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NCT07716202

Overview

NCT ID: NCT07716202
Lead Sponsor: VA Office of Research and DevelopmentFED
Official Title: Homeless Overdose Prevention- Expansion (HOPE) (QUE 25-014)
Brief Summary: Homeless Overdose Prevention - Expansion (HOPE), tests implementation of overdose education and naloxone distribution (OEND), a program that targets homeless experienced Veterans at risk for overdose, including Veterans in community-based supportive housing. HOPE sites will receive a playbook that offers step-by-step instructions, tools, templates, and checklists tailorable to site needs; sites will also receive performance feedback about their performance relative to a standard or benchmark.
Conditions: Homelessness
Opioid Education and Naloxone Distribution (OEND)
Substance Use Disorder

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 30, 2026Actual
Start Date: Aug 31, 2026Estimated
Primary Completion Date: Jul 31, 2030Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Veterans enrolled in HUD-VASH at risk for opioid overdose (based on existing HOPE algorithms aligned with Pharmacy Benefit Manager data definitions), drawing from VA administrative data.

Exclusion Criteria:

Not flagged by existing HOPE algorithms

Not currently enrolled in HUD-VASH

Is not a patient at a participating site of the implementation trial

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 1,200Estimated
Primary Purpose: Health Services Research
Allocation: Non-Randomized
Interventional Model: Sequential Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Amanda M Midboe, PhDContact
Amanda.Midboe@va.gov(650) 493-5000 ext. 27829

Similar Studies

Participant Group/Arms

Low-Intensity (LI)Active Comparator

The LI implementation approach will include providing sites with the HOPE Implementation Playbook, including access to the associated resources (e.g., OEND note templates) on the HOPE SharePoint site. Investigators will begin with an initial training session with each site, and lead a monthly learning collaborative for 6 months. The LI phase will allow evaluation of the effect of a comprehensive playbook on uptake of OEND.

Behavioral: Homeless Overdose Prevention- Expansion (HOPE) - Low Intensity

High-Intensity (HI)Active Comparator

The HI approach will include: (1) creation of a novel clinical team (i.e., prescriber and HUD-VASH team) if not created under LI; (2) monthly overdose education and training delivered synchronously via Microsoft Teams; (3) monthly audit and feedback for each HUD-VASH team on progress toward providing OEND; and (4) technical assistance. Investigators hypothesize the HI implementation strategy will have a greater impact on RE-AIM outcomes.

Behavioral: Homeless Overdose Prevention- Expansion (HOPE) - High Intensity