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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
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
Start Date
August 1, 2018
Primary Completion Date
January 30, 2020
Completion Date
January 31, 2023
Last Updated
August 30, 2024
960
ACTUAL participants
Revised Care Coordination Program
OTHER
Original Care Coordination Program
OTHER
Lead Sponsor
City University of New York, School of Public Health
Collaborators
NCT07071623
NCT01875588
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04929028