Program Refinements to Optimize Model Impact and Scalability Based on Evidence

Status:	Recruiting
Conditions:	HIV / AIDS
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	8/16/2018
Start Date:	August 1, 2018
End Date:	January 31, 2023
Contact:	Denis Nash, PhD
Email:	denis.nash@cuny.sph.edu
Phone:	646-364-9618

In New York, the achievement of 90-90-90 goals is jeopardized not by limited access to
affordable care and treatment, but by persistent disparities in HIV viral suppression (VS).
Complex behavioral and structural barriers to achieving and maintaining VS require
coordinated, combination approaches to meet medical and social service needs. In 2009, at 28
Ryan White Part A (RWPA)-funded agencies, the New York City (NYC) Department of Health and
Mental Hygiene (DOHMH) launched a multi-component HIV Care Coordination Program (CCP)
directed toward the most vulnerable, high-need persons living with HIV (PLWH) in NYC. A
systematic CCP effectiveness study began in 2013 (R01 MH101028; PIs: Irvine, Nash). Findings
to date suggest that the CCP is superior to usual care for high-need subgroups of PLWH, but
there remains substantial room for improvement in short- and long-term VS. In an immediate
evidence-to-practice feedback loop, the DOHMH is implementing a refined CCP model in 2018.
Greater focusing, tailoring and cues for delivery of key components are expected to increase
CCP engagement, reach, fidelity, scalability, effectiveness and impact. The aim of the
proposed study is to estimate the effect of the revised (vs. original) CCP on timely VS
(within 4 months of enrollment), using experimental methods.

Stepped-wedge design. The 17 veteran CCP implementers re-awarded to provide RWPA Care
Coordination services in 2018 will be randomized to immediate or delayed implementation of
the revised CCP model, with delayed implementers continuing to provide services under the
original model until their assigned start date 9 months later, so that we can rigorously and
contemporaneously compare effects of the original and revised CCP for the outcome of timely
VS. The outcome measure will be derived from the New York City HIV surveillance registry, a
population-based data source of longitudinal laboratory (VL, CD4) testing records on all
diagnosed NYC PLWH, regardless of medical provider within NYC, and for periods extending
before and after program enrollment or discontinuation.

Inclusion Criteria:

- The original CCP permits enrollment of HIV-infected adults or emancipated minors who
are eligible for local Ryan White Part A services (based on residence in the NYC grant
area and a household income <435% of federal poverty level) and are 1) newly
HIV-diagnosed; 2) out of care >9 months or never in care; 3) missing visits or
irregularly in care; 4) exhibiting high VL, VL rebound, or ART resistance; 5) new to
ART; 6) incompletely adherent to ART; or 7) facing a potential barrier to adherence

- The revised CCP permits enrollment of HIV-infected adults or emancipated minors who
are eligible for local Ryan White Part A services (based on residence in the NYC grant
area and a household income <435% of federal poverty level) and are 1) newly
HIV-diagnosed; 2) out of care >9 months or never in care; 3) virally unsuppressed at
the most recent known viral load test in the past 12 months; 4) living with untreated
hepatitis C; 5) pregnant; 6)undergoing a change in ART regimen or 7)experiencing other
high risk for falling out of medical care or becoming unsuppressed. For criteria (6)
and (7), eligibility is conditional upon Self-management Assessment results, unless
additional criteria are met.

Exclusion Criteria:

- The stepped-wedge experiment is limited to HIV patients who are virally unsuppressed
at the time of program enrollment. Individuals with VL ≤200 copies/mL at last test
before or on the day of program enrollment will be excluded from the comparison of
model effects on TVS.

We found this trial at

sites

Mount Sinai Beth Israel Medical Center

New York, New York 10003

from

New York, NY