Hiv Clinical Trial
— D2SOfficial title:
Strengthening the Safety Net: Testing a Novel Data-to-Suppression (D2S) Intervention Strategy in the Ryan White HIV/AIDS Program
Verified date | June 2023 |
Source | City University of New York |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 1619 |
Est. completion date | April 30, 2026 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - 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). Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | African Services Committee, Inc. | New York | New York |
United States | After Hours Project | New York | New York |
United States | AIDS Center of Queens County, Inc. | New York | New York |
United States | Alliance for Positive Change | New York | New York |
United States | Bailey House, Inc. | New York | New York |
United States | Boom!Health | New York | New York |
United States | Bridging Access to Care, Inc. | New York | New York |
United States | BronxWorks, Inc. | New York | New York |
United States | CAMBA, Inc. | New York | New York |
United States | Exponents, Inc. | New York | New York |
United States | GMHC | New York | New York |
United States | Harlem United | New York | New York |
United States | Housing Works | New York | New York |
United States | Interfaith Medical Center | New York | New York |
United States | La Nueva Esperanza, Inc. | New York | New York |
United States | Mount Sinai Beth Israel | New York | New York |
United States | New York Harm Reduction Educators, Inc. | New York | New York |
United States | New York Presbyterian Hospital | New York | New York |
United States | NYC Health and Hospitals Harlem | New York | New York |
United States | NYC Health and Hospitals Queens | New York | New York |
United States | NYC Health and Hospitals Woodhull | New York | New York |
United States | Planned Parenthood of Greater New York | New York | New York |
United States | Project Hospitality, Inc. | New York | New York |
United States | Research Foundation of State University of New York | New York | New York |
United States | St. Ann's Corner of Harm Reduction | New York | New York |
United States | The Institute for Family Health | New York | New York |
United States | Tolentine Zeiser Community Life Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
City University of New York | National Institute of Mental Health (NIMH), New York City Department of Health and Mental Hygiene |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | 6 months | |
Secondary | 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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