1. Implementation science to end the HIV/AIDS epidemic Nancy S Padian Harvard, Dec 10, 2015 Nancy Padian, Adjunct professor of Epidemiology UCB School of Public Health Harvard, Dec 10 2015

2. Outline What does it mean to end the epidemic Interventions along the care cascade, how to reach targets Challenges for key vulnerable populations Rethinking data to assess targets Pre-exposure Prophylaxis PrEP Questions/methodological challenges

3. Identify persons with HIV who remain undiagnosed and link them to health care. Link and retains persons diagnosed with HIV in health care to maximize virus suppression so they remain healthy and prevent further transmission. Facilitate access to Pre-Exposure Prophylaxis (PrEP) for high- risk persons to keep them HIV negative. NY State ending the epidemic blueprint, 2015

4. WHO define the essential packages of high-impact HIV interventions along the continuum of HIV services; effectively deliver the cascade of HIV services to different populations and locations to achieve equity, maximize impact and ensure quality; implement sustainable funding models for HIV responses and reducing costs; and innovate new HIV technologies and ways of organizing and delivering services.

5. AMFAR

6. Targets for ending the AIDS epidemic UNAIDS

7. Guided by HIV Care Cascade

8. The NEW HIV Care Cascade 90

9. Seminal Trials at IAS 2015: Building Blocks of the New Cascade 90 HPTN 052

10. HIV Cascade Within a Larger Context Cultural/Gender Norms Stigma/Discrimination Vulnerable Populations Health Systems Financing Policy and Governance Reprioritization Transitional financing Integration Decentralization Task-shifting Targeted resource allocation Drug Policy Human and healthcare rights Integrated services Community mobilization Health Policy Project “HOT SPOTS” “HOT POPS”

11. The First 90: Testing Community Mobilization Strategies Crowdsourcing with MSM in China Tucker Hybrid mobile community HIV testing campaigns SEARCH Trial Mothers2mothers peer support for pregnant women Shimtz Community engagement & dialogue for PMTCT HIV testing uptake Kieffer Health Information to reduce sexual partner stigma & increase HIV testing Derksen Targeted HIV Testing Interventions Recruit & retain men using gender specific outreach SEARCH study Distribution of rapid HIV self testing amongst FSW in Kenya Thirumurthy Targeted HIV testing of older children 5-15 years with unknown HIV status in Kenya Wagner and Zimbabwe Bandason Partner notification Golden

12. The Second and Third 90: Care and Retention “Test and treat” reflecting the new cascade Universal home-based testing ANRS TasP 12249 Hybrid mobile testing SEARCH Same day, observed ART Pilcher Integration, Task shifting, and Decentralization Integration of ART into primary care Rawat Community based ART delivery and suppor t Wilkinson, Grimsrud Mothers2mothers mentor models Schmitz Implementation challenges of taking mHealth to scale Lester, Mbuagbwa, Muessig

13. Key Populations in HIV Key populations: those individuals and communities who have disproportionate burdens of HIV risk and disease and lack of access to essential HIV services Gay, Bisexual, and other men who have sex with men (MSM) Sex Workers of all genders People who inject drugs (PWID) Transgender Women who have sex with men Women and Girls in South, East African hyper-epidemics Adolescents from all of these communities

15. Review of sampling hard-to-reach and hidden populations for HIV surveillance Magnani AIDS 2005, 19 (suppl 2):S67–S72 how to track refusal rates and the potential impact of non-response bias; the assumption of random recruitment within personal networks; the speed with which equilibrium can be reached given the typical sample sizes and timeframes used for surveillance, and the unknown degree of overlap between networks; how initial seeds should be selected to maximize the ability to reach equilibrium in the shortest amount of time; the question of appropriate incentives to maximize participation, and minimize the likelihood of refusal or the recruitment of strangers or ineligible respondents; the degree to which RDS is able to reach a portion of the population missed by other sampling methods; and (vii) how to manage multiple data collection sites, staffing and the verification of whether respondents meet inclusion criteria.

16. How do we know what works

17. AMFAR

18. Cohort-based approach approach to reporting based on individual level data Promotes verification, transparency, timeliness, flexibility, and accuracy meaningful summaries (or indicators) of effective and efficient HIV care and treatment based on individual level data Enables standard comparisons across settings or over time Across subgroups of patient populations

19. Conceptual Framework for Measurement Approach: “Dynamic” Cascade of Care

20. Prevailing Approach: Summarize  Report, Prevailing approach Sub-County # of sites* # tested # HIV positive # referred to other facilities Number enrolled in other facilities # linked within the facility % inter facility linkage # enrolled in care within the testing facility % Intra facility linkage Kisumu14 16,08 6 1117312907912959075 Nyatike318939616158444342932775 Rongo20 1293 4 49184442845227898 Migori221045 5 7052431304035335789 Summarize and report increasingly aggregated data March 2015, Report from Partner to Kenya CDC

21. Dynamic Approach: Report  Summarize idfacility date of encounter ART useDeath dateWHO stageCD4 Value 1119-Oct-07..3147 1111-Mar-081.3. 213-Oct-07..2. 2131-Oct-07..2148 2122-Apr-08.... 2128-May-08.... 218-Jul-08.... 313-Oct-07.1-Dec-074. 318-Oct-07.1-Dec-073. 3112-Oct-07.1-Dec-073. 3115-Oct-07.1-Dec-073. 3116-Oct-0711-Dec-07.. 3123-Oct-0711-Dec-073. 3130-Oct-0711-Dec-073. 3119-Nov-0711-Dec-074. 414-Oct-07..1. 411-Nov-07..1. 4127-Dec-07..2. 4120-Mar-08..2. 4115-May-08..1. Summarize Report individual level data (sample or census)

22. Reporting Individual-Level Data vs. Aggregated Summaries Maximizes flexibility Multidimensional Summarization or disaggregation at different levels (sex, facility, district, etc.) Preserves information Few data elements can yields large number of indicators Captures dates to allow incorporation of time into summaries Time is critical dimension of efficiency and effectiveness in HIV care Enables individual follow-up through multiple cascade steps Control of “gaming” the system Transparency Construct and deconstruct indicators Promotes accuracy of data Focus data quality on completeness and accuracy at the facility level

24. HEALTH Many Doctors Unaware of Truvada, Drug for Preventing H.I.V. By DONALD G. McNEIL Jr.NOV. 25, 2015, NY TimesDONALD G. McNEIL Jr.NOV. 25, 2015, NY Times A third of America’s primary care doctors and nurses have never heard of the drug Truvada, which can help prevent H.I.V. infection, federal health officials said..

25. Related methodological issues Assess cascade targets with individual data Integrate information platforms Build in impact evaluations and capacity for adaptive analytics Alternative methods of randomization/robust quasi-experimental methods; Methods to engage key, hidden populations Methods to measure adherence

26. Outstanding questions Treatment vs prevention Measure and promote adherence Vertical vs Integrated vs Health systems Research  practice  policy Pathway for the transition to country ownership for roll-out, monitoring and evaluation: how do we know we are doing this right? Can the epidemic be ended without a vaccine and/or cure?