2017 HIV Clinical Update. Gender-Affirming Hormone Therapy in the Context of HIV Prevention and Treatment. Learning objectives.

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1 Gender-Affirming Hormone Therapy in the Context of HIV Prevention and Treatment Michelle DallaPiazza MD Assistant Professor of Medicine Division of Infectious Diseases Rutgers New Jersey Medical School Associate Clinical Director, Rugters NJMS Infectious Disease Practice Newark, NJ Learning objectives 1. Define key terminology related to gender identity. 2. Describe the demographics of gender dysphoria as well as key health-related disparities among transgender individuals. 3. Delineate key steps in developing a supportive, gender-affirming clinical environment and in providing culturally competent care for transgender clients. 4. Outline general approaches to holistic preventive and primary care for women of the transgender experience, including genderaffirming hormone therapy, HIV pre-exposure prophylaxis, and HIV management. Key references World Professional Association for Transgender Health Standards of Care, version 7 Callen-Lorde Community Health Center Protocols for the Provision of Hormone Therapy National LGBT Health Education Center HIV Clinical Update 21

2 Basic terminology Sex: identified by visual observation of genitals at birth and usually designated male or female Gender: Identified internally by self-knowledge and understanding and falling somewhere on the spectrum including masculinity, femininity, androgyny, and other terms Transgender: Community term of self-identity encompassing anyone who differs from cultural norms for gender identity, expression, and/or role Cisgender: Anyone who is not transgender Transsexual: Diagnostic term designated for a person who wants to live as opposite of their birth assigned sex and seeks medical treatment to make their body congruent with their identity through hormones and/or surgery Basic terminology Gender non-conformity: Extent to which a person s gender identity, role, or expression differs from the cultural norms prescribed for people of a particular sex Gender queer/neutral/diverse/expansive/ awesome: Community terms of self-identity claimed by people who may feel the traditional gender binary is not an accurate representation of their gender. May identify with two, or more, or no, genders HIV Clinical Update

3 Alternative constructs of gender identity If gender is determined by the anatomic sex/the genitals, then binary understanding of gender: Gender reassignment or transition If gender is determined by the brain/one s internal identity, then the spectrum of gender identity: Gender affirmation 2017 HIV Clinical Update 23

4 Transgender Demographics Massachusetts Behavioral Risk Factor Surveillance Survey (2007, 2009) 0.5% of population between the ages of California LGBT Tobacco Survey 0.1% of adult population Estimate in the U.S. from Williams Institute 0.3% of adults Approximately 700,000 people Incidence between 1/1000 and 1/500 DSM 5: Gender Dysphoria December 2012: American Psychiatric Association replaced Gender Identity Disorder with Gender Dysphoria Definition: The discomfort or distress that is caused by a discrepancy between a person s gender identity and that person s sex assigned at birth, and the associated gender role and secondary sex characteristics The pathology is the dysphoria created when a person with a variant in gender identity tries to negotiate their way in a world that discriminates against them Symptoms are socially induced Stigma and discrimination National LGBTQ task force survey (2008) 63% of trans people surveyed experienced an act of discrimination, including: Lost job or eviction School bullying/harassment leading to drop out Teacher bullying Physical or sexual assault Homelessness because of gender identity/expression Lost relationship with partner or child due to gender identity/expression Denial of medical service Incarceration due to gender identity/expression 23% experienced a catastrophic level of discrimination, ( 3 such events) 21 documented trans women murdered in the US in 2015 Grant et al, Kellaway et al. Advocate, HIV Clinical Update

5 TGNC discrimination in healthcare 24% denied care in doctor s offices and hospitals 25% harassed in places of medical care 2% physically assaulted in medical facilities 33% avoid health care Much higher incidences of alcohol, drug use, and suicide For suicide: rate of 41% compared to general USA population 1.6% Grant et al, Barriers to medical care Trauma Public harassment Physical violence Past negative experiences with healthcare Legal Challenges with identity documents Disproportionate rates of incarceration Economic 15-31% earn <$10,000/year Unemployment rate is twice the general population Unemployment associated with increased risk for homelessness, incarceration, sex work, limited formal education, drug use, HIV, and suicide attempts Familial alienation and limited social support Lombardi EL. J Homosex, 2001 Grant JM et al Nemato T et al Xavier J et al Radix A et al. JIAS 2016 The upstream determinants of health Unequal power and opportunity Physical and emotional trauma Poor education Pollution Social isolation Sprawl Low income Unhealthy homes or homelessness Food options Healthcare access No PrEP Rx Late presentation to care Cars as kings Manchanda, TED Books HIV Clinical Update 25

6 Global HIV risk for transgender women Baral SD et al. Lancet Infect Dis, 2013 Pooled prevalence: 19.1% Baral SD et al. Lancet Infect Dis, 2013 Higher risk, but lower rates of screening for HIV Transgender persons avoid medical care 28% delayed care when ill 33% delayed preventive care Low rates of screening (46% never tested) 45-65% HIV+ TGW unaware of status Grant et al. NTDS HIV Clinical Update

7 Factors linked to HIV risk among TGW Behavioral High rates of sex work (>40%) Lower rates of condom use (financial, primary partner) Needle sharing for hormones/silicone? Biological Anal receptive sex Neovaginal sex? Increased rates of STIs Syphilis, HPV, HBV and HCV, chlamydia Schuden et al. Pub Health Rep 2008 Operario D et al. JAIDS 2008 Radix et al. JIAS 2016 Factors linked to HIV risk among TGW Gender identity discrimination Condomless anal receptive sex Depression Substance use Non-inclusion in STI/HIV campaigns HIV prevention is a low priority Safety, survival, emotional Gender validation Brennan J et al. Am J Pub Health 2012 Radix et al. JIAS 2016 Treatment goal Engage and retain high-risk individuals in HIV prevention and treatment programs HIV HIV PREVENTED PREVENTED HIV Clinical Update 27

8 Global HIV risk for transgender women Baral SD et al. Lancet Infect Dis, 2013 Pooled prevalence: 19.1% Baral SD et al. Lancet Infect Dis, 2013 Higher risk, but lower rates of screening for HIV Transgender persons avoid medical care 28% delayed care when ill 33% delayed preventive care Low rates of screening (46% never tested) 45-65% HIV+ TGW unaware of status Grant et al. NTDS HIV Clinical Update

9 Factors linked to HIV risk among TGW Behavioral High rates of sex work (>40%) Lower rates of condom use (financial, primary partner) Needle sharing for hormones/silicone? Biological Anal receptive sex Neovaginal sex? Increased rates of STIs Syphilis, HPV, HBV and HCV, chlamydia Schuden et al. Pub Health Rep 2008 Operario D et al. JAIDS 2008 Radix et al. JIAS 2016 Factors linked to HIV risk among TGW Gender identity discrimination Condomless anal receptive sex Depression Substance use Non-inclusion in STI/HIV campaigns HIV prevention is a low priority Safety, survival, emotional Gender validation Brennan J et al. Am J Pub Health 2012 Radix et al. JIAS 2016 Treatment goal Engage and retain high-risk individuals in HIV prevention and treatment programs HIV HIV PREVENTED PREVENTED HIV Clinical Update 29

10 Engaging leadership and collaborating with other services Executive mgmt Research Senior management engaged Chief nursing officer: UH LGBT task force Dietician Associate dean of diversity and inclusion: NJMS LGBT task force Director of Rutgers IDP and research unit: recognition Admin of community need Collaborators identified: Nursing Plastic surgery Emergency medicine Adolescent medicine Psychiatry Adolesc care Primary care Social work MCM Transgender health program Med school Commun ity Nursing Mental health /Psych Plastic surgery EM Urology Creating a welcoming environment Make intake forms more inclusive Train staff Update signs and patient materials Forms HIV Clinical Update

11 Training Clinical training for MD at Annual TransHealth conference in Philadelphia June 2016 Safe zone training for key staff in IDP and Rutgers CTU IDP retreat March 2017: all clinic and research staff Invited speaker for training on Gender Identity and Sexuality Pronoun workshop May 2017 Invited transgender speaker Signs and materials 2017 HIV Clinical Update 31

12 Outreach Recruit and retain LGBTQ staff Community engagement Medical school Enhanced medical school curriculum Invited speakers Research program Movie nights Invited speakers Community events CAB meetings Testing events Newark Pride Treatment goal Safely improve quality of life for transgender individuals by facilitating their transition to a physical state that more closely represents their sense of themselves and their identities Treatment is individualized What helps one person may be very different from what helps another May or may not include hormones and surgery No feminization Full feminization Psychotherapy Facial feminization Bottom surgery Feminine grooming and dress Voice therapy Breast augmentation Tracheal shave Body or facial hair removal Feminizing hormones Initial assessment Creation of a welcoming environment is crucial first step Do not assume gender identity or sexual orientation How do I know which pronoun to use? Ask politely What s the presenting gender? Echo the language you hear Make an effort to use the correct pronoun consistently In interactions with the individual and in the medical record HIV Clinical Update

13 Taking a gender history Identified as *** around the age of Socially transitioned at the age of Family/social support: Relationship/sexual history: Physical/sexual abuse and IPV history: Prior hormone therapy: Expectations for hormone therapy: Prior cosmetic/gender-affirming surgery: Plan for future surgery: Fertility plans: MH history: PrEP history: Education: Occupation: Current living situation: Legal issues: Additional key history Family history Cancer DM Heart disease Hypertension Liver disease Osteoporosis Medications Prescribed Herbal, OTC Street Supplements Health care maintenance history TB screening Immunization history Breast/chest self-exam Testicular self-exam Pelvic exam and cervical cancer screening HIV status and risk assessment Colon, prostate, EKG Criteria for starting GAHT Persistent, well-documented gender dysphoria Capacity to make a fully informed decision and to consent for treatment Age of majority in a given country If significant medical or mental health concerns are present, they must be reasonably well-controlled Presence of co-existing mental health concerns does not necessarily preclude access to feminizing/masculinizing hormones; rather, these concerns need to be managed prior to or concurrent with treatment of gender dysphoria Social transition is no longer recommended as a prerequisite 2017 HIV Clinical Update 33

14 Physical effects of feminizing hormones HORMONE EFFECT ONSET (Months) MAXIMUM (Years) Decreased erections Decreased testicular volume Decreased sperm production Unknown >3 Decrease in muscle mass and strength Breast growth Body fat redistribution Softening of skin 3-6 Unknown Decreased body hair and (to a lesser extent) facial hair 6-12 >3 Voice changes None Informed consent Like all medical treatments, benefits and risks must be discussed Hormone therapy may lead to irreversible physical changes: Infertility Breast development Bone density decline Genital changes HIV Clinical Update

15 Discussing risks Risk level Risk Likely Venous thromboembolic disease Hypertriglyceridemia Infertility Liver inflammation Weight gain Gallstones Dry skin or acne Hyperkalemia (spironolactone) Likely with additional risk factors Possible Cardiovascular disease Hypertension Pituitary tumors Depression and anxiety Possible with additional risk factors Inconclusive Diabetes type 2 Breast cancer (c/w female sex at birth) Initial and monitoring bloodwork Initial 4 Weeks 8 Weeks Q 3-6 months Q 6 months Yearly CBC CMP Lipids HBsAb HBsAg HBcAb HCV Ab HIV tests RPR GC/CT IGRA CMP CMP Lipids Prolactin RPR GC/CT CBC CMP Lipids Prolactin HCV Ab Estrogens and androgen blockers Regimen Starting dose Usual dose Maximum dose Estradiol 1mg PO BID 2mg PO BID 4mg PO BID Estradiol cypionate 5mg/ml 0.5cc (2.5mg) IM q 2 weeks 1.0cc (5mg) IM q 2 weeks 10mg IM q 2 weeks Estradiol valerate 20mg/ml Estradiol patch* (preferred age >45) 0.5cc (10mg) IM q 2 weeks mg 1 patch topically twice weekly 1.0cc (20mg) IM q 2 weeks 0.1mg 2 patches topically twice weekly 40mg IM q 2 weeks 0.1mg topically daily Spironolactone 100mg PO daily 100mg PO BID 200mg PO BID Maintain estrogen levels 200pg/ml Maintain serum testosterone levels <55ng/dl 2017 HIV Clinical Update 35

16 ART and hormones Data are based on studies of oral contraceptives Estrogens are metabolized by CYP3A4 Protease inhibitors and NNRTI interactions are possible Avoid using unboosted fosamprenavir with estrogens Boosted proteases reduce estradiol levels, monitor estradiol levels 2 week after ARV change Cobicistat may increase estradiol levels by about 25% PrEP in transgender women: iprex Transwomen: 339/2499 (14%) Compared with MSM, had higher risk behaviors at baseline Lack of efficacy: HR 1.1 TDF was not detected in any TGW at seroconversion TDF was only detected in 18% of the seronegative TGW No seroconversions were observed in TGW with TDF levels taking >4 pills/week TDF levels not linked to behavioral risk Hormone use was associated with lower detection of TDF Due to poor adherence from concerns about drug interactions? Deutsch MB et al. Lancet HIV, 2015 Preventive care Smoking cessation Screen organs present Osteoporosis 50 vs 65 Breast cancer screening Silicone may affect interpretation Follow guidelines for other screenings Colonoscopy, PSA screening, etc HIV prevention and education HIV Clinical Update

17 Collect data and perform QI Average age 26 (19-41) Race AA 83% Hispanic 17% HIV + 58% Other STI + 83% H/o sex work 67% H/o homelessness 33% H/o physical or sexual assault 25% Tobacco use Yes 50% Past 42% Never 8% Drug use None 25% MJ only 58% Multiple substances 17% Education <HS 25% HS 50% Some university 25% Questions? 2017 HIV Clinical Update 37

18 Notes HIV Clinical Update

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