HIV prevalence is elevated among transgender populations with an estimated 13.7% of transgender adults living with HIV in the USA. In addition, transgender people experience significant disparities in biomedical HIV prevention and treatment. The efficacy of topical microbicides for prevention of HIV acquisition have not been tested among transgender people and may be impacted by hormonal therapies and/or surgeries undertaken by some transgender people to align their anatomy with their gender identity. Low pre-exposure prophylaxis (PrEP) uptake and adherence as well as potential drug–hormone interactions impact the efficacy of PrEP among transgender women. Few transgender men have been engaged in the PrEP continuum, and they have been largely excluded from PrEP research until very recently. Prioritisation of hormone therapy over HIV treatment as well as concerns about drug–hormone interactions may impact transgender women’s adherence to antiretroviral therapy. More research is needed to clarify the clinical significance of identified drug–hormone interactions and better inform interventions to improve HIV prevention and care for transgender people.
This is a preview of subscription content, log in to check access.
Buy single article
Instant access to the full article PDF.
Price includes VAT for USA
Fauci AS, Redfield RR, Sigounas G, Weahkee MD, Giroir BP. Ending the HIV epidemic: a plan for the United States. JAMA. 2019;321(9):844–5. https://doi.org/10.1001/jama.2019.1343.
UNAIDS. Key populations. https://www.unaids.org/en/topic/key-populations. Accessed 5 Apr 2020.
James SE, Herman JL, Rankin S, Keisling M, Mottet L, Anafi M. The report of the 2015 U.S. transgender survey. Washington, DC: National Center for Transgender Equality; 2016.
Crissman HP, Berger MB, Graham LF, Dalton VK. Transgender demographics: a household probability sample of US adults, 2014. Am J Public Health. 2017;107(2):213–5. https://doi.org/10.2105/AJPH.2016.303571.
Deutsch MB. Making it count: improving estimates of the size of transgender and gender nonconforming populations. LGBT Health. 2016;3(3):181–5. https://doi.org/10.1089/lgbt.2016.0013.
Goodman M, Adams N, Corneil T, Kreukels B, Motmans J, Coleman E. Size and distribution of transgender and gender nonconforming populations: a narrative review. Endocrinol Metab Clin N Am. 2019;48(2):303–21. https://doi.org/10.1016/j.ecl.2019.01.001.
Coleman E, Bockting W, Botzer M, Cohen-Kettenis P, DeCuypere G, Feldman J, et al. Standards of care for the health of transsexual, transgender, and gender-nonconforming people, version 7. Int J Transgenderism. 2011;13:165. https://doi.org/10.1080/15532739.2011.700873.
Reisner SL, Radix A, Deutsch MB. Integrated and gender-affirming transgender clinical care and research. J Acquir Immune Defic Syndr. 2016;72(Suppl 3):S235–S242242. https://doi.org/10.1097/qai.0000000000001088.
Hembree WC, Cohen-Kettenis PT, Gooren L, Hannema SE, Meyer WJ, Murad MH, et al. Endocrine treatment of gender-dysphoric/gender-incongruent persons: an Endocrine Society* Clinical Practice Guideline. J Clin Endocrinol Metab. 2017;102(11):3869–903. https://doi.org/10.1210/jc.2017-01658.
Safa B, Lin WC, Salim AM, Deschamps-Braly JC, Poh MM. Current concepts in masculinizing gender surgery. Plast Reconstr Surg. 2019;143(4):857e–e871871. https://doi.org/10.1097/prs.0000000000005453.
Schechter LS. Gender confirmation surgery: an update for the primary care provider. Transgender Health. 2016;1(1):32–40. https://doi.org/10.1089/trgh.2015.0006.
Pan S, Honig SC. Gender-affirming surgery: current concepts. Curr Urol Rep. 2018;19(8):62. https://doi.org/10.1007/s11934-018-0809-9.
Bodsworth NJ, Price R, Davies SC. Gonococcal infection of the neovagina in a male-to-female transsexual. Sex Transm Dis. 1994;21(4):211–2.
Matsuki S, Kusatake K, Hein KZ, Anraku K, Morita E. Condylomata acuminata in the neovagina after male-to-female reassignment treated with CO2 laser and imiquimod. Int J STD AIDS. 2015;26(7):509–11. https://doi.org/10.1177/0956462414542476.
Elfering L, van der Sluis WB, Mermans JF, Buncamper ME. Herpes neolabialis: herpes simplex virus type 1 infection of the neolabia in a transgender woman. Int J STD AIDS. 2017;28(8):841–3. https://doi.org/10.1177/0956462416685658.
Radix AE, Harris AB, Belkind U, Ting J, Goldstein ZG. Chlamydia trachomatis infection of the neovagina in transgender women. Open Forum Infect Dis. 2019. https://doi.org/10.1093/ofid/ofz470.
Becasen JS, Denard CL, Mullins MM, Higa DH, Sipe TA. Estimating the prevalence of HIV and sexual behaviors among the US transgender population: a systematic review and meta-analysis, 2006–2017. Am J Public Health. 2018. https://doi.org/10.2105/ajph.2018.304727.
Poteat T, Reisner SL, Radix A. HIV epidemics among transgender women. Curr opin HIV AIDS. 2014;9(2):168–73. https://doi.org/10.1097/coh.0000000000000030.
White Hughto JM, Reisner SL, Pachankis JE. Transgender stigma and health: a critical review of stigma determinants, mechanisms, and interventions. Soc Sci Med. 1982;2015(147):222–31. https://doi.org/10.1016/j.socscimed.2015.11.010.
Radix AE, Lelutiu-Weinberger C, Gamarel KE. Satisfaction and healthcare utilization of transgender and gender non-conforming individuals in NYC: a community-based participatory study. LGBT Health. 2014;1(4):302–8. https://doi.org/10.1089/lgbt.2013.0042.
Rapues J, Wilson EC, Packer T, Colfax GN, Raymond HF. Correlates of HIV infection among transfemales, San Francisco, 2010: results from a respondent-driven sampling study. Am J Public Health. 2013;103(8):1485–92. https://doi.org/10.2105/ajph.2012.301109.
Sevelius JM, Fau. PE, Keatley JG, Johnson MO. Barriers and facilitators to engagement and retention in care among transgender women living with human immunodeficiency virus. (1532–4796 (Electronic)).
Sevelius JM, Patouhas E, Keatley JG, Johnson MO. Barriers and facilitators to engagement and retention in care among transgender women living with human immunodeficiency virus. Ann Behav Med. 2014;47(1):5–16. https://doi.org/10.1007/s12160-013-9565-8.
Reisner SL, White Hughto JM, Pardee D, Sevelius J. Syndemics and gender affirmation: HIV sexual risk in female-to-male trans masculine adults reporting sexual contact with cisgender males. Int J STD AIDS. 2015. https://doi.org/10.1177/0956462415602418.
Sevelius JM, Keatley J, Calma N, Arnold E. 'I am not a man': trans-specific barriers and facilitators to PrEP acceptability among transgender women. Global Public Health. 2016. https://doi.org/10.1080/17441692.2016.1154085.
Wansom T, Guadamuz TE, Vasan S. Transgender populations and HIV: unique risks, challenges and opportunities. J Virus Erad. 2016;2(2):87–93.
Reisner SL, White Hughto JM, Pardee D, Sevelius J. Syndemics and gender affirmation: HIV sexual risk in female-to-male trans masculine adults reporting sexual contact with cisgender males. Int J STD AIDS. 2016;27(11):955–66. https://doi.org/10.1177/0956462415602418.
Sevelius J, Chakravarty D, Neilands TB, Keatley J, Shade SB, Johnson MO, et al. Evidence for the model of gender affirmation: the role of gender affirmation and healthcare empowerment in viral suppression among transgender women of color living with HIV. AIDS Behav. 2019. https://doi.org/10.1007/s10461-019-02544-2.
Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010;363(27):2587–99. https://doi.org/10.1056/NEJMoa1011205.
Murnane PM, Celum C, Mugo N, Campbell JD, Donnell D, Bukusi E, et al. Efficacy of preexposure prophylaxis for HIV-1 prevention among high-risk heterosexuals: subgroup analyses from a randomized trial. AIDS (London, England). 2013;27(13):2155–60. https://doi.org/10.1097/QAD.0b013e3283629037.
Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, et al. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2013;381(9883):2083–90.
Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367(5):399–410. https://doi.org/10.1056/NEJMoa1108524.
Carnevale C, Zucker J, Womack JA, Dixon J, Cohall A, Sobieszczyk ME, et al. Adolescent preexposure prophylaxis administration: an education curriculum for health care providers. J Pediatr Health Care. 2019;33(3):288–95. https://doi.org/10.1016/j.pedhc.2018.09.007.
Van Damme L, Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S, et al. Preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2012;367(5):411–22. https://doi.org/10.1056/NEJMoa1202614.
Marrazzo JM, Ramjee G, Richardson BA, Gomez K, Mgodi N, Nair G, et al. Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2015;372(6):509–18. https://doi.org/10.1056/NEJMoa1402269.
Deutsch MB, Glidden DV, Sevelius J, Keatley J, McMahan V, Guanira J, et al. HIV pre-exposure prophylaxis in transgender women: a subgroup analysis of the iPrEx trial. Lancet HIV. 2015;2(12):e512–e519519. https://doi.org/10.1016/s2352-3018(15)00206-4.
Golub SA, Fikslin RA, Starbuck L, Klein A. High rates of PrEP eligibility but low rates of PrEP access among a national sample of transmasculine individuals. J Acquir Immune Defic Syndr. 2019. https://doi.org/10.1097/qai.0000000000002116.
Reisner SL, Moore CS, Asquith A, Pardee DJ, Sarvet A, Mayer G, et al. High risk and low uptake of pre-exposure prophylaxis to prevent HIV acquisition in a national online sample of transgender men who have sex with men in the United States. J Int AIDS Soc. 2019;22(9):e25391. https://doi.org/10.1002/jia2.25391.
Rael CT, Martinez M, Giguere R, Bockting W, MacCrate C, Mellman W, et al. Barriers and facilitators to oral PrEP use among transgender women in New York City. AIDS Behav. 2018;22(11):3627–36. https://doi.org/10.1007/s10461-018-2102-9.
Eaton LA, Matthews DD, Driffin DD, Bukowski L, Wilson PA, Stall RD. A multi-US City assessment of awareness and uptake of pre-exposure prophylaxis (PrEP) for HIV prevention among black men and transgender women who have sex with men. Prev Sci. 2017;18(5):505–16. https://doi.org/10.1007/s11121-017-0756-6.
Mehrotra ML, Rivet Amico K, McMahan V, Glidden DV, Defechereux P, Guanira JV, et al. The role of social relationships in PrEP uptake and use among transgender women and men who have sex with men. AIDS Behav. 2018. https://doi.org/10.1007/s10461-018-2151-0.
Poteat T, Wirtz A, Malik M, Cooney E, Cannon C, Hardy WD, et al. A gap between willingness and uptake: findings from mixed methods research on HIV prevention among black and latina transgender women. J Acquir Immune Defic Syndr. 2019;82(2):131–40. https://doi.org/10.1097/QAI.0000000000002112.
Krakower D, Maloney KM, Powell VE, Levine K, Grasso C, Melbourne K, et al. Patterns and clinical consequences of discontinuing HIV preexposure prophylaxis during primary care. J Int AIDS Soc. 2019;22(2):e25250. https://doi.org/10.1002/jia2.25250.
Wirtz A, Poteat T, Mayer K, Radix A, Cooney E, Cannon C, Rodriguez A, Wawrzyniak A, Schneider J, Haw S, Beyrer C, Althoff K, Laeyendecker O, Reisner S, and the American Cohort to Study HIV Acquisition among Transgender Women (LITE) Study Group. Pre-exposure prophylaxis (PrEP) indication, use, and adherence among transgender women in eastern and southern US: Interim findings from the LITE cohort, 2018–19. LITE Data: TUPEC482; 10th International AIDS Society Conference on HIV Science (IAS 2019); Mexico City, Mexico: July 22, 2019.
Braun HM, Candelario J, Hanlon CL, Segura ER, Clark JL, Currier JS, et al. Transgender women living with hiv frequently take antiretroviral therapy and/or feminizing hormone therapy differently than prescribed due to drug–drug interaction concerns. LGBT Health. 2017;4(5):371–5. https://doi.org/10.1089/lgbt.2017.0057.
Hiransuthikul A, Janamnuaysook R, Himmad K, Kerr SJ, Thammajaruk N, Pankam T, et al. Drug–drug interactions between feminizing hormone therapy and pre-exposure prophylaxis among transgender women: the iFACT study. J Int AIDS Soc. 2019;22(7):e25338. https://doi.org/10.1002/jia2.25338.
Shieh E, Marzinke M, Fuchs E, Bakshi R, Wutyi A, Poteat T et al., editors. Transgender women on estrogen have significantly lower tenofovir/emtricitabine concentrations during directly observed dosing when compared to cis men. HIV Research for Prevention. Madrid, Spain; 2018.
Cottrell ML, Prince HMA, Schauer AP, Sykes C, Maffuid K, Poliseno A, et al. Decreased tenofovir diphosphate concentrations in a transgender female cohort: implications for human immunodeficiency virus preexposure prophylaxis. Clin Infect Dis. 2019;69(12):2201–4. https://doi.org/10.1093/cid/ciz290.
Reyniers T, Nostlinger C, Laga M, De Baetselier I, Crucitti T, Wouters K, et al. Choosing between daily and event-driven pre-exposure prophylaxis: results of a Belgian PrEP demonstration project. J Acquir Immune Defic Syndr. 2018;79(2):186–94. https://doi.org/10.1097/qai.0000000000001791.
Bekker LG, Roux S, Sebastien E, Yola N, Amico KR, Hughes JP, et al. Daily and non-daily pre-exposure prophylaxis in African women (HPTN 067/ADAPT Cape Town Trial): a randomised, open-label, phase 2 trial. Lancet HIV. 2018;5(2):e68–e78. https://doi.org/10.1016/s2352-3018(17)30156-x.
www.croiwebcasts.org/p/2019croi/104. Accessed 29 Dec 2019.
Centers for Disease Control and Prevention. PrEP. https://www.cdc.gov/hiv/basics/prep.html. Accessed 5 Apr 2020.
US Public Health Service. Pre-exposure prophylaxis for the prevention of HIV infection in the United States—2017 update: A Clinical Practice Guideline. 2017. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf. Accessed 5 Apr 2020.
Lykins WR, Luecke E, Johengen D, van der Straten A, Desai TA. Long acting systemic HIV pre-exposure prophylaxis: an examination of the field. Drug Deliv Transl Res. 2017;7(6):805–16. https://doi.org/10.1007/s13346-017-0391-6.
McPherson TD, Sobieszczyk ME, Markowitz M. Cabotegravir in the treatment and prevention of Human Immunodeficiency Virus-1. Expert Opin Investig Drugs. 2018;27(4):413–20. https://doi.org/10.1080/13543784.2018.1460357.
Markowitz M, Frank I, Grant RM, Mayer KH, Elion R, Goldstein D, et al. Safety and tolerability of long-acting cabotegravir injections in HIV-uninfected men (ECLAIR): a multicentre, double-blind, randomised, placebo-controlled, phase 2a trial. Lancet HIV. 2017;4(8):e331–e34040. https://doi.org/10.1016/s2352-3018(17)30068-1.
Landovitz RJ, Li S, Grinsztejn B, Dawood H, Liu AY, Magnus M, et al. Safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in low-risk HIV-uninfected individuals: HPTN 077, a phase 2a randomized controlled trial. PLoS Med. 2018;15(11):e1002690. https://doi.org/10.1371/journal.pmed.1002690.
HIV Prevention Trials Network. A Phase IIa Safety, Tolerability and acceptability study of an investigational injectable HIV integrase inhibitor, GSK1265744, for PrEP in HIV uninfected men and women. https://www.hptn.org/research/studies/hptn077. Accessed 5 Apr 2020.
HIV Prevention Trials Network. HPTN 083: A phase 2b/3 double blind safety and efficacy study of injectable cabotegravir compared to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), for pre-exposure prophylaxis in HIV-uninfected cisgender men and transgender women who have sex with men. https://www.hptn.org/research/studies/hptn083. Accessed 5 Apr 2020.
HIV Prevention Trials Network. HPTN 084: A phase 3 double blind safety and efficacy study of long-acting injectable cabotegravir compared to daily oral TDF/FTC for pre-exposure prophylaxis in HIV-uninfected women. https://www.hptn.org/research/studies/hptn084. Accessed 5 Apr 2020.
Baeten JM, Hendrix CW, Hillier SL. Topical microbicides in HIV prevention: state of the promise. Annu Rev Med. 2019. https://doi.org/10.1146/annurev-med-090518-3731.
Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010;329(5996):1168–74. https://doi.org/10.1126/science.1193748.
Nel A, van Niekerk N, Kapiga S, Bekker L-G, Gama C, Gill K, et al. Safety and efficacy of a dapivirine vaginal ring for HIV prevention in women. N Engl J Med. 2016;375(22):2133–43. https://doi.org/10.1056/NEJMoa1602046.
Schuetz A, Sacdalan C, Ratnaratorn N, Phuang-Ngern Y, Kroon E, Rerknimitr R et al., editors. Abstract 204: Assessing Biologic Risk for HIV Transmission in Transgender Women. Conference on Retroviruses and Opportunistic Infections, Boston, Massachusetts; 2018.
Exploration of the Neo-Vagina Study. https://clinicaltrials.gov/ct2/show/NCT03049371. Accessed 29 Dec 2019.
Poteat T, Hanna DB, Rebeiro PF, Klein M, Silverberg MJ, Eron JJ, et al. Characterizing the human immunodeficiency virus care continuum among transgender women and cisgender women and men in clinical care: a retrospective time-series analysis. Clin Infect Dis. 2019. https://doi.org/10.1093/cid/ciz322.
Kalichman SC, Hernandez D, Finneran S, Price D, Driver R. Transgender women and HIV-related health disparities: falling off the HIV treatment cascade. Sex Health. 2017;14(5):469–76. https://doi.org/10.1071/sh17015.
Division of Policy and Data HABH. Health Resources and Services Administration (HRSA), Ryan White and Global HIV/AIDS Program annual client-level data report, 2018. Rockville: U.S. Department of Health and Human Services; 2019.
Mizuno Y, Frazier EL, Huang P, Skarbinski J. Characteristics of transgender women living with HIV receiving medical care in the United States. LGBT Health. 2015;2(3):228–34. https://doi.org/10.1089/lgbt.2014.0099.
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. 2019.
Institute of Medicine Committee on Lesbian Gay Bisexual Transgender Health Issues and Research Gaps and Opportunities. The health of lesbian, gay, bisexual, and transgender people: building a foundation for better understanding., vol Book, Whole. National Academies Press; 2011.
Siskind RL, Andrasik M, Karuna ST, Broder GB, Collins C, Liu A, et al. Engaging transgender people in NIH-funded HIV/AIDS clinical trials research. J Acquir Immune Defic Syndr. 2016;72(Suppl 3):S243–S247247. https://doi.org/10.1097/qai.0000000000001085.
Dr Poteat received salary support for this research from the University of North Carolina at Chapel Hill Center for AIDS Research (CFAR), an NIH funded program P30AI050410.
Conflict of interest
Dr Poteat has served on an advisory board for Gilead Sciences and received research grants to her institution from Gilead Sciences and ViiV Healthcare. Dr Radix declares no conflicts of interest.
About this article
Cite this article
Poteat, T.C., Radix, A. HIV Antiretroviral Treatment and Pre-exposure Prophylaxis in Transgender Individuals. Drugs 80, 965–972 (2020). https://doi.org/10.1007/s40265-020-01313-z