HIV Risk Reduction Strategies

Transforming Health
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Today, more tools than ever are available to prevent HIV. In addition to abstinence, limiting number of sexual partners, never sharing needles, and using condoms the right way every time during sex, transgender people may be able to take advantage of interventions such as pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP).

Providers can consider the following key strategies:

  • A photograph shows a transgender person speaking with a health care provider about HIV prevention in the provider’s office.

    Recommend regular screening and treatment for sexually transmitted diseases on the basis of patients’ reported sexual activity. Testing for gonorrhea and chlamydia can be performed at all potentially infected sites (e.g., throat, urinary tract, rectum), as needed.

  • Recommend regular HIV testing; the frequency may be determined by patients’ sexual histories.
  • Assess whether condoms are being used correctly and consistently. Some patients, particularly those who experience a power differential in their sexual relationships, may not be able to negotiate condom use with their partners.
  • Consider offering other prevention options, such as PrEP, to these patients. While the effectiveness of PrEP for transgender women has not yet been proven in trials1, and trials have not been conducted among transgender men, PrEP has been shown to reduce the risk of HIV acquisition during anal sex and penile-vaginal sex. Therefore, its use may be considered in all persons at risk of acquiring HIV sexually.
  • Discuss choosing less risky sexual behaviors and encourage patients to go to visit the HIV Risk Reduction Tool to get customized information about how choices they make can put them at risk or can help protect them.
  • Discuss reducing the number of sexual partners (although this may not be feasible for transgender women engaging in survival sex).
  • For individuals living with HIV, have an open conversation about barriers to and strategies for adherence to ART to achieve viral suppression, which dramatically reduces the risk of transmitting HIV to others.2 In fact, people with HIV who take ART as prescribed and achieve and maintain an undetectable viral load have effectively no risk of transmitting HIV through sex. To learn more about HIV care and treatment as prevention, visit our Prevention is Care website.
  • To learn more about HIV risk reduction strategies, visit CDC’s guidelines on preventing new HIV infections. Providers can also help transgender patients assess their relative risk of HIV transmission associated with various sexual activities by visiting the CDC’s HIV Risk Reduction Tool.

Why PrEP?

Health care providers may consider discussing PrEP as an option with transgender patients who are at high risk of HIV infection.

Transgender women, especially women of color, have a high risk of contracting HIV.3 Because of this risk, some transgender women may benefit from taking pre-exposure prophylaxis (PrEP). PrEP refers to the daily use of specific antiretroviral medications by people with a high risk of acquiring HIV infection to prevent the acquisition of HIV. No clinical trials of PrEP have been devoted to assessing its efficacy among transgender people. However, oral PrEP, a single pill containing a combination of two antiretroviral medications and taken once a day, has been shown to be safe and effective among other groups, including men who have sex with men (MSM),4 heterosexual people,5,6 and people who inject drugs.7 The Centers for Disease Control and Prevention (CDC) recommends PrEP for people at high risk of HIV infection in these groups who need additional prevention options.8

Studies of PrEP have consistently shown that efficacy is contingent on adherence to the medication; with high adherence, PrEP reduces the risk of HIV infection from sex by more than 90%.3 Although more research is needed to understand the effectiveness of PrEP in transgender people, health care providers may consider discussing PrEP as a prevention option with transgender people, especially transgender women of color, who are at high risk of infection. Post-exposure prophylaxis (PEP), which can protect against HIV infection after a single, discrete exposure to HIV, is another prevention option to make available to transgender people.

Health care providers can counsel their patients that it is possible that PrEP may prevent HIV infection in transgender women, but only if it is taken every day.

Most of what is known about PrEP for transgender women comes from a subgroup analysis of the iPrEx study,1 a randomized controlled trial of PrEP that enrolled 2,499 participants across the world. Of the study participants, 339 (14%) were transgender women. In the original iPrEx publication,4 of 2,499 MSM, 29 identified as female (i.e., transgender women).* In a subsequent subgroup analysis,1 men were categorized as transgender women (n=339) if they were born male and either identified as women (n=29), identified as transgender (n=296), or identified as male and used feminizing hormones (n=14). Using this expanded definition, among transgender women, no efficacy of PrEP was demonstrated. There were 11 infections in the PrEP group and 10 in the placebo group (HR 1.1, 95% CI: 0.5-2.7). By drug level testing (always vs. less than always), compared with MSM, transgender women had less consistent PrEP use OR 0.39 (95% CI: 0.16-0.96). In the subsequent open-label extension study, one transgender woman seroconverted while receiving PrEP and one seroconversion occurred in a woman who elected not to use PrEP.

*See “A Note on Terminology” regarding HIV research published in academic journals.

Health care providers can inform patients that PrEP medication has not been reported to diminish the effectiveness of hormone therapy (estrogens and anti-androgens) and that hormone therapy has not been reported to alter the efficacy of PrEP.

Hormone therapy is a priority for many transgender women, and many use hormone therapy at some point in their lives.9 Transgender women may have concerns about potential interactions between PrEP and hormone therapy, which usually consists of estrogens and anti-androgen medications (such as spironolactonepdf iconexternal icon). However, there are no known or predicted drug interactions between the medication used for PrEP, oral TDF/FTC (tenofovir disoproxil fumarate/emtricitabine), and feminizing hormones.10,11 These studies were done with hormone doses significantly lower than those typically used by transgender persons. Although tenofovir levels in blood were lower among the transgender women in the iPrEx study who reported taking hormone therapy compared to those who were not, the authors speculate that the difference is not the result of drug interactions. Instead, it is caused by poor medication adherence.1 Studies to assess the effectiveness PrEP and medication adherence among transgender women are underway.

Health care providers can follow the same CDC guidelines8 to prescribe and monitor PrEP for transgender women as for other people. PrEP adherence tip: Studies show that transgender women may have high adherence to gender-affirming hormones. This can be a source of self-efficacy for transgender patients in regard to taking a daily medication. Health care providers can work with their patients to extend this self-care to include PrEP adherence.

The steps to prescribe and monitor PrEP are the same for transgender women as for other people. Detailed recommendations are available in the CDC guidelines. To be eligible for PrEP, people must have a negative HIV test and normal renal function. Once eligibility has been confirmed, no more than a 90-day prescription of TDF/FTC at a time is recommended so people must return for HIV testing before renewing their prescriptions. It is also recommended that people taking PrEP be screened for HIV infection at least every 3 months and assessed for sexually transmitted diseases at least every 6 months. They also should be assessed for chronic hepatitis B infection, because both tenofovir disoproxil fumarate and emtricitabine are active against hepatitis B and their hepatitis B status should be know when discontinuing PrEP. In addition, serum creatinine should be checked and an estimated creatinine clearance rate determined 3 months after starting PrEP and then every 6 months thereafter, provided estimated creatinine clearance remains in the normal range (≥60 ml/min). It is possible that your transgender women patients are worried that PrEP may negatively affect their feminizing hormones. To alleviate their concerns health care providers may consider monitoring estradiol levels in transgender women taking both PrEP and feminizing hormones (see HIV Status Algorithm below). Offering and monitoring hormone therapy along with PrEP may help and encourage them to remain engaged in care.

Adherence is critical to the efficacy of PrEP, but many transgender women may experience significant barriers to adherence, including poverty, homelessness, substance abuse, and avoidance of health care settings because of concerns about discrimination. Providers can ask about medication adherence and barriers to adherence at follow up visits and refer patients to appropriate services, as needed. Creating a clinic setting that patient-centered transgender patients may also help improve engagement in care and adherence. See Recommended Practices for Health Care Settings for more information on steps toward making health care settings more patient-centered.

PrEP Basics for Transgender Women

  • Baseline testing
    • The most important aspect of the baseline assessment is ascertaining that the patient is not already HIV-infected. HIV testing should be conducted immediately prior to starting PrEP, ideally on the same day the prescription is provided. See HIV Status Algorithm for more details including options for patients with signs/symptoms of acute HIV infection within the prior four weeks.

HIV Status Algorithm

The HIV Status Algorithm flow chart shows HIV testing procedures and options available based on results. First, the HIV Immunoassay blood test is administered. If the test is HIV positive, the patient, pending confirmatory testing, is not eligible for pre-exposure prophylaxis, known as PrEP. If the test results are indeterminate of negative, determine if the patient has experienced signs or symptoms of acute HIV infection anytime in the prior 4 weeks. If not, the patient is found to be HIV negative. If the patient had these symptoms, three options are available: Option 1, retest the antibody in 1 month and defer the PreEP decision. Option 2, send the blood for HIV antigen/antibody assay, using only HIV antigen/antibody tests that are approved by FDA for diagnostic purposes. Option 3, send the blood for an HIV-1 viral load (VL) assay. A VL of greater or equal to 50,000 copies per milliliter means the patient is HIV positive. If the VL is less than 50,000 copies per milliliter, the VL is retested, and the PrEP decision is deferred. If the VL is less than the level of detection and there are no signs or symptoms on the day blood is drawn, the patient is deemed HIV negative. If the VL is less than the level of detection and there are signs or symptoms on the day blood is drawn, a retest is performed in 1 month, and the PrEP decision is deferred.

Baseline testing should also include

  • HBsAg (hepatitis B surface antigen)
  • Creatinine (to calculate creatinine clearance)
  • Monitoring patients on PrEP:
  • 3 months: HIV screening, preferably with a fourth-generation antibody/antigen test
  • Creatinine
  • 6 months: sexually transmitted disease screening (i.e., syphilis serology, NAAT testing for gonorrhea/chlamydia)

Transgender women may encounter several barriers to accessing PrEP. Lack of knowledge about PrEP is one of the most significant barriers. One study showed that transgender women were unlikely to know about PrEP despite having a high risk of HIV infection.11 Other barriers include the cost of medications, lack of access to a Patient-Centered provider, concerns about interactions with hormone therapy, and stigma.12 Stigma can take several forms, including assumptions about promiscuity or HIV positivity based on PrEP use.

Fortunately, health care providers can help transgender women overcome many of these barriers. Health care providers can educate their patients about PrEP and take steps to make their practices more welcoming to transgender people. Counseling about the lack of definitive studies of effectiveness should be provided. Informing patients that there are no known interactions between PrEP and hormonal therapy, along with monitoring of hormonal levels while on PrEP, may help allay concerns about drug interactions. For patients who are uninsured or underinsured for PrEP, referral to a patient assistance program can help overcome financial obstacles to PrEP use. Finally, health care providers can counter stigma by reinforcing to patients that taking PrEP may be a positive step to help preserve health, not a marker of promiscuity or HIV infection.

Some transgender women may be concerned about the cost of PrEP. Health care providers can talk with transgender patients about insurance coverage and payment assistance options that help make PrEP more affordable.

Public and private insurance programs vary in their coverage of PrEP. Without health insurance or with high deductibles or co-pays, PrEP can be expensive. Cost may be a particularly important barrier for transgender women, as studies show that they are more likely than the general population to have incomes below the federal poverty level.9 Prescription assistance programs can help patients without insurance—or those with high copays or deductibles—pay for PrEP. Gilead Sciences, the manufacturer of TDF/FTC, has developed patient assistance programs to help cover medication expenses; these programs can be accessed online at www.gileadadvancingaccess.comexternal icon. In addition, the Patient Advocate Foundationexternal icon provides up to $7,500 of assistance per year for people whose incomes are less than 400% of the federal poverty level. For more information on the current federal poverty level, please visit https://www.healthcare.gov/glossary/federal-poverty-level-FPL/external icon. In addition, several jurisdictions have established PrEP assistance programs that will provide assistance with medications, clinic visit, or lab costs. Learn more about Paying for PrEP pdf icon[PDF – 160 KB].

PrEP Talking Points With Transgender Women

  • PrEP is of unproven effectiveness for transgender persons but may be effective when taken every day, as prescribed.
  • There are no known drug interactions between PrEP and gender-affirming hormones.
  • Periodic HIV testing and estimated creatinine clearance checks are required.
  • PrEP can have initial side effects that usually last 2-3 weeks: headache, flatulence, mild diarrhea.
  • If discontinuing PrEP, discuss typical maximal protection time in populations studied.
  • PrEP does not protect against other sexually transmitted diseases.

Transgender people who are not using PrEP may benefit from PEP after a high-risk sexual encounter or injection drug exposure. PEP consists of antiretroviral medication and should be initiated as soon as possible because HIV establishes infection very quickly (no more than 72 hours) after the encounter and continued for 28 days. Encounters for which PEP should be considered include condomless sex with, or use of drug injection equipment previously used by, an HIV-infected individual or with an individual of unknown HIV status. Sexual assault survivors should be considered for PEP but providers should be aware that studies have shown these patients will need additional assistance with adherence and completing follow up.13 Sexually active patients should be counseled about how to access PEP and the importance of initiating PEP as soon as possible after an exposure. Health care providers should evaluate persons rapidly for PEP when care is sought ≤72 hours after a potential exposure. HIV status should be determined in persons being considered for PEP using rapid combined antigen/antibody (Ag/Ab) or antibody blood tests. If lab results are not immediately available, PEP should be initiated and continuation can be reconsidered if results indicate.
Providers who do not offer PEP themselves, should consider creating a list of local organizations or emergency departments that provide PEP and have experience with transgender patients. Antiretroviral regimens commonly used for PEP (e.g., TDF/FTCplus raltegravir or TDF/FTCplus dolutegravir) have no known drug interactions with feminizing hormones.14,15 Some people seeking PEP may have a high, ongoing risk of HIV infection; if this is the case, it is appropriate to discuss and offer PrEP after completion of a 28-day course of PEP.

Paying for PEP

When public, privately purchased, or employer-based insurance coverage is unavailable, health care providers can assist patients with obtaining antiretroviral medications through the medication assistance programs of the pharmaceutical companies that manufacture the prescribed medications. Applications are available online that can be faxed to the company or certain companies can be called on an established phone line. Requests for assistance often can be handled urgently so that accessing medication is not delayed. Information for specific medications and manufacturers is available here.

Patients being prescribed PEP after sexual assault can be reimbursed for medications and clinical care costs through state Crime Victim’s Compensation Programs funded by the U.S. Department of Justice. Contact information for each state is available here.

Testing

Providers should test for HIV immediately and should also test for other sexually transmitted infections (STIs) while monitoring for seroconversion. Laboratory testing is required to (1) document the HIV infection status of the person presenting for the PEP evaluation, (2) identify and clinically manage any other conditions potentially resulting from sexual-or injection related exposure to potentially infected body fluids, (3) identify any conditions that would affect the PEP regimen, and (4) monitor for safety or toxicities related to the regimen. See the table below for timing of testing.13

Table/Graphic: PEP Basics for Transgender Women

Table/Graphic: PEP Basics for Transgender Women

aAny positive or indeterminate HIV antibody test should undergo confirmatory testing of HIV infection status.
bOnly if hepatitis C infection was acquired during the original exposure; delayed HIV seroconversion has been seen in persons who simultaneously acquire HIV and hepatitis C infection.
cIf exposed person susceptible to hepatitis B at baseline.
dIf exposed person susceptible to hepatitis C at baseline.
eIf determined to be infected with syphilis and treated, should undergo serologic syphilis testing 6 months after treatment.
fTesting for chlamydia and gonorrhea should be performed using nucleic acid amplification tests. For patients diagnosed with a chlamydia or gonorrhea infection, retesting 3 months after treatment is recommended.
– For men and women reporting receptive oral sex, an oropharyngeal swab should be tested for gonorrhea.
– For women reporting receptive vaginal sex, a vaginal (preferred) or endocervical swab or urine specimen should be tested for chlamydia and gonorrhea.
– For men and women reporting receptive anal sex, a rectal swab specimen should be tested for chlamydia and gonorrhea.
– For men and women reporting receptive oral sex, an oropharyngeal swab should be tested for gonorrhea. (http://www.cdc.gov/std/tg2015/tg-2015-print.pdfpdf icon)
gIf not provided presumptive treatment at baseline, or if symptomatic at follow-up visit.
hIf woman of reproductive age, not using effective contraception, and with vaginal exposure to semen.
ieCrCl = estimated creatinine clearance calculated by the Cockcroft-Gault formula; eCrClCG= [(140 − age) x ideal bodyweight] ÷ (serum creatinine x 72) (x 0.85 for females).
jAt first visit where determined to have HIV infection.
Risk Assessment

PEP initiation should be considered in people whose vagina, rectum, eye, mouth or other mucuous membrane, non-intact skin, or perforated skin (eg, needle stick) come into contact with potentially contaminated body fluids from an HIV-infected source, as long as exposure has occurred within a 72-hour window. (If the source is of unknown HIV status, a case-by-case determination may be made.) PEP is not recommended for use in people whose exposure occurred 73 hours or more before they sought treatment, or in people who are considered to have a negligible risk for HIV exposure because of exposure to non-blood contaminated secretions such as urine, saliva, sweat, tears, or nasal secretions. Additionally, people who are already adhering to a daily PrEP regimen under the care of their health care practitioner are not in need of PEP if they experience a potential HIV exposure while they are on PrEP.13 HIV status should be determined in persons being considered for PEP using rapid combined antigen/antibody (Ag/Ab) or antibody blood tests.

Algorithm for Evaluation and Treatment of Possible Nonoccupational HIV Exposures

A flow chart shows the algorithm for evaluation and treatment of possible nonoccupational HIV exposures.   Box A titled “Substantial Risk for HIV Acquisition” has arrows leading into Box B titled “Less than or equal to 72 hours since exposure” and Box C titled “Greater than or equal to 73 hours since exposure.”  Box B has arrows leading into Box D titled “Source patient known to be HIV positive” and Box E titled “Source patient unknown to be HIV positive.”  Box D has an arrow leading into Box F titled “nPEP recommended.”  Box E has an arrow leading to Box G titled “Case-by-case determination.”  Box C and Box H titled “Negligible Risk for HIV Acquisition” have arrows leading into Box I titled “nPEP not recommended.”  A box describes substantial risk for HIV acquisition as: 1) the exposure of: vagina, rectum, eye, mouth or other mucous membrane, nonintact skin, or percutaneous contact; 2) with: blood semen, vaginal secretions, rectal secretions, breast milk, or any fluid that is visibly contaminated with blood; 3) when: the source is known to be HIV-positive.  A box describes negligible risk for HIV acquisition as: 1) the exposure of: vagina, rectum, eye, mouth or other mucous membrane, intact skin or nonintact skin, or percutaneous contact; 2) with: urine, nasal secretions, saliva, sweat, or tears if not visibly contaminated with blood; 3) regardless: of the known suspected HIV status of the source.

  • The preferred PEP regimen for otherwise healthy adults and adolescents is:
    • Tenofovir disoproxil fumarate (TDF)(300 mg) + emtricitabine (FTC)(200 mg) once daily PLUS raltegravir (RAL)(400 mg) twice daily or dolutegravir (DTG)(50 mg) once daily
    • (TDF 300 mg + FTC 200mg is available as a fixed-dose combination called TruvadaR from Gilead Sciences.)
  1. Deutsch MB, Glidden DV, Sevelius J, et al. HIV pre-exposure prophylaxis in transgender women: a subgroup analysis of the iPrEx trial. Lancet HIV. 2015 Dec;2:e512-9.
  2. Cohen MS, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011 Aug;365:493-505.
  3. Herbst JH, Jacobs ED, Finlayson TJ, McKleroy VS, Neumann MS, Crepaz N; HIV/AIDS Prevention Research Synthesis Team. Estimating HIV prevalence and risk behaviors among transgender persons in the United States: a systematic review. AIDS Behav. 2008 Jan;12(1):1-17.
  4. Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010;363(27):2587-2599.
  5. Baeten JM, et al. Antiretroviral prophylaxis for HIV-1 prevention among heterosexual men and women. N Engl J Med. 2012 Aug;367(5):399-410.
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  7. Choopanya K, et al. Antiretroviral prophylaxis in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomized, placebo-controlled, phase 3 trial. Lancet. 2013 June;381(9883):2083-90.
  8. U.S. Public Health Service. Preexposure prophylaxis for prevention of HIV infection in the United States—2014.
  9. Grant J, Mottet LA, Tanis J, et al. Injustice at every turn: a report of the National Transgender Discrimination Surveypdf iconexternal icon [Internet]. Washington, DC: National Center for Transgender Equality and National Gay and Lesbian Task Force. 2011 [cited 2016 Aug 26]. 220 p.
  10. Radix A, Sevelius J, Deutsch MB. Transgender women, hormonal therapy and HIV treatment: a comprehensive review of the literature and recommendations for best practices. J Int AIDS Soc. 2016 Jul 17;19(3 Suppl 2):20810. doi:10.7448/IAS.19.3.20810
  11. 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;11(7-8):1060.
  12. Wilson EC, Jin H, Liu A, Raymond HF. Knowledge, indications, and willingness to take pre-exposure prophylaxis among transwomen in San Francisco, 2013. PLoS One. 2015;10(6):e0128971.
  13. Centers for Disease Control and Prevention (CDC). Updated guidelines for antiretroviral postexposure prophylaxis after sexual, injection-drug use, or other nonoccupational exposure to HIV –– United States, 2016. April 18:1-91.
  14. Center for Excellence in Transgender Health. Guidelines for the Primary and Gender-Affirming Care of Transgender and Gender Nonbinary Peopleexternal icon. 2016.
  15. New York State Department of Health AIDS Institute. HIV prophylaxis following non-occupational exposureexternal icon [Internet]. 2014.