HivD2SNCT05140421

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

A study testing Data to Suppression (D2S) and Usual practice in people with Hiv, run by City University of New York at 27 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Hiv
What is being tested?: Data to Suppression (D2S) and Usual practice
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,494 participants
Where: 27 sitesUnited States
Study dates: 15 Dec 2021to 30 Apr 2026
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

For each stepped-wedge implementation period (Period 0, 1, or 2), clients eligible for trial inclusion must have: (1) ≥1 viral load (VL) test in the report year (evidence that they are in HIV care in NYC); (2) unsuppressed VL (≥200 copies/mL) at last reported VL test during that year; and (3) a reported service in one of the eligible programs/agencies during the report year. In addition, they must still have an open RWPA enrollment in one of the eligible programs and agencies and be presumed living at the time of report generation (two months following the end of the report year on which data are being shared with providers).

Who cannot join

Agencies without current NYC RWPA funding for housing assistance or behavioral health (mental health, supportive counseling or harm reduction) services are excluded. Agencies with <5 clients meeting the above inclusion criteria over three recent pre-implementation sample periods of data are also excluded (due to insufficient numbers of unsuppressed clients). Clients enrolled in NYC RWPA behavioral health or housing programs are excluded from the trial if they are virally suppressed, deceased, or lacking any evidence of NYC HIV care for a full year at the time a D2S report is issued. Given the potential lag in reporting to surveillance and the need to use the freshest available surveillance data for D2S reports, some clients may later be found to have died or to have a VL<200 dated after their qualifying VL≥200 but prior to D2S report generation; such clients will be excluded post hoc from that round of follow-up due to VS at the time of intervention. Similarly, clients later reported (in programmatic data) to have been closed out of all eligible programs before the report issue date will be excluded post hoc.

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

United States27 sites

Alliance for Positive Change
New York, New York, 10001
Mount Sinai Beth Israel
New York, New York, 10003
Exponents, Inc.
New York, New York, 10004
GMHC
New York, New York, 10018
African Services Committee, Inc.
New York, New York, 10027
Harlem United
New York, New York, 10027
New York Presbyterian Hospital
New York, New York, 10032
Bailey House, Inc.
New York, New York, 10035
New York Harm Reduction Educators, Inc.
New York, New York, 10035
The Institute for Family Health
New York, New York, 10035
NYC Health and Hospitals Harlem
New York, New York, 10037
Project Hospitality, Inc.
New York, New York, 10302
Boom!Health
New York, New York, 10451
BronxWorks, Inc.
New York, New York, 10453
St. Ann's Corner of Harm Reduction
New York, New York, 10459
Tolentine Zeiser Community Life Center
New York, New York, 10463
Housing Works
New York, New York, 11201
Research Foundation of State University of New York
New York, New York, 11203
La Nueva Esperanza, Inc.
New York, New York, 11206
NYC Health and Hospitals Woodhull
New York, New York, 11206
Interfaith Medical Center
New York, New York, 11213
Bridging Access to Care, Inc.
New York, New York, 11216
After Hours Project
New York, New York, 11221
Planned Parenthood of Greater New York
New York, New York, 11225
CAMBA, Inc.
New York, New York, 11226
AIDS Center of Queens County, Inc.
New York, New York, 11432
NYC Health and Hospitals Queens
New York, New York, 11432

Other trials in United States

About this study

Official title: Strengthening the Safety Net: Testing a Novel Data-to-Suppression (D2S) Intervention Strategy in the Ryan White HIV/AIDS Program

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.

Read the detailed description

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.

Conditions: Hiv
Being tested: Data to Suppression (D2S), Usual practice
Keywords: viral load suppression, surveillance, HIV treatment engagement, structural intervention
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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 practiceOther
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 groups in NCT05140421
Study group	Role	What they receive
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. Receives: 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). Receives: Other: Data to Suppression (D2S); Other: Usual practice

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 6 months

Secondary outcomes (1)

Time to Viral Suppression
Time to first VL <200 copies/mL after client's first appearance on a D2S report for the period
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 202130 Apr 2026

First posted1 Dec 2021
Study start15 Dec 2021
Primary completion1 Jun 2024
Study completion30 Apr 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HivStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: 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.
Masking: None (open label)
Enrolment: 1,494 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05140421
Sponsor's protocol ID: IRB00000707
Other IDs: R01MH125735
Acronym: D2S
Status last verified: Feb 2026
First submitted: 19 Nov 2021
Last updated: 19 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Publications

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.
PubMed 37451738

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse

All Hiv trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Strengthening the Safety Net: Testing a Novel Data-to-Suppression (D2S) Intervention Strategy in the Ryan White HIV/AIDS Program
ClinicalTrials.gov ID: NCT05140421
Acronym / sponsor ID: D2S / IRB00000707
Conditions: Hiv
Keywords: viral load suppression, surveillance, HIV treatment engagement, structural intervention
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 1,494 participants (actual)
Lead sponsor: City University of New YorkUniversity, hospital or other
Collaborators: New York City Department of Health and Mental Hygiene, National Institute of Mental Health (NIMH)
Study start: 15 Dec 2021 (actual)
Primary completion: 1 Jun 2024 (actual)
Study completion: 30 Apr 2026 (estimated)
First posted: 1 Dec 2021 (actual)
Results: Posted 19 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Early implementation: UC first, then D2S, then D2S again	Experimental	Other: Data to Suppression (D2S), Other: Usual practiceThis 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 comparator	Other: Data to Suppression (D2S), Other: Usual practiceThis 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).

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

For each stepped-wedge implementation period (Period 0, 1, or 2), clients eligible for trial inclusion must have: (1) ≥1 viral load (VL) test in the report year (evidence that they are in HIV care in NYC); (2) unsuppressed VL (≥200 copies/mL) at last reported VL test during that year; and (3) a reported service in one of the eligible programs/agencies during the report year. In addition, they must still have an open RWPA enrollment in one of the eligible programs and agencies and be presumed living at the time of report generation (two months following the end of the report year on which data are being shared with providers).

Key exclusion criteria (1 listed)

Agencies without current NYC RWPA funding for housing assistance or behavioral health (mental health, supportive counseling or harm reduction) services are excluded. Agencies with <5 clients meeting the above inclusion criteria over three recent pre-implementation sample periods of data are also excluded (due to insufficient numbers of unsuppressed clients). Clients enrolled in NYC RWPA behavioral health or housing programs are excluded from the trial if they are virally suppressed, deceased, or lacking any evidence of NYC HIV care for a full year at the time a D2S report is issued. Given the potential lag in reporting to surveillance and the need to use the freshest available surveillance data for D2S reports, some clients may later be found to have died or to have a VL<200 dated after their qualifying VL≥200 but prior to D2S report generation; such clients will be excluded post hoc from that round of follow-up due to VS at the time of intervention. Similarly, clients later reported (in programmatic data) to have been closed out of all eligible programs before the report issue date will be excluded post hoc.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Data to Suppression (D2S)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.	Other	Delayed implementation: UC first, then UC again, then D2S, Early implementation: UC first, then D2S, then D2S again
Usual practiceThe 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).	Other	Delayed implementation: UC first, then UC again, then D2S, Early implementation: UC first, then D2S, then D2S again

Primary outcome

Timely Viral Suppression
Time frame: 6 months
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

1 secondary outcome

Time to Viral Suppression
Time frame: 12 months

Results and safety

Results posted to the registry on 19 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Early Implementation: UC First, Then D2S, Then D2S Again	292	292
Delayed Implementation: UC First, Then UC Again, Then D2S	322	322

Primary outcome: Timely Viral Suppression

Time frame: 6 months. Count of participants. Unit: Participants

Measure	D2S Intervention n = 601	Usual Care n = 893
Value	309	352

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
D2S Intervention	0 of 0	0 of 0	119 of 601
Usual Care	0 of 0	0 of 0	121 of 893

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 37451738Irvine 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.
Free full-text of the protocol manuscriptLink provided by the sponsor.
Individual participant dataSharing planned: 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.

Related trials for Hiv

RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Denis Nash, PhD principal investigator

CUNY School of Public Health and Health Policy

Mary K Irvine, DrPH principal investigator

New York City Department of Health and Mental Hygiene

27 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Data to Suppression (D2S) and Usual practice in people with Hiv, run by City University of New York at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Timely Viral Suppression (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05140421, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.