Program Refinements to Optimize Model Impact and Scalability Based on Evidence

Completed · Not applicable

Conditions studied: Hiv

In brief

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 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 vulnerable 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.

Key facts

Study ID: NCT03628287
Run by: City University of New York, School of Public Health
People needed: 960
Starts: 2018-08-01
Expected to finish: 2023-01-31
Last updated by the study team: 2024-08-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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 antiretroviral therapy (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.

You may not qualify if…

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 timely viral suppression (TVS).

Where it is running

HHC Kings County Hospital Center — Brooklyn, New York, United States
SUNY Downstate Medical Center - STAR Health Center — Brooklyn, New York, United States
Sunset Park Health Council, Inc. — Brooklyn, New York, United States
Wyckoff Heights Medical Center — Brooklyn, New York, United States
HHC Elmhurst Hospital Center — Elmhurst, New York, United States
Mount Sinai- Beth Israel Medical Center — New York, New York, United States
Housing Works Inc — New York, New York, United States
Callen Lorde Community Health Center — New York, New York, United States
APICHA Community Health Center — New York, New York, United States
Mount Sinai-St. Luke's - Roosevelt Hospital — New York, New York, United States
Mount Sinai Medical Center — New York, New York, United States
The Institute for Family Health — New York, New York, United States
Services for the Underserved, Inc. — New York, New York, United States
Community Health Action Of Staten Island — Staten Island, New York, United States
Bronx Lebanon Hospital Center — The Bronx, New York, United States
Argus Community Inc — The Bronx, New York, United States
HHC Jacobi Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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