Permanent Supportive Housing Overdose Prevention+ Study
POP+
Preventing Overdose in Supportive Housing: Stepped Wedge Randomized Controlled Trial of a Multi-Sector, Upstream Intervention
2 other identifiers
interventional
2,940
1 country
1
Brief Summary
This community-partnered study examines a technical assistance intervention designed to help permanent supportive housing agencies implement evidence-based practices to prevent tenant overdose and improve tenant health.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2027
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2025
CompletedFirst Posted
Study publicly available on registry
October 9, 2025
CompletedStudy Start
First participant enrolled
July 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2030
Study Completion
Last participant's last visit for all outcomes
March 31, 2031
May 6, 2026
May 1, 2026
3.3 years
September 24, 2025
May 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Composite Score of Agency-Level Fidelity to Overdose Prevention Evidence-Based Practices
Fidelity will be measured as the extent to which an intervention is implemented as intended by researchers; the specific method of measurement will be determined during the trial's preparatory phase, in consultation with multiple stakeholders. The measurement will comprise a composite score of multiple measures.
Baseline, Month 12 (End of Wave 1), Month 19 (End of Wave 2), Month 26 (End of Wave 3), Month 33 (End of Wave 4)
Study Arms (4)
Wave 1: Control, Intervention, Sustainment
EXPERIMENTALParticipants at agencies assigned to wave 1 will receive the control condition from months 1-6; intervention for months 6-12; and sustainment from months 12-45.
Wave 2: Control, Intervention, Sustainment
EXPERIMENTALParticipants at agencies assigned to wave 2 will receive the control condition from months 1-13; intervention for months 13-19; and sustainment from months 19-45.
Wave 3: Control, Intervention, Sustainment
EXPERIMENTALParticipants at agencies assigned to wave 3 will receive the control condition from months 1-20; intervention for months 20-26; and sustainment from months 26-45.
Wave 4: Control, Intervention, Sustainment
EXPERIMENTALParticipants at agencies assigned to wave 4 will receive the control condition from months 1-27; intervention for months 27-33; and sustainment from months 33-45.
Interventions
Technical assistance (TA) intervention designed to support PSH agencies in sustainably implementing evidence-based practices to reduce tenant overdose and improve tenant health more broadly.
Eligibility Criteria
You may qualify if:
- Supportive Housing Agencies/Individuals who Work at Supportive Housing Agencies:
- Serve at least 40 tenants in New York and/or New Jersey
- Have a significant concern for overdose (as demonstrated by past year tenant overdose)
- Be willing to complete all activities required for participation in the trial
- Tenants who Live in Supportive Housing Agencies:
- Must live in an enrolled Supportive Housing Agency
- Must be 18 years and older
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kelly Doran, MD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2025
First Posted
October 9, 2025
Study Start (Estimated)
July 1, 2027
Primary Completion (Estimated)
September 30, 2030
Study Completion (Estimated)
March 31, 2031
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Study data will be available no later than the time of an associated publication or within 3 months following the end of the study, whichever is first.
- Access Criteria
- Data that has been prepared for public access by the research community will be archived in the NYU Data Catalog, a research data repository maintained by the NYU Langone Health (NYULH) science library, available free to the NYU community and to the public. Data will be made available to qualified researchers who have a research question appropriate to the data. Deidentified data (i.e., not identifiable at an individual or specific PSH agency level) will be made available after completion of a data use agreement (DUA). Data sharing requests will be reviewed by the study PI and study team.
The data that will be shared / made available to the research community resulting from this project includes: analytic summary matrices for focus groups; analytic summary matrices for one-on-one qualitative interviews; deidentified survey data; summary data for analyses using administrative datasets and accompanying code; and all metadata and other documentation. Study data will be available no later than the time of an associated publication or within 3 months following the end of the study, whichever is first. Deidentified data will be made available after completion of a data use agreement (DUA). Data sharing requests will be reviewed by the study PI and study team. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.