Integration of Gender-Affirming Primary Care and Peer Navigation With HIV Prevention and Treatment Services to Improve the Health of Transgender Women: Protocol for a Prospective Longitudinal Cohort Study

Javier R Lama, Kenneth H Mayer, Amaya G Perez-Brumer, Leyla Huerta, Hugo Sanchez, Jesse L Clark, Jorge Sanchez, Sari L Reisner, Javier R Lama, Kenneth H Mayer, Amaya G Perez-Brumer, Leyla Huerta, Hugo Sanchez, Jesse L Clark, Jorge Sanchez, Sari L Reisner

Abstract

Background: Public health strategies are urgently needed to improve HIV disparities among transgender women, including holistic intervention approaches that address those health needs prioritized by the community. Hormone therapy is the primary method by which many transgender women medically achieve gender affirmation. Peer navigation has been shown to be effective to engage and retain underserved populations living with HIV in stable primary medical care.

Objective: This study aims to assess the feasibility and acceptability of an integrated innovative HIV service delivery model designed to improve HIV prevention and care by combining gender-affirming primary care and peer navigation with HIV prevention and treatment services.

Methods: A 12-month, nonrandomized, single-arm cohort study was implemented in Lima, Peru, among adult individuals, assigned a male sex at birth, who identified themselves as transgender women, regardless of initiation or completion of medical gender affirmation, and who were unaware of their HIV serostatus or were living with HIV but not engaged in HIV treatment. HIV-negative participants received quarterly HIV testing and were offered to initiate pre-exposure prophylaxis. HIV-positive participants were offered to initiate antiretroviral treatment and underwent quarterly plasma HIV-1 RNA and peripheral CD4+ lymphocyte cell count monitoring. All participants received feminizing hormone therapy and adherence counseling and education on their use. Peer health navigation facilitated retention in care by visiting participants at home, work, or socialization venues, or by contacting them by social media and phone.

Results: Patient recruitment started in October 2016 and finished in March 2017. The cohort ended follow-up on March 2018. Data analysis is currently underway.

Conclusions: Innovative and culturally sensitive strategies to improve access to HIV prevention and treatment services for transgender women are vital to curb the burden of HIV epidemic for this key population. Findings of this intervention will inform future policies and research, including evaluation of its efficacy in a randomized controlled trial.

Trial registration: ClinicalTrials.gov NCT03757117; https://ichgcp.net/clinical-trials-registry/NCT03757117.

International registered report identifier (irrid): DERR1-10.2196/14091.

Keywords: HIV; Peru; culturally competent care; health services; patient navigation; retention in care; transgender persons.

Conflict of interest statement

Conflicts of Interest: None declared.

©Javier R Lama, Kenneth H Mayer, Amaya G Perez-Brumer, Leyla Huerta, Hugo Sanchez, Jesse L Clark, Jorge Sanchez, Sari L Reisner. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 27.06.2019.

Figures

Figure 1
Figure 1
Schematic of gender-affirming health care and peer navigation to improve the HIV prevention and treatment cascades. ART: antiretroviral therapy; PrEP: pre-exposure prophylaxis; STI: sexually transmitted infection; TW transgender women.

References

    1. Baral SD, Poteat T, Strömdahl S, Wirtz AL, Guadamuz TE, Beyrer C. Worldwide burden of HIV in transgender women: a systematic review and meta-analysis. Lancet Infect Dis. 2013 Mar;13(3):214–22. doi: 10.1016/S1473-3099(12)70315-8.
    1. Silva-Santisteban A, Eng S, de la Iglesia G, Falistocco C, Mazin R. HIV prevention among transgender women in Latin America: implementation, gaps and challenges. J Int AIDS Soc. 2016 Jul;19(3 Suppl 2):20799. doi: 10.7448/IAS.19.3.20799.
    1. Sanchez J, Lama JR, Kusunoki L, Manrique H, Goicochea P, Lucchetti A, Rouillon M, Pun M, Suarez L, Montano S, Sanchez JL, Tabet S, Hughes JP, Celum C. HIV-1, sexually transmitted infections, and sexual behavior trends among men who have sex with men in Lima, Peru. J Acquir Immune Defic Syndr. 2007 Apr 15;44(5):578–85. doi: 10.1097/QAI.0b013e318033ff82.
    1. Silva-Santisteban A, Raymond HF, Salazar X, Villayzan J, Leon S, McFarland W, Caceres CF. Understanding the HIV/AIDS epidemic in transgender women of Lima, Peru: results from a sero-epidemiologic study using respondent driven sampling. AIDS Behav. 2012 May;16(4):872–81. doi: 10.1007/s10461-011-0053-5.
    1. Clark JL, Konda KA, Silva-Santisteban A, Peinado J, Lama JR, Kusunoki L, Perez-Brumer A, Pun M, Cabello R, Sebastian JL, Suarez-Ognio L, Sanchez J. Sampling methodologies for epidemiologic surveillance of men who have sex with men and transgender women in Latin America: an empiric comparison of convenience sampling, time space sampling, and respondent driven sampling. AIDS Behav. 2014 Dec;18(12):2338–48. doi: 10.1007/s10461-013-0680-0.
    1. García PJ, Holmes KK, Cárcamo CP, Garnett GP, Hughes JP, Campos PE, Whittington WL. Prevention of sexually transmitted infections in urban communities (Peru PREVEN): a multicomponent community-randomised controlled trial. The Lancet. 2012 Mar;379(9821):1120–8. doi: 10.1016/S0140-6736(11)61846-1.
    1. Ministry of Health of Peru [National Center for Epidemiology, Prevention and Control of Diseases] [2019-01-17]. Epidemiological situation of HIV-AIDS in Peru .
    1. Chow JY, Konda KA, Borquez A, Caballero P, Silva-Santisteban A, Klausner JD, Cáceres CF. Peru's HIV care continuum among men who have sex with men and transgender women: opportunities to optimize treatment and prevention. Int J STD AIDS. 2016 Dec;27(12):1039–48. doi: 10.1177/0956462416645727.
    1. Sevelius JM. Gender affirmation: a framework for conceptualizing risk behavior among transgender women of color. Sex Roles. 2013 Jun 01;68(11-12):675–89. doi: 10.1007/s11199-012-0216-5.
    1. Bockting W, Coleman E, Deutsch MB, Guillamon A, Meyer I, Meyer W, Reisner S, Sevelius J, Ettner R. Adult development and quality of life of transgender and gender nonconforming people. Curr Opin Endocrinol Diabetes Obes. 2016 Apr;23(2):188–97. doi: 10.1097/MED.0000000000000232.
    1. Glynn T, Gamarel K, Kahler C, Iwamoto M, Operario D, Nemoto T. The role of gender affirmation in psychological well-being among transgender women. Psychol Sex Orientat Gend Divers. 2016 Sep;3(3):336–344. doi: 10.1037/sgd0000171.
    1. Hembree WC, Cohen-Kettenis PT, Gooren L, Hannema SE, Meyer WJ, Murad MH, Rosenthal SM, Safer JD, Tangpricha V, T'Sjoen GG. Endocrine treatment of gender-dysphoric/gender-incongruent persons: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2017 Dec 01;102(11):3869–903. doi: 10.1210/jc.2017-01658.
    1. White Hughto JM, Reisner SL. A systematic review of the effects of hormone therapy on psychological functioning and quality of life in transgender individuals. Transgend Health. 2016 Jan;1(1):21–31. doi: 10.1089/trgh.2015.0008.
    1. 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 Feb;47(1):5–16. doi: 10.1007/s12160-013-9565-8.
    1. Sevelius JM, Saberi P, Johnson MO. Correlates of antiretroviral adherence and viral load among transgender women living with HIV. AIDS Care. 2014;26(8):976–82. doi: 10.1080/09540121.2014.896451.
    1. Braun HM, Candelario J, Hanlon CL, Segura ER, Clark JL, Currier JS, Lake JE. 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 Dec;4(5):371–5. doi: 10.1089/lgbt.2017.0057.
    1. Reisner SL, Perez-Brumer AG, McLean SA, Lama JR, Silva-Santisteban A, Huerta L, Sanchez J, Clark JL, Mimiaga MJ, Mayer KH. Perceived barriers and facilitators to integrating HIV prevention and treatment with cross- sex hormone therapy for transgender women in Lima, Peru. AIDS Behav. 2017 Dec;21(12):3299–3311. doi: 10.1007/s10461-017-1768-8.
    1. Bradford J, Coleman S, Cunningham W. HIV system navigation: an emerging model to improve HIV care access. AIDS Patient Care STDS. 2007;21 Suppl 1:S49–58. doi: 10.1089/apc.2007.9987.
    1. Kay ES, Batey DS, Mugavero MJ. The HIV treatment cascade and care continuum: updates, goals, and recommendations for the future. AIDS Res Ther. 2016;13:35. doi: 10.1186/s12981-016-0120-0.
    1. Schaefer R, Gregson S, Fearon E, Hensen B, Hallett T, Hargreaves J. HIV prevention cascades: a unifying framework to replicate the successes of treatment cascades. Lancet HIV. 2019 Jan;6(1):e60–6. doi: 10.1016/S2352-3018(18)30327-8.
    1. Bauer MS, Damschroder L, Hagedorn H, Smith J, Kilbourne AM. An introduction to implementation science for the non-specialist. BMC Psychol. 2015 Sep 16;3:32. doi: 10.1186/s40359-015-0089-9.
    1. Odeny TA, Padian N, Doherty MC, Baral S, Beyrer C, Ford N, Geng EH. Definitions of implementation science in HIV/AIDS. Lancet HIV. 2015 May;2(5):e178–80. doi: 10.1016/S2352-3018(15)00061-2.
    1. Perez-Brumer AG, Reisner SL, McLean SA, Silva-Santisteban A, Huerta L, Mayer KH, Sanchez J, Clark JL, Mimiaga MJ, Lama JR. Leveraging social capital: multilevel stigma, associated HIV vulnerabilities, and social resilience strategies among transgender women in Lima, Peru. J Int AIDS Soc. 2017 Dec 28;20(1):21462. doi: 10.7448/IAS.20.1.21462.
    1. Reisner SL, Bradford J, Hopwood R, Gonzalez A, Makadon H, Todisco D, Cavanaugh T, VanDerwarker R, Grasso C, Zaslow S, Boswell SL, Mayer K. Comprehensive transgender healthcare: the gender affirming clinical and public health model of Fenway Health. J Urban Health. 2015 Jun;92(3):584–92. doi: 10.1007/s11524-015-9947-2.
    1. UNAIDS . Good participatory practice: Guidelines for biomedical HIV prevention trials (2011) Geneva, Switzerland: Joint United Nations Programme on HIV/AIDS; 2011. Jun 29, [2019-01-07]. .
    1. Leung M, Yen I, Minkler M. Community based participatory research: a promising approach for increasing epidemiology's relevance in the 21st century. Int J Epidemiol. 2004 Jun;33(3):499–506. doi: 10.1093/ije/dyh010.
    1. The Fenway Institute . Fenway Health. Boston, MA: 2015. [2019-01-17]. The medical care of transgender persons .
    1. [Ministry of Health of Peru] Digemid - Minsa. Lima, Peru: [Ministry of Health of Peru]; 2014. [2019-01-07]. [Technical standard of health of integral care of the adult with infection with the virus of human immunodeficiency (HIV)] .
    1. World Health Organization . Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection. Geneva, Switzerland: World Health Organization; 2016. [2019-01-07]. .
    1. Workowski K, Bolan G, Centers for Disease Control and Prevention Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep. 2015 Jun 05;64(RR-03):1–137.
    1. Fitzmaurice GM, Laird NM, Ware JH. Applied Longitudinal Analysis. Hoboken: Wiley; 2011.
    1. Zeger S, Liang K, Albert P. Models for longitudinal data: a generalized estimating equation approach. Biometrics. 1988 Dec;44(4):1049–60.
    1. Liang K, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika. 1986;73(1):13–22. doi: 10.1093/biomet/73.1.13.
    1. Lee KJ, Carlin JB. Multiple imputation for missing data: fully conditional specification versus multivariate normal imputation. Am J Epidemiol. 2010 Mar 01;171(5):624–32. doi: 10.1093/aje/kwp425.
    1. van Buuren Stef. Multiple imputation of discrete and continuous data by fully conditional specification. Stat Methods Med Res. 2007 Jun;16(3):219–42. doi: 10.1177/0962280206074463.
    1. Henderson R, Diggle P, Dobson A. Joint modelling of longitudinal measurements and event time data. Biostatistics. 2000 Dec;1(4):465–80. doi: 10.1093/biostatistics/1.4.465.
    1. Wang Y, Taylor J. Jointly modeling longitudinal and event time data with application to acquired immunodeficiency syndrome. J Am Statistical Assoc. 2014 Sep;96(455):895–905. doi: 10.1198/016214501753208591.
    1. Tsiatis A, Davidian M. Joint modeling of longitudinal and time-to-event data: An overview. Statistica Sinica. 2004 Jul;14(3):809–834.
    1. Albert PS, Shih JH. On estimating the relationship between longitudinal measurements and time-to-event data using a simple two-stage procedure. Biometrics. 2010 Sep;66(3):983–7. doi: 10.1111/j.1541-0420.2009.01324_1.x.
    1. Tsiatis AA, DeGruttola V, Wulfsohn MS. Modeling the relationship of survival to longitudinal data measured with error. Applications to survival and CD4 counts in patients with AIDS. J Am Stat Assoc. 1995 Mar;90(429):27–37. doi: 10.2307/2291126.
    1. Wulfsohn M, Tsiatis A. A joint model for survival and longitudinal data measured with error. Biometrics. 1997 Mar;53(1):330–9.
    1. Rizopoulos D. JM: An R package for the joint modelling of longitudinal and time-to-event data. J Statistical Software. 2010;35(9):1–33. doi: 10.18637/jss.v035.i09.
    1. [Ministry of Health of Peru] [Ministry of Health of Peru] Lima, Peru: [Ministry of Health of Peru]; 2016. [2019-01-07]. [Health Technical Standard N ° 126-MINSA / 2016 / DGIESP. Technical standard of health of comprehensive care of the female transgender population for the prevention and control of sexually transmitted infections and HIV / AIDS] .
    1. National LGBT Health Education Center. Boston, MA: 2018. [2019-05-24]. Creating a Transgender Health Program at Your Health Center: From Planning to Implementation .
    1. United States Agency for International Development. Washington, DC: FHI 360/LINKAGES; 2017. [2019-05-26]. Peer navigation for key populations .
    1. TargetHIV. Rockville, MD: 2018. [2019-05-25]. The SPNS Transgender Women of Color Initiative Interventions Manual .
    1. Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011 May;45(5):626–9. doi: 10.1016/j.jpsychires.2010.10.008.
    1. Reisner SL, Radix A, Deutsch MB. Integrated and gender-affirming transgender clinical care and research. J Acquir Immune Defic Syndr. 2016 Dec 15;72(Suppl 3):S235–42. doi: 10.1097/QAI.0000000000001088.

Source: PubMed

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