Revised October 2015
- On April 29, 2015, Governor Andrew Cuomo unveiled the Blueprint to End AIDS Epidemic by 2020, which contained the statewide task force’s recommended strategies to end the AIDS epidemic in New York State by reducing the number of annual new HIV infections to 750 by the year 2020. The three-point plan calls for efforts to identify those with undiagnosed HIV infection and to link and retain them in care, including providing antiretroviral therapy to maximize viral suppression. The third point outlined in this plan is to provide access to pre-exposure prophylaxis (PrEP) as part of a strategy to prevent HIV infection among individuals at high risk. By including access to PrEP as a major element in this bold initiative, New York State emphasizes the importance of PrEP as a safe and effective method to prevent HIV infection, demonstrating the use of PrEP as a strategy that should be adopted by all interested in ending the epidemic. It is the intention of this guidance document to give all New York State providers the information needed to successfully manage patients on PrEP.
- This document provides guidance for delivery of HIV preventive care that includes the use of PrEP. This document includes information on service delivery and program implementation and does not contain recommendations that are rated to indicate the strength of the recommendation and the quality of the supporting evidence, as is customary for NYSDOH AIDS Institute formal guidelines.
The Medical Care Criteria Committee is now developing an evidence-based, clinically focused guideline for administration and management of PrEP for prevention of HIV infection. As soon as the PrEP clinical guideline is finalized (expected November 2015), it will be posted on this website and disseminated in an email to website subscribers, and this guidance document will be archived.
New York State Summary on Pre-Exposure Prophylaxis to Prevent HIV Infection
The New York State Department of Health AIDS Institute (NYSDOH AI) and the Centers for Disease Control and Prevention (CDC)1,2 recommend pre-exposure prophylaxis (PrEP) as an evidence-based intervention to prevent HIV transmission. Throughout its history, the NYSDOH AI has been a leader in recommending biomedical interventions to prevent HIV infection, beginning with establishing a standard of care for the prevention of mother-to-child HIV transmission using antiretroviral agents during pregnancy, labor and delivery, and as prophylaxis for the newborn. Since 1991, NYSDOH AI has recommended a combination of antiretroviral agents for post-exposure prophylaxis (PEP) to prevent HIV transmission in the context of occupational and non-occupational exposures. NYSDOH AI recommends that antiretroviral therapy (ART) be initiated in all patients with a diagnosis of HIV infection. This recommendation is based on increasing evidence that patients with established HIV infection benefit from ART at all stages of disease3,4 and on data that demonstrate a dramatic reduction of HIV transmission risk among ART-treated patients with viral suppression,5 which is a strategy commonly known as “treatment as prevention.”
Several clinical trials have demonstrated the efficacy of PrEP.6,7 In July 2012, the Food and Drug Administration approved tenofovir + emtricitabine (TDF/FTC, Truvada) for use as PrEP in adults. This regimen consists of one pill taken once per day; when taken consistently, it has demonstrated a high level of protection against HIV infection.
New York State continues to promote effective use of this biomedical intervention through this clinical guidance document, provider implementation protocols, and ongoing educational programs. The NYSDOH AI recognizes that a comprehensive system-wide approach is necessary to ensure that patients are effectively managed on PrEP and that individuals throughout the State who will most benefit have access to PrEP. Key populations that are most at risk for HIV should be prioritized for outreach and access to ensure that they are aware of PrEP and its benefits; such populations include men who have sex with men (MSM), injection drug users, and serodiscordant couples, particularly couples with an HIV-infected partner who is not virally suppressed or whose viral suppression is unknown.
Following is a summary of the key principles that are described in this document.
In September 2012, the New York State Department of Health convened a PrEP Advisory Panel to develop clinical guidance on the use of PrEP. The Panel consisted of primary care providers caring for high-risk populations, clinicians experienced in the treatment of HIV, obstetricians, adolescent care providers, pharmacists, program administrators, social workers, policy makers, representatives from the New York City Department of Health and Mental Hygiene, and consumer representatives.*
The following document provides guidance for delivery of an HIV prevention program that includes the use of PrEP. This guidance is based on the results of the clinical trials of PrEP, a review of published data, and the guidelines of the Centers for Disease Control and Prevention.1,2 Available data are limited regarding the best practices for monitoring the use of TDF/FTC in non-HIV-infected individuals in the clinical setting. When there were no data on which to base recommendations, recommendations were formulated based on both expert opinion and experience with use of these agents in the HIV-infected population.
This PrEP guidance document is intended for practitioners in all clinical practice settings where PrEP will be prescribed and monitored, including primary care, HIV care, STI clinics, and community-based centers. The information has been formatted as a series of tables and checklists for ease of use at the point of care in a variety of settings. This guidance document will be updated regularly as new data are published and more experience is accumulated with the use of PrEP.
* Prior to participation, each panel member submitted a financial disclosure form in accordance with the program’s conflict of interest policy. Two panel members reported potential conflicts with Gilead, manufacturer of Truvada. JB-M, Speaker’s Bureau; AU, Speaker’s Bureau.
HIV prevention through PrEP involves the use of antiretroviral medications by non-HIV-infected individuals to reduce their risk of acquiring HIV. In July 2012, the Food and Drug Administration (FDA) approved the use of tenofovir + emtricitabine (TDF/FTC) for HIV PrEP in adults who are at high risk for becoming HIV-infected.
Use of tenofovir alone and tenofovir + emtricitabine as PrEP has been studied in clinical trials in several populations, including men who have sex with men,8 heterosexual discordant couples,9 heterosexual men and women,10-12 transgender women,8 and injecting drug users.13 All of the trials found PrEP to be safe. Four trials found PrEP to be effective for preventing HIV infection when taken as prescribed. The FEM-PrEP11 and VOICE trials12 did not show a benefit, likely because of poor adherence to the daily PrEP regimen. See Appendix A for a summary of results from the clinical trials.
Studies of other antiretroviral agents for use as PrEP, such as maraviroc, rilpivirine, and dapivirine, are underway.
Recommendation: PrEP should be offered to adolescents at high risk for HIV infection. To date, no efficacy or safety studies have been published on the use of PrEP in individuals younger than 18 years of age, but studies in this population are underway. Since the time of licensing for treatment of HIV in adolescents, TDF/FTC has been used without any indication of unique toxicity in this population. Off-label use of TDF/FTC as part of a PEP regimen is recommended for adolescents 13-18 years of age to prevent HIV infection after a high-risk exposure. The CDC and the International Antiviral Society-USA have now extended the use of TDF/FTC to include PrEP for adolescents in sexual or other behavioral situations that put them at high risk for HIV infection.1,14 In addition to known concerns about renal complications associated with tenofovir use, theoretical concerns from osteopenia have been proposed, particularly in younger age groups.
Providers should carefully weigh the potential benefits and risks, including acquiring HIV infection, before prescribing PrEP to a younger adolescent and should make clear that the efficacy of PrEP is highly dependent on strict adherence. Clinicians should refer to their institution’s policy or consult with the institution’s legal department about consent to care for adolescents under 18 years of age according to New York State law (for additional information, see HIV Disclosure to Parents and Consent to HIV Treatment Among Adolescents).
PrEP should not be offered as a sole intervention for HIV prevention. PrEP should only be prescribed as part of a comprehensive prevention plan that includes counseling and education about the following:
- Consistent and correct condom use
- Safer-sex practices and risk-reduction counseling
- Adherence to PrEP
- Importance of frequent HIV testing and screening for other sexually transmitted infections (STIs) that can facilitate HIV transmission
- For individuals in serodiscordant relationships, the importance of suppressive ART (treatment as prevention) for HIV-infected partners
III. CANDIDATES FOR PRE-EXPOSURE PROPHYLAXIS
PrEP is indicated for individuals who have a documented negative HIV test result and are at ongoing high risk for HIV infection. A negative HIV test result needs to be confirmed as close to initiation of PrEP as possible, ideally on the same day the prescription is given (see Section V: Pre-Prescription Assessments, Education, and Laboratory Tests). PrEP should only be prescribed to those who are able to adhere to the regimen and express a willingness to do so.
PrEP is not meant to be used as a lifelong intervention, but rather as a method of increasing prevention during periods when people are at greatest risk of acquiring HIV. The length of use will depend on the individual’s behaviors, which may change over time. Providers need to obtain a thorough sexual and drug use history and regularly discuss risk-taking behaviors with their patients to assess candidacy for PrEP, encourage safer-sex practices and safer injection techniques (if applicable), and assist in the decision of when to use PrEP and when to discontinue use.
Other individuals may qualify for PrEP who may not fit within the above risk categories. Decisions to initiate PrEP should be individualized by weighing patients’ personal risk of acquiring HIV infection against the potential benefits and risks of TDF/FTC.
Individuals who do not necessarily have continued risk for acquiring HIV but may have episodic exposures may be good candidates for non-occupational post-exposure prophylaxis (nPEP) rather than PrEP. For example, nPEP may be a better option for an individual who uses condoms regularly, but may experience an occasional broken condom or lapse in use. These individuals should be educated about nPEP and the need to receive medication within 36 hours of the exposure.
A 7-item screening index has been developed to identify MSM who are at risk of HIV seroconversion (see Appendix B).
Use of PrEP to Prevent HIV Transmission During Attempts to Conceive
PrEP may be one option to help protect the HIV seronegative partner in a serodiscordant relationship during attempts to conceive. Risk of HIV transmission may be further reduced in serodiscordant sexual relationships when the HIV-infected partner is receiving suppressive ART. Data supporting treatment as prevention are strongest for heterosexual couples based on the findings of HPTN 052.22 These data have been extrapolated to MSM although primary data supporting “treatment as prevention” in this population are lacking.
IV. PrEP: CONTRAINDICATIONS AND CONSIDERATIONS
Although consistent condom use is a critical part of a prevention plan for all people prescribed PrEP, lack of use of barrier protection is not a contraindication to PrEP.
The considerations outlined in Table 3 are not absolute contraindications to prescribing PrEP. Clinicians should consider these factors and proceed with caution.
V. PRE-PRESCRIPTION ASSESSMENTS, EDUCATION, AND LABORATORY TESTS
Following is a series of tables, formatted as checklists, that outline what this Panel believes are the essential assessments, patient education, and laboratory tests that need to be performed before a prescription for PrEP is given.
Once it is decided that the patient is a candidate for PrEP according to the criteria in Table 1, further assessments (listed in Table 4) are needed to clearly understand the prevention needs of the individual patient and whether initiation of PrEP is an appropriate option. Patient education is critical to shared decision-making and the success of PrEP as part of the prevention plan. Tables 4 and 5 provide the basis from which shared decision-making about initiation of PrEP can occur, providing the clinician with the opportunity to educate the patient about risks, benefits, and options, while providing the patient with the opportunity to discuss preferences, needs, and individual circumstances. Medication adherence may be improved when patients participate in treatment decisions.23
Patients need to understand how PrEP works, including risks and benefits, the need for strict adherence to maintain protective drug levels, and what it will and will not do for them. Explanations should be given in the patient’s native language and should be easy to understand. For example: The pill Truvada has two drugs in it that are commonly used to treat HIV in persons who are HIV-positive. When taken daily by people who are HIV-negative, they can block HIV from infecting the body. The pill needs to be taken every day in order for the body to build up sufficient drug levels to block HIV. It cannot be expected to work if it is only taken just before or just after sex. PrEP reduces but does not eliminate HIV transmission risk. You still need to use condoms even if you are taking PrEP because PrEP does not protect against other sexually transmitted diseases.
Table 5 lists the areas to educate patients about before prescribing PrEP.
Pre-Prescription: Laboratory Tests
The laboratory tests listed in Table 6 should be obtained at the pre-prescription visit. It is imperative that a negative HIV test result is confirmed as close to initiation of PrEP as possible, ideally on the same day the prescription is given. Clinicians should wait to prescribe PrEP until confirmation of a negative test result is available. Drug-resistant HIV has been found in patients with undiagnosed HIV who were using TDF/FTC as PrEP. If the HIV test result is not immediately available, it may be necessary to inform the patient of a negative test result by phone with the option for the clinician to either call in the prescription or schedule another visit.
When patients are engaged in care to receive PrEP, providers should use the opportunity to administer vaccinations for HAV, HBV, HPV, and meningococcus as indicated.*
* See the Centers for Disease Control and Prevention’s adult schedule for immunizations for non-HIV-infected adults. See New York State Department of Health recommendations for vaccinating against meningococcal disease.
VI. PRESCRIBING PrEP
Table 7 provides the recommended regimen for TDF/FTC when used for a PrEP indication. The first prescription should only be for 30 days to allow for a follow-up visit to assess adherence, tolerance, and commitment. At the 30-day visit, a prescription for 60 days may be given; the patient should then return for 3-month HIV testing and other assessments (see Table 8). After that visit, prescriptions can be given for 90 days, provided that the patient is adherent.
Figure 1 provides a general guide for the schedule of visits and follow-up assessments in the first year of receiving PrEP.
VII. PrEP FOLLOW-UP MANAGEMENT AND MONITORING
Patients receiving PrEP require regular visits, at least every 3 months, to monitor HIV status, adherence, and side effects. Follow-up and monitoring of patients receiving PrEP also includes prevention services that are part of a comprehensive prevention plan, such as risk-reduction counseling, access to condoms, STI screening, and mental health and substance use screening, when indicated.
Table 8 lists the elements of a follow-up visit for patients receiving PrEP.
Adherence and Retention in Care
In all studies of PrEP, efficacy is highly dependent on adherence. For patients who report intermittent use, more frequent visits may be necessary to reinforce adherence. Some providers use patient contracts to reinforce adherence to medication and appointments. Some providers may contact the pharmacy to confirm that medication is being refilled at time intervals consistent with adherence (e.g., every 30 days if 30-day supply given). If patients are consistently unable to adhere to the regimen, PrEP should be discontinued, and tailored risk-reduction messages should be delivered.
For patients who are not receiving routine primary care, PrEP is an opportunity for engagement and retention in care. Engagement in primary care should be strongly encouraged, and health maintenance, such as immunizations and standard age-appropriate prevention screening should be offered. Clinicians should partner with providers within or outside of their organization to provide services, including subspecialty services, mental health and substance use treatment, case management, navigation and linkage services, housing assistance, and income/benefits assessments. Referrals should also be made to support groups if indicated. See the HIV Patient Resources Directory for services listed by region.
Discussions about risk reduction should be tailored according to the patient’s individual needs (see Appendix C for a detailed listing of AIDS-Institute-funded HIV prevention programs that provide risk-reduction counseling). Clinicians should provide condoms at every visit, and should discuss use of effective contraception and desire to use contraception. PrEP users should be counseled to continue use of condoms while using PrEP (see Prevention with Positives, Appendix B, for more information about types of condoms and proper use).
For patients in serodiscordant relationships with HIV-infected partners who are not receiving ART, clinicians should recommend treatment for the HIV-infected partner and should reinforce this message at each visit.
For injection drug users, clinicians should make referrals for substance use treatment and should prescribe clean syringes and needles and refer to needle-exchange programs. New York State’s two syringe access initiatives are the Expanded Syringe Access Demonstration Program and Syringe Exchange Programs.
Routine HIV testing is an integral component of safe use of PrEP. Frequent screening is meant to prevent the development of resistance in PrEP users who become HIV-infected while using PrEP, as well as protect transmission to HIV-negative partners. Quarterly testing with a 4th generation (recommended) or 3rd generation (alternative) HIV screening test is recommended (see list of available 3rd and 4th generation HIV tests).
HIV testing should also occur whenever patients present with symptoms consistent with acute HIV infection. If acute HIV infection is suspected, an HIV serologic screening test should be used in conjunction with a plasma HIV RNA assay; a fourth-generation HIV antigen/antibody combination test is the recommended serologic screening test if available. Detection of HIV RNA in the absence of serologic evidence of HIV infection should be considered a preliminary positive result. More detailed recommendations for testing for acute HIV infection are available (see Diagnosis and Management of Acute HIV Infection).
For information about what to do when the HIV test of a patient receiving PrEP is positive, see Section VIII: HIV Acquisition During PrEP.
The most common side effects of TDF/FTC are headache, abdominal pain, and weight loss; however, these side effects usually resolve or improve after the first month. Two weeks after initiation of PrEP, clinicians should follow up either in person or by phone to assess side effects. Standard measures, such as antidiarrheal agents, anti-gas medications, and antiemetics, should be used to alleviate gastrointestinal side effects as needed.
Use of TDF/FTC in HIV-infected patients has shown that side effects, such as renal impairment or bone density loss, can occur. Although uncommon, regular laboratory monitoring for these parameters is necessary (see Table 8). If a decrease in serum creatinine and calculated creatinine clearance is observed, potential causes should be evaluated.
Pregnancy Screening and Management
Pregnancy tests should be obtained at each follow-up visit for women. Clinicians should discuss the known risks and benefits of taking TDF/FTC during pregnancy. Continuation of PrEP during pregnancy is an individualized decision based on patient preference and whether there are ongoing risks for HIV during pregnancy. The patient’s obstetrical provider should be informed of the use of TDF/FTC during pregnancy.
VIII. HIV ACQUISITION DURING PrEP
For patients who receive a reactive HIV screening result while on PrEP:
- Initiate fully active ART or consult with a provider experienced in HIV treatment to discuss treatment
- Perform supplemental diagnostic testing according to the CDC HIV testing algorithm; ART should be initiated while awaiting confirmatory results
- Assess for interruption in medications and duration of such interruption, and discuss any access or adherence barriers
- If supplemental laboratory testing confirms HIV infection
- Perform HIV RNA testing (if not already obtained as part of the diagnostic algorithm for suspected acute HIV infection) to measure viral load
- Perform HIV genotypic resistance testing; adjustments to the current ART regimen can be made once genotypic resistance results are available or when considering side effects (see current ART guidelines regarding treatment)
- If supplemental laboratory testing does not confirm HIV infection, PrEP may be resumed
For patients who present with symptoms of acute retroviral illness (see Table 5) and for whom acute HIV infection is suspected:
- A plasma HIV RNA assay should always be performed in conjunction with an HIV screening test (refer to current guidelines on acute infection for testing)
- For patients who receive a reactive HIV screening result, manage as described above for reactive screening
- For patients who receive a nonreactive screening result with HIV RNA ≥5,000 copies/mL:
- Initiate fully active ART and perform HIV genotypic resistance testing; adjustments to the current ART regimen can be made according to genotypic resistance results or side effects (see current ART guidelines regarding treatment)
- A presumptive diagnosis of HIV infection can be made*
- For patients who receive a nonreactive HIV screening result but detectable low-level HIV RNA (<5,000 copies/mL), repeat HIV RNA to exclude a false-positive result; ART may be offered as described above while awaiting results from repeat HIV RNA testing
- If diagnostic laboratory testing does not confirm HIV infection, PrEP may be resumed
*If a presumptive diagnosis of HIV infection is made on the basis of HIV RNA testing alone, a new specimen should be collected 3 weeks later and HIV diagnostic testing should be repeated according to the CDC HIV testing algorithm.
Clinicians should be vigilant for signs of potential HIV seroconversion in patients receiving PrEP (see Table 5 for a list of signs and symptoms of acute seroconversion). For information regarding testing and diagnosis of acute HIV infection, see Diagnosis and Management of Acute HIV Infection for guidance on screening for acute infection.
IX. DISCONTINUATION OF PrEP REGIMEN
Indications for discontinuation of PrEP are listed in Table 9. When discontinuing PrEP in patients who have chronic hepatitis B virus, close monitoring for rebound hepatitis B viremia is recommended.
Centers for Disease Control and Prevention (CDC) guidelines for the use of daily pre-exposure prophylaxis (PrEP) for the prevention of HIV infection:
- Centers for Disease Control and Prevention. Preexposure prophylaxis for the prevention of HIV infection in the United States – 2014: A clinical practice guideline. Atlanta: Department of Health and Human Services, 2014. Available at www.cdc.gov/
hiv/ pdf/ guidelines/ PrEPguidelines2014.pdf
- Centers for Disease Control and Prevention. Preexposure prophylaxis for the prevention of HIV infection in the United States – 2014: Clinical providers’ supplement. Atlanta: Department of Health and Human Services, 2014. Available at www.cdc.gov/
hiv/ pdf/ guidelines/ PrEPProviderSupplement2014.pdf
World Health Organization. Guidance on oral pre-exposure prophylaxis (PrEP) for serodiscordant couples, men and transgender women who have sex with men at high risk of HIV: Recommendations for use in the context of demonstration projects; July 2012. Available at: www.who.int/hiv/pub/guidance_prep/en/index.html
Truvada Risk Evaluation and Mitigation Strategy (REMS) Materials:
Available at: www.truvadapreprems.com/truvadaprep-resources
Truvada Package Insert:
Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2013/021752s042lbl.pdf
AIDS Vaccine Advocacy Coalition (AVAC) website: Pre-Exposure Prophylaxis
PrEP Watch: www.prepwatch.org/
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APPENDIX A. RESULTS FROM CLINICAL TRIALS OF THE EFFICACY OF DAILY ORAL PrEP FOR PREVENTING HIV INFECTION
APPENDIX B. HIRI-MSM RISK INDEX
APPENDIX C. AIDS INSTITUTE-FUNDED HIV PREVENTION COUNSELING PROGRAMS
The following link contains information about how to contact an AIDS Institute-funded HIV prevention program that provides risk-reduction counseling:
APPENDIX D. PAYMENT OPTIONS FOR PRE-EXPOSURE PROPHYLAXIS (PrEP)