Preventing HIV in Primary Care: Preexposure Prophylaxis

Description: The purpose of this project was to create a continuing online education module to improve primary care provider knowledge in prescribing the preexposure prophylaxis (PrEP) medication emtricitabine-tenofovir (FTC-TDF) in high-risk men who have sex with men. Problem Statement: In 2012, the Food and Drug Administration approved the brand name drug Truvada (FTC-TDF) for the prevention of HIV in high-risk men who have sex with men. Despite being 99% effective in preventing HIV transmission in this high-risk population, primary care provider prescription of PrEP remains low. One of the biggest barriers to PCP prescribing of PrEP is a lack of knowledge regarding indications, patient selection, monitoring parameters, safety, and effectiveness. Objectives: The objectives of this project were to identify effective methods and resources for online learning, create an online education program incorporating current evidence-based guidelines for PrEP use in high-risk patients, and disseminate the project to PCPs in Utah through submission to a continuing medical education (CME) program and as an on-demand tool available through the Utah AIDS Foundation. Literature Review: FTC-TDF has been available as an effective antiretroviral HIV treatment for years, but in 2010, a study was published with evidence that this medication could prevent HIV transmission in patients without HIV infection. Follow-up studies demonstrated PrEP had even greater efficacy in real-world use. The studies found no increases in sexually transmitted infections in patients. PrEP is a cost-effective choice to lower the rates of HIV infection. PrEP has been extensively studied in HIV-positive patients and is considered safe. Implementation and Evaluation: Project implementation and evaluation included (a) evaluation, selection, and learning of online learning software based on established criteria; (b) creation of a script of the video portion and completion of a mock-up, followed by transcription and production of the mock-up video format; (c) creation of a website, www.knowPrEPnow.org, to host the online material and assist in dissemination; and (d) presentation of the project to the Utah AIDS Foundation for their use in provider education and submission for CME accreditation. Summary: This final product met the goals of this project by being a sustainable, modifiable, and accessible CME education program to help reduce HIV infection in high-risk individuals. The project is sustainable through a low yearly upkeep cost for the domain name. As new information or evidence regarding PrEP becomes available, the project is easily modifiable to keep the information current. The project is accessible to anyone with an Internet connection, free of charge, on any type of Internet-capable device.

Running head: PREVENTING HIV IN PRIMARY CARE Preventing HIV in Primary Care: Preexposure Prophylaxis Philip M. Howland University of Utah In partial fulfillment of the requirements for the Doctor of Nursing Practice 1 PREVENTING HIV IN PRIMARY CARE 2 Executive Summary Description: The purpose of this project was to create a continuing online education module to improve primary care provider knowledge in prescribing the preexposure prophylaxis (PrEP) medication emtricitabine-tenofovir (FTC-TDF) in high-risk men who have sex with men. Problem Statement: In 2012, the Food and Drug Administration approved the brand name drug Truvada (FTC-TDF) for the prevention of HIV in high-risk men who have sex with men. Despite being 99% effective in preventing HIV transmission in this high-risk population, primary care provider prescription of PrEP remains low. One of the biggest barriers to PCP prescribing of PrEP is a lack of knowledge regarding indications, patient selection, monitoring parameters, safety, and effectiveness. Objectives: The objectives of this project were to identify effective methods and resources for online learning, create an online education program incorporating current evidence-based guidelines for PrEP use in high-risk patients, and disseminate the project to PCPs in Utah through submission to a continuing medical education (CME) program and as an on-demand tool available through the Utah AIDS Foundation. Literature Review: FTC-TDF has been available as an effective antiretroviral HIV treatment for years, but in 2010, a study was published with evidence that this medication could prevent HIV transmission in patients without HIV infection. Follow-up studies demonstrated PrEP had even greater efficacy in real-world use. The studies found no increases in sexually transmitted infections in patients. PrEP is a cost-effective choice to lower the rates of HIV infection. PrEP has been extensively studied in HIV-positive patients and is considered safe. Implementation and Evaluation: Project implementation and evaluation included (a) evaluation, selection, and learning of online learning software based on established criteria; (b) creation of a script of the video portion and completion of a mock-up, followed by transcription and production of the mock-up video format; (c) creation of a website, www.knowPrEPnow.org, to host the online material and assist in dissemination; and (d) presentation of the project to the Utah AIDS Foundation for their use in provider education and submission for CME accreditation. Summary: This final product met the goals of this project by being a sustainable, modifiable, and accessible CME education program to help reduce HIV infection in high-risk individuals. The project is sustainable through a low yearly upkeep cost for the domain name. As new information or evidence regarding PrEP becomes available, the project is easily modifiable to keep the information current. The project is accessible to anyone with an Internet connection, free of charge, on any type of Internet-capable device. Project Committee: Suzanne Martin, DNP, FNP-C; Julie Balk, DNP, APRN, FNP-BC; and Pam Hardin, PhD, RN Content Experts: Chris Davis, PA-C; Jared Hafen Director of Programming, Utah AIDS Foundation PREVENTING HIV IN PRIMARY CARE 3 Table of Contents Executive Summary………………………………………………….……………………………2 Table of Contents……………………………………………………………………….…………3 Problem Statement………………………………………………………………………………...6 Clinical Significance………………………………………………………………………………6 Objectives…………………………………………………………………………………………8 Literature Review………………………………………………………………………………….8 Background……………………………………………………………………………..…8 Efficacy and Safety………………………………………………………………………..8 Patient Selection………………………………………………………………………….10 Barriers…………………………………………………………………………………...10 Theoretical Framework…………………………………………………………………………..11 Implementation and Evaluation………………………………………………………………….12 Future Recommendations………………………………………………………………………..15 DNP Essentials…………………………………………………………………………………...15 Conclusion……………………………………………………………………………………….16 References………………………………………………………………………………………..18 Appendices Appendix A: Proposal Defense………………………………………………………….22 Appendix B: Final Poster Presentation………………………………………………….26 Appendix C: Graphical Markup Outline………………………………………………...28 Appendix D: Education Script…………………………………………………………..35 Appendix E: Test Your Knowledge Questions………………………………………….53 PREVENTING HIV IN PRIMARY CARE 4 Appendix F: Feedback Questionnaire…………………………………………………...57 Appendix G: Website Pages……………………………………………………..……...59 PREVENTING HIV IN PRIMARY CARE Acknowledgements For Greg, without your support and patience on this journey I would not be where I am today. Thank you. 5 PREVENTING HIV IN PRIMARY CARE 6 Preventing HIV in Primary Care: Preexposure Prophylaxis Problem Statement In 2013, 2,565 Utahns were living with the human immunodeficiency virus (HIV) (Centers for Disease Control and Prevention [CDC], 2015b). The most at-risk population, which accounts for between 56 and 61% of new infections, is men who have sex with men (MSM) (Juusola, Brandeau, Owens, & Bendavid, 2012). In 2012, the FDA approved the medication emtricitabine and tenofovir disoproxil fumarate (FTC - TDF) for preexposure prophylaxis (PrEP) to reduce the risk of sexually acquiring HIV-1. PrEP, utilizing FTC-TDF, can reduce the risk of sexually acquiring HIV-1 infection by 92% (Grant et al., 2010). Despite the 2014 CDC clinical guidelines on PrEP, knowledge of PrEP among primary care providers (PCPs) remains low, creating one the greatest barriers to more widespread use of PrEP (Krakower, Ware, Mitty, Maloney, & Mayer, 2014). Increasing provider knowledge as a health systems intervention among Utah PCPs in the areas of patient screening/selection, safety/efficacy, monitoring, and reimbursement can improve PrEP prescribing and intent to prescribe (Blumenthal et al., 2015). Clinical Significance HIV is no longer considered an automatic death sentence, and life expectancy for an HIV-positive 20-year-old on antiretroviral therapy (ART) is nearing that of the U.S. average (Samji et al., 2013). However, this disease still imparts significant economic, legal, and psychological burdens on both individuals and society. Patients with HIV must commit to consistent daily medication use, frequent visits to healthcare providers, and regular monitoring. ART therapy is expensive and can have significant side effects. In 2010, the estimated cost of lifetime treatment for one patient with HIV was $379,688 (CDC, 2015a). The estimated total lifetime treatment cost for all HIV-positive people in Utah is $46,000,000 (CDC, 2015a). With PREVENTING HIV IN PRIMARY CARE 7 large numbers of people in the US living with HIV and 50,000 annual incident cases, HIV transmission is a continuing health crisis, especially among MSM (CDC, 2015b). Rates of HIV infection are decreasing in every risk group except MSM, and barring any changes in preventive approaches, this group will continue to be the most affected (CDC, 2009). Without a new prevention modality, the number of HIV infections in the MSM population is estimated to approach 500,000 over the next 20 years (Juusola et al., 2012). Up to 250,000 cases of those HIV infections could be prevented by using PrEP (Juusola et al., 2012). The outcome measure of quality-adjusted life years (QALY) factors in the quantity of years a person has to live and the quality of those years. Interventions are considered cost-effective if the intervention cost is between $50,000 and $100,000 per QALY (CDC, 2015a). If PrEP were targeted at highrisk MSM, the cost of PrEP would be $52,443/QALY, which would be considered cost-effective (Juusola et al., 2012). In addition to individuals most at risk of HIV, other stakeholders are involved in PrEP and HIV prevention in Utah. The roles these stakeholders have in the prevention of HIV include (a) public awareness campaigns, (b) case management, (c) HIV screening, (d) provider education, (e) patient selection, and (f) patient care. Community-based organizations involved in HIV prevention include the Utah AIDS Foundation (UAF), Centro Hispano, and the Salt Lake County Health Department. Identified educational stakeholders are the University of Utah's College of Nursing and School of Medicine. Healthcare delivery stakeholders include the major hospitals, clinics, and healthcare organizations in Utah (e.g., Intermountain Healthcare, University Hospital and Clinics) and private practices. PREVENTING HIV IN PRIMARY CARE 8 Purpose and Objectives The purpose of this scholarly project was to develop an online education program for PCPs on patient selection, monitoring, and prescribing PrEP in order to decrease the rate of HIV infection in high-risk individuals. The following project objectives supported this purpose: • • • Identify effective methods and resources for online learning Create an online education program incorporating the current evidence-based guideline for PrEP in high-risk patients Disseminate the project to primary care providers in Utah through submission to a CME program and as an on-demand tool available through the Utah AIDS Foundation. Literature Review Antiretroviral drugs, specifically the combination of FTC-TDF, have proven effective in preventing HIV infection in MSM. Grant et al. (2010), as part of the Pre-exposure Prophylaxis Initiative (iPrEx), published the results of a randomized controlled trial of almost 2,500 HIVnegative MSM or transgender women who have sex with men who were given either a placebo or the trial drug FTC-TDF. Approval for FTC-TDF use in high-risk HIV negative adults was based on the study results (Blumenthal et al., 2015). Efficacy and Safety The iPrEx study results showed 44% more protection using FTC-TDF versus placebo, in combination with a comprehensive HIV prevention package against HIV acquisition in MSM and transgendered women who have sex with men (Grant et al., 2010). After taking into account subjects in the study who had HIV sero-conversion but did not have a significant or detectable amount of treatment drug in the treatment arm, the relative HIV risk reduction increased to 92% (Grant et al., 2010). Subjects in the iPrEx study were blinded to treatment, and both arms showed a decrease in the number of sexual partners and an increase in condom usage, which could have made FTC-TDF appear to be less efficacious (Grant et al., 2010). PREVENTING HIV IN PRIMARY CARE 9 McCormack et al. (2016) tested the efficaciousness of PrEP in real-world usage in an open-label study with over 500 men in the United Kingdom (UK) with an immediate PrEP treatment arm and a 1-year deferred arm. The data from the study highlighted a significant decrease in the incidence of HIV infection in the immediate treatment arm (3/275 versus 20/235), which suggests no breakthrough infections. Of the three men who tested positive for HIV, one man tested positive 4 weeks after intake, suggesting pre-study acquisition; one man received 30 days of treatment and tested positive at 63 weeks; and one man received 90 days of medication and tested positive at 53 weeks. The McCormack et al. study found 1.2 HIV infections per 100 person-years, and 13 participants needed PrEP treatment for 1 year to prevent one HIV infection. An open-label PrEP study in the United States of over 500 men in three cities had an incidence of 0.43 HIV infections per 100 person-years (Liu et al., 2016). The medications that comprise PrEP (FTC/TDF) have been studied extensively in HIVpositive patients and are considered safe. The FTC component has no special monitoring considerations, with the most significant adverse reaction being gastrointestinal upset (Li, Dufrene, & Okulicz, 2014). TDF has been associated with both reversible and permanent renal toxicity in patients with and without HIV infection (Grant et al., 2010; Li et al., 2014). Liu et al. (2016) reported 23 incidents of elevated serum creatinine and 3 that persisted beyond the study conclusion. Of the three incidents that persisted, only one was considered related to treatment and none of the serum creatinine elevations required withdrawal from the trial (Liu et al., 2016). McCormack et al. (2016) reported 3/275 patients who withdrew from treatment because of elevated serum creatinine. In the phase II studies for PrEP over 1 year, Li et al. (2014) reported no difference in adverse events between FTC - TDF and placebo. A case report of a 73-year-old male receiving FTC - TDF documented increased serum creatinine levels after 6 months on PREVENTING HIV IN PRIMARY CARE 10 PrEP and two instances of a glomerular filtration rate of less 50 mL/min, but no other adverse effects (Girometti et al., 2016). Patient Selection The highest non-blood transfusion risk activities for transmission of HIV are unprotected receptive anal (bottom) intercourse (138/10,000 acts), IV needle-sharing drug use (68/10,000 acts), and unprotected insertive anal (top) intercourse (11/10,000 acts) (Patel et al., 2014). The indications for PrEP are based on risk of HIV, with the focus on the MSM population, as this population in the US and other wealthy Western countries (e.g., UK) is still experiencing increasing rates of HIV (McCormack et al., 2016). Almost 25% of adult MSM in the US meet the CDC indications for PrEP (CDC & DHHS, 2014; Smith et al. 2015). The CDC in its 2014 Practice Guidelines recommends PrEP for any adult male who meets the following criteria: • • • • • • Without acute or established HIV infection Any male sex partners in past 6 months Not in a monogamous partnership with a recently tested, HIV-negative man AND at least one of the following Any anal sex without condoms (receptive or insertive) in past 6 months Any STI diagnosed or reported in past 6 months Is in an ongoing relationship with an HIV-positive male partner. (p. 29) Barriers In a qualitative study among HIV care providers, Krakower et al. (2014) identified perceived barriers to prescribing PrEP: efficacy of PrEP in real-world settings, changes in patient behavior that could increase risk, and the perception that primary care providers are best suited to prescribe the medication. Despite the indications, efficacy, and safety, PCPs who are not knowledgeable about PrEP are less likely to identify and prescribe PrEP to appropriate patients (Blumenthal et al., 2015). Smith, Mendoza, Stryker, and Rose (2016) report that through the 6 years of survey results, awareness of PrEP has increased among physicians and nurse PREVENTING HIV IN PRIMARY CARE 11 practitioners, from 24% in 2009 to over 65% in 2015. In 2014, only 17% of prescribers had read the CDC interim guidance regarding PrEP use, and 7% reported prescribing PrEP as of 2015 (Smith et al., 2016). Concern regarding risk compensation is a potential barrier to prescribing PrEP among PCPs, as the perceived decreased risk of HIV infection in an MSM patient may increase risk behavior (Li et al., 2014). Based on a Canadian study of MSM, the perception of HIV risk in this population may be discordant even without PrEP use (Wilton et al., 2016). Of 420 subjects in the survey, 27% perceived a moderate to high risk of HIV, whereas 64% were objectively assessed at high risk (Wilton et al., 2016). Concern regarding risk compensation may be mitigated based on PrEP study data. For example, condom usage increased during the iPrEx study (Grant et al., 2010). Real-world trials reported no increases in STI rates between patients who received PrEP and those who did not (Liu et al., 2016; McCormack et al., 2016). Theoretical Framework Everett Roger's 1962 Diffusion of Innovation Theory explores the way an innovation diffuses through an applicable community. In this theory, an innovation is a concept, idea, or mode of practice that is perceived as being new. These components of the theory essentially translate into a process to communicate an innovation through various channels over a time period to effect change. The theory describes the cumulative adoption process through different types of adopters, ranging from early adopters to laggards. This theoretical framework supported this scholarly project by facilitating the design of an appropriate presentation communication to meet the needs of the adopter group to help diffuse the innovation. In the context of PrEP, healthcare providers can be divided into HIV specialists, primary care providers, reproductive healthcare providers, and other providers. Looking at those PREVENTING HIV IN PRIMARY CARE 12 groups as whole, HIV specialists are the innovators and early adopters, with the other groups falling into early adopters, late majority, and laggard categories. The primary care subset of potential PrEP providers is also broken down into categories from early adopters to laggards. This project sought to effect change via knowledge and persuasion using this framework. Albert Bandura's (1977) Social Cognitive Theory helps to explain how individuals learn and adapt new behaviors. The theory is that people learn from observing others and that observation provides reciprocal feedback among the three pillars of behavior: personal, environmental, and behavioral, the interplay of which influences an individual's behavior. The Social Cognitive Theory supported this project by providing background for the development of the presentation to emphasize the learner's sense of efficacy (personal pillar). One goal of the presentation was to have learners feel confident in their ability to successfully prescribe and monitor PrEP in appropriate patients. The other goal was to improve the environment by providing tools to identify appropriate patients. Implementation and Evaluation This PrEP online education module required a stepwise process, and successful implementation of each step was required before beginning the next. For this reason, implementation and evaluation will be discussed together. The stepwise process included (a) project approval and implementation of the project; (b) selection of an effective method of content delivery based on an assessment of online education content; (c) a graphic outline of the project and creation of a written presentation after approval by the content expert; (d) translation of the written presentation into a video and creation of a website incorporating the video and a case scenario; and (e) submission of the project for CME accreditation through the University of Utah School of Medicine's Office of Continuing Medical Education. PREVENTING HIV IN PRIMARY CARE 13 The first objective for this project was to identify effective methods and resources for online learning. A subjective and objective assessment of current online education content helped determine an appropriate online vehicle for the project. Objective factors in the assessment included cost, time to master format, exportability, ability to adapt material in the future, and ability to work on major operating systems. The subjective factors included aesthetics and professionalism of the final product. The lower than expected cost associated with the software and potential for conflicts of interest with CME submission led to the decision to not apply for a grant. Video Scribe software was selected for the video content, and WordPress was chosen to host the online web-hosting format. The software for the production of the online module required development of an education plan to learn how to use the software. The education plan included online tutorials from the Video Scribe site, searching online for Web-based tutorials on audience engagement, web design tutorials, and sound editing tutorials. This portion of the project was completed concurrently during applicable-production portions of the program. For example, the sound editing software was not needed until the later stages of the project when recording the voiceover occurred, and so learning this software was given a lower priority compared to other portions of the project until then. The second objective was to create the education program for PrEP based on the current evidence-based guidelines for high-risk patients. A background paper, which included the supporting data for the project, provided the basis for the graphical markup. The markup was created using a PowerPoint presentation (Appendix C) that served as the outline and timing for the video presentation. The background paper and graphical markup then provided the basis for the project script (Appendix D), which was used for the voiceover for the video portions of the PREVENTING HIV IN PRIMARY CARE 14 project. The graphical markup and script were submitted for approval to the content expert, Chris Davis, PA-C. Conversion of the graphical markup to an animated video using the selected software, Video Scribe, followed the content expert's approval of the script and markup. A case scenario was created and interwoven into the script to integrate learning and create an engaging education tool. Test your knowledge questions were created using information from the script and approved by the content expert (Appendix E). The content expert approved the completed videos, which were then reviewed by the Utah AIDS Foundation director of programming. A website created for the project enhanced the dissemination and sustainability of the project (Appendix G). The site, created for providers, also has links for patients to access patient resources, and has a format designed to allow for an interactive component. The site includes resources cited throughout the presentation. The link was provided to the UAF. The final objective was dissemination of the project to PCPs in Utah through the UAF PrEP outreach program and submission for approval to the Office of Continuing Medical Education (approved pending resource allocation). The approval process included a review of the project's intended audience, methods, disclosures, dissemination plan, and feedback mechanism. Future Recommendations The overarching purpose of this project has been to reduce HIV infection in high-risk patients by increasing PrEP usage among primary care providers. This education project is sustainable with a small annual domain name payment. The software used in the production of the project allows changes to be made following the publication of new evidence or the announcement of new practice guidelines, which makes this education tool easily modifiable. PREVENTING HIV IN PRIMARY CARE 15 This project should continue to be accessible until PrEP education is no longer needed. Further dissemination will occur once the site is searchable to online search engines following CME accreditation. Dissemination could also occur through incorporation into the College of Nursing's nurse practitioner program and the University of Utah's community clinics. DNP Essentials For this scholarly project, the applicable Doctor of Nursing Practice essentials from the American Association of College of Nursing (2006) are essentials I and IV. These essentials were utilized throughout the development and implementation of this PrEP online educational tool. The following is a description of how each essential relates to the project. Essential I, Scientific Underpinnings for Practice, is relevant to this scholarly project. The education tool created from this project was based on the scientific foundation of evidencebased practice. The tool addresses the current practice issue of reducing HIV infection among high-risk groups in primary care. Developing new practice approaches based on nursing theories, two of which have been described, is a part of this Essential for DNP practice. This PrEP online education tool has the potential to be an effective new approach to providing specialized education content to providers when and where they need it. Essential IV, Information Systems, Technology for the Improvement and Transformation of Health Care, was the major basis for the project. PCPs, both rural and urban, have limited time for continuing education. Providing PrEP education in a format that utilizes information technology and enables the education to be accessible any time increases the chance a provider will complete the education. Since provider knowledge of PrEP is a major barrier to prescribing and intent to prescribe, improving provider knowledge through this format may decrease HIV infection in high-risk patients. PREVENTING HIV IN PRIMARY CARE 16 Conclusion Reducing the incidence of HIV infection in at-risk populations should be a top goal of primary care providers. Ample literature supports PCP use of PrEP in these providers' high-risk MSM patients. PrEP is effective in preventing sexually acquired HIV and is cost effective for high-risk MSM population. The purpose of this project was to provide an easily sustainable, modifiable, and accessible evidenced-based tool to increase provider awareness and comfort in prescribing PrEP. During the course of implementation of the project, the final version changed from a purely desktop-based tool to a mobile-friendly format. The software selected for the video presentation is user friendly and has the ability to be modified as new recommendations are released to keep the content current. In line with the goal of increasing provider usage of PrEP, access to the tool is free to anyone with an Internet connection. Education formats that are engaging and available on-demand are more likely to be used by PCPs with multiple demands on their time. The format selected for this project allows the user to create a very engaging and interactive program, but the time requirements to initially learn the software are considerable. Future presentation preparations should be less time intensive. The opportunity exists to change other static online education programs into more interactive formats. During the course of the project, more online education tools on PrEP have become available. The increased availability of online education tools allows for greater PCP exposure to PrEP and potentially increased use and decreased HIV infection rates in high-risk patients. Regardless of which education format is used to address the PCP knowledge gap, as long as PREVENTING HIV IN PRIMARY CARE evidence-based knowledge of PrEP is used to guide practice behaviors, then the goals of this project will be met. 17 PREVENTING HIV IN PRIMARY CARE 18 References American Association of Colleges of Nursing. (2006). The essentials of doctoral education for advanced nursing practice. Retrieved from: http://www.aacn.nche.edu/publications/position/DNPEssentials.pdf Bandura, A. (1977). Social learning theory. Englewood Cliffs, NJ: Prentice Hall. Blumenthal, J., Jain, S., Krakower, D., Sun, X., Young, J., Mayer, K., . . . Team, C. (2015). Knowledge is power! Increased provider knowledge scores regarding pre-exposure prophylaxis (PrEP) are associated with higher rates of PrEP prescription and future intent to prescribe PrEP. AIDS Behavior, 19(5), 802-810. doi:10.1007/s10461-015-0996-z Centers for Disease Control and Prevention. (2015a). HIV cost effectiveness. Retrieved from http://www.cdc.gov/hiv/programresources/guidance/costeffectiveness /index.html Centers for Disease Control and Prevention. (2015b). HIV Surveillance Report, 2014, Volume 26. Retrieved from http://www.cdc.gov/hiv/pdf/library/reports/ surveillance/cdc-hiv-surveillance-report-us.pdf Centers for Disease Control and Prevention. (2009). HIV prevention in the United States: At a critical crossroads. Retrieved from: https://www.cdc.gov/hiv/resources/ reports/pdf/hiv_prev_us.pdf Centers for Disease Control and Prevention, Department of Health and Human Services [CDC, DHHS]. (2014). Preexposure prophylaxis for the prevention of HIV infection in the United States. 2014 Clinical Practice Guidelines. Retrieved from http:www.cdc.gov/hiv/pdf/prepguidelines2014.pdf PREVENTING HIV IN PRIMARY CARE 19 Girometti, N., Jones, R., Levy, J., McCormack, S., Sullivan, A., & Barber, T. J. (2016). Risks and benefits of HIV pre exposure prophylaxis with tenofovir/emtricitabine in an older man with co-morbidities. AIDS. doi:10.1097/QAD.0000000000001171 Grant, R. M., Lama, J. R., Anderson, P. L., McMahan, V., Liu, A. Y., Vargas, L., . . . iPrEx Study, T. (2010). Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. New England Journal of Medicine, 363(27), 2587-2599. doi:10.1056/NEJMoa1011205 Juusola, J. L., Brandeau, M. L., Owens, D. K., & Bendavid, E. (2012). The cost-effectiveness of preexposure prophylaxis for HIV prevention in the United States in men who have sex with men. Annals of Internal Medicine, 156(8), 541-550. doi:10.1059/0003-4819-156-8201204170-00001 Krakower, D., Ware, N., Mitty, J. A., Maloney, K., & Mayer, K. H. (2014). HIV providers' perceived barriers and facilitators to implementing pre-exposure prophylaxis in care settings: A qualitative study. AIDS Behavior, 18(9), 1712-1721. doi:10.1007/s10461-0140839-3 Li, J., Dufrene, S. L., & Okulicz, J. F. (2014). Systemic preexposure prophylaxis for HIV: Translating clinical data to clinical practice. Annals of Pharmacotherapy, 48(4), 507-518. doi:10.1177/1060028014520880 Liu, A. Y., Cohen, S. E., Vittinghoff, E., Anderson, P. L., Doblecki-Lewis, S., Bacon, O., . . . Kolber, M. A. (2016). Preexposure prophylaxis for HIV infection integrated with municipal and community based sexual health services. Journal of the American Medical Association Internal Medicine, 176(1), 75-84. doi:10.1001/jamainternmed.2015.4683 PREVENTING HIV IN PRIMARY CARE 20 McCormack, S., Dunn, D. T., Desai, M., I., D. D., Gafos, M., Bilson, R., . . . Gill, O. N. (2016). Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): Effectivemess results from the pilot phase of a pragmatic open-label randomised trial. Lancet, 387, 53-60. doi:10.1016/ Patel, P., Borkowf, C. B., Brooks, J. T., Lasry, A., Lansky, A., & Mermin, J. (2014). Estimating per-act HIV transmission risk: A systematic review. AIDS, 28(10), 1509-1519. doi:10.1097/QAD.0000000000000298 Rogers, E. M. (2003). Diffusion of innovations (5th ed.). New York, NY: Free Press. Samji, H., Cescon, A., Hogg, R. S., Modur, S. P., Althoff, K. N., Buchacz, K., . . . Gange, S. J. (2013). Closing the gap: Increases in life expectancy among treated HIV-positive individuals in the United States and Canada. PLoS One, 8(12), e81355. doi:10.1371/journal.pone.0081355 Smith, D. K., Mendoza, M. C., Stryker, J. E., & Rose, C. E. (2016). PrEP awareness and attitudes in a national survey of primary care clinicians in the United States, 2009-2015. PLoS One, 11(6), e0156592. doi:10.1371/journal.pone.0156592 Smith, D. K., Van Handel, M., Wolitski, R. J., Stryker, J. E., Hall, I., Prejean, J., . . . Valleroy, L. A. (2015, November 27). Vital signs: Estimated percentages and numbers of adults with indications for preexposure prophylaxis to prevent HIV acquisition - United States, 2015. Centers for Disease Control and Prevention: Morbidity and Mortality Weekly Report, 64(46), 1291-1295. Wilton, J., Kain, T., Fowler, S., Hart, T. A., Grennan, T., Maxwell, J., & Tan, D. H. (2016). Use of an HIV-risk screening tool to identify optimal candidates for PrEP scale-up among PREVENTING HIV IN PRIMARY CARE men who have sex with men in Toronto, Canada: Disconnect between objective and subjective HIV risk. J Int AIDS Soc, 19(1), 20777. doi:10.7448/IAS.19.1.20777 21 PREVENTING HIV IN PRIMARY CARE Appendix A Proposal Defense 22 PREVENTING HIV IN PRIMARY CARE 23 PREVENTING HIV IN PRIMARY CARE 24 PREVENTING HIV IN PRIMARY CARE 25 PREVENTING HIV IN PRIMARY CARE Appendix B Final Poster Presentation 26 PREVENTING HIV IN PRIMARY CARE 27 PREVENTING HIV IN PRIMARY CARE Appendix C Graphical Markup Outline 28 PREVENTING HIV IN PRIMARY CARE 29 PREVENTING HIV IN PRIMARY CARE 30 PREVENTING HIV IN PRIMARY CARE 31 PREVENTING HIV IN PRIMARY CARE 32 PREVENTING HIV IN PRIMARY CARE 33 PREVENTING HIV IN PRIMARY CARE 34 PREVENTING HIV IN PRIMARY CARE Appendix D Education Script 35 PREVENTING HIV IN PRIMARY CARE 36 PREVENTING HIV IN PRIMARY CARE: PRE-EXPOSURE PROPHYLAXIS Philip Howland ACT I INTRODUCTION NARRATOR HIV continues to affect over a million people in the United States and there will be over 50,000 new infections in this year. Primary care providers have a cost effective opportunity to reduce the risk of HIV infection in their highest risk patients. The goal of program is to improve primary care provider knowledge of Pre-exposure prophylaxis in the areas of efficacy, safety, patient selection and monitoring. MEET JAMES NARRATOR First though, please meet James. James is a 24 year old male presenting to a primary care clinic with complaints of dysuria for one day after a recent sexual encounter. James' history revealed his sexual partners to be male and he reported inconsistent condom use. He occasionally uses marijuana, but denies any other drug use. He reports usually drinking 5 or more drinks on the weekend. A urinalysis was completed and James was tested for chlamydia, gonorrhea, HIV, and syphilis. These tests all resulted as negative. He was not empirically treated for CT/GC at that time, but was counseled on safer sex practices, ETOH abuse risk factors, and then sent on his way. WHAT IS PREP? VOICE So, what is PrEP? PREVENTING HIV IN PRIMARY CARE 37 NARRATOR PrEP is pre-exposure prophylaxis to prevent HIV infection. It is different from PEP or post-exposure prophylaxis in that it contains two anti-HIV medications, tenofovir and emtricitabine instead of a complete 3-drug regimen. Unlike PEP, PrEP is not taken in emergency situations. PrEP should be taken on a regular basis. PrEP is sold under the brand name Truvada. PrEP was approved in 2012 by the FDA for pre-exposure prophylaxis to reduce the risk of sexually acquiring HIV. In 2014, the CDC published practice guidelines recommending the use of PrEP in high-risk individuals. NEED FOR PREP VOICE Some people believe HIV infection rates are decreasing and that condom use is enough. They often ask: Is there really a need for PrEP? NARRATOR The short answer is "Yes". Consistent condom use is the cornerstone of prevention and should be encouraged in all patients. Nevertheless, despite population-based education, condom distribution programs, and public service campaigns there are around 50,000 new HIV infections each year in the U. S. Moreover, while the incidence in most risk groups has been stable or even declining, HIV infection rates in men who have sex with men have actually been increasing. According to 2015 data from the CDC, this population accounts for over 60% of new infections. PrEP is a valuable tool to help prevent the spread of HIV. BARRIERS NARRATOR PrEP faces many barriers to primary care use. In qualitative studies, providers have questioned the efficacy of PrEP. NARRATOR (Cont.) (In foreground) PREVENTING HIV IN PRIMARY CARE 38 (Simultaneously with VOICE) Some providers don't feel they see potential patients. Others felt that specialists should be giving this medication. On the other hand, infectious disease providers felt PrEP was appropriate to be used in most cases in primary care. Other barriers include questions about reimbursement, safety, risk compensation, and HIV resistance. We'll try to address these concerns in the following sections. VOICES (In background) I don't see these patients. Shouldn't ID clinics give PrEP? How will I be reimbursed for this? Is it safe? Does it work? ACT II JAMES GETS AN STD NARRATOR It's been 6 months since we last saw James, and in that time he went to a local AIDS foundation STD screening. There, he was screened for rectal GC/CT and received a positive test result a week later. He returned to his PCP where he was treated for GC/CT, retested for HIV and syphilis, (which were negative), and again counseled on safer sex practices. James was scheduled for a follow-up in 3 months. IS PREP EFFECTIVE? VOICE Is PrEP effective? NARRATOR First, it is important to know that PrEP is highly effective in preventing HIV in high-risk patients. Gold standard randomized, placebo-controlled trials of PrEP to determine if it can prevent HIV have been conducted. IPREX The pre-exposure prophylaxis initiative (iPrEx) was a phase III trial to determine if PrEP could safely and effectively prevent HIV in MSM and transgendered women. Subjects in the study were HIV negative adults PREVENTING HIV IN PRIMARY CARE 39 who had sex with another man in the past 6 months and considered high risk for HIV. In addition to either receiving placebo or PrEP, every 4 weeks patients also received risk-reduction counseling, condoms and treatment for any STIs acquired. For the subjects on PrEP, the HIV infection rate was 44% lower than the control group. In subjects that selfreported taking the drug more than 90% of the time, the efficacy was 73%. For subjects that had measurable drug levels the relative risk reduction with PrEP was 92%. The absolute risk reduction was 2.25% and the overall number needed to treat one HIV infection in the study was 44. However, analyzing the data from the iPrEx study, the NNT was actually lower with different behaviors. Receptive anal intercourse without a condom reduced the NNT to around 35. Concurrent cocaine use decreased the NNT to less than 15. For comparison, the NNT for simvastatin in the Scandinavian Simvastatin Survival study was 30. Throughout the study, condom usage increased and the number of sexual partners decreased in both arms of the study. PARTNERS NARRATOR The PARTNERS PrEP trial, another randomized placebo control study, had over 4,700 serodiscordant heterosexual couples. PrEP had a 73% reduction in the risk of HIV infection and the trial was stopped early due to the efficacy seen vs. placebo. TDF2 TRIAL NARRATOR The TDF2 study was a placebo randomized control trial examining heterosexual men and women. PrEP had an efficacy of 63% in subjects who had detectable serum drug level. FEM-PREP STUDY NARRATOR In the FEM-PREP study, which consisted of heterosexual females the effectiveness of PrEP versus placebo was not shown. However, adherence to the study drug was very poor in this study. There was also a low perceived risk of HIV in the women in the study. Although self- PREVENTING HIV IN PRIMARY CARE 40 reported adherence was high (95% in the study), measured drug levels of tenofovir were below the target goal of 10 ng/mL in 74% of the women who seroconverted at the beginning of the infection window. The target drug was not present in 79% of the women who seroconverted at the end of the target window. The high pregnancy rate in both study arms, among women who were also taking oral contraceptive pills, further suggests an overall problem with pill adherence during this study. PROUD STUDY NARRATOR An open label study in the United Kingdom, between immediate and deferred PrEP use among men who reported recent unprotected anal intercourse found PrEP to be effective. PROUD was noteworthy as a "real-world" study instead of placebo. It showed higher protection than placebo trials with an 86% risk reduction. In addition, the NNT was lower than previous studies with 13 patients needing to be treated with PrEP to prevent one HIV infection. IPERGAY NARRATOR The authors wanted to determine if a demand dosing for PrEP would be effective. This trial is interesting both for it's high efficacy, which was similar to the PROUD study at 86% and for the unique dosing regiment. Subjects received either PrEP or placebo. The number needed to treat in the IPERGAY study was 18 and no HIV infections occurred in patients who had detectable serum drug levels. ACT III PREP SAFETY NARRATOR The components of PrEP (tenofovir and emtricitabine) have been studied extensively and are considered safe. In the 5 major studies of PrEP, the adverse event rates were similar between PrEP and placebo. Statistically significant effects with PrEP in men were unintentional weight loss which occur in 0.8 cases per 100 useryears with a number needed to harm of 96. There were no serious, irreversible events in the studies. PREVENTING HIV IN PRIMARY CARE 41 Decreased creating clearance has been seen with the current tenofovir formulation in some patients. However, this is reversible and has not been progressive. Management consists of monitoring serum creatinine. Bone mineral density loss is associated with PrEP use in HIV-negative men, but there have been no associated fractures and no additional monitoring is recommended. The most common side effect of PrEP has been GI upset with nausea being cited the most. This usually resolves in less than one month. RESISTANCE VOICE Does taking PrEP increase the chance of developing resistance? NARRATOR During studies, patient's who seroconverted after enrollment did not show resistance to either component of PrEP. There was some resistance seen in patients who were in the PrEP arm and seroconverted prior to enrollment. Because of the window period in HIV it was possible for patients to be HIV+, but still have a negative HIV result. If a patient is HIV+ and begins to take PrEP (an incomplete HIV treatment regiment) they could develop resistance. Usually resistance initially occurs in one component of a treatment regimen, leaving several other antiviral treatment options available to achieve viral suppression. Resistance to one of the components of PrEP that was in seen 8 patients in multiple trials who were already infected with HIV at enrollment should be weighed against the numbers of HIV infections prevented in those trials. RISK COMPENSATION VOICE If I prescribe my patients PrEP, will they be at greater risk for other STIs and HIV? NARRATOR PREVENTING HIV IN PRIMARY CARE 42 In both placebo controlled and real world studies of PrEP STI rates have not increased. Condom usage has not decreased, even in open label studies. In several studies, the number of reported sexual partners has decreased. Overall, studies have not shown risk compensation in MSM who are taking PrEP. This should not factor into a decision to not prescribe PrEP. COST EFFECTIVENESS VOICE PrEP seems expensive and condoms are cheap, is it really cost effective for me to prescribe PrEP instead of safer sex education? NARRATOR PrEP is cost-effective when it is prescribed to patients at high-risk for HIV infection. The incidence of HIV in high-risk MSM is increasing, despite comprehensive population-based prevention education and condom promotion. Without any changes to our current prevention paradigm, in the next 20 years this population is estimated to have 500,000 new HIV infections. The cost effectiveness of PrEP in patients at lower risk has not been proven. When PrEP becomes generic, it is estimated that it will be cost effective to offer PrEP to lower risk individuals. JAMES' FOLLOW-UP VOICE So, who is high risk then? NARRATOR That's next, but first let's check back in with James. He's back in clinic for his three-month follow-up. He is undergoing asymptomatic STI screening. His risk behaviors have not changed substantially, although he has decreased his alcohol usage. He heard about PrEP through some acquaintances and asked if he could have a prescription. His PCP had not used it in clinic and did not feel comfortable prescribing it. He recommended that James follow-up with the large infectious disease clinic in town to receive the medication. PREVENTING HIV IN PRIMARY CARE 43 JAMES'S PCP office submitted a referral for James, who heard back from the ID clinic two weeks later. Their first available non-HIV appointment was in three months. PATIENT SELECTION VOICE OK, but who is high-risk? How do we define this? NARRATOR Identifying appropriate patients that can benefit from PrEP can only be done with open and honest communication between you and your patient. You should ask a thorough sexual history which includes: Partners, practices, protection from sexually transmitted infections, past history of sexually transmitted infections, and if applicable, prevention of pregnancy. The CDC 2014 clinical practice guidelines recommend PrEP use in these high-risk patients: Men who have sex with men: Adult, without acute or established HIV infection, with any male sexual partners in the past 6 months, who is not in a monogamous partnership with a recently tested HIV negative male AND at least one of the following: • • • Any anal sex without condoms in the past 6 months Any STI diagnosed or reported in the past 6 months Is in an ongoing sexual relationship with an HIV+ male partner Heterosexual M/F adult, without acute or established HIV infection, who has any sex with an opposite sex partner in the past 6 months and is not in a monogamous partnership with a recently tested HIVnegative partner: AND at least one of the following: • • • Is a man who has sex with both women and men Infrequently uses condoms during sex with one or more partners of unknown HIV status who are known to be at substantial risk of HIV infection (IV drug users or bisexual male partner) Is in an ongoing relationship with an HIV-positive partner PREVENTING HIV IN PRIMARY CARE 44 IV drug user adult, without acute or established HIV infection, who has injected drugs not prescribed by a clinician within the past six months AND at least one of the following: • • • Any sharing of injection or drug preparation equipment in the past 6 months Been in a methadone, buprenorphine, or suboxone treatment program in the past six months Has risk of sexual acquisition (MSM or Heterosexual evaluation) ACT IV HOW TO PRESCRIBE VOICE OK, great. I've identified some patients who could benefit from PrEP. How is PrEP prescribed? NARRATOR PrEP should be prescribed as part of a comprehensive HIV prevention package including condom promotion, STI screening, and risk reduction. It is written as an oral daily dose of tenofovir/emtricitabine for a maximum of 90 days. Take one pill at the same time every day. However, we're getting a little ahead of ourselves here. JAMES SEE SPECIALIST NARRATOR James was finally able to get in to see an infectious disease specialist after a three month wait. The ID team is very familiar with PrEP and utilized a CDC screening tool to assess James HIV risk. Any score of 10 or greater indicates an especially high risk of HIV infection and PrEP would be indicated. The tool can be filled out by the patient prior to the visit. Age is a big risk factor as is unprotected receptive anal sex. The tool also asks about drug use, a known predictor of HIV infection risk. PREVENTING HIV IN PRIMARY CARE 45 James is 24 years old and has had unprotected receptive anal intercourse more than once in the past six months. His risk analysis score is 18 and it's appropriate to continue to evaluate him for PrEP. PRE-PREB LABS NARRATOR There are labs that need to be completed prior to initiating or reinitiating PrEP. First, evaluate for acute HIV infection. You should suspect acute infection in patients with known recent exposure and viral syndrome within the past month or on the day of testing. Viral syndrome symptoms include fever, fatigue, myalgia, rash, headache, pharyngitis, adenopathy, arthralgia, night sweats, and diarrhea. In patients with this presentation and a negative HIV test, you can retest for HIV in one month and defer PrEP until then or obtain an HIV AB/antigen assay or HIV-1 viral load assay. A testing algorithm is included in resources. For patients without suspected acute HIV infection, document a negative HIV antibody test completed within one week of initiating PrEP. This can be a serum HIV EIA. Also acceptable for documenting a negative HIV status is an FDA approved rapid, point of care finger stick blood test. This is a list of CDC recommended HIV tests and is available from the CDC website and under resources on this site. An oral rapid test is not acceptable documentation of negative HIV status. You should not accept anonymous or patient reported test results. PREPREP LABS (Cont.) Screen your potential PrEP patients for hepatitis B and C. There is an increased risk of hepatitis B and hepatitis C in the MSM population and in IV drug users. Both components of PrEP are active against HBV and stopping PrEP in someone with HBV can potentially reactivate the infection causing liver damage. This has not been seen in HIV uninfected users. Document the immunity titer results of either a prior vaccination or natural infection and offer vaccination for a negative HBV screen. Patients beginning PrEP should have their serum creatinine check and have an estimated creatine clearance of ≥ 60 ml/min using the CockcroftGault formula. PREVENTING HIV IN PRIMARY CARE 46 You should complete a pregnancy test for women who can become pregnant. EDUCATION NARRATOR Patients should be educated to take PrEP everyday. Taking it at the same time everyday will improve adherence. Not taking PrEP everyday increases the chance of HIV infection. PrEP is not 100% effective and patients should use condoms when engaging in sexual activities. PrEP does not protect against other types of sexually transmitted infections like herpes, gonorrhea, or chlamydia. PrEP by itself cannot treat HIV. Patients should not share PrEP with other people. If a person is HIV-positive and takes PrEP for more than a few weeks, they can develop resistance to this class of medication. You should go over signs and symptoms of acute HIV infection with your patient. If your patient is on PrEP and suspects they have an acute HIV infection, they should return to clinic to have additional blood work. Your patients must agree to be seen at least every 3 months for repeat HIV screening. You should stop PrEP if tests are positive for acute HIV infection. Patients can take PrEP with or without food. Some people who take PrEP have an upset stomach or headache. These symptoms usually go away in less than a month in those people who are affected. Most people are able to tolerate the medication without stopping it. Co-administration of acyclovir, valacyclovir, aminoglycosides, high-dose or multiple NSAIDs or other renal function reducing drugs may increase serum concentration of these drugs or tenofovir. Monitor for dose related renal toxicities if the patient takes any of these medications concurrently. If the patient misses a dose of PrEP then they should take it as soon as they remember unless it almost time for the next dose. In that case, they would skip the missed dose and continue with their regular schedule. PrEP can be discontinued at any time, but will not provide protection against HIV once it is stopped. You should document your patient's HIV status at that time, the reason for stopping, and what the patient reported as their PrEP adherence and risk behaviors. PREVENTING HIV IN PRIMARY CARE 47 FOLLOW UP NARRATOR At least every 3 months, you should repeat HIV testing and assess for signs and symptoms of acute HIV infection. Document your patient's HIV negative status. Refill prescription for PrEP with no more than a 90-day supply. Discuss patient's questions regarding treatment, side effects, adherence, and risk of HIV infection. You can improve your patient's adherence by education on side effect management. Explain the adherence/efficacy relationship in simple terms and identifying barriers to adherence. When taken as a daily dose, PrEP can by 99% effective in preventing HIV. If taken four times a week, efficacy drops to 96% and to 76% at 2 doses (on average) per week. Repeat pregnancy tests for women who may become pregnant. At least every 6 months, you need to monitor your patient's creatine clearance and screen for STIs in sexually active adults. STI screening should include rectal and pharyngeal GC/CT in patients engaging in oral or anal intercourse. If a patient's serum creatinine is increasing, this is not a reason to stop PrEP. As long as the GFR remains ≥ 60 ml/min, the patient is still a candidate for PrEP. However, a declining GFR may indicate a need for further evaluation of renal health threats unrelated to PrEP, for example diabetes or hypertension. These patients may require more frequent monitoring. At least annually, you should re-evaluate your patient's need for PrEP as an additional tool to prevent HIV infection. In addition to the MSM risk index, the CDC has an interactive HIV risk estimator. The link is provided under resources on the site. SPECIAL POPULATIONS VOICE What about PrEP for older adults? NARRATOR PREVENTING HIV IN PRIMARY CARE 48 There are special populations where it may be appropriate to offer PrEP. Some populations may require collaboration with another specialty. For patients in serodiscordant relationships who are trying to conceive, PrEP may be an option. Expert consultation is recommended. HIV infection risk increases during pregnancy. PrEP is approved for use in HIV-negative women who are pregnant, however safety data information on the fetus is limited in HIV uninfected women. No adverse effects on the fetus have been observed in HIV-positive women taking the components of PrEP. Expert consultation is recommended. Patients who test positive for hepatitis B surface antigen should be comanaged with an infectious or hepatic disease specialist and PrEP should not be initiated until then as there are special considerations when stopping PrEP in these patients. Patients who have chronic renal failure are not appropriate for PrEP. Older adults, with adequate renal function, who are high risk for HIV, should be considered for PrEP. Condom use is lower in older adults due to less perceived risk and inability to use a condom. COST VOICE All right, let's talk some numbers. Will my patients be able to afford this? NARRATOR PrEP is covered by most insurances and MEDICAID. There have not been any reports of denial for PrEP, although your patients may need preauthorization. They will also have to pay the co-pay for a branded medication. Gilead Sciences, the maker of the only approved PrEP formulation does offer co-pay assistance program that covers up to $3,600 annually regardless of income. There is also a patient assistance program for patients without insurance, which is income dependent. RESOURCES VOICE PREVENTING HIV IN PRIMARY CARE 49 This is a lot of information and I have some specific questions. How can I access this information? NARRATOR On the resources tab on this website, you can access the CDC Practice guidelines, Provider supplement, common billing codes, the MSM index, links to the CDC risk assessment, and more. There is a patient/provider check-list you can use in your office for your patients on PrEP. Patient education on PrEP is also available. You can also contact the PREPLINE of the AIDS Education and & Training Center Program at (855) HIV-PREP or [phone] or your local AETC office. CONCLUSION VOICE Wait a minute. What about James? NARRATOR First, you should know that while "James" is not a specific patient, he is based on actual patient experiences. When James was tested for HIV at the ID clinic, he did not have any signs of acute HIV infection. However, sometime in the 3 months between his last primary care appointment and his most recent HIV test, he seroconverted to become HIV-positive. At that point, James was no appropriate for PrEP. He went on a single-pill three-drug anti-HIV regimen and has an undetectable HIV virus load with a normal CD-4 count. Could this have been prevented if James had been able to access PrEP earlier? We can't say for sure. However, the fact is that PrEP reduces a high-risk patients chance of HIV infection. Out current prevention paradigm for HIV prevention is not effective in our highest risk patients. We can and should do more. PREVENTING HIV IN PRIMARY CARE PrEP is appropriate for primary care providers to prescribe to their patients. For future consideration, as PrEP becomes generic, it will potentially be cost effective to also treat lower risk patients. 50 PREVENTING HIV IN PRIMARY CARE Appendix E Test Your Knowledge Questions After 1st Video 51 PREVENTING HIV IN PRIMARY CARE 52 1. Which medications make up the components of PrEP? (Select all that apply) efavirenze abacavir tenofovir ritonavir emtricitabine *tenofovir is a nucleotide reverse transcriptase inhibitor (NtRTI) and emtricitabine is nucleoside reverse transcriptase inhibitor (NRTI) 2. In the U. S., men who have sex with men have the greatest risk for HIV infection. True False *The MSM population accounts for approximately 60% of new HIV infections, part of this is that unprotected anal intercourse is the highest non-blood transfusion risk activity. After 2nd Video 3. In the iPrEx study, subjects with detectable serum drug levels of (FTC - TDF) had an risk reduction for HIV infection of: 44% 86% 92% 73% * In the iPrEx study, subjects who has detectable drug levels of FTC-TDF had a risk reduction of 92%. On an intent to treat basis, which includes people who dropped out or were not adherent, the overall risk reduction was 44%. For patients who reported taking PrEP more than 90% of the time, the efficacy was 73% - regardless of serum drug levels. 4. The authors of the FEM-PREP study suggested ____ and ____ may have contributed to the lack of efficacy seen in heterosexual women studied. (select all that apply) Low perceived risk of HIV infection Stigma of being in a trial Low socioeconomic status Pill adherence *Reported use of PrEP in subjects was 95%, but over 70% of subjects who seroconverted did not have measureable serum drug levels (10 ng/mL) at either end of the HIV virus window period. After 3rd Video 5. The most common side effect seen with PrEP use is/are: PREVENTING HIV IN PRIMARY CARE 53 Myalgia GI upset Rash Headache *GI upset is the most common side effect, most patients are able to tolerate the medication and symptoms usually resolve. In the five major PrEP studies, adverse event rates were similar between PrEP and placebo. 6. Serum creatinine levels can increase during PrEP use indicating a decrease in kidney function, what is the minimum GFR for a patient taking PrEP? No minimum, PrEP has not effect on the kidneys 60 30 75 *A patient taking PrEP should maintain a GFR of 60 ml/min as the TDF component can cause reversible decreased creatinine clearance. Co-administration of renal function reducing drugs should be used in caution in patients with decreased creatinine clearance. A persistent decrease in CrCl should be investigated to rule out other causes. PrEP is contraindicated in renal failure. 7. All of the following sexually active, adult, non-monogamous, HIV negative MSM patients are recommended for PrEP use EXCEPT: Reported positive chlamydia test 3 months ago Uses parental recreational drugs on the weekend during sex and reports intermittent condom use Spouse has an undetectable HIV viral load All of these patients are recommended for PrEP After 4th Video 8. PrEP can be dosed PRN. True/False True False *PrEP is 99% effective when taken on a daily basis. Efficacy rates decrease with each reduction in daily use. Daily dosing with consistent condom use is the CDC recommendation. The IPERGAY study did examine demand dosing of 2-24 hours prior to sex, one pill on each day of sex, and one pill the day after the last exposure with promising results; demand dosing is not recommended at this time. 9. An initial work-up for PrEP initiation must include: Metabolic panel - including renal function Oral POC HIV test HbA1c Quantiferon gold test *Renal failure is a contraindication for PrEP and Oral POC HIV tests cannot be used to screen for HIV prior to PrEP use. PREVENTING HIV IN PRIMARY CARE 10. Patients who test positive for HIV while on PrEP should continue daily dosing and be referred to an HIV provider as soon as possible. True/False True False *PrEP is comprised of an NtRTI and NRTI, which are 2 components of a 3 drug minimum regimen for HIV treatment. Prolonged use of PrEP in a patient who has HIV infection will increase the risk for resistance to one of the components of PrEP. Patients should know the symptoms of acute HIV infection and come to clinic if they experience those symptoms for additional testing. Patients MUST commit to follow-up every 90 days. Do not prescribe PrEP for more than 90 days. 54 PREVENTING HIV IN PRIMARY CARE Appendix F Feedback Questionnaire Although optional, please complete this evaluation form prior to proceeding to your certificate 55 PREVENTING HIV IN PRIMARY CARE 1. The online format was appropriate for the subject matter and I was able to complete and access all components of the activity Strongly agree Agree No opinion Disagree Strongly Disagree 2. As a result of my participation in this activity, I am better able to: • Identify patients who are appropriate candidates for PrEP Strongly agree Agree No opinion Disagree Strongly Disagree • Discuss PrEP indications and contraindications Strongly agree Agree No opinion Disagree Strongly Disagree • Discuss the efficacy of PrEP in high-risk patients Strongly agree Agree No opinion Disagree Strongly Disagree • Discuss the monitoring and safety parameters for patients on PrEP Strongly agree Agree No opinion Disagree Strongly Disagree 3. The content was provided objectively and without commercial bias Strongly agree Agree No opinion Disagree Strongly Disagree 4. The material was organized to promote learning Strongly agree Agree No opinion Disagree Strongly Disagree 5. The speaker, Philip Howland BSN, RN was knowledgeable and effective Strongly agree Agree No opinion Disagree Strongly Disagree 6. The content learned will impact my practice and patient outcomes Strongly agree Agree No opinion Disagree Strongly Disagree 7. I would recommend this activity to my colleagues Strongly agree Agree No opinion Disagree Strongly Disagree 8. The activity enhanced my current knowledge base Strongly agree Agree No opinion Disagree Strongly Disagree 9. What recommendations would you like to share? ___________________________ 56 PREVENTING HIV IN PRIMARY CARE Appendix G Website Pages 57 PREVENTING HIV IN PRIMARY CARE 58 PREVENTING HIV IN PRIMARY CARE 59 PREVENTING HIV IN PRIMARY CARE 60