Testing a Novel Data-to-Suppression (D2S) Intervention Strategy in the Ryan White HIV/AIDS Program
D2S
Strengthening the Safety Net: Testing a Novel Data-to-Suppression (D2S) Intervention Strategy in the Ryan White HIV/AIDS Program
2 other identifiers
interventional
1,494
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started Dec 2021
Longer than P75 for not_applicable hiv
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2021
CompletedFirst Posted
Study publicly available on registry
December 1, 2021
CompletedStudy Start
First participant enrolled
December 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedResults Posted
Study results publicly available
March 19, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedMarch 19, 2026
February 1, 2026
2.5 years
November 19, 2021
September 29, 2025
February 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
6 months
Secondary Outcomes (1)
Time to Viral Suppression
12 months
Study Arms (2)
Early implementation: UC first, then D2S, then D2S again
EXPERIMENTALThis arm will receive usual quality management supports (usual practice) from the NYC Health Department during Period 0 (months 1-12) and D2S intervention components during Period 1 (months 13-24) as well as throughout Period 2 (months 25-36) of the stepped-wedge trial.
Delayed implementation: UC first, then UC again, then D2S
ACTIVE COMPARATORThis arm will receive the usual quality management supports (usual practice) from the NYC Health Department during Period 0 (months 1-12) and Period 1 (months 13-24), and will transition to receiving the D2S intervention components during Period 2 (months 25-36).
Interventions
The NYC Health Department's usual practice with Ryan White Part A behavioral health and housing service providers includes sharing an annual aggregate surveillance-based report on viral suppression prevalence at each site and across all Part A sites (with trends for the past three years and breakdowns of viral suppression for specific populations in the latest year), a guidance document delivered with the aggregate viral suppression report, annual site visits to monitor program delivery, and on-demand quality improvement project guidance (for whatever Part A quality improvement project each site may identify and select).
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 the current Ryan White Part A behavioral health and housing service providers for those clients. 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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Alliance for Positive Change
New York, New York, 10001, United States
Mount Sinai Beth Israel
New York, New York, 10003, United States
Exponents, Inc.
New York, New York, 10004, United States
GMHC
New York, New York, 10018, United States
African Services Committee, Inc.
New York, New York, 10027, United States
Harlem United
New York, New York, 10027, United States
New York Presbyterian Hospital
New York, New York, 10032, United States
Bailey House, Inc.
New York, New York, 10035, United States
New York Harm Reduction Educators, Inc.
New York, New York, 10035, United States
The Institute for Family Health
New York, New York, 10035, United States
NYC Health and Hospitals Harlem
New York, New York, 10037, United States
Project Hospitality, Inc.
New York, New York, 10302, United States
Boom!Health
New York, New York, 10451, United States
BronxWorks, Inc.
New York, New York, 10453, United States
St. Ann's Corner of Harm Reduction
New York, New York, 10459, United States
Tolentine Zeiser Community Life Center
New York, New York, 10463, United States
Housing Works
New York, New York, 11201, United States
Research Foundation of State University of New York
New York, New York, 11203, United States
La Nueva Esperanza, Inc.
New York, New York, 11206, United States
NYC Health and Hospitals Woodhull
New York, New York, 11206, United States
Interfaith Medical Center
New York, New York, 11213, United States
Bridging Access to Care, Inc.
New York, New York, 11216, United States
After Hours Project
New York, New York, 11221, United States
Planned Parenthood of Greater New York
New York, New York, 11225, United States
CAMBA, Inc.
New York, New York, 11226, United States
AIDS Center of Queens County, Inc.
New York, New York, 11432, United States
NYC Health and Hospitals Queens
New York, New York, 11432, United States
Related Publications (1)
Irvine MK, Abdelqader F, Levin B, Thomas J, Avoundjian T, Peterson M, Zimba R, Braunstein SL, Robertson MM, Nash D. Study protocol for data to suppression (D2S): a cluster-randomised, stepped-wedge effectiveness trial of a reporting and capacity-building intervention to improve HIV viral suppression in housing and behavioural health programmes in New York City. BMJ Open. 2023 Jul 14;13(7):e076716. doi: 10.1136/bmjopen-2023-076716.
PMID: 37451738BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The intervention was administered to sites, whose implementation of any follow-up with individual clients was voluntary, left to the discretion of service providers at the sites. The trial spanned the pandemic period. Sites reported some implementation barriers, e.g., understaffing and resource constraints. The Health Department did not administer any intervention to individuals followed for the trial and did not interview or otherwise collect study-specific data from those individuals directly.
Results Point of Contact
- Title
- Mary Irvine, NYC Health Department PI
- Organization
- New York City Department of Health and Mental Hygiene
Study Officials
- PRINCIPAL INVESTIGATOR
Denis Nash, PhD
CUNY School of Public Health and Health Policy
- PRINCIPAL INVESTIGATOR
Mary K Irvine, DrPH
New York City Department of Health and Mental Hygiene
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of HIV Care and Treatment Research and Evaluation
Study Record Dates
First Submitted
November 19, 2021
First Posted
December 1, 2021
Study Start
December 15, 2021
Primary Completion
June 1, 2024
Study Completion
April 30, 2026
Last Updated
March 19, 2026
Results First Posted
March 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
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.