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. .

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!

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.