Arizona AIDS Education & Training Center Infectious Disease, University of Arizona Sascha Bianchi, MPH PEP Coordinator Britt Nigon, MPH Program Manager HIV Post-Exposure Prophylaxis (PEP) 2 "This presentation is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $3,278,366. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS or the U.S. Government." The views and opinions expressed in this presentation are not necessarily those of the Pacific AIDS Education and Training Centers (PAETC), the Regents of the University of California or its San Francisco campus (UCSF or collectively, University) nor of our funder the Health Resources and Services Administration (HRSA). Neither PAETC, University, HRSA nor any of their officers, board members, agents, employees, students or volunteers make any warranty, express or implied, including the warranties of merchantability and fitness for a particular purpose; nor assume any legal liability or responsibility for the accuracy, completeness or usefulness of information [,apparatus, product] or process assessed or described; nor represent that its use would not infringe privately owned rights. Disclaimer ? WHO Who we are 3 Medical care for People with HIV Prevention through Pre- and Post- Exposure Prophylaxis WHAT What we do 4 WHY Why we're in this training 5 HOW By the end of this session, participants will be able to: Explain basic HIV concepts and terms Understand and describe what PEP is Describe the types of exposures that warrant PEP medication Understand PEP initiation and follow-up processes Identify resources to help patients access PEP medication How advocates can help 6 Learning Mindset We all come from different experiences and lenses of the work. This is a space to ask questions, get guidance, and learn from each other. No one is expected to leave as an expert in HIV care, PrEP, or nPEP. Take what is useful. Arizona AETC Provide healthcare professionalswith the knowledge and skills necessary to provide outstanding care to people with or at risk for HIV. Educational programs about HIV infection for healthcare professionals Clinical training at HIV patient care sites Timely updates to health care professionals on HIV-related treatment and care issues Information about HIV service programs and resources Petersen HIV Clinic State of the art medicine with a small clinic feel' Clinic Profile HIV Medical Providers: 10 HIV Program Staff: 18 HIV Patients: ~865 PrEP Patients: ~200 nPEP: >300 (7-14/month) Maybe not necessary since we are short on time I don't think we need to talk about our funding sources. Just who we are HIV in the United States 1.2 million people with HIV 1 in 7 people are unaware of their HIV infection Southern states bear the greatest burden of HIV, accounting for 50% of new infections in 2014. From 2008to 2014, the estimated number of annual HIV infections in the U.S. declined 18%. In 2016, there were 39,782 new diagnoses From 2008to 2014, the estimated number of annual HIV infections in the U.S. declined 18%. Gay and bisexual men, particularly young African American gay and bisexual men, are most affected. The same group of young men and women (age 1825) most at risk for sexual assault are also the fastest growing groups contracting HIV (El-Bassel, Cadeira, Ruglass & Gilbert, 2009;Greenwood et al., 2002;Petroll, Hare & Pinkerton, 2008). 10 5 counties 23,071 square miles Total People with HIV in Arizona: 18,190 Total People with HIV in Southern Arizona: 3,186 Pima 2,863 Cochise 228 Santa Cruz 53 Graham 35 Greenlee 7 Total Ryan White Service Providers: 4 UA's Petersen HIV Clinic El Rio SIA Southern Arizona AIDS Foundation Pima County Health Department Total UA Petersen Clinic patients: +/- 865 HIV in Arizona Total People Living with HIV/AIDS in Arizona: 17,464 Total People Living with HIV in Southern Arizona Pima 2,611 Santa Cruz 50 Cochise 228 Graham 32 Greenlee Counties 7 TOTAL = 2,793 approximate Total Ryan White Service Providers: 3 UA's Petersen HIV Clinic El Rio SIA Southern Arizona AIDS Foundation Total UA Petersen Clinic patients: +/- 1000 11 HIV Basics 12 HIV Overview 5-5-5 Blood Semen (pre-cum) Vaginal Fluid Breast Milk Rectal Fluid 5 fluids containing HIV Condomless Sexual Activity (Anal, Vaginal, Oral) Sharing IDU syringes/works Vertical Transmission Blood Transfusion Occupational Exposure 5 routes of transmission 5 conditions for transmission 13 5 conditions for transmission 1. 2+ people 2. At least one person HIV+ 3. One of the 5 fluids present 4. Pathway into the bloodstream 5. Activity to get fluid into bloodstream 14 CD4 Count: Want this number to be high Viral Load: Want this number to be low HIV/AIDS Basics Before we discuss how to prevent HIV, let's talk about what it is" 15 HIV/AIDS Basics Fluids that CAN transmit HIV Blood And Visibly Bloody Body Fluids Semen Vaginal Secretions Cerebrospinal Fluid Synovial Fluid Pleural Fluid Peritoneal Fluid Pericardial Fluid Amniotic Fluid Fluids that CANNOT transmit HIV Feces Nasal Secretions Saliva Sputum Sweat Tears Urine Vomitus 16 Acute HIV Infection 40-90% develop symptoms of acute HIV Usually begin 2-4 weeks after exposure Acute HIV symptoms are often missed. Emphasize importance of sexual history 17 Percutaneous (blood) Mucous membrane exposure 0.3% 0.09% Receptive anal intercourse 0.3 - 3% Insertive anal intercourse 0.06% Receptive vaginal intercourse 0.1 0.2% Insertive vaginal intercourse 0.03 0.14% Receptive oral (male) 0.06% Female-female orogenital 4 case reports IDU needle sharing 0.67% Vertical (no prophylaxis) 24% Exposure Risks (average, per episode, involving HIV-infected source patient) 18 Receptive anal intercourse 3 out of 100 Receptive vaginal intercourse 1 out of 1000 Needle sharing about 6 or 7 out of 100 Vertical (mother child, no intervention) 1. Bell DM. Am J Med 1997;102(suppl 5B):9--15. 2. Ippolito G et al. Arch Int Med 1993;153:1451--8. 3. Am J Epidemiology 1999;150:306-11. 4. Am J Epidemiology 1999;150:306-11. 5. MMWR 47;RR-17, 1998. 6. NEJM 336(15):1072-8. (rates in Europe & U.S.) 7. Am J Epidemiology 1999;150:306-11. 8. Rothenberg RB et al. AIDS 1998;12:2095-2105. 9. MMWR 47;RR-17, 1998. 10. ACTG 076 HIV Testing 19 With the most recent HIV tests, how soon can the virus be detected from the date of contraction? 36-72 hours 10-14 days 3-4 weeks 1-3 months Poll Title: With the most recent HIV tests, how soon can the virus be detected from the date of contraction? 20 4th Generation HIV testing Can detect HIV as early as 2 weeks after infection Looks for HIV antibodies and something called p24 antigens Can be performed in a hospital lab HIV Prevention 22 True or False: There are pills you can take to prevent getting HIV True False . Poll Title: True or False: There are pills you can take to prevent contraction of HIV. 23 What is Post-Exposure Prophylaxis (PEP)? A 28-day course of antiretroviral medication taken AFTER potential HIV exposure. Consists of 2 pills. One pill is a combination of two medications. PEP is not effective if initiated after 72 hours PEP is an urgent request to be handled as soon as possible. 24 Post-Exposure Prophylaxis (PEP) Regimens + = or PEP Medications 25 When is PEP recommended? HIGHER-RISK Exposures Vaginal or anal intercourse with HIV+ or unknown status Needle sharing with HIV+ or unknown status Injuries with exposure to blood or other potentially infected fluids (needlestick, injuries, human bites) LOWER-RISK Exposures Oral-vaginal contact Oral-anal contact Receptive penile-oral contact Insertive penile-oral contact Factors That Increase Risk Source person is known to be HIV-infected with high viral load Oral mucosa is not intact (oral lesions, wounds) Presence of genital ulcer or STD Unprotected vaginal or anal sex with someone who is HIV infected or their status is unknown Needle sharing with someone who is infected with HIV or their status is unknown Oral sex is considered lower risk exposures Factors that increase risk viral load, oral lesions or wounds, presence of genital ulcer/ std 26 When is PEP NOT recommended? NEGLIGIBLE RISK Oral-to-oral contact without mucosal damage Examples: kissing or mouth-to-mouth resuscitation Human bites not involving blood Exposure to solid-bore needles or sharps not in recent contact with blood When to initiate PEP Risk for HIV Infection Negligible Risk < 72 hours since exposure > 72 hours since exposure Source known to be living with HIV PEP IS RECOMMENDED as soon as possible Case-by-case determination PEP NOT recommended Source of unknown status If the decision is made to administer post-exposure prophylaxis, it should be started as early as possible after an exposure Post-exposure prophylaxis is not indicated if the patient presents for care more than 72 hours after an exposure Initiating PEP Baseline Testing at Hospital HIV antigen/antibody combo test Pregnancy test for women CMP (complete metabolic panel) Hepatitis Panel Gonorrhea* and Chlamydia* Syphilis STD screening is recommended for PEP. However, in the case of sexual assault they are not necessary because patients are empirically treated. 30 Treatment options at Hospital Emergency contraception Azithromycin & ceftriaxone to prevent chlamydia, gonorrhea, and trichomonas HPV and TDAP vaccines (if they haven't already received the full vaccination) HIV Post Exposure Prophylaxis This is where you come in! Emphasize that PEP doesn't just happen. 31 Recommended PEP Regimen Tenofovir + emtricitabine [Truvada] + dolutegravir (Tivicay) or raltegravir (Isentress) Excellent tolerability Proven potency in established HIV infection Highly effective in reducing transmission if taken as prescribed Ease of administration + = or PEP Medications Many providers don't know this This is where you come in May touch on side effects we see with survivors more side effects reported (GI and sleep disturbances) could be attributed to medsbutthey have been through a trauma and prophylactically treated for everything (ceftriaxone injection, 1 gram azithromycin, flagyl, plan b, plus PEP, plus any pain killers, also may have been given rohipnol, may be sobering up from drugs/alcohol understandable that they feel very sick. Give PEP a few days before stopping. AG: agree! Seems important to mention 32 Timing is everything! *PEP is most effective when taken as soon as possible. 33 PEP Navigation Talked about who we are, HIV basics, HIV testing, HIV prevention. This section advocate role in obtain PEP therapy for survivors 34 PEP and SACASA HIV transmission during sexual assault is highly under-researched Physical trauma sustained by sexual assault survivors can contribute to increased HIV risk PEP is a harm reduction and prevention method recommended by the CDC Collaboration is key in accessing PEP The types and frequency of genital injuries sustained by sexual assault victims are typically classified in relation to tears, ecchymosis, abrasions, and redness. Each may contribute to increased HIV risk through bleeding, breaks in skin and inflammation. Reference - Klot JF, Auerbach JD, Berry MR. Sexual Violence and HIV Transmission: Summary Proceedings of a Scientific Research Planning Meeting.American journal of reproductive immunology (New York, NY: 1989). 2013;69(0 1):5-19. doi:10.1111/aji.12033. 35 PEP Process Overview TMC/ SACASA Petersen Clinics Initiate PEP within 72 hours. Conduct baseline testing. Ensure patient is able to access at least 3 days of medication. Ensure patient accesses remainder of medication. Follow-up within 1 week. Follow-up at 4-6 weeks. Initiate PEP within 72 hours Conduct baseline testing Ensure patient is able to access at least 3 days of medication Ensure patient accesses remainder of medication Follow-up within 1 week Follow-up at 4-6 weeks 36 What YOU can do Keep track of the 72-hour window Answer survivor's questions about baseline testing and side effects Ensure patient is able to access at least 3 days of medication Have the patient sign Petersen Clinic Release of Info (ROI) form and fax it to the number listed Email us to let us ensure the ROI was received. Give survivor the 3-day bridge form Initiate PEP within 72 hours Conduct baseline testing Ensure patient is able to access at least 3 days of medication Ensure patient accesses remainder of medication Follow-up within 1 week Follow-up at 4-6 weeks 37 PEP includes 28 days of medication, lab work, and follow up medical appointments Side effects are minimal and might include stomach upset, nausea or fatigue There are no permanent long-term side effects of medication Patients need follow up HIV testing at 4-6 weeks and 3 months to rule out infection Share with patient that 38 Challenges in Accessing PEP Survivor presents at local ED and is informed that unless she files police report, she is not allowed to have SAFE exam/MFE. Patient does not want to file a police report at this time, so she is not referred to TMC and the SACASA advocate is not contacted. Patient is not aware of all options and refuses PEP in ED. Patient is linked to Petersen clinic and decides to begin PEP. Narrowing PEP window and reducing PEP efficacy. Many parties involved: CBO/County Health/other care provider/internet/word of mouth providing initial PEP messages ER Urgent care PHC or PCP for follow up Pharmacy 39 True or False: A survivor must complete a SANE exam/medical forensic exam in order to be prescribed PEP and linked to the Petersen Clinic True False Challenges in Accessing PEP at the Pharmacy Survivor presents at ED, undergoes MFE and is prescribed PEP. Patient takes both PEP prescriptions to a local pharmacy but is unable to get the medication because they don't have money for their copay. Patient leaves pharmacy without medication. Many parties involved: CBO/County Health/other care provider/internet/word of mouth providing initial PEP messages ER Urgent care PHC or PCP for follow up Pharmacy Alternative comment Survivor completes SANE exam, does not take the first dose of PEP in the ED and is handed a prescription for PEP to be filled at pharmacy of choice. 41 True or False: PEP is most effective if taken every day as directed. True False When not to refer patients to Petersen Clinics When the survivor is a minor (under 18 years of age) If the exposure happened more than 72 hours ago If the patient is not interested in using PEP 43 Three Day Bridge Meds Patients who are referred to the Petersen Clinic for follow up care can get a free 3-day bridge at Banner UMC Tucson Outpatient Pharmacy 1625 N. Campbell Ave 85724 Open M-F 7-8pm, Sat.-Sun. 8-6pm Attach this note to paper prescriptions before survivor leaves TMC Copay Assistance/Free Medications Available! Release of Information "Don't say goodbye without the ROI!" Follow-Up Plan Petersen Clinics Complete the ROI form for ID referral (fax or secure email ROI to Petersen Clinic) Petersen Clinics will call patient next business day to schedule follow-up appointment Reinforce PEP discharge instructions, treatment adherence, and share availability should concerns come up before the follow-up appointment Help patient navigate patient assistance program if needed to access medications Secure email, go back to ED if no meds 47 PEP Follow-up Care at Petersen Clinic 1 Week Evaluate for acute HIV Assess for adherence and side effects Provide any necessary referrals 4-6 Weeks Lab-based HIV antigen/antibody combo CMP, STIs, Pregnancy test 3 Months Follow-up with primary care or community provider Lab-based HIV antigen/antibody combo The PEP STEPs Start PEP ASAP (within 72 hours) Three-day bridge Fill out Medication Request Form Ensure patient has both RXs plus Medication Request Form Petersen Clinic Linkage ROI Thank you! Britt Nigon, MPH Program Manager, Arizona AETC University of Arizona, Infectious Disease (520) 626-7635 [email protected] Sascha Bianchi, MPH Clinical Coordinator, Petersen Clinics University of Arizona, Infectious Disease (520) 626-9458 [email protected] 50