Program Refinements to Optimize Model Impact and Scalability Based on Evidence

Hiv Clinical Trial

— PROMISE  

Official title:

Program Refinements to Optimize Model Impact and Scalability Based on Evidence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03628287
• Other study ID #: R01MH117793
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2024
• Source: City University of New York, School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 960
• Est. completion date: January 31, 2023
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hiv

Intervention

Other:
• Revised Care Coordination Program
Greater focusing, tailoring and cues for delivery of key components of Care Coordination
• Original Care Coordination Program
Original Care Coordination

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
City University of New York, School of Public Health	New York City Department of Health and Mental Hygiene

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. Erratum In: Clin Infect Dis. 2015 Jun 15;60(12):1879. Laraque, Fabienne [added]. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timely Viral Suppression (TVS)	TVS defined as achieving viral suppression (VL <200 copies/mL) on the last VL test in the four months following CCP enrollment.	Four months after CCP enrollment

External Links

•   HIV CARE COORDINATION PROGRAM Evidence-Informed for Retention in HIV Care