D2S Intervention for HIV

(D2S Trial)

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

1619 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the D2S treatment for HIV?

The D2S treatment aims to improve HIV viral suppression by using data to identify and support people with unsuppressed viral loads. Similar strategies, like Data to Care (D2C), have shown success in re-engaging people in HIV care, which suggests that D2S could also be effective in improving adherence and viral suppression. ^{1 2 3 4 5}

What makes the D2S treatment unique for HIV?

The D2S (Data to Suppression) treatment is unique because it uses surveillance data to help support-service programs identify clients with unsuppressed HIV and provides capacity-building assistance to improve viral suppression, focusing on adherence to antiretroviral therapy rather than just linking patients to care. ^{2 3 4 6 7}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

HIV Provider Documentation and Actions Following Patient Reports of At-risk Behaviors and Conditions When Identified by a Web-Based Point-of-Care Assessment. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Predictors of Successful HIV Care Re-engagement Among Persons Poorly Engaged in HIV Care. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Correlates of Durable Viral Suppression (DVS) Among Criminal Justice-involved (CJI) Black Men Living with HIV in Louisiana. [2022]

4. England pubmed.ncbi.nlm.nih.gov

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. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Provider perceptions of the value of same-day, electronic patient-reported measures for use in clinical HIV care. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Advancing data to care strategies for persons with HIV using an innovative reconciliation process. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Data to Care Opportunities: An Evaluation of Persons Living With HIV Reported to Be "Current to Care" Without Current HIV-Related Labs. [2020]