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

August 28, 2024 updated by: Denis Nash, City University of New York, School of Public Health
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
960

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10453
        • Bronx Lebanon Hospital Center
      • Bronx, New York, United States, 10456
        • Argus Community Inc
      • Bronx, New York, United States, 10461
        • HHC Jacobi Medical Center
      • Brooklyn, New York, United States, 11237
        • Wyckoff Heights Medical Center
      • Brooklyn, New York, United States, 11203
        • HHC Kings County Hospital Center
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate Medical Center - STAR Health Center
      • Brooklyn, New York, United States, 11220
        • Sunset Park Health Council, Inc.
      • Elmhurst, New York, United States, 11373
        • HHC Elmhurst Hospital Center
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • New York, New York, United States, 10003
        • Mount Sinai- Beth Israel Medical Center
      • New York, New York, United States, 10009
        • Housing Works Inc
      • New York, New York, United States, 10011
        • Callen Lorde Community Health Center
      • New York, New York, United States, 10013
        • APICHA Community Health Center
      • New York, New York, United States, 10025
        • Mount Sinai-St. Luke's - Roosevelt Hospital
      • New York, New York, United States, 10035
        • The Institute for Family Health
      • New York, New York, United States, 10452
        • Services for the Underserved, Inc.
      • Staten Island, New York, United States, 10302
        • Community Health Action Of Staten Island

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 "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
Greater focusing, tailoring and cues for delivery of key components of Care Coordination

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Timely Viral Suppression (TVS)
Time Frame: Four months after CCP enrollment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
City University of New York, School of Public Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
New York City Department of Health and Mental Hygiene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01MH117793 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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