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PrEParation: An FQHC’s guide to PrEP implementation

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Presentation on theme: "PrEParation: An FQHC’s guide to PrEP implementation"— Presentation transcript:

1 PrEParation: An FQHC’s guide to PrEP implementation
Joey Wynn, Community Relations Director Empower U – FQHC November 9th, 2016 Miami, FL 33147

2 Agency Background: Empower U was founded in 1999 as a 501(c)3 nonprofit organization. In , EU became an FQHC. Originally started to provide HIV services such as C & T and outreach, case management & Ryan White funded activities to the general population in the Liberty City area. EU quickly grew to specialize in provision of HIV prevention education, social services and mental health for HIV to men and women living with the disease. Several programs were introduced to specialize in care for gay, bisexual, and other men who have sex with men. In the past 2 years, EUCHC has expanded to provide comprehensive medical services to the entire community, and established programs for Transgender women of color (Trans Illuminati) and Pediatric vaccination & Immunization programs for the local communities.

3 Terminology Reference Guide
Pre-exposure prophylaxis Post-exposure prophylaxis Treatment as prevention PrEP PEP TasP

4 TAsP This slide shows what is commonly referred to as the prevention tool box and what that means is a collection of different approaches to HIV prevention. This slide is from a few years ago & Treatment as Prevention isn’t even listed on this slide - but its now an important proven part of the toolbox. The different items and approached in the tool box are a combination of behavioral and biomedical approaches. They can be used in different combinations for different people in different circumstances and at different times in their lives. Some are already proven and in use and others such as vaccine development is still a work in progress. People sometimes think its just condoms but we know there’s a lot more in the HIV prevention tool kit. For example- treating of STD is a part of effective HIV prevention. There are other things that are also important in HIV prevention that are not on this slide ( for example, stable housing) and are the content for another discussion. .

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6 PrEP Candidates Who? Discordant Couples
Individuals with recent diagnoses of an STI Individuals who frequent high-risk venues Having unprotected sex in Miami Dade County

7 PrEP Care Team Provider Clinic staff Eligibility HIV testing staff
Patient Educators

8 PrEP Education Strategy
Internal: Team meetings Staff PrEP Rallies Provider Champions External: Community Forums Focus Groups Community Health Workers PrEP “Down It” Marketing Campaign

9 Access Points? Internal Providers HIV testing staff referrals Community referrals Walk-ins (Marketing)

10 PrEP Media Strategy & Marketing

11 PrEP Workflow Patient Navigators:
Education session occurs with Patient Navigator, regardless of point of entry Patient Navigators schedule Eligibility and PrEP labs Labs are ready for 1st Provider PrEP visit

12 PrEP Access Medication Access:
Lab and clinic visit costs are covered through the normal eligibility process ACA and Private Insurance companies are covering PrEP; some require a denial first, then an appeal, but ultimately they cover it. FL Medicaid Managed care Plans must cover PrEP Gilead PrEP Medication Assistance Program provides only a 90-day supply. Labs must be done before next provision of medication, payor of last resort for this

13 PrEP Workflow Initial Provider Visit:
Provider discusses lab results, PrEP protocol and patient readiness (agreement form). EU’s 340b Specialty Pharmacy provider helps uninsured patients apply for Gilead’s PrEP Patient Medication Program behind the scenes, or paperwork for Industry co pay cards, other required documentation for Insurance programs, etc….

14 PrEP Documentation ICD-10 code utilized for PrEP
Z41.8 “Encounter for other procedures for purposes other than remedying health state” Z79 “Long Term drug use for Prophylactic Purposes” Electronic Health Records “Enabling Service Form” Internal PrEP database

15 ARV-Based Prevention Pipeline
January 2016 avac.org/infographic PRE-CLINICAL PHASE I PHASE II PHASE III PHASE IV IPM Pop Council IPM IPM TaiMed CONRAD HPTN/ACTG CONRAD R IPM Gilead IPM CHAARM IPCP NIAID IPM IPM CONRAD GSK/ViiV Janssen IPM R Pop Council CONRAD Albert Einstein IPM CONRAD MVA TDF/FTC TFV/FTC TMC 278 MIV 150 GRF TFV TDF DAP 744 MAb Maraviroc Tenofovir GSK 744 Tenofovir disoproxil fumarate/emtricitabine Dapivirine Ripilvirine Tenofovir disoproxil fumarate Monoclonal antibody Tenofovir/ emtricitabine Griffithsin DS003 DS003 (BMS793) DAR Darunavir No drug tested currently 5P12 5P12-RANTES IQP IQP-0528 Tenofovir prodrug ACTIVE DRUG RAL Raltegravir ImQuest CHAARM ImQuest Pop Council CDC IPM RTI IPM R DELIVERY SYSTEM Oral pills Vaginal tablet Pop Council Mintaka PBS R Vaginal gel Rectal gel Long acting injectable Vaginal ring Pop Council Thin film polymer Vaginal film PBS Phosphate buffered saline Nano-fiber

16 GSK744 Long Acting Is Formulated as a 200 mg/mL Nanosuspension
GSK (GSK744) Dolutegravir 1. Müller et al. Eur J Pharm Biopharm. 2011;78: Spreen et al. IAS 2013; Kuala Lumpur, Malaysia. Abstract WEAB Min et al. ICAAC 2009; San Francisco, CA. Abstract H Taoda et al. International Congress on Drug Therapy in HIV Infection 2012; Glasgow, Scotland. Abstract P206. Andrews et al. CROI 2014; Boston, MA. Abstract 39.

17 Pharmacokinetic Evaluation of a Single Intramuscular GSK744 LA Injection in Human Volunteers
4X PAIC90 1X PAIC90 Adapted from Spreen et al. IAC 2012; Washington, DC. Abstract TUPE040. Andrews et al. CROI 2014; Boston, MA. Abstract 39.

18 CROI Updates are promising!

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20 PrEP: Lessons Learned Preparation is key! Think through logistics carefully Keep in mind PrEP points of entry Providers must be familiar with PrEP protocol and necessary follow-up appointments Provider PrEP champion helps with “buy-in” Rapport between Patient and Patient Navigator is vital Eligibility specialist /Pharmacy skilled in medication program Prepare for how to properly document in patient’s medical record if working in a EHRS

21 THANK YOU!!! Questions? I can be reached for further information about these materials at 3TC, lamivudine; ABC, abacavir; ATV, atazanavir; COBI, cobicistat; DRV, darunavir; DTG, dolutegravir; EVG, elvitegravir; FTC, emtricitabine; TAF, tenofovir alafenamide.


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