NCT05140421

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,494

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Dec 2021

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

27 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

December 15, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

March 19, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

March 19, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

November 19, 2021

Results QC Date

September 29, 2025

Last Update Submit

February 26, 2026

Conditions

Keywords

viral load suppressionsurveillanceHIV treatment engagementstructural intervention

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

EXPERIMENTAL

This 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.

Other: Data to Suppression (D2S)Other: Usual practice

Delayed implementation: UC first, then UC again, then D2S

ACTIVE COMPARATOR

This 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).

Other: Data to Suppression (D2S)Other: Usual practice

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).

Delayed implementation: UC first, then UC again, then D2SEarly implementation: UC first, then D2S, then D2S again

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.

Delayed implementation: UC first, then UC again, then D2SEarly implementation: UC first, then D2S, then D2S again

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Alliance for Positive Change

New York, New York, 10001, United States

Location

Mount Sinai Beth Israel

New York, New York, 10003, United States

Location

Exponents, Inc.

New York, New York, 10004, United States

Location

GMHC

New York, New York, 10018, United States

Location

African Services Committee, Inc.

New York, New York, 10027, United States

Location

Harlem United

New York, New York, 10027, United States

Location

New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Bailey House, Inc.

New York, New York, 10035, United States

Location

New York Harm Reduction Educators, Inc.

New York, New York, 10035, United States

Location

The Institute for Family Health

New York, New York, 10035, United States

Location

NYC Health and Hospitals Harlem

New York, New York, 10037, United States

Location

Project Hospitality, Inc.

New York, New York, 10302, United States

Location

Boom!Health

New York, New York, 10451, United States

Location

BronxWorks, Inc.

New York, New York, 10453, United States

Location

St. Ann's Corner of Harm Reduction

New York, New York, 10459, United States

Location

Tolentine Zeiser Community Life Center

New York, New York, 10463, United States

Location

Housing Works

New York, New York, 11201, United States

Location

Research Foundation of State University of New York

New York, New York, 11203, United States

Location

La Nueva Esperanza, Inc.

New York, New York, 11206, United States

Location

NYC Health and Hospitals Woodhull

New York, New York, 11206, United States

Location

Interfaith Medical Center

New York, New York, 11213, United States

Location

Bridging Access to Care, Inc.

New York, New York, 11216, United States

Location

After Hours Project

New York, New York, 11221, United States

Location

Planned Parenthood of Greater New York

New York, New York, 11225, United States

Location

CAMBA, Inc.

New York, New York, 11226, United States

Location

AIDS Center of Queens County, Inc.

New York, New York, 11432, United States

Location

NYC Health and Hospitals Queens

New York, New York, 11432, United States

Location

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

Acquired Immunodeficiency Syndrome

Interventions

dextrin 2-sulfate

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

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

  • 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

    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
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 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 early or delayed implementation, with delayed implementers receiving the usual NYC Health Department quality management supports (usual practice) until their assigned D2S implementation date, 12 months after the start of D2S at early implementing sites.
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.

Locations