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Pre-exposure Prophylaxis (PrEP) for Health Care Providers Introduction: Biomedical Revolution in HIV Prevention Treatment as Prevention Recent dramatic advances in HIV treatment have led the CDC to declare that “HIV Prevention is a winnable battle.” 1 High-Impact Prevention (HIP) is the Centers for Disease Control and Prevention’s (CDC’s) call for combinations of scientifically proven, cost-effective, and scalable interventions targeted to the right populations in the right geographic area. Recent years have seen the importance of biomedical interventions in HIP. In 2011, with the release of results from the HPTN 052 study, it was clear that achieving undetectable viral loads not only yielded better health outcomes, it also reduced the risk of transmitting HIV to others by at least 96%.2 These dramatic results were confirmed three years later by A. Rodger and colleagues who found that there were no transmissions from persons with undetectable viral loads3 When PLWHAs are identified and tested early in their disease progression, swiftly linked to treatment, remain in continuous treatment, and ultimately achieve viral suppression, they experience stronger health outcomes, and dramatically reduce the risk of transmitting HIV to others.

Pre-Exposure Prophylaxis for HIV Infection A crucial new tool in the HIV prevention tool kit was added in 2012 with the approval of the medication Truvada® for the Pre-Exposure Prophylaxis of HIV infection (PrEP). PrEP is highly effective in preventing the acquisition of HIV infection. The CDC, summarizing the latest research on effectiveness, has estimated that PrEP reduces the risk of getting HIV by 92%. In all PrEP clinical studies its efficacy was highly dependent on adherence. This requires strong collaborations and partnerships between clinicians and health care providers to provide support services such as adherence counseling, HIV testing, primary care services and additional subspecialty services. The message is nicely summarized by the CDC: “When taken consistently, PrEP has been shown to reduce the risk of HIV infection in people who are at high risk by up to 92%. PrEP is much less effective if it is not taken consistently.”4

Best Practices for Health Care Providers providing PrEP Only health care providers can prescribe PrEP; therefore knowledge transfer is required in order to maximize the uptake of PrEP for HIV prevention. The purpose of this information briefing is to share emerging best practices and offer resources for health care providers and senior organizational management providing or interested in providing PrEP.

PrEP is not just a Pill The PrEP prevention method is based on prescribing a daily pill to HIV-negative persons at high risk of becoming infected. But PrEP is not just a pill. Rather, it is a system of prevention and supportive services built around the pill as part of a comprehensive prevention plan including:

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Safer sex practices and risk reduction counseling and condoms

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Adherence counseling (to PrEP)

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Regular Testing for HIV and screening for other sexually transmitted infections Medical Follow up

This system is designed to support and enhance the HIV negative person’s ability to stay HIV negative by taking the pill as directed and being regularly monitored for HIV Infection, STIs, adherence and side effects, and receiving coaching on the use of condoms to prevent STIs

This document will briefly explore the stories of successful PrEP implementation projects and will then present some comprehensive resource inventories.

NEW YORK STATE The State of New York initiated a plan to reduce HIV epidemic levels by the year of 2020. PrEP is included in this statewide plan as one of the key strategies to reduce new HIV infections. The New York State Department of Health leads this effort in ending the HIV epidemic. With the help of the AIDS Institute, New York identified six steps to utilize in program development and implementation for PrEP:

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Monitoring new developments: A DOH Working Group followed the develop- ments of PrEP research. Based on research findings and results, the group delineated policy, programmatic and fiscal implications for PrEP.5



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Partnering with the community: Input about PrEP was gathered from consumer and advocacy groups, community leaders, at-risk populations, and clinical care providers.



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Providing clinical guidance: In January 2014, the NY State DOH AIDS Institute released clinical guidelines on the PrEP system, including, HIV testing, daily medication, STD screening, adherence support, education about condoms use to prevent STDs and sexual harm reduction options. The Guidelines are available online.



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Addressing reimbursement issues: A first step was to work with Medicaid to establish reimbursement for PrEP. The DOH HIV Uninsured Programs also established a PrEP Assistance Program (PrEP-AP) modeled on the NY State ADAP programs with similar eligibility. PrEP-AP pays for clinical visits and labs and links patients with Gilead for medication through its Medication Assistance Program.

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Testing and refining program models: The DOH partnered with six Community Health Centers across NY State to pilot the PrEP system presented in the Guidelines and the reimbursement systems. The pilot programs will test the components of the system, track results, identify successes and challenges, etc. The goal is to identify a set of best practices for the implementation of PrEP.



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Communicating, disseminating and integrating best practices: The DOH has disseminated messages about the importance of PrEP to clinical and non-clinical HIV care providers throughout the state. Guidelines are available online as is a statewide PrEP Provider Directory that identifies agencies and prescribers of PrEP. HIV prevention, health education and peer workers are being trained in PrEP messaging and referral to PrEP services.

“In New York, we are hoping PrEP will have the same level of impact as expanded syringe access and our Perinatal Transmission Prevention program. Both of these bold programs led to dramatic reductions in new infections, and have brought us to the point where we are openly talking about bringing HIV below epidemic levels in this state in the foreseeable future.”6

NEW YORK CITY New York City has approximately twenty-four clinics that have experience providing PrEP and Post Exposure Prophylaxis (PEP).7 The Callen-Lorde Community Health Center delivers PrEP services in the Bronx and Manhattan areas.8 The Callen-Lorde PrEP Program is led by three key staff: a supervisor and two PrEP specialists. Together this team conducts eligibility assessments, PrEP access navigation, insurance and/or Medication Assistance Program (MAP) linkage and assistance. The PrEP team at Callen-Lorde also develops and maintains PrEP related protocols and guidelines, as well as performs contact reporting, data monitoring and entry. In addition, this team conducts community outreach and facilitates education and marketing activities. Similar to other clinics in New York providing PrEP, Callen-Lorde participates in collaborative efforts to increase PrEP utilization, especially with local Community Based Organizations (CBOs).

WASHINGTON STATE 9 Like New York, the Washington State Department of Health also views PrEP as a powerful addition to the HIV prevention toolbox. Washington was one of the first to implement a state-funded program to provide support and assistance for PrEP. The state’s strategy to maximize uptake of PrEP is by implementing the Pre-Exposure Prophylaxis Drug Assistance Program (PrEP DAP) to help residents who are at high risk of infection pay for the daily pill, TRUVADA®. PrEP DAP is a model for states receiving federal funding to increase access to PrEP.

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However, such programs to support the sustainability of PrEP require health care providers’ promotion and support. Health care providers are also knowledgeable of eligibility criterion and are trained to assist state residents in filling out the application for PrEP DAP. Washington has five counties and close to thirty health care organizations that screen and prescribe PrEP in high HIV prevalence areas. Community Health Care in Tacoma, Washington provides primary care services to individuals living with HIV/AIDS, and is the only provider in Pierce County providing prescriptions for PrEP. Community Health Care integrated PrEP programming into existing HIV prevention services and has a formal working relationship with the Tacoma Pierce County Health Department and the Pierce County AIDS Foundation. The heath care organization’s lead clinical provider is actively involved in the local HIV planning and steering group that engages in advocacy efforts around PrEP. Patients prescribed PrEP visit the clinic every two to three months for adherence assessments. The onsite nurse, provider and health department are also engaged in the assessment process and conduct regular follow-up with patients. One of the Community Health Care’s greatest accomplishments is engaging patients in regular medical care as a result of prescribing PrEP. PrEP programming, services and the PrEP DAP program have become tools to increase awareness about HIV/AIDS prevention. Providers and clinicians in Washington also frequently utilize advice and consultation resources offered by the CDC and the CCC Pre-Exposure Prophylaxis Service; and they utilize the CDC’s guidelines and recommendations as clinic protocol. Please see Resources section.

SAN FRANCISCO AIDS FOUNDATION 10 In San Francisco, PrEP is spearheaded by a collaboration with the San Francisco AIDS Foundation, the San Francisco Department of Public Health, community based providers, and local advocates. With Project Inform, the collaboration of partners promotes the dissemination of guidance tools and documents for providers across the nation. Keynotes for health care providers are based on considerations before prescribing PrEP, follow-ups during the regimen, discontinuance of the regimen if indicated, and billing codes. The following considerations are detailed in the San Francisco AIDS Foundation’s PrEP Facts brochure:



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Review facts about PrEP and increase understanding of how the drug works, its potential side effects, and the importance of medication adherence.



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Understand recommended criteria to assess a person’s HIV risk and indication to use PrEP. Review guidelines around HIV and STI testing for PrEP by conducting recommended testing. Include condom usage and risk reduction counseling when prescribing PrEP.

To access the PrEP Facts brochure, please see Resources section. Those advocating for PrEP in San Francisco acknowledge one of the biggest barriers to PrEP access for community members is often providers who are resistant to providing a prescription. To overcome this barrier the brochure helps health care providers and clients understand more about PrEP. This tool can be used to assist providers with determining ways to submit services for payment from insurance companies and Medicaid. It can also be used with clients to help them learn about the benefits of PrEP.

AIDS FOUNDATION OF CHICAGO 11 Providers in the city of Chicago have taken bold steps to recognize PrEP as a revolutionary medical advancement for the prevention of HIV infection. The AIDS Foundation of Chicago (AFC) aims to ensure that providers are informed and unbiased about the medical intervention, PrEP. Transfer of knowledge is one of the key approaches to increasing provider confidence and comfort in discussing PrEP with clients. AFC also features an online blog, My PrEP Experience http://myprepexperience.blogspot.com/. The blog provides a platform for meaningful discussions and advice for PrEP users, potential users, and providers.

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Capacity Building Assistance Opportunity Building Organizational Capacity For PrEP Implementation: Considering the significant diversity of settings nationwide it may be necessary for HCOs to adapt and/or adjust the way PrEP is implemented into their settings. Comprehensive PrEP implementation may require development of protocols, staff training, strengthening lab and billing infrastructures and more. Our CDC-funded HIV CBA Center can help your HCO conduct needs assessments, identify resources, plan for implementation and provide you with training and capacity building support that leads to a robust and successful PrEP program implementation. Our approach includes building capacity of the providers and support staff in areas such as:



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Strategic targeting of PrEP How to initiate discussions on difficult topics (sex, substance use, mental health) Counseling and adherence for PrEP Billing for PrEP Documentation Monitoring and evaluation

For more information on how to obtain our capacity building services to incorporate Pre-Exposure Prophylaxis into your Health Care Organization, visit the HIVCBAcenter.org. CDC. “HIV,” Winnable Battles. http://www.cdc.gov/winnablebattles/hiv/

1

Cohen, Myron S, MD; et al; (2011) “Prevention of HIV-1 Infection with Early Antiretroviral Therapy,” New England Journal of Medicine 2011; 365:493-505. August 11, 2011.

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Rodger A; et al; (2014) HIV transmission risk through condomless sex if HIV+ partner on suppressive ART: PARTNER study. 21st Conference on Retrovi ruses and Opportunistic Infections, Boston, abstract 153LB, 2014.

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Centers for Disease Control and Prevention, (2014) “Pre-Exposure Prophylaxis,” Prevention Research, September 30, 2014. http://www.cdc.gov/hiv/ prevention/research/prep/

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O’Connell, Dan; (2014) How New York is Using Pre-Exposure Prophylaxis (PrEP) to End HIV. Published on National Alliance of State & Territorial AIDS Directors website. September 10, 2014. http://www.nastad.org/blog/how-new-york-using-pre-exposure-prophylaxis-prep-end-hiv

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O’Connell, Dan; (2014) How New York is Using Pre-Exposure Prophylaxis (PrEP) to End HIV. Published on National Alliance of State & Territorial AIDS Directors website. September 10, 2014. http://www.nastad.org/blog/how-new-york-using-pre-exposure-prophylaxis-prep-end-hiv

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The New York City Department of Health and Mental Hygiene. Where to get PrEP in New York City. Retrieved from http://www.nyc.gov/html/doh/html/ living/prep-pep-resources.shtml

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Callen-Lorde Community Health Center. PrEP Program. Retrieved from http://callen-lorde.org/our-services/

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Washington State Department of Health. Pre-Exposure Drug Assistance Program (PrEP DAP). Retrieved from http://www.doh.wa.gov/YouandYourFamily/ IllnessandDisease/HIVAIDS/HIVCareClientServices/PrEPDAP

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San Francisco AIDS Foundation (2014). PrEP Facts. Retrieved from http://prepfacts.org

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National Alliance of State & Territorial AIDS Directors. November 2012. Pre-Exposure Prophylaxis (PrEP): State Health Department Implementation Plans. Retrieved from http://www.nastad.org/docs/slides-prep-state-implementation-plans-11-05-1212.pdf

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National Alliance of State & Territorial AIDS Directors. November 2012. Pre-Exposure Prophylaxis (PrEP): State Health Department Implementation Plans. Retrieved from http://www.nastad.org/docs/slides-prep-state-implementation-plans-11-05-1212.pdf

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The Fenway Institute. July 2012. Policy Focus, Pre-Exposure Prophylaxis for HIV Prevention: Moving Toward Implementation. Retrieved from http://www. fenwayhealth.org/site/DocServer/PolicyFocus_PrEP_v7_02.21.12.pdf?docID=9321

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Cairns, Gus; (2014) “Overall PrEP effectiveness in iPrEx OLE study 50%, but 100% in those taking four or more doses a week,” NAM AIDSmap. 22 July 2014. http://www.aidsmap.com/Overall-PrEP-effectiveness-in-iPrEx-OLE-study-50-but-100-in-those-taking-four-or-more-doses-a-week/page/2892435/

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ADDRESSING CONCERNS ABOUT PREP12,13 It is important to recognize and address stigma and other barriers to PrEP. One of the major stigmatizing ideas associated with PrEP is the belief that PrEP users will engage in unsafe sex, increasing their risk for STDs. The iPrEx study had found that risk sexual behavior actually DECLINED in people on PrEP during the course of the study. “Self-reported sexual risk behaviour declined during the study: at the start 34% of those allocated PrEP reported receptive anal sex without a condom and this dropped to 25% during the study: in those not allocated PrEP it started at 27% and ended at 20%.”14 Another concern is that those taking PrEP will not adhere to the regimen. PrEP is a single pill that is taken only once per day. Which is simpler than ART regimens that can involve several pills more than once per day along with food requirements or restrictions. PrEP adherence research shows that “people were adjusting their PrEP use according to their perceived risk of acquiring HIV.”15 Participants that perceived themselves to be at higher risk adhered at higher rates. In fact, 80% of participants adhered well enough to achieve 92% or better reduction in the risk of acquiring HIV.16 All of these concerns can be address through training, transfer of knowledge and technical assistance in implementation.

Robert Grant, quoted in Cairns, Gus; (2014) “Overall PrEP effectiveness in iPrEx OLE study 50%, but 100% in those taking four or more doses a week,” NAM AIDSmap. 22 July 2014. http://www.aidsmap.com/Overall-PrEP-effectiveness-in-iPrEx-OLE-study-50-but-100-in-those-taking-four-ormore-doses-a-week/page/2892435/

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Cohen SE et al; (2014) Implementation of PrEP in STD Clinics: High Uptake and Drug Detection Among MSM in the Demonstration Project. 21st Conference on Retroviruses and Opportunistic Infections (CROI), abstract 954, 2014. PPT presentation available at www.iapac.org/AdherenceConfer ence/presentations/ADH9_OA377.pdf

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Resources for Health Care Providers AIDS.gov. Pre-Exposure Prophylaxis (PrEP). May 2014. http://www.aids.gov/hiv-aids-basics/prevention/reduce-your-risk/pre-exposureprophylaxis/ Centers for Disease Control and Prevention, US Public Health Service. Pre-exposure Prophylaxis for the Prevention of HIV Infection in the United States-2014 Clinical Practice Guideline. http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf Centers for Disease Control and Prevention, US Public Health Service. Pre-exposure Prophylaxis for the Prevention of HIV Infection in the United States-2014 Clinical Providers; Supplement. http://www.cdc.gov/hiv/pdf/PrEPProviderSupplement2014.pdf Centers for Disease Control and Prevention, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. Pre-Exposure Prophylaxis (PrEP) for HIV Prevention. May 2014 http://www.cdc.gov/hiv/pdf/PrEP_fact_sheet_final.pdf Centers for Disease Control and Prevention, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. PrEP Infographic: Talk to your Doctor about PrEP. http://www.cdc.gov/hiv/basics/prep.html Gilead Sciences, Educational Materials for Providers and Patients http://www.truvadapreprems.com/ National Alliance of State & Territorial AIDS Directors. Fact sheet: Pharmaceutical Company Patient Assistance Programs and CoPayment Assistance Programs for Pre-exposure Prophylaxis (PrEP) and Post-exposure Prophylaxis (PEP). http://www.nastad.org/docs/ PrEP%20and%20PEP%20PAP%20fact%20sheet.pdf New York State Department of Health, AIDS Institute, HIV, HCV & STD Clinical Education Initiative. Learning Modules: HIV Prevention with Pre-Exposure Prophylaxis Video Presentation. August 2014 http://www.ceitraining.org/resources/audio-video-detail. cfm?mediaID=320#.VIC9lSgaAiG PrEP Support Hotline for Clinicians. PrEPline, 1-855-448-7737 (1-855 HIV-PREP). The CCC Pre-Exposure Prophylaxis Service Project Inform. PrEP (Pre-Exposure Prophylaxis) http://www.projectinform.org/prep Project Inform. Talking to patients about Pre-Exposure Prophylaxis. http://www.projectinform.org/pdf/prep_providers.pdf San Francisco AIDS Foundation (February 2014). PrEP Facts Brochure. http://prepfacts.org/assets/PrEP_Facts_16-pager_brochure_ mech_FINAL.pdf

The CAI CBA project is supported by the Grant or Cooperative Agreement Number, U65PS004408, funded by the Center for Disease Control and Prevention. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the Center for Disease Control and Prevention or the Department of Health and Human Services.

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