Providing PrEP to Connecticuts Youth A Training for Healthcare Providers Krystn Wagner MD Jay Sicklick JD October 16 2019 Faculty Krystn Wagner MD PhD Medical Director HIV and Infectious Disease ID: 772344
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Providing PrEP to Connecticut’s Youth A Training for Healthcare Providers Krystn Wagner, MD Jay Sicklick , JD October 16, 2019
Faculty Krystn Wagner, MD PhD Medical Director, HIV and Infectious DiseaseFair Haven Community Health CareJay Sicklick, JD Deputy Director; Director, Center for Children’s AdvocacyDirector, Center for Children’s Advocacy
Disclosures No disclosures
Outline of TrainingOverview of PrEPLegislative Change: Minor’s Access to PrEP (2019) Determining Eligibility for PrEPAccessing HIV RiskMedical Eligibility Clinical Protocol for PrEPCoverage for PrEP Culturally Competent Sexual Health Care for LGBTQ+ Teens
Case Presentation
Case Discussion17 year old Hispanic student requests HIV/STI testing at his school based health center Test ResultsHIV, gonorrhea and chlamydia negative Treponemal antibody positive. RPR positive 1:128 APRN refers him to you for syphilis treatment and HIV/STI prevention What will you ask this teen during the initial visit?
Sexual History: 5 P’sPast sexually transmitted infections (STI) ChlamydiaSyphilis (current)PartnersMultiple male partnersMeet partners on dating apps Sexual PracticesReceptive anal sex Pregnancy PlanPrevention of STIs/HIVCondoms not used consistently
High Risk of HIV Syphilis (CDC, 2018) 64% of reported P&S syphilis cases in men who have sex with men (MSM) 50% MSM with P&S syphilis were HIV positive Receptive anal sexHighest risk sexual activity for acquiring HIVWithout condom use
Overview of PrEP
What is PrEP?HIV pre-exposure prophylaxis ( PrEP)HIV prevention pill PrEP is an antiretroviral medicationPrEP is a once a day pill “On demand” or episodic PrEP use is currently off label When taken consistently by someone who is HIV uninfected, PrEP is nearly 99% effective in preventing sexual transmission of HIV. Also effective for persons with injection drug use PrEP is endorsed by CDC and WHO
What is PrEP?Two medications approved as daily oral pill for PrEPFTC/TDFBrand name = Truvada®2012 FDA approved as prevention for adults2018 FDA extended approval to anyone > 35kgGeneric anticipated in 2020FTC/TAFBrand name = Descovy ® 2019 FDA approved for MSM and Transgender women only
PrEP interferes with replication of the HIV virusPrEP prevents HIV from establishing a permanent infection 12345 6 7 8 9 HIV Virus CD4 Cell How Does PrEP Work? PrEP Works Here
PrEP works well (if you take it) How Well Does PrEP Work?
PrEP vs. PEP PrEP = pre-exposure prophylaxisTaken daily for undefined period to provide ongoing protection for someone with ongoing risk of exposure Started before the risk events for which it will provide protection PEP = post -exposure prophylaxis Taken daily for 28 days to prevent HIV from establishing an infection in the body once the exposure has already occurred Started within 72 hours after the risk event for which it will provide protection
Why PrEP for Youth Matters
HIV Impact on Youth 1 in 5 new HIV infections among 13-24 year olds (CDC, 2017) 75% new infections among Black and Hispanic/Latino MSM44% of youth infected with HIV have not yet been diagnosedLargest percentage (29.5%) new HIV diagnoses in CT among 20-29 year olds (DPH, 2017) Black MSM have 1 in 2 lifetime risk of an HIV diagnosis
Connecticut StatutesAdolescents have legal right to access sexual health care services without parental consent, including:HIV diagnosis and treatmentSTI diagnosis and treatmentContraceptionAbortion
Minor Access to PrEP Seventeen states have statutes that include HIV/STD prevention and PrEP for minorsConnecticut amended Section 19a-592 to include “prophylaxis” for human immunodeficiency virus infection. (effective July 1, 2019)
The New Law – How It Works “Prophylaxis” now available in addition to existing HIV treatment for minors No parental/guardian consent necessary if providers deems reasons to do so and minor consentsProvider determines parent/guardian would deny consent or minor would not seek, pursue or continue PrEP intervention Minors 12 or younger seeking PrEP who are sexually active must be reported to DCF or law enforcement
Who Pays for PrEP Medicaid Private InsuranceMinor personally liable for “care and treatment” = co-pays and deductibles Compassionate care exemption for uninsured individuals
Determining Eligibility for PrEP
What Does the CDC Suggest?MSM Any male sex partner in past 6 months and not in monogamous relationship with a recently tested, HIV-negative male.And ≥ 1 of these criteria:Bacterial STI in past 6 months (gonorrhea, chlamydia, syphilis)Any anal sex without a condom in the past 6 months HeterosexualAny sex with opposite sex partner in previous 6 months and not in monogamous relationship with a recently tested, HIV-negative partner.And ≥ 1 of these criteria:Bacterial STI in past 6 months (syphilis, gonorrhea)Sex without condom in past 6 months with partner who has higher risk of HIV (bisexual, PWID) or with an HIV positive partner.
What Does the CDC Suggest?Injection Drug UsersAny injection of drugs not prescribed by clinician in past 6 monthsAnd ≥ 1 of These CriteriaAny sharing of injection/drug equipment in past 6 monthsRisk of sexual acquisitionUS Public Health Service, 2018
What If CDC Criteria Are Not Met?CDC criteria serve as a useful starting pointCDC guidelines are not perfect and have missed patients who are subsequently HIV infected All patients should be educated about PrEP as part of routine sexual healthcareDecision to start PrEP is made with patient Revisit decision to start and/or continue PrEP
What Are the Benefits of A Routinized Approach to Determining Eligibility?Avoids missing patients who are at risk for HIVHelps to destigmatize/normalize HIV preventionFacilitates patient-centered carePromotes awareness of PrEP in broader community
What I tell patients about PrEP Highly effective option for HIV prevention Empower yourself to stay HIV negativeEffectiveness of PrEP depends on taking the pill Some “forgiveness” if you miss a dosePotenial Side effectsNausea (start up, improves) Renal toxicity (rare)Small decrease in bone mineral density (unclear clinical significance) Condoms still needed to prevent STIs PrEP is not a lifetime commitment
PrEP Clinical Protocol Slides and protocol information adapted from K. Wagner, MD
Baseline Labs (complete within 1 week)HIV testing: 4th generation HIV-1/2 Ag/Ab Hepatitis B and C serologiesSTI testingSyphilis Gonorrhea/chlamydiaUrethralOral and rectal (recommended at all sites where mucosal exposure may have occurred)Estimated creatinine clearance (eCrCl) > 60 ml/minPregnancy test (not contraindication)
How Should PrEP Be Prescribed?TRUVADA® (emtricitabine/tenofovir disoproxil fumarate) tablets orally once daily Protective after 7 days of use (receptive anal sex)Protective after 21 days of use (receptive vaginal sex, injection drug use)Prescription refills for no more than 90 daysGilead’s assistance programsAdvancing Access® Patient Assistance ProgramUninsured patients Truvada free of charge Co-Pay Coupon Card
Monitoring a Patient on PrEP: 1 Month After InitiationAssess and address:AdherenceSide effectsSexual activity and condom use Signs or symptoms of acute HIVMono like symptoms Overall experience being on PrEPAny issues or questionsGive 60-day prescription
Every 3 months Test for:HIVOther STIs Even if asymptomaticExtragenital sites PregnancyAssess and address:Signs or symptoms of acute HIVAdherenceSexual activity and condom useAttitudes toward PrEPAny issues or questionMonitoring a Patient on PrEP: Ongoing Every 6 months Monitor : eCrCl Monitor eCrCl more frequently (e.g., every 3 months) for those with risk factors for kidney disease Give prescription for no more than 90 days at a time
Developing A PrEP Clinical ProgramPrEP provider is a primary care providerPrEP protocol for your clinicPrEP program can involve whole team PrEP NavigatorTracks patients on PrEP (labs, 3 mo visits)Adherence support (text messaging)New patient referrals for PrEPPrEP Database
Guidelines and Resources There are many resources available to support care team members in the process of providing PrEP
Culturally Competent PrEP Care: Communicating About Sex
Enhancing Communication About SexSexual health is critical part of adolescent health care For all adolescents:Ask about sex at every visitNormalize conversations“I discuss HIV prevention with all of my patients.”Avoid assumptions and ask about sexual orientation and gender identityHow do they describe themselves? Their partners?Ask patients what name and pronouns they prefer. Reassure confidentiality unless risk of harm to self or others
36Create safe space with visual signs. Invite open conversation with non-judgmental, affirming responses.Provide care that meets the needs of LGBTQ+ youth. PrEP can be empowering toward future self care. Talking about Sexual Orientation and Gender Identity
Thank you! Please feel free to contact us:Krystn Wagner Email: k.wagner@fhchc.org Jay Sicklick Email:
Q & A