Clinical trial NCT03628287: Program Refinements to Optimize Model Impact and Scalability Based on Evidence
Official title: Program Refinements to Optimize Model Impact and Scalability Based on Evidence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Keywords: viral load suppression
medical case management
Lead sponsor: City University of New York, School of Public Health
Sponsor class: OTHER
Collaborators: name: New York City Department of Health and Mental Hygiene
First posted: 2018-08-14
Enrollment: 960
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped-wedge design: To compare effects of the original and revised CCP contemporaneously for timely viral suppression, we will randomize (within matched pairs and one trio) 17 veteran CCP-implementing agencies to immediate or delayed implementation of the revised model, with delayed implementers providing services under the original model until their assigned start date 9 months later.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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 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.

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 timely viral suppression (TVS).

Primary outcomes:
measure: Timely Viral Suppression (TVS)
timeFrame: Four months after CCP enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Bronx Lebanon Hospital Center
state: New York
city: Bronx
country: United States
facility: Argus Community Inc
state: New York
city: Bronx
country: United States
facility: HHC Jacobi Medical Center
state: New York
city: Brooklyn
country: United States
facility: HHC Kings County Hospital Center
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center - STAR Health Center
state: New York
city: Brooklyn
country: United States
facility: Sunset Park Health Council, Inc.
state: New York
city: Brooklyn
country: United States
facility: Wyckoff Heights Medical Center
state: New York
city: Elmhurst
country: United States
facility: HHC Elmhurst Hospital Center
state: New York
city: New York
country: United States
facility: Mount Sinai- Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: Housing Works Inc
state: New York
city: New York
country: United States
facility: Callen Lorde Community Health Center
state: New York
city: New York
country: United States
facility: APICHA Community Health Center
state: New York
city: New York
country: United States
facility: Mount Sinai-St. Luke's - Roosevelt Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: The Institute for Family Health
state: New York
city: New York
country: United States
facility: Services for the Underserved, Inc.
state: New York
city: Staten Island
country: United States
facility: Community Health Action Of Staten Island
state: New York
Study officials:
affiliation: CUNY School of Public Health and Health Policy
name: Denis Nash, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York City Department of Health and Mental Hygiene
name: Mary Irvine, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Robertson MM, Waldron L, Robbins RS, Chamberlin S, Penrose K, Levin B, Kulkarni S, Braunstein SL, Irvine MK, Nash D. Using Registry Data to Construct a Comparison Group for Programmatic Effectiveness Evaluation: The New York City HIV Care Coordination Program. Am J Epidemiol. 2018 Sep 1;187(9):1980-1989. doi: 10.1093/aje/kwy103.
citation: Irvine MK, Chamberlin SA, Robbins RS, Kulkarni SG, Robertson MM, Nash D. Come as You Are: Improving Care Engagement and Viral Load Suppression Among HIV Care Coordination Clients with Lower Mental Health Functioning, Unstable Housing, and Hard Drug Use. AIDS Behav. 2017 Jun;21(6):1572-1579. doi: 10.1007/s10461-016-1460-4.
citation: Irvine MK, Chamberlin SA, Robbins RS, Myers JE, Braunstein SL, Mitts BJ, Harriman GA, Laraque F, Nash D. Improvements in HIV care engagement and viral load suppression following enrollment in a comprehensive HIV care coordination program. Clin Infect Dis. 2015 Jan 15;60(2):298-310. doi: 10.1093/cid/ciu783. Epub 2014 Oct 9.
citation: Robertson MM, Penrose K, Irvine MK, Robbins RS, Kulkarni S, Braunstein SL, Waldron L, Harriman G, Nash D. Impact of an HIV Care Coordination Program on Durable Viral Suppression. J Acquir Immune Defic Syndr. 2019 Jan 1;80(1):46-55. doi: 10.1097/QAI.0000000000001877.
citation: Nash D, Robertson MM, Penrose K, Chamberlin S, Robbins RS, Braunstein SL, Myers JE, Abraham B, Kulkarni S, Waldron L, Levin B, Irvine MK. Short-term effectiveness of HIV care coordination among persons with recent HIV diagnosis or history of poor HIV outcomes. PLoS One. 2018 Sep 24;13(9):e0204017. doi: 10.1371/journal.pone.0204017. eCollection 2018.
citation: Penrose K, Robertson M, Nash D, Harriman G, Irvine M. Social Vulnerabilities and Reported Discrimination in Health Care Among HIV-Positive Medical Case Management Clients in New York City. Stigma Health. 2020 May;5(2):179-187. doi: 10.1037/sah0000187. Epub 2019 Aug 12.
citation: Stevens ER, Nucifora KA, Irvine MK, Penrose K, Robertson M, Kulkarni S, Robbins R, Abraham B, Nash D, Braithwaite RS. Cost-effectiveness of HIV care coordination scale-up among persons at high risk for sub-optimal HIV care outcomes. PLoS One. 2019 Apr 25;14(4):e0215965. doi: 10.1371/journal.pone.0215965. eCollection 2019.
citation: Irvine MK, Levin B, Robertson MM, Penrose K, Carmona J, Harriman G, Braunstein SL, Nash D. PROMISE (Program Refinements to Optimize Model Impact and Scalability based on Evidence): a cluster-randomised, stepped-wedge trial assessing effectiveness of the revised versus original Ryan White Part A HIV Care Coordination Programme for patients with barriers to treatment in the USA. BMJ Open. 2020 Jul 27;10(7):e034624. doi: 10.1136/bmjopen-2019-034624.