Approved to significantly reduce the risk of sexually acquired HIV-1 in individuals at risk1,2
TRUVADA FOR PrEP is one tablet taken once daily.1
HIV-1–negative status must be confirmed immediately prior to initiating TRUVADA FOR PrEP and at least every 3 months thereafter.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
See more Important Safety Information below Indication.
INDICATION
TRUVADA FOR PrEP (pre‑exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV‑1 in adults and adolescents (≥35 kg) who are at risk for HIV. HIV‑1–negative status must be confirmed immediately prior to initiation
Please see full Prescribing Information for TRUVADA FOR PrEP, including BOXED WARNING.
INDICATION
TRUVADA FOR PrEP (pre‑exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV‑1 in adults and adolescents (≥35 kg) who are at risk for HIV. HIV‑1–negative status must be confirmed immediately prior to initiation
IMPORTANT SAFETY INFORMATION (cont'd)
Contraindication
Health guidelines recommend TRUVADA FOR PrEP and emphasize the importance of counseling on adherence and HIV‑1 risk reduction strategies.
National HIV/AIDS Strategy (NHAS) recommends TRUVADA FOR PrEP in combination with safer sex practices for HIV prevention8
The NHAS recommends TRUVADA FOR PrEP in combination with behavioral interventions that support engagement in care and adherence to treatment.8
IMPORTANT SAFETY INFORMATION (cont'd)
Warnings and precautions
IN AN ANALYSIS OF REAL-WORLD DATA,
TRUVADA FOR PrEP UPTAKE WAS SIGNIFICANTLY ASSOCIATED WITH A REDUCTION IN NEW HIV DIAGNOSES9,10The study modeled the impact of TRUVADA FOR PrEP on the number of annual HIV diagnoses in the U.S. from 2012-2016. The effect of TRUVADA FOR PrEP independent from the effect of treatment as prevention (TasP) was also evaluated using available viral suppression data (averaged from 2012-2015).
First Analysis: Evaluated association between TRUVADA FOR PrEP uptake and HIV diagnoses.
Repeat Analysis: Examined whether the association of TRUVADA FOR PrEP uptake and HIV diagnoses changes when controlling for viral suppression levels.
Study Limitations: The analyses are ecological and don't imply a causal association between TRUVADA FOR PrEP use and HIV diagnoses. HIV diagnoses and TRUVADA FOR PrEP use may be underreported. The calculation of the number of people at risk for HIV in this analysis was based on 2015 data and applied to all analytic years. The relative contributions of TRUVADA FOR PrEP vs viral suppression (TasP) to the declining trend in HIV diagnoses cannot be determined. Measures of changing risk behaviors or HIV testing behaviors were not included in the study design.
Data sources (2012-2016) included National HIV Surveillance System for annual number of HIV diagnoses (2012-2016) and viral suppression rates (2012-2015); U.S. Census Bureau for HIV diagnosis rates in the general U.S. population; a U.S. national prescription database representing more than 83% of all prescriptions dispensed by commercial U.S. pharmacies for estimating TRUVADA FOR PrEP use during a calendar year, and a validated algorithm was used to exclude FTC/TDF use for non-PrEP reasons (access to data on TRUVADA FOR PrEP was provided by AIDSVu.org); and a CDC estimation method for the number of people per state with a TRUVADA FOR PrEP indication.
Disclaimer: Two authors are employees of Gilead Sciences, Inc. and participated in the study design.
In a Retrospective Analysis of Real-World Data, TRUVADA FOR PrEP Use Impacted HIV Diagnosis RatesEstimated Annual Percent Change (EAPC) in HIV Diagnoses of Persons ≥13 Years of Age for U.S. States Grouped Into Quintiles of TRUVADA FOR PrEP Use 2012-2016*
*Persons indicated for TRUVADA FOR PrEP from 2012-2016.
†Highest TRUVADA FOR PrEP use quintile = mean 110/1000 prescriptions/people with TRUVADA FOR PrEP indication.
Lowest TRUVADA FOR PrEP use quintile = mean 33/1000 prescriptions/people with TRUVADA FOR PrEP indication.
‡In the 39 states for which there are viral suppression data, averaged for available years from 2012-2015.
§Data shown for quintiles are trends and do not represent the EAPC for each individual state.
IMPORTANT SAFETY INFORMATION (cont'd)
Warnings and precautions
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Contraindication
Warnings and precautions
Warnings and precautions
Adverse reactions
Drug interactions
Pregnancy and lactation
Dosage and administration
INDICATION
TRUVADA FOR PrEP (pre‑exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV‑1 in adults and adolescents (≥35 kg) who are at risk for HIV. HIV‑1–negative status must be confirmed immediately prior to initiation
Learn more about lifetime risk of HIV infection in the U.S. by selecting a risk level OR interacting with the map below.
LIFETIME RISK OF HIV
DIAGNOSIS BY STATE13
STATE | RISK* |
DC | 1 in 13 |
MD | 1 in 49 |
GA | 1 in 51 |
FL | 1 in 54 |
LA | 1 in 56 |
NY | 1 in 69 |
TX | 1 in 81 |
STATE | RISK* |
NJ | 1 in 84 |
MS | 1 in 85 |
SC | 1 in 86 |
NC | 1 in 93 |
DE | 1 in 96 |
AL | 1 in 97 |
STATE | RISK* |
NV | 1 in 98 |
IL | 1 in 101 |
CA | 1 in 102 |
TN | 1 in 103 |
PA | 1 in 115 |
VA | 1 in 115 |
MA | 1 in 121 |
STATE | RISK* |
AZ | 1 in 138 |
CT | 1 in 139 |
RI | 1 in 143 |
OH | 1 in 150 |
MO | 1 in 155 |
AR | 1 in 159 |
STATE | RISK* |
MI | 1 in 167 |
OK | 1 in 168 |
KY | 1 in 173 |
IN | 1 in 183 |
WA | 1 in 185 |
CO | 1 in 191 |
NM | 1 in 196 |
STATE | RISK* |
HI | 1 in 202 |
OR | 1 in 214 |
MN | 1 in 216 |
KS | 1 in 262 |
NE | 1 in 264 |
STATE | RISK* |
WV | 1 in 302 |
WI | 1 in 307 |
IA | 1 in 342 |
UT | 1 in 366 |
ME | 1 in 373 |
AK | 1 in 384 |
SD | 1 in 402 |
STATE | RISK* |
NH | 1 in 411 |
WY | 1 in 481 |
VT | 1 in 527 |
ID | 1 in 547 |
MT | 1 in 578 |
ND | 1 in 670 |
STATE | RISK* |
NV | 1 in 98 |
CA | 1 in 102 |
WA | 1 in 185 |
CO | 1 in 191 |
HI | 1 in 202 |
OR | 1 in 214 |
UT | 1 in 366 |
STATE | RISK* |
AK | 1 in 384 |
WY | 1 in 481 |
ID | 1 in 547 |
MT | 1 in 578 |
STATE | RISK* |
DC | 1 in 13 |
MD | 1 in 49 |
NY | 1 in 69 |
NJ | 1 in 84 |
DE | 1 in 96 |
PA | 1 in 115 |
MA | 1 in 121 |
STATE | RISK* |
CT | 1 in 139 |
RI | 1 in 143 |
ME | 1 in 373 |
NH | 1 in 411 |
VT | 1 in 527 |
STATE | RISK* |
GA | 1 in 51 |
FL | 1 in 54 |
LA | 1 in 56 |
MS | 1 in 85 |
SC | 1 in 86 |
NC | 1 in 93 |
AL | 1 in 97 |
STATE | RISK* |
TN | 1 in 103 |
VA | 1 in 115 |
AR | 1 in 159 |
KY | 1 in 173 |
WV | 1 in 302 |
STATE | RISK* |
TX | 1 in 81 |
AZ | 1 in 138 |
OK | 1 in 168 |
NM | 1 in 196 |
STATE | RISK* |
IL | 1 in 101 |
OH | 1 in 150 |
MO | 1 in 155 |
MI | 1 in 167 |
IN | 1 in 183 |
MN | 1 in 216 |
KS | 1 in 262 |
STATE | RISK* |
NE | 1 in 264 |
WI | 1 in 307 |
IA | 1 in 342 |
SD | 1 in 402 |
ND | 1 in 670 |
Overall, 1 in 99 Americans will be diagnosed with HIV in their lifetime.13
*Chances of an individual being diagnosed with HIV during their lifetime.
Men14 | Women14 | |
Overall | 1 in 68 | 1 in 253 |
African American | 1 in 22 | 1 in 54 |
Hispanic | 1 in 51 | 1 in 256 |
Native Hawaiian/ Pacific Islander |
1 in 95 | 1 in 432 |
Caucasian | 1 in 140 | 1 in 941 |
Asian | 1 in 176 | 1 in 943 |
70% OF HETEROSEXUALS AT RISK OF SEXUALLY ACQUIRED HIV ARE WOMEN11†
†Approximately 258,000 heterosexuals are at risk of HIV.
~1.4 million Americans identify as transgender18
*Chances of an individual being diagnosed with HIV during their lifetime.
MSM=men who have sex with men.
Without a condom
With partner(s)
of unknown status
While under the influence
of drugs or alcohol
Many STIs are asymptomatic. Comprehensive STI screening is recommended, including at all sites of exposure.32,33
IMPORTANT SAFETY INFORMATION (cont'd)
Warnings and precautions
CDC=Centers for Disease Control and Prevention.
Nearly
2 out of 3
patients newly diagnosed with HIV had visited a healthcare facility at least once prior to diagnosis
(n=504/785)
Patients had a mean of
healthcare visits
before an HIV diagnosis
IMPORTANT SAFETY INFORMATION (cont'd)
Warnings and precautions (cont'd)
Uncover HIV risk by starting a dialogue with patients about:
STI history
"Have you or your partner(s) ever had an STI?"38
HIV testing habits
"Do you tend to get tested for HIV regularly, or just when you think you may have been exposed?"39
Sexual relationships
"Are your sexual partner(s) new or long-term? Are you and your partner(s) in an open relationship?"38
IMPORTANT SAFETY INFORMATION (cont'd)
Adverse reactions
TRUVADA FOR PrEP (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV‑1 in adults and adolescents (≥35 kg) who are at risk for HIV. HIV‑1–negative status must be confirmed immediately prior to initiation
When prescribing TRUVADA FOR PrEP, consider the following1:
TRUVADA FOR PrEP should only be prescribed to individuals who are confirmed to be HIV-1 negative immediately prior to initial use and who do not have signs or symptoms consistent with acute HIV infection.
While using TRUVADA FOR PrEP, HIV-1 testing should be repeated at least every 3 months, and upon diagnosis of any other STIs.
Individuals must strictly adhere to the dosing schedule because the effectiveness of TRUVADA FOR PrEP is strongly correlated with adherence.
Use TRUVADA FOR PrEP to reduce the risk of HIV-1 infection as part of a comprehensive strategy that includes adherence to daily dosing and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs).
*Number of persons prescribed TRUVADA FOR PrEP divided by the number of people estimated to be indicated for pre-exposure prophylaxis.
IMPORTANT SAFETY INFORMATION (cont'd)
Drug interactions
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Contraindication
Warnings and precautions
Warnings and precautions
Adverse reactions
Drug interactions
Pregnancy and lactation
Dosage and administration
INDICATION
TRUVADA FOR PrEP (pre‑exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV‑1 in adults and adolescents (≥35 kg) who are at risk for HIV. HIV‑1–negative status must be confirmed immediately prior to initiation
Randomized, double-blind, placebo-controlled efficacy and safety study in adults1,2
*TDF alone is not approved to reduce the
risk of sexually acquired HIV-1.
Primary endpoint: Seroconversion of HIV-negative partner2
Study population2
Baseline characteristics of uninfected partners1
Participants received1,2
Duration2
July 2008, with data collected through July 2011
Location1,2
Kenya, Uganda
Randomized, double-blind, placebo-controlled efficacy and safety study in adults1,41
Primary endpoint: Seroconversion of HIV-negative partner1
Study population1,41
Baseline characteristics of uninfected partners1
Participants received1
Duration1,41
July 2007, with data collected through May 2010
Location41
Peru, Ecuador, South Africa, Brazil, Thailand, and the U.S. (Boston, San Francisco)
IMPORTANT SAFETY INFORMATION (cont'd)
Pregnancy and lactation
ART=antiretroviral therapy; TDF=tenofovir disoproxil fumarate.
HIV-1 seroconversion was observed in1,2:
HIV-1 seroconversion was observed in1:
(post-hoc analysis)
Among TRUVADA users who became infected with HIV-1, 9 out of 12 did not have detectable drug levels.42
(post-hoc analysis)
Among TRUVADA users who became infected with HIV-1, 31 out of 34 did not have detectable drug levels.41
†These results were based on a post-hoc case control study of detectable plasma and intracellular drug levels in about 10% of subjects. Risk reduction appeared to be the greatest in subjects with detectable intracellular tenofovir levels.1,2,41
Efficacy was strongly correlated with adherence1
IMPORTANT SAFETY INFORMATION (cont'd)
Dosage and administration
CI=confidence interval.
Of the individuals who became infected with HIV-1 after initiating TRUVADA FOR PrEP, no cases of resistance to the components of TRUVADA were identified at the time of HIV-1 seroconversion in two pivotal trials.1,41,42
Individuals Who Became HIV Positive During the Study
HIV+ (Subjects, n) |
HIV+ WITH RESISTANCE (Subjects, n) |
||||
Partners PrEP Trial | PLACEBO | 51 | ➝ | 0 | |
TRUVADA | 12 | ➝ | 0 | ||
iPrEx Trial | PLACEBO | 83 | ➝ | 0 | |
TRUVADA | 48 | ➝ | 0 |
Of the individuals who had unrecognized/acute HIV-1 infection at the time of TRUVADA FOR PrEP initiation, resistance to the components of TRUVADA was observed in two pivotal trials.1,2,41
Individuals With Unrecognized/Acute HIV Infection at Baseline
HIV+ (Subjects, n) |
HIV+ WITH RESISTANCE (Subjects, n) |
||||
Partners PrEP Trial | PLACEBO | 6 | ➝ | 0 | |
TRUVADA | 3 | ➝ | 1‡ | ||
iPrEx Trial | PLACEBO | 8 | ➝ | 1‡ | |
TRUVADA | 2 | ➝ | 2‡ | ||
‡M184V/I. |
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Contraindication
Warnings and precautions
Warnings and precautions
INDICATION
TRUVADA FOR PrEP (pre‑exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV‑1 in adults and adolescents (≥35 kg) who are at risk for HIV. HIV‑1–negative status must be confirmed immediately prior to initiation
Contraindication
Drug interactions
iPrEx
Selected Adverse Events (All Grades) Reported in ≥2% in Any Treatment Group and Greater Than Placebo1
TRUVADA | Placebo | |||
(n=1251) | (n=1248) | |||
Headache | 7% | 6% | ||
Abdominal pain | 4% | 2% | ||
Weight decreased | 3% | 2% | ||
Partners PrEP
*Adherence in the TRUVADA arms of these two pivotal trials varied across participants.
Partners PrEP Trial2,40
iPrEx Trial41
Partners PrEP Trial1 | TDF-Containing Arms (Subjects, n) |
Placebo (Subjects, n) |
Discontinuations due to an increase in serum creatinine | 6 | 0 |
iPrEx Trial1 | TRUVADA (Subjects, n) |
Placebo (Subjects, n) |
Discontinuations due to an increase in serum creatinine | 1 | 0 |
Discontinuations due to low serum phosphorus | 1 | 0 |
TDF=tenofovir disoproxil fumarate.
Laboratory Abnormalities (Highest Toxicity Grade
Reported for Each Subject) in Pivotal Trials1
Grade 2-4† | Partners PrEP Trial | iPrEx Trial | |||
TRUVADA (n=1579) |
Placebo (n=1584) |
TRUVADA (n=1251) |
Placebo (n=1248) |
||
Creatinine (>1.4 x ULN) | <1% | <1% | <1% | <1% | |
Phosphorus (<2.0 mg/dL) | 9% | 9% | 10% | 8% | |
AST (>2.6 x ULN) | <1% | <1% | 5% | 5% | |
ALT (>2.6 x ULN) | <1% | <1% | 7% | 7% | |
Hemoglobin (<9.4 mg/dL) | 2% | 2% | 1% | 2% | |
Neutrophils (<750/mm3) | 5% | 3% | <1% | <1% | |
†Grading is per Division of AIDS (DAIDS) criteria.
ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal.
iPrEx Trial1 | Partners PrEP Trial1 | |||
TRUVADA | Placebo | TRUVADA | Placebo | |
Subjects who lost at least 5% of BMD at the spine during treatment | 13% | 6% | — | — |
Bone fractures | 1.7% | 1.4% | 0.8% | 0.6% |
iPrEx Trial1
Partners PrEP Trial1
ATN1131
In a 48-week, single-arm, open-label safety study examining TRUVADA FOR PrEP among 67 adolescent (15-18 years of age) MSM‡:
‡Interpretation of these data may be limited due to low rate of adherence by Week 48.
MSM=men who have sex with men.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Warnings and precautions
Warnings and precautions
Pregnancy and lactation
Dosage and administration
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Contraindication
Warnings and precautions
Warnings and precautions
Adverse reactions
Drug interactions
Pregnancy and lactation
Dosage and administration
INDICATION
TRUVADA FOR PrEP (pre‑exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV‑1 in adults and adolescents (≥35 kg) who are at risk for HIV. HIV‑1–negative status must be confirmed immediately prior to initiation
Conduct pregnancy testing prior to initiating TRUVADA FOR PrEP
Consider HIV prevention methods, including TRUVADA FOR PrEP, due to the potential increased risk of HIV-1 infection during pregnancy, and mother to child transmission during acute HIV-1 infection
Providers are encouraged to register women taking TRUVADA FOR PrEP during pregnancy in an Antiretroviral Pregnancy Registry to monitor fetal outcomes (1-800-258-4263)
CrCl=creatinine clearance; HBV=hepatitis B virus.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Confirm HIV-negative
status at least every
3 MONTHS
and upon diagnosis of an STI
Screen every
3-6 MONTHS
per CDC recommendations
1Reassess HIV risk
2Counsel individuals on the importance of adherence and safer sex practices
3Continue monitoring renal function
CDC=Centers for Disease Control and Prevention.
IMPORTANT SAFETY INFORMATION (cont'd)
Warnings and precautions
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Contraindication
Warnings and precautions
Warnings and precautions
Adverse reactions
Drug interactions
INDICATION
TRUVADA FOR PrEP (pre‑exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV‑1 in adults and adolescents (≥35 kg) who are at risk for HIV. HIV‑1–negative status must be confirmed immediately prior to initiation
Insured or not, TRUVADA FOR PrEP® could cost as little as $0*
Advancing Access specialists can help provide insurance information support, including determining prior authorization and appeals process requirements, and connecting patients to available resources to help them navigate coverage.
They can also help your patients understand and navigate health insurance and Gilead medication costs. For more information, you can direct your patients to visit www.GileadAdvancingAccess.com or call 1-800-226-2056.
*Eligible, commercially insured patients could pay as little as $0 co-pay with the Advancing Access co-pay coupon card. Uninsured patients can reach out to Gilead's Advancing Access program for information about support options. See full terms and conditions at GileadAdvancingAccess.com/hcp. Co-pay support is available for commercially insured eligible patients only. Additional restrictions may apply. Subject to change; for full terms and conditions, visit www.gileadadvancingaccess.com/copay-coupon-card. This is not health insurance. Only accepted at participating pharmacies.
Want to stay up-to-date on TRUVADA FOR PrEP and HIV prevention? Register and we'll send updates as new information becomes available.
If your patients need assistance finding an HCP in their area who can prescribe TRUVADA FOR PrEP, direct them to preplocator.org
This tool is not owned or maintained by Gilead Sciences, Inc. Gilead Sciences, Inc. is not responsible for the content of the PrEP Provider Locator or how it is used. The PrEP Provider Locator was developed by researchers from Emory University's Rollins School of Public Health with funding from MAC AIDS Fund.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Contraindication
Warnings and precautions
Warnings and precautions
Adverse reactions
Drug interactions
Pregnancy and lactation
INDICATION
TRUVADA FOR PrEP (pre‑exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV‑1 in adults and adolescents (≥35 kg) who are at risk for HIV. HIV‑1–negative status must be confirmed immediately prior to initiation
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Contraindication
Warnings and precautions
Warnings and precautions
Adverse reactions
Drug interactions
Pregnancy and lactation
Dosage and administration
Please click here to view full Prescribing Information for TRUVADA FOR PrEP, including BOXED WARNING.
References: 1. Truvada. Package Insert. Gilead Sciences, Inc.; 2020. 2. Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367(5):399-410. 3. Centers for Disease Control and Prevention. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2017 Update: A Clinical Practice Guideline. Published March 2018. Accessed July 18, 2020. http://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf. 4. World Health Organization. Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection: Recommendations for a Public Health Approach. 2nd ed. Published June 2016. Accessed July 18, 2020. http://www.who.int/hiv/pub/arv/arv-2016/en. 5. The American College of Obstetricians and Gynecologists Committee on Gynecologic Practice. Committee Opinion No 595: Preexposure prophylaxis for the prevention of human immunodeficiency virus. Obstet Gynecol. 2014;123(5):1133-1136. 6. Saag MS, Benson CA, Gandhi RT, et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2018 recommendations of the International Antiviral Society-USA Panel. JAMA. 2018;320(4):379-396. 7. American College Health Association. ACHA Guidelines: HIV Pre-exposure Prophylaxis. Published January 2019. Accessed July 18, 2020. https://www.acha.org/documents/resources/guidelines/ACHA_HIV_PrEP_Guidelines_Jan2019.pdf. 8. White House Office of National AIDS Policy. National HIV/AIDS Strategy for the United States: Updated to 2020. Published July 2015. Accessed July 18, 2020. https://files.hiv.gov/s3fs-public/nhas-update.pdf. 9. Sullivan PS, Smith DK, Mera-Giler R, et al. The impact of pre-exposure prophylaxis with FTC/TDF on HIV diagnoses, 2012-2016, United States. Presented at: 22nd International AIDS Conference; July 23-27, 2018; Amsterdam, the Netherlands. Poster LBPEC036. 10. Sullivan PS, Smith DK, Mera-Giler R, et al. The impact of pre-exposure prophylaxis with TDF/FTC on HIV diagnoses, 2012-2016, United States. Accessed July 18, 2020. http://www.natap.org/2018/IAC/IAC_17.htm. 11. Smith DK. Race/ethnicity, blacks have highest number needing PrEP in the United States, 2015. Presented at: 25th Annual Conference on Retroviruses and Opportunistic Infections; March 4-7, 2018; Boston, MA. 12. Centers for Disease Control and Prevention. HIV Surveillance Report, 2017; vol 29. Published November 2017. Accessed July 18, 2020. https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2017-vol-29.pdf. 13. Centers for Disease Control and Prevention. Lifetime risk of HIV diagnosis in the United States. Published February 2016. Accessed July 18, 2020. https://www.justfacts.com/document/lifetime_risk_hiv.pdf. 14. Hess KL, Hu X, Lansky A, Mermin J, Hall HI. Lifetime risk of a diagnosis of HIV infection in the United States. Ann Epidemiol. 2017;27(4):238-243. 15. Nunn A, Zaller N, Cornwall A, et al. Low perceived risk and high HIV prevalence among a predominantly African American population participating in Philadelphia's rapid HIV testing program. AIDS Patient Care STDS. 2011;25(4):229-235. 16. Anal sex and HIV risk. Centers for Disease Control and Prevention. Reviewed November 8, 2019. Accessed July 18, 2020. https://www.cdc.gov/hiv/risk/analsex.html. 17. Centers for Disease Control and Prevention. 2016 Conference on Retroviruses and Opportunistic Infections. Published February 24, 2016. Accessed July 18, 2020.https://www.cdc.gov/nchhstp/newsroom/2016/croi-2016.html. 18. Flores AR, Herman JL, Gates GJ, Brown TNT. How Many Adults Identify as Transgender in the United States? Los Angeles, CA: The Williams Institute; 2016. Accessed July 18, 2020. https://williamsinstitute.law.ucla.edu/wp-content/uploads/How-Many-Adults-Identify-as-Transgender-in-the-United-States.pdf. 19. Clark H, Babu AS, Wiewel EW, Opoku J, Crepaz N. Diagnosed HIV infection in transgender adults and adolescents: results from the National HIV Surveillance System, 2009—2014. AIDS Behav. 2017;21(9):2774-2783. 20. Herbst JH, Jacobs ED, Finlayson TJ, et al. Estimating HIV prevalence and risk behaviors of transgender persons in the United States: a systematic review. AIDS Behav. 2008;12(1):1-17. 21. Reisner SL, Murchison GR. A global research synthesis of HIV and STI biobehavioural risks in female-to-male transgender adults. Glob Public Health. 2016;11(7-8):866-887. 22. Maragh-Bass AC, Torain M, Adler R, et al. Is it okay to ask: transgender patient perspectives on sexual orientation and gender identity collection in healthcare. Acad Emerg Med. 2017;24(6):655-667. 23. Centers for Disease Control and Prevention. STDs and HIV. Published July 2017. Accessed July 18, 2020. https://www.cdc.gov/std/hiv/STD-HIV-factsheet.pdf. 24. Centers for Disease Control and Prevention. Reported STDs in the United States, 2017. Published September 2018. Accessed July 18, 2020. https://www.cdc.gov/nchhstp/newsroom/docs/factsheets/std-trends-508.pdf. 25. Centers for Disease Control and Prevention. The U.S. is experiencing steep, sustained increases in sexually transmitted diseases. Accessed July 18, 2020. https://www.cdc.gov/nchhstp/newsroom/docs/2018/infographic_Experiencing-Steep-Sustained-Increases-in-STD.pdf. 26. Boily MC, Baggaley RF, Wang L, et al. Heterosexual risk of HIV-1 infection per sexual act: a systematic review and meta-analysis of observational studies. Lancet Infect Dis. 2009;9(2):118-129. 27. Peterman TA, Newman DR, Maddox L, Schmitt K, Shiver S. Risk for HIV following a diagnosis of syphilis, gonorrhea or chlamydia: 328,456 women in Florida, 2000-2011. Int J STD AIDS. 2015;26(2):113-119. 28. Peterman TA, Newman DR, Maddox L, Schmitt K, Shiver S. High risk for HIV following syphilis diagnosis among men in Florida, 2000-2011. Public Health Rep. 2014;129(2):164-169. 29. 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