Iowa TelePrEP: Delivering PrEP through Telemedicine and Public Health Partnerships Michael Ohl, MD MSPH Division of Infectious Disease University of Iowa College of Medicine Center for Access and Delivery Research and Evaluation (CADRE) Iowa City VA April 6, 2018

Disclosures Funding from: Gilead Sciences, Inc. Iowa Department of Public Health (IDPH) VA HSR&D

Outline PrEP delivery in rural United States Iowa TelePrEP Model Iowa TelePrEP Study Replicating TelePrEP in Rural Settings

TelePrEP Team at U of Iowa & Iowa DPH Pat Young, HIV & Hepatitis Prevention Program – Program Director, IDPH Angela Hoth, PharmD MPH TelePrEP Coordinator, UI Cody Shafer, EIS/PrEP Coordinator, IDPH Dena Dillon, PharmD, UI

Rural Populations are Small & Dispersed Rural USA: 97% of land area 18% of population 6% of people with new HIV diagnoses https://www.cdc.gov/hiv/statistics/index.html http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0012756 https://www.census.gov/geo/maps-data/maps/thematic_2010ua.html American Community Survey: 2015.

Rural and Small Urban Areas Matter HIV Incidence in the Upper Midwest Location HIV Annual Incidence* Chicago metro area 903 Illinois, not Chicago 569 Iowa 136 Nebraska 93 Wisconsin** 100 Minnesota*** 168 North Dakota 24 South Dakota 28 Total, rural/small urban 1,118 *Source: CDC and state surveillance; AIDSvu.org; 2013-16 ** Excluding Milwaukee *** Excluding Minneapolis / St. Paul

Public health clients with PrEP need in IDPH STD & HIV Programs County public health / STD clinics (N=58) Disease Intervention Specialists / Partner Services Integrated Testing Services (HIV testing) 5,596 PrEP-eligible public health clients in 2016 1,057 (19%) rural

IDPH STD & HIV Testing Programs 2016 data HIV risk factors among rural public health clients with PrEP indications, N=1057 46% MSM 23% PWID 3% MSM and PWID 28% high-risk heterosexual

Vignette 42 year old MSM (non gay/bisexually identified) in a primary relationship with a female. MSM contact occurs infrequently with inconsistent condom use. He lives in a rural community with population 2,000. Travels 75+ miles to access rapid HIV screening services in a public health clinic on a regular basis - bypassing clinics nearer his home. PrEP is recommended during his last HIV testing encounter, but he is reluctant to discuss PrEP with a provider due to privacy concerns.

Rural PrEP Barriers Stigma / privacy concerns Distance Rural provider shortages

Where do we start? “Start where you are. Use what you have. Do what you can.” – Arthur Ashe

Iowa TelePrEP Development, 2017 Partnerships: IDPH, UI Health Care, Community Representatives Resources: IDPH programs, UI HIV care team, telehealth platforms, existing public health STD clinic / lab network Stakeholder Interviews: Users, Public Health, Health Care Rapid Prototyping: with Johnson County Public Health

The Iowa TelePrEP Model More than Telemedicine Public Health Screening and Referral Marketing Telephone Navigator In-home Vidyo® Visit Provider Outreach Medication by Mail Local labs

Pharmacist Collaborative Practice TelePrEP Service Protocol driven USPHS/CDC guidelines Approved by UIHC Pharmacy & Therapeutics Committee Collaborative practice agreement Formal relationships between MDs and PharmDs Registry-based population management Behavioral counseling States with Collaborative Practice Laws https://www.cdc.gov/dhdsp/pubs/docs/translational_tools_pharmacists.pdf

Public Health Partnered – Local Labs Statewide public-health- affiliated sites Blood draws Self-swab for extragenital GC/CT screening Refer clients with + STD screens to DIS / local public health for treatment

Barriers and TelePrEP Interventions Rural PrEP Barrier TelePrEP Intervention Stigma / privacy concerns In-home video visits Discrete medication mailing Distance to PrEP providers Local labs Mailed medication Provider Shortages Pharmacist collaborative practice / task shifting

Local TelePrEP Pilot: Feb 2017 – Jan 2018 115 referrals (53% PH, 37% self, 10% HIV clinics) 73 clients with telehealth visits 67 PrEP starts 76% retained in TelePrEP at 6 months

Local TelePrEP Pilot: Feb 2017 – Jan 2018 Median age 31 (18-60) 93% men, 7% women Race / ethnicity: 77% white, 9% black, 7% Latinx, 4% multiracial, 3% Asian Insurance: 73% commercial 18% uninsured 5% Medicaid 4% Medicare

Local TelePrEP pilot: Feb 2017 – Jan 2018 13 clients (18%) with 18 new STD diagnoses syphilis 5 (2 early) gonorrhea 5 (4 extragenital) chlamydia 8 (7 extragenital) 1 Pregnancy Vaccines series initiated Hepatitis A 29 Hepatitis B 9 HPV 11

TelePrEP Initiation and Retention Study Gilead N-US-276-4448 Screen clients for PrEP indications in public health Control Regions TelePrEP Regions Community Provider Referral (Control Regions) TelePrEP Referral Initiate PrEP anywhere within 30 days? 4 IDPH Regions Retention in PrEP at 6 months?

TelePrEP Initiation and Retention Study Gilead N-US-276-4448 Cohort Flow Study Aims Compare PrEP Initiation within 30 days in Control vs. TelePrEP Regions Compare PrEP Retention at 180 days Enroll PrEP-Eligible Clients in Public Health N = 240 Baseline Survey Day 30 Follow Up Survey ? PrEP Initiation Anywhere Day 180 Medical Record Review ? Retained in PrEP

TelePrEP – sustaining no-cost visits for clients Visit fee-for-service (subject to state telehealth laws) Truvada® margin through 340B pharmacy dispensing Public health programs and Iowa State Hygienic Lab to offset lab costs

Implementation - Lessons Learned Monitor “opt-out” automated electronic health information sharing in EHR Variable implementation of self swab protocols for extragenital STD screening “Critically distant” labs? Social network referrals are key for rural clients with greatest privacy concerns

Iowa TelePrEP - Conclusions Innovation can be combinatorial: Technology secondary to systems redesign and network creation through partnerships Pharmacist collaborative practice overcomes PrEP barriers related to provider shortages in rural areas Contact: michael-ohl@uiowa.edu TelePrEP: teleprep@healthcare.uiowa.edu