An interventional study of Data to Suppression (D2S) and Usual practice in Hiv, sponsored by City University of New York. Completed at 27 sites in United States. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by City University of New York · Not applicable, Interventional, and Treatment
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.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's enrollment of 1,494 is above the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →City University of New York is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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).
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
Time frame: 6 months
Time to Viral Suppression
Time to first VL \<200 copies/mL after client's first appearance on a D2S report for the period
Time frame: 12 months
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.
| Milestone | Early Implementation: UC First, Then D2S, Then D2S Again | Delayed Implementation: UC First, Then UC Again, Then D2S |
|---|---|---|
| Started | 292 | 322 |
| Completed | 292 | 322 |
| Not completed | 0 | 0 |
| Milestone | Early Implementation: UC First, Then D2S, Then D2S Again | Delayed Implementation: UC First, Then UC Again, Then D2S |
|---|---|---|
| Started | 209 | 279 |
| Completed | 209 | 279 |
| Not completed | 0 | 0 |
| Milestone | Early Implementation: UC First, Then D2S, Then D2S Again | Delayed Implementation: UC First, Then UC Again, Then D2S |
|---|---|---|
| Started | 197 | 195 |
| Completed | 197 | 195 |
| Not completed | 0 | 0 |
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
| Participants | D2S Intervention | Usual Care |
|---|---|---|
| Timely Viral Suppression | 309 | 352 |
Time to first VL \<200 copies/mL after client's first appearance on a D2S report for the period
Results for this outcome have not been posted.
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| D2S Intervention | 119/601 (19.8%) | — | — |
| Usual Care | 121/893 (13.5%) | — | — |
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.
| Age, Categorical(Participants) | Early Implementation: UC First, Then D2S, Then D2S Again | Delayed Implementation: UC First, Then UC Again, Then D2S | Total |
|---|---|---|---|
| <=18 years | 1 | 0 | 1 |
| Between 18 and 65 years | 628 | 743 | 1371 |
| >=65 years | 69 | 53 | 122 |
| Sex/Gender, Customized(Participants) | Early Implementation: UC First, Then D2S, Then D2S Again | Delayed Implementation: UC First, Then UC Again, Then D2S | Total |
|---|---|---|---|
| Cisgender man or boy | 460 | 500 | 960 |
| Cisgender woman or girl | 200 | 225 | 425 |
| TGNCNB* individual | 38 | 71 | 109 |
| Ethnicity (NIH/OMB)(Participants) | Early Implementation: UC First, Then D2S, Then D2S Again | Delayed Implementation: UC First, Then UC Again, Then D2S | Total |
|---|---|---|---|
| Hispanic or Latino | 200 | 235 | 435 |
| Not Hispanic or Latino | 497 | 556 | 1053 |
| Unknown or Not Reported | 1 | 5 | 6 |
| Race (NIH/OMB)(Participants) | Early Implementation: UC First, Then D2S, Then D2S Again | Delayed Implementation: UC First, Then UC Again, Then D2S | Total |
|---|---|---|---|
| American Indian or Alaska Native | 3 | 5 | 8 |
| Asian | 0 | 3 | 3 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 526 | 573 | 1099 |
| White | 108 | 140 | 248 |
| More than one race | 13 | 11 | 24 |
| Unknown or Not Reported | 47 | 64 | 111 |
| Region of Enrollment(Participants) | Early Implementation: UC First, Then D2S, Then D2S Again | Delayed Implementation: UC First, Then UC Again, Then D2S | Total |
|---|---|---|---|
| United States | 698 | 796 | 1494 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
City University of New York