D2S Intervention for HIV

(D2S Trial)

Not currently recruiting at 26 trial locations

Overseen By Mary K Irvine, DrPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: City University of New York

Disqualifiers: Virally suppressed, Deceased, No NYC HIV care

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve health outcomes for people with HIV who receive support through the Ryan White HIV/AIDS Program in New York City. It focuses on those in HIV care who still have high viral levels in their blood. Researchers are testing a new approach called Data to Suppression (D2S) to help these individuals achieve viral suppression, or lower virus levels. Individuals with a recent viral load test showing unsuppressed levels and who receive services from certain programs may be good candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance HIV care strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for specific guidance.

What prior data suggests that the Data to Suppression (D2S) intervention is safe?

Research shows that the Data to Suppression (D2S) program aims to improve health for people living with HIV. The program uses reports to identify clients who are not achieving viral suppression, meaning the virus is not detectable in their blood. This enables service providers to develop strategies to assist them.

While specific information about side effects for D2S is unavailable, the program focuses on support and health improvement. This suggests a non-invasive approach, utilizing data tracking and support services instead of medical procedures or drugs. Consequently, there are typically fewer safety concerns compared to treatments involving medication or surgery.

The trial is labeled "not applicable" for phases, indicating it doesn't follow the usual clinical trial stages. This often suggests the program is considered low-risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the D2S Intervention for HIV because it focuses on improving the process of achieving viral suppression by using data-driven strategies. Unlike traditional treatments that primarily focus on medication adherence, D2S aims to optimize how health data is used to enhance care delivery and patient outcomes. By implementing this intervention early, or comparing its delayed application, the trial seeks to demonstrate how strategic data use can bridge gaps in existing care models and improve the speed and effectiveness of achieving viral suppression.

What evidence suggests that the Data to Suppression (D2S) intervention is effective for improving viral suppression in people with HIV?

Research has shown that the Data to Suppression (D2S) program uses reports to help HIV services identify and support individuals who struggle to maintain low virus levels. This method addresses care gaps by directing assistance to those most in need. In this trial, participants in the Early Implementation arm will receive D2S intervention components from the start, while those in the Delayed Implementation arm will begin receiving these components 12 months later. Early results suggest that identifying individuals who need support allows programs to implement strategies that help lower their virus levels. In New York City, data has shown that certain groups, such as Black and Latinx people in low-income areas, have lower rates of virus control. The D2S program aims to address these disparities by using data to ensure everyone receives the necessary care to manage their HIV effectively. ^{1 2 3 4 5}

Who Is on the Research Team?

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

Are You a Good Fit for This Trial?

This trial is for low-income individuals in New York City with HIV who are already receiving care but have not achieved viral suppression. They must have had at least one viral load test showing unsuppressed levels and be enrolled in eligible Ryan White HIV/AIDS Program services.

Inclusion Criteria

Clients eligible for trial inclusion must have: ≥1 viral load (VL) test in the report year, unsuppressed VL (≥200 copies/mL) at last reported VL test during that year, a reported service in one of the eligible programs/agencies during the report year, 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) for each stepped-wedge implementation period (Period 0, 1, or 2)

Exclusion Criteria

Agencies without current NYC RWPA funding for housing assistance or behavioral health services, agencies with <5 clients meeting the above inclusion criteria over three recent pre-implementation sample periods of data, clients enrolled in NYC RWPA behavioral health or housing programs who are virally suppressed, deceased, or lacking evidence of NYC HIV care for a full year at the time a D2S report is issued, clients found to have died or to have a VL<200 dated after their qualifying VL≥200 but prior to D2S report generation, clients reported to have been closed out of all eligible programs before the report issue date

Timeline for a Trial Participant

Pre-implementation

Baseline data collection and retrospective D2S report generation

12 months

Early Implementation

Early implementation of the D2S intervention for the experimental arm

12 months

Delayed Implementation

Delayed implementation of the D2S intervention for the comparator arm

12 months

Follow-up

Participants are monitored for viral load outcomes after intervention implementation

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Data to Suppression (D2S)

Trial Overview The study tests a 'data-to-suppression' (D2S) strategy aimed at improving viral suppression among patients using behavioral health and housing support programs within the Ryan White HIV/AIDS Program, by providing targeted interventions based on surveillance data.

How Is the Trial Designed?

Group I: Early Implementation Experimental Treatment 1 Intervention

This arm will receive D2S intervention components during Period 1 (Early Implementation) as well as throughout Period 2 of the stepped-wedge trial.

Group II: Delayed Implementation Active Control 1 Intervention

This arm will receive no D2S intervention components during Period 1 (Early Implementation), but will then receive all D2S intervention components in Period 2, starting 12 months later.

Who Is Running the Clinical Trial?

City University of New York

Lead Sponsor

Trials

23

Recruited

6,000+

New York City Department of Health and Mental Hygiene

Collaborator

Trials

20

Recruited

19,400+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37451738/

Study protocol for data to suppression (D2S) - PubMed - NIH A 'data-to-suppression' intervention that offers HIV support-service programmes surveillance-based reports listing their virally unsuppressed clients.

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/record/NCT05140421

Testing a Novel Data-to-Suppression (D2S) Intervention ... Testing a Novel Data-to-Suppression (D2S) Intervention Strategy in the Ryan White HIV/AIDS Program ... Outcomes data will be derived from the NYC HIV Surveillance ...

3. bmjopen.bmj.com bmjopen.bmj.com/content/13/7/e076716

Study protocol for data to suppression (D2S) The Data-to-Suppression (D2S) trial, conducted in real-world service settings, leverages existing programmatic and surveillance data to assess the effectiveness ...

4. mountsinai.org mountsinai.org/clinical-trials/testing-novel-data-to-suppression-d2s-intervention-strategy-in-ryan-white-hiv-aids-program

Testing a Novel Data-to-Suppression (D2S) Intervention ... 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, ...

5. cunyisph.org cunyisph.org/projects/data-to-suppression-d2s/

Data-to-Suppression (D2S) We propose to implement and rigorously evaluate a novel “data-to-suppression” (D2S) intervention with Ryan White HIV/AIDS Program Part A (RWPA) support-service ...