#AIDS2016 Superior Outcomes with Same-Day HIV Testing and ART Initiation Serena Koenig, MD, MPH GHESKIO, Haiti Brigham and Women’s Hospital, USA

#AIDS2016 Study Leaders Dr. Jean W. Pape Dr. Patrice Severe Jessy Dévieux Dr. Nancy Dorvil, Mr. Christian Perodin, and Dr. Cynthia Riviere

#AIDS2016 Current Situation Attrition rates are high from HIV testing to ART initiation, resulting in delays in treatment Delays in treatment are associated with: – Increased mortality – Diminished recovery of CD4 cells – Higher cost of treatment for opportunistic infections (for those with access to advanced hospital care) – Ongoing HIV transmission Removal of requirements for multiple pre-ART visits may decrease pre-ART attrition

#AIDS2016 Opportunities for Improvement WHO recommendation of universal treatment makes ART eligibility screening unnecessary Point-of-care testing and same-day counseling can accelerate ART initiation ART could potentially be started as soon as the day of HIV testing

#AIDS2016 Reasons for Multiple Pre-ART Visits Concerns about missing TB and other OIs Concerns that patients will not be ready to start lifelong treatment Need to wait for test results (CD4 count) Feeling that ART initiation is generally not urgent

#AIDS2016 Missed Opportunity Patients present for HIV testing because they are concerned about having HIV With standard testing, patients are given bad news and discharged without treatment Extra attention and same-day ART could give a sense of hope, optimism, and overall connectedness to care providers

#AIDS2016 Objectives and Participants Objective: To compare standard vs. same-day ART Inclusion criteria: – Non-pregnant ART-naïve adults – WHO stage 1 or 2 disease – CD4 count ≤500 cells/mm 3 Exclusion – CXR consistent with TB or pneumonia – Failed ART readiness questionnaire – Planned to transfer care during study period

#AIDS2016 Care Provided to Both Groups Same-day HIV counseling and testing, CD4 count, physician evaluation, CXR, ART readiness questionnaire Multiple clinician and counseling visits in the first month (same number for both groups) Monthly visits after first month Community health worker phone call/home visit for missed visits $US 1.70 per visit for transportation subsidy

#AIDS2016 Schedule of Visits Standard group – Days 7, 14, and 21: Physician/social worker visits – Day 21: ART initiation – Week 5: Physician/social worker visits Same-day ART group – Day 1: Counseling and ART initiation – Days 3, 10, and 17: Physician/social worker visits – Day 24: Physician visit Only difference was timing of ART initiation

#AIDS2016 Study Endpoints Primary: Retention in care with VL <50 copies/ml at 12-month visit Secondary – ART initiation – Survival – Retention in care with VL <1000 copies/ml at 12- month visit

#AIDS2016 Screening and Enrollment 1255 patients with CD4 count ≤500 cells/mm 3 evaluated by HIV clinic physician on day of HIV testing; 434 had WHO Stage 3 or 4 disease or CXR consistent with TB 821 patients referred to study team on day of HIV testing – 51 excluded for Stage 3 or 4 disease or prior ART – 1 refused – 7 failed ART readiness questionnaire 762 enrolled/randomized – 51 transferred and excluded April 2016 DSMB recommended publication due to superior results with same-day ART Analysis includes 564 enrolled by Feb 2015

#AIDS Month Outcomes Standard Group (n=285) Same-Day ART Group (n=279) P-value Initiated ART262 (92%)279 (100%)p<0.001 Died19 (7%)8 (3%)p=0.035 Alive and in care201 (71%)224 (80%)p=0.007 In care with VL <50 copies/ml 120 (42%)151 (54%)p=0.004 In care with VL <1000 copies/ml 143 (50%)171 (61%)p=0.008 Standard group: 15% LTFU and 8% late returners; same-day ART group 12% LTFU and 5% late returners

#AIDS2016 Adjusted Odds Ratios of Study Outcomes Adjusted OR95% CIP-value Retained in care with VL <50 copies/ml Standard1.0 Same-day ART , 2.49p=0.002 Retained in care with VL <1000 copies/ml Standard1.0 Same-day ART , 2.36p=0.004 Mortality Standard1.0 Same-day ART , 0.86P=0.021

#AIDS2016 Standard vs. Same-day ART

#AIDS2016 Retention in Care – Africa and Haiti (GHESKIO) *Blood drawn, test performed and patient returned for the test results; Rosen et al PLoS Med 2011; Clouse et al. JAIDS 2013 Huge Gap Gap

#AIDS2016 Conclusions Same-day ART initiation is feasible and beneficial. – Improves retention with virologic suppression – Decreases mortality We believe same-day ART increases the sense of hope, optimism, and connectedness to health care providers. The new WHO recommendations to provide universal ART should facilitate same-day test and treat.

#AIDS2016 Acknowledgements National Institutes of Allergy and Infectious Diseases R01 AI Melanie Bacon, NIAID program officer Same-day ART study team GHESKIO study participants Data Safety Monitoring Board – Drs. Carlos del Rio, Kenneth Mayer, and Larry Moulton, and Ms. Yanick Fevry Dr. Paul Farmer, BWH/Harvard for advice regarding study design and conduct Drs. Daniel Fitzgerald, Warren Johnson, and Margaret McNairy of Cornell for advice on study design and conduct Dr. Heejung Bang of UCSD for statistical advice