PrEP (and PEP) for trans* people in rural communities Cory Frederick, M.Ed. Mozaic Program Manager
Disclosures The speakers and members of the planning committee do not have a conflict of interest in this topic. There is no commercial support for this program.
Survey Cory Frederick, M.Ed. Mozaic Program Manager
1 in 4 transwomen 50x more likely 20% AA transwomen
Research and data Overall HIV decline PrEP and PEP Not targeting TGNC
Barriers to care Transphobia Stigma Economic Access Informed providers
Additional barriers Transmen under-researched Rectal vs vaginal tissue (PrEP) Hormone interactions Screening for pregnancy Screening for STIs
Survey Cory Frederick, M.Ed. Mozaic Program Manager
Ways to improve Professional development Gender-affirming language Community outreach
PrEP and PEP for Providers Preventing HIV in the 21 st Century Randle Moore, III PreventionSupervisor, Equitas Health
Mission Our mission is to deliver highquality patient-centered, accessible, cost-effective, and timely primary health care to all; provide highimpact prevention, health, and wellness services; and be the gateway to good health for those at-risk of or affected by HIV/AIDS, for the LGBTQ community, and for those seeking a welcoming healthcare home. Core Values Cultural Competency We have the cultural awareness to provide competent care to nontraditional genders, various gender identifications, sexual orientations, and gender expressions. Relationship Oriented We allow our providers to spend more time with patients. This gives them the opportunity to listen to the patients concerns, build a relationship, and build competency in treating the patient with a person-centered approach. Multi-Disciplinary Through our network of facilities and expertise, we can address the full needs of patients, offering services in the fields of medical, social, and behavioral care. Respectful and Reaffirming We are affirming and safe. We offer a no-judgment zone. Inclusive The breadth and depth of our services will be greater and we will be able to serve anyone in the community in addition to those at-risk or living with HIV/AIDS. Forward Thinking We stay at the forefront of evolving medical approaches, technology, and treatment to meet the changing needs of our community. EquitasHealth.com
The production of this presentation was partially supported by funding from Gilead Sciences, Inc.
Objectives 1. HIV update 2. What is PEP? 3. What is PrEP? 4. Access Barriers 5. Stigma 6. Resources/Opportunities
Goals 1. Open, honest, and safe dialogue 2. Look at intersections of race, class, identity, and orientation 3. Begin a conversation 4. Gain knowledge and resources
The Care Continuum Achieving Viral Suppression ART can help a person reach viral suppression Reduces transmission and prolongs life Remaining engaged in care is one key to success +2/3 of new infections come from those out of care
HIV in the U.S. Good HIV diagnosis rate has dropped 19% since 2005 63% among people who inject drugs 40% among women Bad Huge disparities for men who have sex with men (MSM) +22% for Black men +24% for Latino men +87% for Black and Latino youth (13-24) Trans women - ~50x more likely CDC HIV Stats Overview: Estimated New HIV Infections in the United States, 2014, for the Most Affected Subpopulations
Lifetime Risk for HIV Infection MSM BLACK MSM LATINO MSM WHITE MSM 1 in 2 1 in 4 1 in 11 HIV- 50% HIV+ 50% HIV + 25% HIV + 9% HIV- 75% HIV- 91% CDC 2016
What is PEP & PrEP? New Methods of Biomedical Prevention
Plan B for HIV Post-Exposure Prophylaxis May prevent HIV after a single high-risk event of potential HIV exposure (condomless sex, needle sharing, sexual assault) PEP must begin within 72 hours of exposure PEP is not 100% effective, but the quicker it is started, the better CDC Newsroom Fact Sheet: PrEP for HIV Prevention, 5.16.2014
PEP Regimen 28 day full HIV-treatment regimen Initial HIV test Follow-up testing at 4 and 12 weeks Side-effects on uptake may be moderate to severe Consider moving to PrEP if risks are likely to continue ICD10 Dx code: Exposure to HIV CDC: recommended & alternative therapies
PEP for Victims of Sexual Assault When deciding to recommend PEP, clinicians should assess for: 1. Whether or not a significant exposure has occurred during the assault 2. Knowledge of the HIV status of the alleged assailant 3. Whether the victim is ready and willing to complete the PEP regimen Significant exposure: direct contact of the vagina, penis, anus, or mouth with the semen, vaginal fluids, or blood of the alleged assailant, with or without injury, tissue damage, or presence of blood. Potential Barriers: Accessing assistance programs Side effects Willing pharmacy Insurance/privacy concerns
When Is PEP Right? Was sex consensual? Was there a condom used? If so, did it break? Did they patient bottom or top? Do you know the HIV status of those involved? Have they used PEP in the past year? Have any partners been treated for an STI recently? Were alcohol and/or other drugs involved?
Screening PEP Process Flow 2 weeks 4 weeks 12 weeks First Visit: Assessment Sexual Risk Assessment SAFE kit? Basic medical history, exam PEP Basics: How it works, adherence, side effects, Labs: HIV, STI, safety (Renal, HBV) Navigation/support services if offered Dispense 28-30 tablets, call ahead to pharmacy Refer out for f/u if needed Phone call or nurse consult Assess adherence Side effects Acute infection? Patient Assistance Programs: www.fairpricingcoalition.org Follow-Up Symptom review Acute infection? Assessment, counseling: Behavior, safety HIV, STI testing Renal function PrEP Recommendation? Adapted from Test-to-PrEP, SFDPH & CPN, webinar, August 2016
Pre-Exposure Prophylaxis Any medicine that someone takes to prevent something from happening before a potential exposure (like birth control) The Lowdown on PrEP Prevents HIV before a potential HIV exposure. When taken daily as prescribed, PrEP has been shown to be 92-99% effective in preventing HIV infection Missed doses can reduce effectiveness an average of 5x/week results in highest level of protection
Those taking PrEP can use other effective strategies to further minimize risk, including; Combine with Other Tools Use condoms consistently and correctly Get tested with partners (ohiv.org) Choosing less risky behaviors (oral sex) Accessing drug treatment programs or sterile equipment if injection drug user CDC Newsroom Fact Sheet: PrEP for HIV Prevention, 5.16.2014
The Drug Currently, Truvada, made by Gilead, is the only medication prescribed for PrEP Other drugs are being researched Truvada is a two-drug component of a three-part HIV treatment regimen (old drug, new tricks) Emtricitabine (FTC) and Tenofovir (TDF) Works by preventing replication of HIV. If HIV can t replicate, it dies. Common in Antiretroviral Therapy, but not enough to treat HIV! No known drug, hormone, or testosterone interactions About 1-3 weeks to reach full protection CDC Newsroom Fact Sheet: PrEP for HIV Prevention, 5.16.2014
Treatment Regimen Once-daily, with or without food Every 3 months Monitor kidneys HIV and STD testing Behavioral health counseling Risk reduction Treatment adherence Assessment and management of side effects Side effects: minimal and temporary ~9% report nausea ~4% headaches ~2% weight loss Knowing your status is as simple as one pill a day. Let s be real everyone should be on this. Continue until risk is no longer present ICD10 Dx Code: Contact with and suspected exposure to other viral communicable diseases; high-risk sexual behavior Jay
Effectiveness at Protecting Against HIV The Research Bangkok Tenofovir Partners PrEP TDF2 iprex PROUD 0 10 20 30 40 50 60 70 80 90 100 Overall Efficacy Risk Reduction with Strict Adherence Bangkok Tenofovir for IDUs, Thailand; Partners PrEP for discordant couples, Uganda, Kenya; TDF2, heterosexual women and men, Botswana; iprex MSMs, US, Thailand, South Africa; Fem-PrEP for high-risk women, adherence too low to assess, Africa
San Francisco STRUT Clinic STIs between 10-20% testing or behavior change? Frequency did not increase over time STIs indicate high-risk population and effective HIV prevention! Some condom use decreased over time 92% reported condomless sex at initiation 1195 individuals (mostly MSM) on PrEP since 2014 0 new HIV diagnoses Majority reported no increase in number of sexual partners NATAP Report, International AIDS Conference, Durbin, South Africa 2016
Screening* PrEP Process Flow Start* (1 week) 4 weeks 12 weeks 24 weeks 36 weeks 48 weeks First Visit: Assessment Sexual Risk Assessment Basic medical history, exam Acute infection? PrEP Basics: How it works, adherence, side effects, Labs: HIV, STI, safety (Renal, HBV) Navigation/support services if offered Repeat HIV test Review PrEP basics Dispense 30 or 90 tablets Follow-Up Symptom review Acute infection? Assessment, counseling: Behavior, adherence HIV, STI testing Renal function 90 tablets *Same-day screen/start if: Rapid, 4 th gen RNA pending Unlikely acute infection Adapted from Test-to-PrEP, SFDPH & CPN, webinar, August 2016
CDC HIV Testing Recs Document nonreactive antibody test within ONE week prior to starting/restarting PrEP, and every 3 months on PrEP Lab-based antibody (EIA) on blood or Rapid FDA approved finger stick antibody NOT oral rapid antibody test NOT patient self-reported test NOT anonymous test Standard confirmatory testing, CD4, viral load if antibody-reactive If acute HIV suspected, delay PrEP, send RNA USPHS: Preexposure Prophylaxis For the Prevention of HIV Infection in the United States- 2014: A Clinical Practice Guideline
Detecting Acute Infection Patients are antibody (-) during acute HIV infection, and are Highly infectious biologically Highly infectious behaviorally A substantial proportion of all infections thought to be acquired from a partner with acute infection Acute infection often asymptomatic Patients with HIV infection (acute or chronic) need three drugs to suppress their virus and prevent resistance mutations Starting PrEP (2 drugs) in someone who has acute HIV infection (antibody negative) can lead to selection of drug resistance mutations, requiring more complicated therapy Adapted from Test-to-PrEP, SFDPH & CPN, webinar, August 2016
Case Study 23yo woman just found out her bf has had sex with other men without her consent Boyfriend says he s clean. She has no other partners Conflicted about how to proceed with the relationship She uses Nexplanon for birth control Last intercourse was last night Has heard about this new PrEP thing Wants HIV testing Adapted from Test-to-PrEP, SFDPH & CPN, webinar, August 2016
Recommend PEP (to PrEP?) PEP Has significant risk for HIV and other STIs Last exposure within 24 hours Adherence, risk reduction counseling Needs referral BH counseling Recommend testing of partner PrEP If relationship is maintained, ongoing risk present Recommend PrEP for both partners if both HIV negative Continued adherence, risk reduction
When Is PrEP Right? Is your primary sexual partner HIV+? Have you bottomed without a condom recently? Have you been treated for an STI in your butt? Have you used PEP more than once in the past year? Have you or your partner been in prison? Do you or your sex partners use alcohol and/or drugs heavily? Do you or your sex partners exchange sex for money, housing, drugs/alcohol, or other things? Has your partner every threatened or forced you to have sex against your will? Do you know what consent means? Are you afraid to ask your partner to use condoms?
Why PrEP? Who is it for? CDC Vital Signs Report, 2015
Access Barriers Cost is the greatest perceived barrier to PrEP but Patient assistance programs are available Usually covered under insurance or Medicaid Not all labs are required
Access Barriers Stigma and awareness are the greatest barriers to PrEP and PEP utilization Only 1 in 3 medical providers report knowledge of PrEP Not all who do are willing to prescribe PrEP suffers from stigma at every turn Gay community Straight community Health professionals
Access Barriers Knowledge/Information Reaching which communities? Misinformation has created confusion/distrust Messaging must be destigmatizing and informational
Access Barriers Social Determinants of Health Factors that influence adherence, ability to pay, navigate complex systems, arrive to appointments Minority Stress in Health Systems Lack of cultural competency and exploitation in health systems has led to hesitancy/caution Privacy Many youth on parent or guardian s health insurance
Why PrEP? ~50,000 new infections each year since the 90s Study found that 40% uptake in key populations would reduce new infections by a third. http://www.washingtonpost.com/blogs/wonkblog/files/2013/04/new-hiv-infections.jpg; Journal of Infectious Diseases, Jules Levin, July 2016
Why PrEP? PrEP works 130 = # of people taking statins to prevent one cardiac event 13 = # needed to take Truvada to prevent one HIV infection. PrEP works even if you miss a dose, condoms don t PrEP is discreet doesn t involve negotiation PrEP destigmatizes HIV by bridging the gap for + & - people New HIV statuses?
Available Resources Statewide Online Resources: 0hioprep.org PrEP 101 Provider Registry For any need, email PrEP@equitashealth.com Columbus Region Randle Moore randlemoore@equitashealth.com Other PrEP Resources: Ohiv.org free mail-order condoms, STI questions, etc. Projectinform.org PrEP information booklets Clevelandprep.com Regional resource NE Ohio Get Involved: OhioPrEP on Facebook Ohio PrEP Working Group FAQs Get Help
Questions? For questions about the presentation slides, content, or to access the slides contact: Randle Moore randlemoore@equitashealth.com