Clinical trial NCT05140421: Testing a Novel Data-to-Suppression (D2S) Intervention Strategy in the Ryan White HIV/AIDS Program
Official title: Strengthening the Safety Net: Testing a Novel Data-to-Suppression (D2S) Intervention Strategy in the Ryan White HIV/AIDS Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hiv
Keywords: viral load suppression
surveillance
HIV treatment engagement
structural intervention
Lead sponsor: City University of New York
Sponsor class: OTHER
Collaborators: name: New York City Department of Health and Mental Hygiene
name: National Institute of Mental Health (NIMH)
First posted: 2021-12-01
Enrollment: 1619
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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 immediate or delayed implementation of D2S (12 months apart).
Primary purpose: TREATMENT

Brief 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.

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.

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 early (Period 1) or delayed (Period 2) D2S intervention implementation. Our design will also use baseline data from a 12-month pre-implementation period (Period 0), 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. Period 2 will begin 12 months after the start of Period 1. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Timely viral suppression
timeFrame: 6 months
Secondary outcomes:
measure: Time to viral suppression
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Alliance for Positive Change
state: New York
city: New York
country: United States
facility: Mount Sinai Beth Israel
state: New York
city: New York
country: United States
facility: Exponents, Inc.
state: New York
city: New York
country: United States
facility: GMHC
state: New York
city: New York
country: United States
facility: African Services Committee, Inc.
state: New York
city: New York
country: United States
facility: Harlem United
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Bailey House, Inc.
state: New York
city: New York
country: United States
facility: New York Harm Reduction Educators, Inc.
state: New York
city: New York
country: United States
facility: The Institute for Family Health
state: New York
city: New York
country: United States
facility: NYC Health and Hospitals Harlem
state: New York
city: New York
country: United States
facility: Project Hospitality, Inc.
state: New York
city: New York
country: United States
facility: Boom!Health
state: New York
city: New York
country: United States
facility: BronxWorks, Inc.
state: New York
city: New York
country: United States
facility: St. Ann's Corner of Harm Reduction
state: New York
city: New York
country: United States
facility: Tolentine Zeiser Community Life Center
state: New York
city: New York
country: United States
facility: Housing Works
state: New York
city: New York
country: United States
facility: Research Foundation of State University of New York
state: New York
city: New York
country: United States
facility: La Nueva Esperanza, Inc.
state: New York
city: New York
country: United States
facility: NYC Health and Hospitals Woodhull
state: New York
city: New York
country: United States
facility: Interfaith Medical Center
state: New York
city: New York
country: United States
facility: Bridging Access to Care, Inc.
state: New York
city: New York
country: United States
facility: After Hours Project
state: New York
city: New York
country: United States
facility: Planned Parenthood of Greater New York
state: New York
city: New York
country: United States
facility: CAMBA, Inc.
state: New York
city: New York
country: United States
facility: AIDS Center of Queens County, Inc.
state: New York
city: New York
country: United States
facility: NYC Health and Hospitals Queens
state: New York
Study officials:
affiliation: CUNY School of Public Health and Health Policy
name: Denis Nash, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York City Department of Health and Mental Hygiene
name: Mary K Irvine, DrPH
role: PRINCIPAL_INVESTIGATOR
References: