The Undetectables Viral Load Suppression (VLS) Project

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The Undetectables Viral Load Suppression (VLS) Project AIDS Institute, Clinical Advisory Committee September 8, 2016 Vaty Poitevien, Chief Medical Officer Housing Works, Inc. www.housingworks.org

About Housing Works The nation s largest grassroots AIDS service organization, as well as the largest minority-controlled AIDS service organization Direct social services: primary/mental health care, housing, case management, job training, legal services, and much more Three FQHC sites: Downtown Brooklyn, East New York, Lower East Side Approximately 1,500 active HIV-positive clients: 84% black or Hispanic 33% identify as LGBT or gender nonconforming > 50% histories of incarceration > 50% co-infection with hepatitis C 100% living at or below poverty line 90% extended histories of mental illness and/or chemical dependence

What is The Undetectables? Launched in March 2014 to help HIV-positive clients achieve and maintain an undetectable viral load ( 50/ml copies) Eligibility: Clients receiving integrated care (primary health care plus case management/care coordination) Enrollment: 663 active participants (as of September 2016) Retention rate: 81% at 24 months Goal: At least 80% viral suppression A core component of Housing Works commitment to the New York State plan to end the AIDS epidemic by 2020

A stepped approach to ARV adherence What s in the tool kit? Individual-level ARV adherence planning and support Case conferences with client, health providers, and case manager Motivational interviewing and assistance to meet subsistence needs Behavioral health assessment/referral $100 gift card incentive for quarterly lab result showing undetectable viral load ( 50 copies/ml), up to 4 per year Cognitive behavioral therapy (CBT) adherence support groups Adherence devices such as pill-boxing and text or other daily medication reminders Directly observed ARV therapy (DOT) formal and informal

Using the tool kit Enrolled clients are encouraged to participate in the tool kit interventions that best match their need for adherence support. Interventions are agreed upon in the first medical case conference after enrolling in the program and documented. The medical case conference addresses the client s strengths as well as the barriers to attaining or maintaining undetectable viral load. Clients may switch interventions as needed and do not need to participate in all cascade interventions.

Financial incentives Clients may receive up to $400 annually (a $100 gift card per quarter) for achieving or maintaining viral load 50/ml. Clients have blood drawn at clinically appropriated intervals (determined by providers). The viral reports need to be actual lab reports reviewed by the PCP or RN. New lab work is required each quarter in order to receive the financial incentive.

Reporting and monitoring A registry of clients in the program is maintained in e-icare. Case managers document enrollment, participation in tool kit interventions, distribution of incentives, and disenrollment (e.g., due to 2 quarters of missed lab work). A monthly report is sent to case managers for use in individual supervision and team meetings. Quality data teams meet monthly at each primary care site to review program data.

How is it going? High level of agency-wide buy-in and oversight: Regular meetings of executive team and senior staff 2-year enrollment goal met early Successes and challenges Program-level evaluation, quality assurance, and improvement: Regular meetings of program directors Ongoing evaluation of outcomes and evolving processes/strategies Tracking and monitoring: Tracking systems and tools Staff survey Client interviews and focus groups

Results at 24 months Among 441 clients eligible for enrollment at launch: 54% virally suppressed ( 50 copies/ml) 37% detectable 9% unknown (refused testing or inconclusive result) Among 640 clients enrolled as of April 2016: 81% virally suppressed ( 50 copies/ml) 18% detectable 1% unknown (refused testing or inconclusive result) Among 454 clients enrolled 12 months as of April 2016: 83% virally suppressed ( 50 copies/ml) 16% detectable 1% unknown (refused testing or inconclusive result)

Formal evaluation Forthcoming evaluation from the University of Pennsylvania to examine efficiency, feasibility, and cost-effectiveness Using each participant as their own control, assesses viral load and cumulative viral exposure pre- and post-enrollment Qualitative interviews and focus groups with participants and staff to examine attitudes regarding program efficacy Standard methods of cost analysis to evaluate cost-utility as a function of incremental program costs and medical costs saved through averted downstream infections

Durable viral load suppression Durable Viral Load Suppression at 21 Months ( 50 copies/ml) Includes 441 clients enrolled through December 31, 2015 with at least 2 VL time point measures in the 12 months prior to enrollment and at least one post enrollment At and before baseline Post-enrollment Proportion of individuals with suppressed VLs at all time points Mean proportion of suppressed VLs for all individuals at all time points 37.4 59.9* 64 76** *Chi sq p <.0001 **p<.0001 (paired t test)

Social marketing

Social marketing Why become an Undetectable? Becoming an Undetectable is becoming a Hero! Becoming an Undetectable improves your health, well-being, and life expectancy! Becoming an Undetectable can reduce the likelihood of transmitting HIV to sexual partners! Becoming an Undetectable helps to end the HIV epidemic!

Citywide scale-up Housing Works collaborated in a consortium with NYC DOHMH and others to prepare the VLS model for replication. In 2016 DOHMH issued an RFP and awarded $1.5 million in contracts to 7 organizations to scale up The Undetectables: o AIDS Service Center of Lower Manhattan o Harlem United: Community AIDS Center o o o APICHA Community Health Center Community Healthcare Network Housing Works Community Healthcare o o William F. Ryan Community Health Center Wyckoff Heights Medical Center Housing Works will provide training/technical assistance to each agency. Year 1 implementation begins January 1, 2017.