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Testing a Novel Data-to-Suppression (D2S) Intervention Strategy in the Ryan White HIV/AIDS Program (D2S)

Primary Purpose

Hiv

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Data to Suppression (D2S)
Sponsored by
City University of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hiv focused on measuring viral load suppression, surveillance, HIV treatment engagement, structural intervention

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • For each stepped-wedge implementation period (Period 0, 1, or 2), clients eligible for trial inclusion must have: (1) ≥1 viral load (VL) test in the report year (evidence that they are in HIV care in NYC); (2) unsuppressed VL (≥200 copies/mL) at last reported VL test during that year; and (3) a reported service in one of the eligible programs/agencies during the report year. In addition, they must still have an open RWPA enrollment in one of the eligible programs and agencies and be presumed living at the time of report generation (two months following the end of the report year on which data are being shared with providers).

Exclusion Criteria:

  • Agencies without current NYC RWPA funding for housing assistance or behavioral health (mental health, supportive counseling or harm reduction) services are excluded. Agencies with <5 clients meeting the above inclusion criteria over three recent pre-implementation sample periods of data are also excluded (due to insufficient numbers of unsuppressed clients). Clients enrolled in NYC RWPA behavioral health or housing programs are excluded from the trial if they are virally suppressed, deceased, or lacking any evidence of NYC HIV care for a full year at the time a D2S report is issued. Given the potential lag in reporting to surveillance and the need to use the freshest available surveillance data for D2S reports, some clients may later be found to have died or to have a VL<200 dated after their qualifying VL≥200 but prior to D2S report generation; such clients will be excluded post hoc from that round of follow-up due to VS at the time of intervention. Similarly, clients later reported (in programmatic data) to have been closed out of all eligible programs before the report issue date will be excluded post hoc.

Sites / Locations

  • Alliance for Positive Change
  • Mount Sinai Beth Israel
  • Exponents, Inc.
  • GMHC
  • African Services Committee, Inc.
  • Harlem United
  • New York Presbyterian Hospital
  • Bailey House, Inc.
  • New York Harm Reduction Educators, Inc.
  • The Institute for Family Health
  • NYC Health and Hospitals Harlem
  • Project Hospitality, Inc.
  • Boom!Health
  • BronxWorks, Inc.
  • St. Ann's Corner of Harm Reduction
  • Tolentine Zeiser Community Life Center
  • Housing Works
  • Research Foundation of State University of New York
  • La Nueva Esperanza, Inc.
  • NYC Health and Hospitals Woodhull
  • Interfaith Medical Center
  • Bridging Access to Care, Inc.
  • After Hours Project
  • Planned Parenthood of Greater New York
  • CAMBA, Inc.
  • AIDS Center of Queens County, Inc.
  • NYC Health and Hospitals Queens

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early Implementation

Delayed Implementation

Arm Description

This arm will receive D2S intervention components during Period 1 (Early Implementation) as well as throughout Period 2 of the stepped-wedge trial.

This arm will receive no D2S intervention components during Period 1 (Early Implementation), but will then receive all D2S intervention components in Period 2, starting 12 months later.

Outcomes

Primary Outcome Measures

Timely viral suppression
Registry-reported VL <200 copies/mL on any VL test dated in the six months after the client first appeared as unsuppressed on a D2S report for the period

Secondary Outcome Measures

Time to viral suppression
Time to first VL <200 copies/mL after client's first appearance on a D2S report for the period

Full Information

First Posted
November 19, 2021
Last Updated
June 21, 2023
Sponsor
City University of New York
Collaborators
New York City Department of Health and Mental Hygiene, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05140421
Brief Title
Testing a Novel Data-to-Suppression (D2S) Intervention Strategy in the Ryan White HIV/AIDS Program
Acronym
D2S
Official Title
Strengthening the Safety Net: Testing a Novel Data-to-Suppression (D2S) Intervention Strategy in the Ryan White HIV/AIDS Program
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
City University of New York
Collaborators
New York City Department of Health and Mental Hygiene, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The Ryan White HIV/AIDS Program (RWHAP) for low-income people with HIV (PWH) is a key resource for reducing HIV health disparities and scaling up evidence-based interventions. As RWHAP serves >50% of US PWH, RWHAP outcomes are vital to achieving "getting-to-zero"/ Ending the HIV Epidemic (EHE) Plan targets. As a grantee for RWHAP Part A (RWPA) funding distributed to the counties/cities severely affected by HIV, New York City (NYC) conducts regular HIV care continuum monitoring citywide and in its RWPA programs, which offer support services to reduce social and behavioral barriers to care/treatment. Local data consistently show lower viral suppression (VS) among RWPA clients in HIV care than among non-RWPA PWH in HIV care. Relative to NYC HIV cases overall, NYC RWPA clients (~14,000 per year) over-represent Black and Latinx PWH and high-poverty neighborhoods. To address local outcome disparities and to fill gaps left by data-to-care strategies and research focused on medical care (re-)linkage, the investigators propose to implement and rigorously evaluate the effectiveness of a novel 'data-to-suppression' (D2S) intervention among RWPA behavioral health and housing program clients who are in HIV care but unsuppressed. Surveillance-based reports on unsuppressed clients plus D2S capacity-building assistance will guide RWPA providers in targeting and delivering evidence-informed strategies to improve VS.
Detailed Description
The investigators will implement and evaluate the Data-to-Suppression (D2S) intervention in Aim 1, which applies a cluster-randomized, stepped-wedge design. Agencies eligible for the trial will be matched in pairs and then randomized within pairs to early (Period 1) or delayed (Period 2) D2S intervention implementation. Our design will also use baseline data from a 12-month pre-implementation period (Period 0), for which D2S reports will be retrospectively generated. Each period will include two rounds of report releases (six months apart), each with a 12-month look-back period. Period 2 will begin 12 months after the start of Period 1. In both arms, clients without viral suppression (VS) will be followed forward for viral load (VL) outcomes after report issue date. Outcomes data will be derived from the NYC HIV Surveillance Registry, a population-based data source of longitudinal laboratory (VL, CD4) testing records on all diagnosed NYC PWH, regardless of medical provider within NYC, and for periods extending before and after RWPA program enrollment or discontinuation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiv
Keywords
viral load suppression, surveillance, HIV treatment engagement, structural intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Stepped-wedge design: To isolate the effects of D2S on viral suppression, the investigators will randomize (within matched pairs and one trio) 27 RWPA-funded behavioral health and housing services provider agencies to immediate or delayed implementation of D2S (12 months apart).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1619 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early Implementation
Arm Type
Experimental
Arm Description
This arm will receive D2S intervention components during Period 1 (Early Implementation) as well as throughout Period 2 of the stepped-wedge trial.
Arm Title
Delayed Implementation
Arm Type
Active Comparator
Arm Description
This arm will receive no D2S intervention components during Period 1 (Early Implementation), but will then receive all D2S intervention components in Period 2, starting 12 months later.
Intervention Type
Behavioral
Intervention Name(s)
Data to Suppression (D2S)
Intervention Description
Intervention components include (1) reporting and (2) capacity building to facilitate identification of and follow-up with PWH who are in care but virally unsuppressed. The NYC Health Department will send client-level, surveillance-based reports on individual clients' viral suppression status to those clients' current Ryan White Part A behavioral health and housing service providers. The Health Department will also provide capacity building and technical assistance (TA) support to service providers on following up with clients flagged as unsuppressed, and on addressing barriers to viral suppression through root cause analyses and the development and implementation of D2S quality improvement projects. The intervention components are all delivered to Ryan White Part A providers by the Health Department, in order to enhance program resources to achieve and maintain viral suppression in the Ryan White Part A client population in NYC.
Primary Outcome Measure Information:
Title
Timely viral suppression
Description
Registry-reported VL <200 copies/mL on any VL test dated in the six months after the client first appeared as unsuppressed on a D2S report for the period
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Time to viral suppression
Description
Time to first VL <200 copies/mL after client's first appearance on a D2S report for the period
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: For each stepped-wedge implementation period (Period 0, 1, or 2), clients eligible for trial inclusion must have: (1) ≥1 viral load (VL) test in the report year (evidence that they are in HIV care in NYC); (2) unsuppressed VL (≥200 copies/mL) at last reported VL test during that year; and (3) a reported service in one of the eligible programs/agencies during the report year. In addition, they must still have an open RWPA enrollment in one of the eligible programs and agencies and be presumed living at the time of report generation (two months following the end of the report year on which data are being shared with providers). Exclusion Criteria: Agencies without current NYC RWPA funding for housing assistance or behavioral health (mental health, supportive counseling or harm reduction) services are excluded. Agencies with <5 clients meeting the above inclusion criteria over three recent pre-implementation sample periods of data are also excluded (due to insufficient numbers of unsuppressed clients). Clients enrolled in NYC RWPA behavioral health or housing programs are excluded from the trial if they are virally suppressed, deceased, or lacking any evidence of NYC HIV care for a full year at the time a D2S report is issued. Given the potential lag in reporting to surveillance and the need to use the freshest available surveillance data for D2S reports, some clients may later be found to have died or to have a VL<200 dated after their qualifying VL≥200 but prior to D2S report generation; such clients will be excluded post hoc from that round of follow-up due to VS at the time of intervention. Similarly, clients later reported (in programmatic data) to have been closed out of all eligible programs before the report issue date will be excluded post hoc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis Nash, PhD
Organizational Affiliation
CUNY School of Public Health and Health Policy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mary K Irvine, DrPH
Organizational Affiliation
New York City Department of Health and Mental Hygiene
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alliance for Positive Change
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Name
Mount Sinai Beth Israel
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Exponents, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10004
Country
United States
Facility Name
GMHC
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States
Facility Name
African Services Committee, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Facility Name
Harlem United
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Bailey House, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Facility Name
New York Harm Reduction Educators, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Facility Name
The Institute for Family Health
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Facility Name
NYC Health and Hospitals Harlem
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Project Hospitality, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10302
Country
United States
Facility Name
Boom!Health
City
New York
State/Province
New York
ZIP/Postal Code
10451
Country
United States
Facility Name
BronxWorks, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10453
Country
United States
Facility Name
St. Ann's Corner of Harm Reduction
City
New York
State/Province
New York
ZIP/Postal Code
10459
Country
United States
Facility Name
Tolentine Zeiser Community Life Center
City
New York
State/Province
New York
ZIP/Postal Code
10463
Country
United States
Facility Name
Housing Works
City
New York
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Research Foundation of State University of New York
City
New York
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
La Nueva Esperanza, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
11206
Country
United States
Facility Name
NYC Health and Hospitals Woodhull
City
New York
State/Province
New York
ZIP/Postal Code
11206
Country
United States
Facility Name
Interfaith Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
11213
Country
United States
Facility Name
Bridging Access to Care, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
11216
Country
United States
Facility Name
After Hours Project
City
New York
State/Province
New York
ZIP/Postal Code
11221
Country
United States
Facility Name
Planned Parenthood of Greater New York
City
New York
State/Province
New York
ZIP/Postal Code
11225
Country
United States
Facility Name
CAMBA, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
11226
Country
United States
Facility Name
AIDS Center of Queens County, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
NYC Health and Hospitals Queens
City
New York
State/Province
New York
ZIP/Postal Code
11432
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Due to New York State Public Health Law 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 Department of Health and Mental Hygiene (DOHMH) staff are available to assist external researchers who may have further specific data questions or uses. Please send an email to the DOHMH PI Mary Irvine (mirvine@health.nyc.gov) with questions or requests for additional information.

Learn more about this trial

Testing a Novel Data-to-Suppression (D2S) Intervention Strategy in the Ryan White HIV/AIDS Program

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