SEARCH test and treat study in Uganda and Kenya exceeds the UNAIDS cascade target by achieving over 80% population-level viral suppression after 2 years M. Petersen, L. Balzer, D. Kwarsiima, N. Sang, G. Chamie, J. Ayieko, J. Kabami, A. Owaraganise, T. Liegler, F. Mwangwa, K. Kadede, V. Jain, A. Plenty, G. Lavoy, D. Black, E. Bukusi, C. Cohen, T. Clark, E. Charlebois, M. Kamya, D. Havlir

Thank you to UNAIDS, PEPFAR, NIH, WHO for support My great appreciation for all who work on SEARCH, our multilateral partners, funders and the communities we serve PIs: Diane Havlir, Moses Kamya, Maya Petersen Statistician: Laura Balzer, Mark van der Laan Vice-Chair: Edwin Charlebois Virologist: Teri Liegler KEMRI: Elizabeth Bukusi, NortonSang, James Ayieko, Kevin Kadeke KEMRI:/UCSF: Craig Cohen MU-UCSF: Dalsone Kwarisiima, Jane Kabami, Asiphas Owaraganise, Florence Mwangwa, Tamara Clark, Gabe Chamie, Starley Shade, Vivek Jain, Carol Camlin, Mucu Atukunda SEARCH

Background ART for treatment and prevention has potential to dramatically alter the trajectory of the epidemic To realize this benefit, effective scalable strategies are needed to optimize each step of HIV care cascade 1.Diagnosing all HIV+ 2.Initiating ART among all diagnosed HIV+ 3.Virally Suppressing all HIV+ on ART

SEARCH Study Ongoing cluster randomized trial to evaluate an HIV “test and treat” strategy – 32 communities; ~10,000 residents in each 12 Kenya, 10 Western Uganda, 10 Eastern Uganda Intervention: 1.Annual community-based HIV & multi disease testing 2.Universal ART eligibility with streamlined care NCT:

#AIDS2016 SEARCH Testing Intervention: Annual Community-Based Testing Goal: >90% HIV testing Approach: –Community based, out of facility –Multi-disease: HIV, DM, HT, malaria –“Collapse the Cascade”- immediate link to public health services 1.Census/Mobilization 2.Two week Health Fair 3.Home testing for non-participants Chamie, Lancet HIV 2016

SEARCH Treatment Intervention: Universal Streamlined ART Delivery 1. Efficient Visits for Patients and Staff ART start at first clinic visit as indicated Triage by nurse or other extender at all follow-up visits Clinic visits and ART dispensation every 3 months rather than every 1-2 months 2. Patient-centered approach to care Welcoming environment Fostering trust, connection, and a sense of investment in the patient Flexible clinic hours Tiered Tracking Multi-disease chronic care model 3. Telephone hotline access for patients Easy triage of medical questions Appointment/scheduling logistics for retention 4. Appointment reminders by phone/SMS One week to few days in advance Retention tool 5. Viral Load Counseling Structured format for discussion of undetectable and detectable results Jain et al., AIDS, 2014 Kwarisiima et al., CROI 2016

Objectives of this Analysis Characterize evolution in HIV care cascade in SEARCH intervention communities – Baseline, follow up year 1, and follow up year 2 annual testing campaigns 1.Cascade among all prevalent HIV+ community residents – Serial cross-sectional 2.Cascade among residents who tested HIV+ at baseline – Longitudinal cohort

UNAIDS Target This Analysis: Suppression = plasma HIV RNA< 500 cps/ml

Population & Measures Inclusion Criteria: – Adult (>=15 years at baseline) – Stable resident (>6 months/past year) of one of 16 SEARCH intervention communities – Enumerated in baseline census Population-based measures – Demographics at baseline census – HIV serostatus and plasma HIV RNA level measured at annual community-based testing – Prior HIV care, including ART measured through linkage to clinic records

Statistical Analyses Inverse weights/Targeted maximum likelihood to adjust for 1.Incomplete ascertainment of prevalent HIV+ 2.Incomplete HIV RNA measures 3.Censoring by death/migration (longitudinal analyses) Restriction to 11/16 communities with two full years follow up when estimating 1.Year 2 cascade among prevalent HIV+ 2.Longitudinal analyses of baseline HIV+

Baseline Characteristics KenyaW UgandaE UgandaTotal Stable adults (N)27,64025,01325,12077,773 HIV+20.1%6.5%3.5%10.3% Male44%47%45% Age years33%34%38%35% years24%23%21%23% >34 years32%43%41%42% Occupation Farmer43%55%62%53% Fisher7%0%0.2%3% Student21%18%20% No job7%5%3%5% >1mo past year away 4%10%8%

UN AIDS Target Exceeded UNAIDS Target

Year 2: >80% HIV+ Virally Suppressed UNAIDS Target

Cascade by Gender

Cascade by Age

Cascade Evolution Among Subjects Tested HIV+ at Baseline Viral Suppression Viral Failure Prior Dx, no ART Migrated New Diagnosis Died

Cascade Evolution Among Men Tested HIV+ at Baseline Viral Suppression Viral Failure Prior Dx, no ART Migrated New Diagnosis Died

Cascade Evolution Among Youth Tested HIV+ at Baseline Viral Suppression Viral Failure Prior Dx, no ART Migrated New Diagnosis Died

Viral Suppression Over Time Among Baseline HIV+

Conclusions Population viral suppression increased from 48% to 82% during two years of the SEARCH intervention Baseline lower suppression in men and youth – After two years of intervention, disparity among men reduced – Suppression remains below target in youth SEARCH Study poised to evaluate the impact of achieving the UNAIDS target on HIV incidence, health, education and economic outcomes. – Primary Endpoint: Paris 2017

Funding Research reported in this presentation was supported by Division of AIDS, NIAID of the National Institutes of Health under award number U01AI and in part by the President’s Emergency Plan for AIDS Relief and Gilead Sciences. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH, PEPFAR, or Gilead. The SEARCH project gratefully acknowledges the Ministries of Health of Uganda and Kenya, our research team, collaborators and advisory boards, and especially all communities and participants involved. Thank you!