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Program Refinements to Optimize Model Impact and Scalability Based on Evidence (PROMISE)

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ClinicalTrials.gov Identifier: NCT03628287
Recruitment Status : Active, not recruiting
First Posted : August 14, 2018
Last Update Posted : October 14, 2019
Sponsor:
Collaborator:
New York City Department of Health and Mental Hygiene
Information provided by (Responsible Party):
Denis Nash, City University of New York, School of Public Health

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.

Condition or disease Intervention/treatment Phase
Hiv Other: Revised Care Coordination Program Other: Original Care Coordination Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 824 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Program Refinements to Optimize Model Impact and Scalability Based on Evidence
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Original Care Coordination Program
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
Original Care Coordination

Experimental: Revised Care Coordination Program
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 iART ("immediate" ART: 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
Greater focusing, tailoring and cues for delivery of key components of Care Coordination




Primary Outcome Measures :
  1. Timely viral suppression [ Time Frame: 4 months ]
    Timely VS (TVS) will be defined as VL <200 copies/mL on the last VL test reported to the Registry in the 4 months following CCP enrollment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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 TVS.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03628287


Locations
Show Show 17 study locations
Sponsors and Collaborators
City University of New York, School of Public Health
New York City Department of Health and Mental Hygiene
Investigators
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Principal Investigator: 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

Additional Information:
Publications:
Penrose, K., Robertson, M., Nash, D., Harriman, G., & Irvine, M. (2019). Social vulnerabilities and reported discrimination in health care among HIV-positive medical case management clients in New York City. Stigma and Health. Advance online publication.

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Responsible Party: Denis Nash, Professor, City University of New York, School of Public Health
ClinicalTrials.gov Identifier: NCT03628287    
Other Study ID Numbers: R01MH117793 ( U.S. NIH Grant/Contract )
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to the legal restrictions (New York Public Health Law Article 21, Title III) and the confidential nature of HIV surveillance data in New York, public health authorities in New York City cannot release individual-level data on reported HIV cases for purposes other than ensuring appropriate HIV care. The NYC DOHMH staff are available to assist external researchers who may have further specific data questions or uses. Please send an email to hivreport@health.nyc.gov with questions or requests for additional information.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Denis Nash, City University of New York, School of Public Health:
viral load suppression
medical case management