HPTN 065 TLC-Plus: Feasibility of an enhanced test, link-to- care plus treat approach for HIV prevention in the U.S. HIV Research Catalyst Forum April 21, 2010, Baltimore, MD A. Toni Young Executive Director Community Education Group

TLC+ Test and Treat enough HIV+ people Granich et al, 2009 Decrease in HIV Transmission Granich et al, 2009

High uptake of annual testing by all >15 year old individuals All HIV+ individuals start ART immediately, irrespective of stage of HIV disease 99% decrease in infectiousness High adherence with ART Low failure with first line ART Model Assumptions

Study Communities Intervention communities ◦Washington DC ◦Bronx, NY Comparison communities ◦Houston ◦Philadelphia ◦Chicago ◦Miami

Study Objectives and Outcomes Assesses feasibility and effectiveness outcomes, dependent on study component Assesses the feasibility of using surveillance data for outcomes All aim at determining feasibility of overall strategy TLC-Plus is not designed to measure a change in HIV incidence

TLC+ 065 Protocol Overview PURPOSE To evaluate the feasibility of an enhanced community-level HIV test, link-to-care plus treat strategy in the U.S.

Study Objectives and Outcomes Assesses feasibility and effectiveness outcomes, dependent on study component Assesses the feasibility of using surveillance data for outcomes All aim at determining feasibility of overall strategy TLC-Plus is not designed to measure a change in HIV incidence

Study Duration

Key Issues Addressed Financial incentives ◦Plans to minimize the risk of overuse of financial incentives ◦Address risk of migration from sites randomized to different interventions Provider training ◦Supportive services for PLWH (mental health, substance use, adherence support) ◦Mapping of resources in the communities ◦Use of ART for achievement of maximal viral suppression Timeliness and quality of surveillance data

Expanded HIV Testing Social mobilization Universal offer of testing in ED/hospital admissions Test Linkage-to- Care Provider Training Linkage to services [ SA, MH] HIV prevention counseling Maximize ART initiation per current guidelines Provider & Patient Surveys Knowledge & attitudes regarding ART & FIs Initiate/Continue ART per current guidelines Viral Suppression Linkage-to-Care Randomization of HIV Test Sites FI to link to care SOC to link to care Prevention for Positives Randomization of HIV+ Patients CARE plus SOC SOC alone Viral Suppression Randomization of HIV Care Sites FI for viral suppression SOC for viral suppression What Will the Study Entail

Thank You To HPTN and FHI for Use of Slides A. Toni Young 3233 Pennsylvania Avenue, SE Washington, DC,