Skip to content

Homeless Overdose Prevention- Expansion

Homeless Overdose Prevention- Expansion (HOPE) (QUE 25-014)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07716202
Acronym
HOPE
Enrollment
1200
Registered
2026-07-21
Start date
2026-08-31
Completion date
2030-09-30
Last updated
2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Homelessness, Opioid Education and Naloxone Distribution (OEND), Substance Use Disorder

Keywords

Veterans, Risk Mitigation, Unstably Housed, Social Work, Implementation Science

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.

Detailed description

The proposed HOPE project builds on the Phase 1 implementation trial at 6 Veterans Health Administration health care systems (part of the current Bridge QUERI). This trial evaluated a 6-month implementation approach that was tailored based on the determinants identified for each of the Housing and Urban Development-VA Supportive Housing (HUD-VASH) teams as part of pre-implementation formative evaluations at each site. During the Phase 1 HOPE trial, HUD-VASH case managers reached more than 1700 HUD-VASH Veterans at risk for opioid overdose, providing education about their risk and naloxone to those who accepted the prescription. The implementation trial was conducted with 33 HUD-VASH teams at 6 low performing VISN 21 sites selected in partnership with regional HUD-VASH leadership. Approximately 300 HUD-VASH social workers were trained on OEND. Five of the 6 healthcare systems also became high performers (i.e., above the national average for naloxone receipt across all VA healthcare systems). Phase 2 of the HOPE trial will rely on the core evidence-based practice (EBP) of OEND, including identifying community-based naloxone resources, but the investigators will also provide each HUD-VASH team education and training regarding xylazine (including how it may increase opioid-overdose mortality risk) and fentanyl test strips. The latter is particularly important given that the investigators will identify community partnerships for receipt of confidential OEND since many non-VA harm reduction services do offer drug test strips. Also, drug test strips are prohibited in certain states that identify them as illegal drug paraphernalia. States are regularly revisiting these laws, and the investigators will update each implementation site about the current status of laws regarding drug test strips as part of implementation. In Phase 2 of the HOPE trial, the investigators will evaluate the use of an Implementation Playbook developed during HOPE's Phase 1 implementation trial. The Low Intensity (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. The investigators will begin with an initial training session with each site, and investigators will lead a monthly learning collaborative for 6 months. The LI phase will allow investigators to evaluate the effect of a comprehensive playbook on uptake of OEND. The High Intensity (HI) approach, led by investigators, includes: (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 MS Teams; (3) monthly audit and feedback for each HUD-VASH team on progress toward providing OEND; and (4) technical assistance.

Interventions

BEHAVIORALHomeless Overdose Prevention- Expansion (HOPE) - Low Intensity

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. During pre-implementation, investigators will conduct a rapid qualitative evaluation with 5-10 key informants at each of the identified implementation sites to refine the implementation approach. Investigators will evaluate low-intensity (LI) vs high-intensity (HI) strategy. The LI implementation approach will include providing sites with the HOPE Implementation Playbook, including access to the associated resources on the HOPE SharePoint site.

BEHAVIORALHomeless Overdose Prevention- Expansion (HOPE) - High Intensity

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. During pre-implementation, investigators will conduct a rapid qualitative evaluation with 5-10 key informants at each of the identified implementation sites to refine the implementation approach. Investigators will evaluate low-intensity (LI) vs high-intensity (HI) strategy. The HI approach includes: (1) creation of a novel clinical 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

During implementation, investigators will conduct rapid qualitative evaluation with 5-10 key informants at each implementation site to refine the implementation approach (Aim1). Investigators will evaluate low intensity (LI) vs high intensity (HI) strategy. The LI implementation approach will include providing sites with the HOPE Implementation Playbook and access to the associated resources on the HOPE SharePoint site. Investigators will provide an initial training session with each site and lead a monthly learning collaborative for 6 months. The HI approach includes: (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 (Aim2). Investigators will incorporate findings from the Phase 2 implementation trial (Aim3).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Reach - VA administrative data12 monthsReach will be measured in terms of the proportion of Veterans who receive OEND, including overdose education and/or a naloxone prescription, using VA administrative data.
Adoption - VA administrative data12 monthsAdoption will be measured in terms of the proportion of VHA pharmacy and other prescriber staff who delivered OEND, using VA administrative data.
Implementation - Electronic Data Capture12 monthsImplementation will be measured in terms of adherence of sites to tailored implementation. Implementation fidelity will be captured using electronic data capture.
Maintenance - Rapid Qualitative Interviews6-12 monthsMaintenance will be assessed by the extent to which OEND has become part of routine organizational practices and policies, including clinical processes to maintain OEND. Maintenance will be assessed 6-12 months post-implementation using semi-structured interviews. Interviews will be conducted with HUD-VASH staff and measured using rapid qualitative methods and administrative data. Administrative data will be used to measure whether OEND continues to be provided in the maintenance period.

Secondary

MeasureTime frameDescription
Effectiveness12 monthsAmong Veterans who received overdose education and/or naloxone, the number of Veterans at-risk of opioid overdose who were hospitalized for an opioid overdose or visited a VA emergency department for an opioid overdose, as measured by VA administrative data.

Countries

United States

Contacts

CONTACTAmanda M Midboe, PhD
Amanda.Midboe@va.gov(650) 493-5000
CONTACTMadeleine C Golding, MPH BA
madeleine.golding@va.gov(650) 614-9997
PRINCIPAL_INVESTIGATORAmanda M. Midboe, PhD

VA Palo Alto Health Care System, Palo Alto, CA

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026