Immediate Antiretroviral Therapy for Better Patient Health and HIV Prevention

1. Immediate Antiretroviral Therapy for Better Patient Health and HIV Prevention Oliver Bacon, MD, MPH 2 February 2016

2. Disclosures • The views expressed herein do not necessarily reflect the official policies of the City and County of San Francisco; nor does mention of the San Francisco Department of Public Health imply its endorsement.

3. Capacity Building Assistance inHigh-Impact HIV Preventionfor Health Departments Our team includes nationally-recognized experts specializing in HIV Testing, Prevention for High-Risk Negative Individuals, and Policy. Our philosophy: Provide customized, peer-to-peer TA, with a focus on engagement in person and online, by utilizing creative and innovative technologies. www.getSFcba.org

4. Capacity Building Assistance inHigh-Impact HIV Preventionfor Health Departments • Peer-to-peer mentoring • Site visits • Resources and toolkits • Online learning communities How we deliver: • Webinars • Live chat office hours • Cooperative approach Contact Us! Visit: www.getSFcba.org Call: 415.437.6226 Email: get.SFcba@sfdph.org

5. Getting to Zero San Francisco: The Power of Collective Impact—and guided by data 90% fewer HIV infections 90% fewerHIV deaths Zero stigma and discrimination By 2020:

6. Where was San Francisco On Dec 1 2013? 2006: HIV test w/o written consent 2010: Universal ART; HIV test scale-up 2011: LINCS iPrEx 2012: PrEP-DEMO

7. Strategic Plan: Signature Initiatives • PrEP: Expand access to pre-exposure prophylaxis for San Franciscans at-risk for HIV infection • RAPID (Rapid ART Program for Individuals with new Diagnosis): Immediate linkage to care and treatment of HIV at the time of diagnosis • RETENTION in HIV care • STIGMA reduction interventions Committee for each initiative is developing action plan, metrics and milestones, budget

8. Linkage, retention, and sustained virologic suppression in San Francisco SFDPH HIV Epidemiology Annual Report 2014

9. SFDPH HIV Epidemiology Annual Report 2014

10. Data Highlight the Gaps • If the goal is virologic suppression, 67% is insufficient • Need better, faster Linkage • Need better Retention • Need something to prevent HIV(-)s from getting infected by unknown HIV (+)s • Need to decrease stigma, psychosocioeconomic discrimination as a barrier to care, prevention, especially among most vulnerable populations

11. Universal ART = better care, better prevention • Delivering ART as early as possible after a new diagnosis of HIV: • improves morbidity and mortality in all stages of infection (START INSIGHT Team NEJM 2015) • in acute/recent HIV infection: limits reservoirs and hyper-infectivity (Jain et al. JID 2013; Saez-Cirion et al. VISCONTI team, PLoSPathog. 2013) • reduces transmission by 96% (HPTN052--Cohen et al. NEJM 2011) • Typical interval of weeks to months between diagnosis, ART, and virologic suppression=lost opportunities • Delayed or dropped linkage, retention • Immunologic dysfunction • Onward Transmission WHY WAIT????

12. RAPID Implementation: Overview • Step II • Same day, expedited referral • Medical/psychosocial evaluation • Start ART • Partner Services • Linkage to HIV 1° care Step I Day one New HIV+ Diagnosis • Step III • 5-7 days • Follow-up with HIV 1° care • Review baseline Labs • Modify ART as needed • The Goal of RAPID is to improve the health of newly diagnosed patients by eliminating delays in ART and access to high-quality HIV care. This means: • Starting ART the same day as someone is newly diagnosed with HIV (or within 2-3 days if same-day start is impossible) • Their first follow-up visit with HIV 1° care within a week of starting ART • Sometimes RAPID patients will be referred to you at Step III, having already completed Steps I and II. • Sometimes RAPID patients will undergo all Steps I-III or II-III at your clinic (especially if they were your patients when they were HIV-uninfected)

13. RAPID Pilot at SFGH: 2013-15 • PHAST (Positive Health Access to Services and Treatment) Team paged with any new confirmed new HIV+ patients on SFGH campus • PHAST Team paged by testing sites in SF with any new HIV+ with no/public insurance • Expedited intake, counseling, insurance navigation, ART initiation at Ward 86 (UCSF HIV Clinic at SFGH) • Implementation Science Question: Comparison of linkage, virologic outcomes, by era: • CD4-guided ART (2006-9) • Universal ART (2010-13) • RAPID (immediate ART) (7/13-12/14)

14. Engagement Timeline, SFGH 1st PCP Visit Viral load suppressed 1st Clinic Visit ART Prescribed Referral CD4-guided (2006-9) Universal (2010-3) RAPID 37 132 1 56 Pilcher, IAS 2015

15. Time to VL suppression by ART initiation strategy: SFGH 2006-2014 RAPID Universal ART CD4-guided ART Proportion <200 copies RAPID vs. universal ART P<0.001 Pilcher, IAS 2015

16. Qualitative Lessons from Interviews with RAPID Pilot Team Members: Keys to Success • Single point-of-contact for referrals activates the team (PHAST Pager) • Committed team is essential (Counseling, Benefits Navigation, Clinical) • Minimize handoffs: Every handoff is a warm handoff • Talk about Care first, Insurance later • Have a plan for medication access • Emergency ADAP • Presumptive Medi-Cal • Pharma Patient Assistance Cards • Check in with patient in the 1-2 days after he/she leaves the appointment

17. Taking ART Citywide • Develop a RAPID Protocol • Develop a capacity-building strategy • Clinic-wide education Sessions • Public Health Detailing of Individual Clinicians, with RAPID Guide for Providers • Target High Prevalence Testing Sites + populations at high risk • Target HIV Clinics where newly HIV+ persons are linked (referral sites) • High volume sites • Sites serving populations at high risk of non-linkage, non-suppression • Develop an Evaluation Plan

18. Testing sites SF City Clinic (14%) Private/UCSF/StM/CPMC (22%) SFGH (13%) AHP/Magnet/Glide/DPH (CHN+ Consortium) (37%) Other (5%) Kaiser (9%) Citywide RAPID (same day as HIV+ if possible) Disclosure Counseling Partner Services Medical Evaluation Benefits/Insurance Navigation and Rapid Enrollment Linkage to HIV Primary Care within 5 Days Immediate ART (Starter Pack or Prescription) Evaluation HIV Primary Care Sites Kaiser (14%) Private/UCSF/StM (32%) ???(7%) SFGH (26%) SFCC/DPH (12%) Other/AHP/VA/OOJ/Jail (9%)

19. The Goal: Test, Treat, Retain, and PrEP I. Universal, accessible HIV/STI testing -Frequency determined by risk -Testing for acute infection in high-risk populations/settings IF (-) IF(+) • III. COMBINATION PREVENTION • Condoms and Risk Reduction coaching • Referrals for Substance use treatment, Mental health care • PEP for occasional exposures • PrEP for Pts with elevated risk: • Inconsistent condom use • Multiple partners/non-monogamous steady partnerships • Serodiscordant partners including periconception • h/o Rectal STIs, PEP • II. Immediate ART • Eliminate OIs/AIDS • ↓ nonAIDS complications • ↓ transmission to partners • Retention in care to maintain suppression

20. Acknowledgments G2Z Rapid Committee • Diane Havlir • Diane Jones • Stephanie Cohen • Chris Pilcher • HiroyuHatano • Susa Coffey • Tim Patriarca • Janet Grochowski G2Z Steering Committee • Shannon Weber PHAST • Clarissa Ospina-Norvell • Sandra Torres • Fabi Calderon Kaiser-SF • Brad Hare • Marc Solomon • Ed Chitty SFDPH • Jonathan Fuchs • DarpunSachdev • Andy Scheer • Susan Scheer