

Figure 4

Recommendations and guidance on increasing inclusion of transgender and non-binary individuals in clinical research

  • 6 articles detailed specific measures and best practices to increase inclusion of transgender and non-binary individuals in clinical studies. Key considerations are presented below:

Involve members of the trans community in research whenever possible (eg, include transgender individuals in the recruitment process or in Community Advisory Boards)

Provide a clear rationale for the study while highlighting its value for transgender and non-binary populations. Adjust the clinical protocols, informed consent documents, and data collection forms

Be mindful about how the study is advertised/promoted, both during the recruitment phase and throughout data collection by running trial awareness campaigns and developing study materials

Ask sex assigned at birth and gender identity questions and implement the “2-step approach”; assess gender identity separately from sexual orientation

Maximize accessibility for potential participants and offer basic incentives such as transportation costs, food, and monetary reimbursement

Properly train all personnel involved in clinical research in transgender-related health issues

Periodically evaluate transgender participants’ satisfaction with research program and service

Additional reading
  1. Blotner C, Rajunov M. Engaging transgender patients: using social media to inform medical practice and research in transgender health. Transgender Health. 2018;3(1):225-228. doi.org/10.1089/trgh.2017.0039
  2. Chen B, Jin H, Yang Z, et al. An approach for transgender population information extraction and summarization from clinical trial text. BMC Medical Inform. 2019;19(suppl 2):62. doi.org/10.1186/s12911-019-0768-1
  3. Jones NC, Reyes ME, Quinn GP, et al. Survey of principal investigators in biobanking: knowledge, attitudes, and research behaviors about transgender and gender-diverse patients. JCO Oncol Pract. 2020;16(10):e1192-e1201. doi.org/10.1200/OP.20.00193
  4. Moseson H, Zazanis N, Goldberg E, et al. The imperative for transgender and gender nonbinary inclusion: beyond women's health. Obstet Gynecol. 2020;135(5):1059-1068. doi.org/10.1097/AOG.0000000000003816
  5. Smith TM. American Medical Association. Why IRBs must scrutinize collection of LGBTQ information. 2020. Available at: https://www.ama-assn.org/delivering-care/population-care/why-irbs-must-scrutinize-collection-lgbtq-information. Accessed May 12, 2022.
  6. Staples JM, Bird ER, Masters TN, et al. Considerations for culturally sensitive research with transgender adults: a qualitative analysis. J Sex Res. 2018;55(8):1065-1076. doi.org/10.1080/00224499.2017.1292419

Polling Question

Would you consider including transgender patients in future clinical trials?
Yes, it is a top priority
Yes, if there was more guidance available
No, I don’t think it is necessary

Please select one of the above options to vote


Acknowledgments

This study was supported by Parexel International.

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All authors are employees of Parexel International.

Presented at DIA Global Annual Meeting, June 19-23, 2022, Chicago, IL.

This ePoster will be available via QR code until August 19, 2022

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