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

Part of paid clinical trials in New York, New York.

Sponsor
City University of New York
Study ID
NCT05140421
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Data to Suppression (D2S) — OTHER
    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.
  • Usual practice — OTHER
    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).

Study Details

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.

Key Dates

Start date
Dec 15, 2021
Status verified
Feb 2026
Primary completion
Jun 1, 2024
Completion
Apr 30, 2026

Study Design

Enrollment
1,494 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Early implementation: UC first, then D2S, then D2S again
    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.
  • Active Comparator: Delayed implementation: UC first, then UC again, then D2S
    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).

Primary Outcome Measure

Timely Viral Suppression [ Time Frame: 6 months ]

Locations (27)

FacilityCityStateZIPSite coordinators
African Services Committee, Inc.New YorkNew York10027-
After Hours ProjectNew YorkNew York11221-
AIDS Center of Queens County, Inc.New YorkNew York11432-
Alliance for Positive ChangeNew YorkNew York10001-
Bailey House, Inc.New YorkNew York10035-
Boom!HealthNew YorkNew York10451-
Bridging Access to Care, Inc.New YorkNew York11216-
BronxWorks, Inc.New YorkNew York10453-
CAMBA, Inc.New YorkNew York11226-
Exponents, Inc.New YorkNew York10004-
GMHCNew YorkNew York10018-
Harlem UnitedNew YorkNew York10027-
Housing WorksNew YorkNew York11201-
Interfaith Medical CenterNew YorkNew York11213-
La Nueva Esperanza, Inc.New YorkNew York11206-
Mount Sinai Beth IsraelNew YorkNew York10003-
New York Harm Reduction Educators, Inc.New YorkNew York10035-
New York Presbyterian HospitalNew YorkNew York10032-
NYC Health and Hospitals HarlemNew YorkNew York10037-
NYC Health and Hospitals QueensNew YorkNew York11432-
NYC Health and Hospitals WoodhullNew YorkNew York11206-
Planned Parenthood of Greater New YorkNew YorkNew York11225-
Project Hospitality, Inc.New YorkNew York10302-
Research Foundation of State University of New YorkNew YorkNew York11203-
St. Ann's Corner of Harm ReductionNew YorkNew York10459-
The Institute for Family HealthNew YorkNew York10035-
Tolentine Zeiser Community Life CenterNew YorkNew York10463-

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