Program Refinements to Optimize Model Impact and Scalability Based on Evidence

NCT03628287 | Completed Results

• 1 other identifier: R01MH117793
• Study Type: interventional
• Target: 960
• Locations: 1 country
• Sites: 17

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.

Conditions

Hiv

Keywords

viral load suppression; medical case management

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Original Care Coordination Program

ACTIVE COMPARATOR

Specific intervention components include: 1) outreach for initial case finding and after any missed appointment; 2) case management, including social services and benefits assessments; 3) multidisciplinary care team communication and decision-making via case conferences; 4) patient navigation, including appointment reminders, assistance with scheduling appointments, transportation resources, and accompaniment to primary care visits; 5) antiretroviral treatment adherence support, including directly observed therapy for individuals with greatest need; and 6) structured health promotion, for which clients are assigned to program tracks (determining their frequency of health promotion visits: weekly, monthly or quarterly), depending on their level of assessed need.

Other: Original Care Coordination Program

Revised Care Coordination Program

EXPERIMENTAL

The revised model includes the original intervention components without program track assignments or the three-month induction period of weekly visits. Program additions include a set of tools for assessment and counseling around client HIV self-management capacity; allowance of video chat for delivery of some services; and optional "immediate" antiretroviral therapy (iART: ensuring the client has a filled prescription within 4 days of enrollment or diagnosis). Other changes include greater guidance on recruiting individuals with unsuppressed VL and a switch from per-member-per-day reimbursement to fee-for-service reimbursement that accounts for resource demands, such as staff travel to clients' homes, and offers higher rates for meeting performance standards.

Other: Revised Care Coordination Program

Interventions

Revised Care Coordination Program OTHER

Greater focusing, tailoring and cues for delivery of key components of Care Coordination

Revised Care Coordination Program

Original Care Coordination Program OTHER

Original Care Coordination

Original Care Coordination Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• City University of New York, School of Public Health: lead
• New York City Department of Health and Mental Hygiene: collaborator

Study Sites (17)

HHC Kings County Hospital Center

Brooklyn, New York, 11203, United States

Location

SUNY Downstate Medical Center - STAR Health Center

Brooklyn, New York, 11203, United States

Location

Sunset Park Health Council, Inc.

Brooklyn, New York, 11220, United States

Location

Wyckoff Heights Medical Center

Brooklyn, New York, 11237, United States

Location

HHC Elmhurst Hospital Center

Elmhurst, New York, 11373, United States

Location

Mount Sinai- Beth Israel Medical Center

New York, New York, 10003, United States

Location

Housing Works Inc

New York, New York, 10009, United States

Location

Callen Lorde Community Health Center

New York, New York, 10011, United States

Location

APICHA Community Health Center

New York, New York, 10013, United States

Location

Mount Sinai-St. Luke's - Roosevelt Hospital

New York, New York, 10025, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

The Institute for Family Health

New York, New York, 10035, United States

Location

Services for the Underserved, Inc.

New York, New York, 10452, United States

Location

Community Health Action Of Staten Island

Staten Island, New York, 10302, United States

Location

Bronx Lebanon Hospital Center

The Bronx, New York, 10453, United States

Location

Argus Community Inc

The Bronx, New York, 10456, United States

Location

HHC Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Related Publications (10)

• 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.

  PMID: 29788080 BACKGROUND

• 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.

  PMID: 27342990 BACKGROUND

• 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.

  PMID: 25301208 BACKGROUND

• 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.

  PMID: 30299346 BACKGROUND

• 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.

  PMID: 30248136 BACKGROUND

• 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.

  PMID: 32432165 BACKGROUND

• 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.

  PMID: 31022280 BACKGROUND

• Hernandez M, Guarino H, Kozlowski S, Srivastava A, Schenkel R, Tapia T, Seabrook TB, Nash D, Irvine MK. Addressing Mental Health Barriers in HIV Care Coordination Is Crucial to Providing Optimal HIV/AIDS Care. AIDS Patient Care STDS. 2024 Mar;38(3):107-114. doi: 10.1089/apc.2023.0240.

  PMID: 38471091 DERIVED

• Irvine MK, Levin B, Abdelqader F, Carmona J, Avoundjian T, Thomas J, Braunstein SL, Robertson M, Nash D. Evaluation of the Revised Versus Original Ryan White Part A HIV Care Coordination Program in a Cluster-Randomized, Stepped-Wedge Trial. J Acquir Immune Defic Syndr. 2023 Apr 1;92(4):325-333. doi: 10.1097/QAI.0000000000003139. Epub 2022 Dec 22.

  PMID: 36729538 DERIVED

• 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.

  PMID: 32718922 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

This was an observational trial. The only change made for the purpose of this trial was randomization (within matched pairs) of sites to early or delayed implementation of program revisions. No test, data collection, or treatment was administered specifically for this trial. All persons observed were enrolling for HIV Care Coordination regardless of the trial, and all received the original or revised model of Care Coordination, based on the site and period in which they joined the program.

Results Point of Contact

• Title: Denis Nash, PhD
• Organization: City University of New York, School of Public Health

denis.nash@sph.cuny.edu

347-331-6554

Study Officials

• Denis Nash, PhD

  CUNY School of Public Health and Health Policy

  PRINCIPAL INVESTIGATOR

• Mary Irvine, DrPH

  New York City Department of Health and Mental Hygiene

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 14, 2018
• Study Start: August 1, 2018
• Primary Completion: January 30, 2020
• Study Completion: January 31, 2023
• Last Updated: August 30, 2024
• Results First Posted: December 23, 2022

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)