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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH125735 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| New York City Department of Health and Mental Hygiene | OTHER_GOV |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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 the Early Implementation arm (receiving the D2S intervention in Periods 1 and 2, months 13-36) or the Delayed Implementation arm (receiving the D2S intervention in Period 2 only, months 25-36). Our design will also use baseline data from a 12-month pre-implementation period (Period 0, months 1-12), 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. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Viral Suppression | Time to first VL <200 copies/mL after client's first appearance on a D2S report for the period | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alliance for Positive Change | New York | New York | 10001 | United States | ||
| Mount Sinai Beth Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37451738 | Background | 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. |
| Label | URL |
|---|---|
| Free full-text of the protocol manuscript | View source |
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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.
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We excluded 6 RWHAP Part A sites with <5 eligible individuals (clients in HIV care but virally unsuppressed) in any period, based on simulated D2S reports from 2018-2021. Those sites were not enrolled in the trial at all. The small numbers of potentially eligible individuals disqualified them.
In addition, 386 clients from the 27 sites were excluded from the trial based on more mature surveillance data indicating they had not been eligible at the time that they were listed on a D2S report.
There is no client recruitment for this trial, which relies on data collected as part of surveillance and routine Ryan White HIV/AIDS Program (RWHAP) Part A reporting. The settings are 20 NYC community-based organizations and 7 hospitals funded through the RWHAP Part A grant to provide housing and behavioral health services. The 27 sites were matched in pairs (in one case, two smaller sites were matched to one larger one), and then randomized within pairs to early or delayed implementation.
| ID | Title | Description |
|---|---|---|
| FG000 | Early Implementation: UC First, Then D2S, Then D2S Again | Early implementation sites received the Data to Suppression (D2S) intervention components in this sequence: 12 months of no D2S (usual practice only), December 2020-November 2021 (Period 0, months 1-12), followed by 24 months of the D2S intervention, December 2021-November 2023 (Period 1, months 13-24 and Period 2, months 25-36). Viral suppression status was followed for 6 months from each client's appearance on a D2S report, and the last 6-month follow-up period extended through November 2023 (end of Period 2). |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Period 0: Months 1-12/Dec 2020-Nov 2021 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2023 |
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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.
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| 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). |
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| 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 |
| FG001 | Delayed Implementation: UC First, Then UC Again, Then D2S | Delayed implementation sites received the Data to Suppression (D2S) intervention in this sequence: 24 months of no D2S (usual practice only), December 2020-November 2022 (Period 0, months 1-12 and Period 1, months 13-24), followed by 12 months of the D2S intervention, December 2022-November 2023 (Period 2, months 25-36). Viral suppression status was followed for 6 months from each client's appearance on a D2S report, and the last 6-month follow-up period extended through November 2023 (end of Period 2). |
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| COMPLETED | Usual practice at all sites |
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| NOT COMPLETED |
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| Period 1: Months 13-24/Dec 2021-Nov 2022 |
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| Period 2: Months 25-36/Dec 2022-Nov 2023 |
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There is no difference, in that the total numbers in each arm are the sum of the per-arm subtotals in each period of the trial. There is no duplication of individuals within a given period; however, as stated in the Protocol, individuals could be included in more than one period, if they were included on a D2S report (as virally unsuppressed) in more than one period.
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| ID | Title | Description |
|---|---|---|
| BG000 | Early Implementation: UC First, Then D2S, Then D2S Again | Early Implementation sites received the Data to Suppression (D2S) intervention components December 2021-November 2023 (Period 1, months 13-24, and Period 2, months 25-36). |
| BG001 | Delayed Implementation: UC First, Then UC Again, Then D2S | Delayed Implementation sites received the Data to Suppression (D2S) intervention components December 2022-November 2023 (Period 2, months 25-36) only. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex/Gender, Customized | Gender (using a combination of self-identified gender and sex assigned at birth). *TGNCNB=Transgender, gender non-conforming, non-binary or questioning/unsure | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The analysis population includes those who were included on a D2S report (whether delivered or not delivered to their service site) as requiring follow-up for viral suppression, and who were later confirmed through updated surveillance data to have still been alive and virally unsuppressed at the time of report issue. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Time to Viral Suppression | Time to first VL <200 copies/mL after client's first appearance on a D2S report for the period | Not Posted | 12 months | Participants |
The three 12-month trial periods were: December 2020 - November 2021 (no intervention at all sites; months 1-12, Period 0) , December 2021 - November 2022 (D2S intervention at Early Implementation sites only, no intervention at Delayed Implementation sites; months 13-24, Period 1), December 2022 - November 2023 (D2S intervention at all sites; months 25-36, Period 2). For TVS outcome follow-up, clients who appeared on D2S reports were followed for six months after they first appeared on a report.
Serious and Other (Not Including Serious) Adverse Events were not monitored/assessed. [We did not collect data directly from participants or contact them for enrollment or intervention. Trial eligibility checks and analyses relied on secondary data sources. The intervention was delivered to service providers, who could use it to identify and triage clients for follow-up. Deaths were tracked during six-month follow-up via merges of death registry/vital statistics data with HIV surveillance data.]
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | D2S Intervention | Sites received the D2S intervention components | 119 | 601 | 0 | 0 | 0 | 0 |
| EG001 | Usual Care | Sites received usual quality management supports | 121 | 893 | 0 | 0 | 0 | 0 |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Irvine, NYC Health Department PI | New York City Department of Health and Mental Hygiene | 7188552880 | mirvine@health.nyc.gov |
| Oct 17, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C091377 | dextrin 2-sulfate |
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| >=65 years |
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| Cisgender woman or girl |
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| TGNCNB* individual |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|