NCT03628287

Program Refinements to Optimize Model Impact and Scalability Based on Evidence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 960 (actual)
• Sponsor: City University of New York, School of Public Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Hiv

Interventions

Type	Name	Description
OTHER	Revised Care Coordination Program	Greater focusing, tailoring and cues for delivery of key components of Care Coordination
OTHER	Original Care Coordination Program	Original Care Coordination

Timeline

• Start date: 2018-08-01
• Primary completion: 2020-01-30
• Completion: 2023-01-31
• First posted: 2018-08-14
• Last updated: 2024-08-30
• Results posted: 2022-12-23

Locations

17 sites across 1 country: United States