HHS Office of Population Affairs - PowerPoint Presentation

HHS Office of Population AffairsReady to Offer PrEP? Implementing PrEP Services in Family Planning Sites September 26, 2019 3:00 pm ET

Welcome!Objectives Discuss the role of Title X family planning clinics in assuring access to PrEP services in their communities.Describe the key steps for rolling out PrEP services in family planning settings.Identify resources for implementing PrEP services.Today’s SpeakerErika Aaron, CRNP, PrEP Clinical Advisor, Philadelphia Department of Public Health Note: This call will be recorded

OutlineEstablishing ProtocolsBrief review of prescribing PrEP Preparing Clinicians and Staff Identifying Key Partners Monitoring and EvaluationResources

Pre-Exposure Prophylaxis (PrEP) Pre-exposure prophylaxis (PrEP) is a once-a-day pill (brand name Truvada) demonstrated to reduce the risk of HIV infection up to 92% when taken as directed. Source: Centers for Disease Control and Prevention (CDC). Preexposure Prophylaxis for the Prevention of HIV Infection in the United States - 2014: A Clinical Practice Guideline.

New Family Planning-Specific PrEP Resources from OPA https://www.hhs.gov/opa/sites/default/files/OPA-PrEP-Decision-Guide.pdf OPA PrEP Training Webinar Series National Kick-Off Webinar: PrEP for HIV Prevention in Family Planning Settings Prescribing PrEP in Family Planning Sites Financing PrEP Services in Family Planning Sites Innovative Models for PrEP Services in Family Planning Sites *Recordings and slides for past webinars are available on www.fpntc.org

Establishing Clinical Protocols

Starting the Conversation: Educating Clients about PrEPDiscuss HIV vulnerability with every sexually active woman/men Start to integrate universal PrEP educationA discussion about PrEP should be presented to any person who presents for STD treatment, STD testing, Pregnancy testing, and HIV testing.This can be done by the Medical Providers as well as the nurses, the medical assistants and the lab staff.Present the range of prevention options Focus on positive reasons why persons may want to take PrEP other than sexual riskTake control over their sexual health - empowering Increase sexual satisfaction and intimacy Staying safe and healthy

Prescribing PrEP: A ReviewAssess if patient is a candidate: high risk, can adhere to daily medication regimen, willing to come to clinic every 3 – 6 months. HIV test must be negative before starting PrEP. Labs: STD screen, Creatinine clearance (>60 ml/min)HBV screen – if patient has chronic Hep B, tenofovir is treatment; if negative w/out immunities, offer vaccinationHep C and A screen

TDF + FTC Write for PrEP (TDF+FTC) once daily – no more than 90 daysTenofovir (TDF) 300 mg plus Emtricitabine (FTC) 200 mg

Monitor: Every Three MonthsHIV 4th generation serum test Assess for signs and symptoms of acute HIV infection STI triple screen if at risk Assess adherence and side effects Provide effective contraception if desired Pregnancy test, if attempting pregnancy or not using effective birth control

Follow up: Every Six MonthsCreatinine clearance and STI testingRefill 90-day supply if HIV negativeReassess need to continue PrEP At-risk pregnant women may remain on PrEPSafe to breastfeed with PrEP

Stopping PrEPAssess reasons for discontinuingIf patient becomes HIV positive while taking PrEP , provide linkage to HIV care, order resistance test, and viral load If confirmed seroconversion immediate escalation to 3-drug regimen. Do not wait for VL or resistance resultsIf patient remains HIV negative, continue to provide risk reduction support services as neededIf patient has chronic Hep B, when stopping PrEP, monitor for liver flare. Check LFTs within one monthRecommend continuation of tenofovir for chronic Hep B

PrEP During Preconception PeriodPregnancy and breastfeeding are not contraindications to PrEP No evidence of an increase in congenital anomalies during first trimester Infants exposed to TDF through breast milk have limited drug exposure The CDC recommends that an individual who does not have HIV and is planning a pregnancy with a partner who does have HIV start daily PrEP beginning one month before conception is attempted and continuing for one month after conception is achieved. Report to Antiretroviral Pregnancy Registry: 800-258-4263

Resources for Clinical Protocols https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf https://www.acha.org/documents/resources/guidelines/ACHA_HIV_PrEP_Guidelines_Jan2019.pdf https://www.smchealth.org/sites/main/files/file-attachments/prep_protocol_pending_approval_5-27-2015.pdf

EMR PrEP Template from Planned Parenthood in Phila Triple Screen: oral rectal cervical urine Initial PrEP Visit Patient education provided on the use of Truvada for HIV pre exposure prophylaxis, (PrEP).  Discussed possible drug risks and side effects. Informed Truvada > 90% effective in decreasing HIV acquisition when taken as prescribed.  PrEP must only be taken if HIV negative. Family planning discussed, baseline labs were drawn.  Patient informed a three month prescription of Truvada will be prescribed providing the baseline HIV test is negative, kidney function is normal and screening for STIs including HBV and pregnancy are reviewed.   Instructed on importance of medication compliance as adherence is tied to efficacy. Prevention and risk reduction messages provided to decrease acquisition of HIV and other STIs, as PrEP alone is not 100% effective. Teaching performed on signs and symptoms of acute HIV infection and instructed to return to clinic for testing if symptoms develop following an exposure.  Follow up plan includes HIV testing every 3 months, and STI testing. Pt is aware they are responsible for setting up all follow up before med run out. Patient education booklet given

Protocols*Every 6 months if not at risk of STDs, every 3 months if high risk for STD **Every visit if attempting pregnancy or if not using a birth control method Base line 3m 6m 9m 12m 15m 18m 24M Sexual Health Assessment and adherence X X X X X X X X HIV Ab /Ag test X X X X X X X X Syphilis serology* X X X X CT/NG testing* X X X X Pregnancy test** X X X X X X X X HBsAG , HBsAb , HBV vaccine status X HCV Ab X X X Serum Creatinine X X X X

Example of a PrEP Protocol

Example of a PrEP Protocol printed on a pocket card

New York City Health Dept “On Demand” dosing schedule for PrEP Has not been studied in cis gender women. Only recommended for cis gender males.https://www1.nyc.gov/assets/doh/downloads/pdf/han/alert/2019/prep-to-prevent-hiv-alert.pdf

Preparing Clinicians and Staff

Preparing Clinicians and Staff for PrEPLeadership support is vital to successful PrEP program implementation and sustainability Identify a PrEP Champion in the Clinic Assess staff capacity: HIV testing staff, health educators, patient navigators, financial counselors, pharmacists can all help reduce the clinical burden and costs Staff buy-in is a key factor for service success. Staff training and standardized PrEP screening toolsCulturally appropriate way to approach risk reduction counselingDestigmatize risk assessmentsNon-clinical staff trained on PrEP with a tailored approach to individual job function (e.g., Billing staff; Front desk staff; Lab personnel etc.)

Consider various staff who may be involved in the PrEP program

PrEP and PEP Best Practices

Front Desk or Call Center InstructionsHow to handle a call for PrEP or PEP Confirm which medication the person is requesting:A person may be calling for PEP if they have had a recent (recent = within the past 72 hours) potential exposure to HIV. A person is probably calling for PrEP if they are interested in starting a daily medication that will reduce their risk of HIV infection.If a person is calling for PEPOption 1: Arrange for the patient to be seen ASAP.The appointment should be within the 72-hour window.Option 2: Transfer the call to the dedicated navigator/nurse.If your agency has a dedicated navigator/nurse, you can refer the caller to them for intake and assessment. For any confusing or unclear cases, this will be the best option. Your agency should have a plan in place to return a PEP call within 90 minutes. Option 3: Refer to another agency or emergency department. If the person is unable to come into your agency, or your agency cannot accommodate the patient for a PEP appointment within 1 day, please refer to: Local Referral Clinic __________________ Urgent Care Centers Emergency Departments (EDs)

Front Desk Steps for Triaging a PrEP/PEP Call A1) Which actions will the front desk take once a caller makes a request for PrEP ? (Select all that may apply)Route call to navigator/nurse immediately – Proceed to A1.2Continue to speak to the caller to collect more information – Proceed to A1.3A1.2) Which information should the front desk give to the caller before routing calls? (Select all that apply)Name of individual receiving callJob title of individual receiving callReason for routingInform caller that they may reach voicemail, but that call will be returned shortlyRequest for caller name and phone number for follow up (if follow up will be conducted)A1.3) Which information will the front desk collect from/inform the caller? (Select all that apply) Physical location of caller Phone number Name Insurance type* Confirm that caller is requesting PrEP Other (please specify): _________________________________

Short Video on Messages for Providers to Say About PrEP PrEP : More Than HIV Prevention

Training Resources for Clinician and Staff TrainingAIDS Education and Training Center Program (AETC) has a series of short training videos on different topics related to PrEP .American Academy of HIV Medicine has CME credits for PrEP WebinarsNational Clinical Training Center for Family PlanningFamily Planning National Training CenterRecordings and slides for past webinars are available on fpntc.org OPA PrEP Training Webinar Series National Kick-Off Webinar: PrEP for HIV Prevention in Family Planning Settings Prescribing PrEP in Family Planning Sites Financing PrEP Services in Family Planning SitesInnovative Models for PrEP Services in Family Planning Sites

Financial Resources for PrEPFinancial counseling and other client resources for accessing low- or no-cost PrEP medication may help minimize barriers to care and increase patient adherence to the medication. State and local prescription programs: Washington State PrEP Assistance Program, New York Dept of Health PrEP-AP, Illinois PrEP Assistance Program.Advancing Access Program provides free medication for those without insurance and co pays up to $7200/yearPatient Advocate Foundation assists with out of pocket co-pays for PrEP up to $7500/yr National Alliance of State and Territorial AIDS Directors ( NASTAD ) also offers a Billing Coding Guide for HIV Prevention: PrEP , Screening, and Linkage Services 340B Pricing Program may assist with discounted medication

ICD-10 Codes for PrEP Services

Identifying Key Partners

Identifying Key Partners for your Health CenterPartnerships with outside organizations present valuable opportunities for collaboration when beginning to offer PrEP services Partners include: State and local health departmentsWomen-serving community-based organizationsHIV prevention and treatment-focused community-based organizationsLocal pharmaciesLocal college, universities, and academic medical centersOther local health centers offering PrEP servicesOther key stakeholder agenciesConsider the partnerships you already have in place!

Working with Key PartnersPartners may be helpful for:Offering trainings to clinicians and staff Educating community members about PrEP and referring them to the family planning siteHosting community outreach events, such as local health fairsDiscussing specific PrEP cases and troubleshooting unusual challengesOffering complementary services, such as counseling and other social servicesActing as referral partners for any clients identified as HIV+

PrEP Provider Locators www.pleaseprepme.org www.preplocator.org

Identifying HIV+ IndividualsEstablish a relationship with an HIV clinical specialistRyan White Clinic near youGo to: https://findhivcare.hrsa.gov/ As you start to increase testing while screening persons for PrEP and PEP you may increase the incidence of HIV+ individuals in your clinic.Recommendations to start ART immediately after a new diagnosis – “Rapid Start”

Monitoring and Evaluation

Monitoring and EvaluationConsider adopting performance measures to assess the success of service implementation. Percentage of clients who received PrEP counseling and education services. Percentage of clients screened for PrEP services and at significant risk for HIV who began medication.Percentage of PrEP clients who attended scheduled follow-up visits at 3, 6, 9, and 12 months. Percentage of PrEP clients reporting proper adherence to medication and duration of PrEP use. Number of PrEP clients (taking the medication for more than one month) who seroconvert. Percentage of PrEP clients choosing to discontinue medication. Reasons why discontinued meds

Resources

CDC PrEPCDC HIV Prevention > PrEP https://www.cdc.gov/hiv/basics/prep.htmlVideo PrEP 101: https://youtu.be/TR8-3uAuZGo

Additional ResourcesTelephone consultation line: 1-855-448-7737 9 am to 8 pm ET Monday–Friday http://nccc.ucsf.edu/clinician-consultation/prep-pre-exposure-prophylaxis/ .

CDC HIV Risk Reduction Tool https://www.cdc.gov/hivrisk/

PrEP Implementation Toolshttps://www.prepwatch.org/users-guide-prep-tools-use/

HIVE Clinical and Training Resources https://hiveonline.org/old-prep4women/

Videos PrEP: HIV Prevention That Promotes Care – Bridging The Gap (http://immersive.thebodypro.com/LBLN/hiv-prep/?ap=tbptd)Powered by PrEP: Keith - Virginia Greater Than AIDS (https://youtu.be/gnvAuNlLMEo) Gender Affirming Hormone Therapy (https://www.plannedparenthood.org/planned-parenthood-massachusetts/campaigns/gender-affirming-hormone-therapy)PrEP: I Choose Protection, I Choose Control, I Choose My Future. No Apologies. (https://youtu.be/hYJhMm57oHk)

YouTube Videos for PrEP Awareness https://youtu.be/hYJhMm57oHk

Videos on HIV Awarenesshttps://www.greaterthan.org/stories-empowered-women-and-hiv /

Educational videos on PrEP can be used for community education. You can download copies for your waiting room or easily embed them in web pages

Making PrEP Accessible Project Inform / HIVE, accessed 9/28/2018 https ://vimeo.com/186448201

THANK YOU!QUESTIONS?