HomelessnessHOPENCT07716202
Homeless Overdose Prevention- Expansion
A study testing Homeless Overdose Prevention- Expansion (HOPE) - Low Intensity and Homeless Overdose Prevention- Expansion (HOPE) - High Intensity in people with Homelessness and Opioid Education and Naloxone Distribution (OEND), run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Homelessness, Opioid Education and Naloxone Distribution (OEND), Substance Use Disorder
- What is being tested?
- Homeless Overdose Prevention- Expansion (HOPE) - Low Intensity and Homeless Overdose Prevention- Expansion (HOPE) - High Intensity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 30 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Not flagged by existing HOPE algorithms
- Not currently enrolled in HUD-VASH
- Is not a patient at a participating site of the implementation trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
About this study
Official title: Homeless Overdose Prevention- Expansion (HOPE) (QUE 25-014)
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.
Read the 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.
- Being tested
- Homeless Overdose Prevention- Expansion (HOPE) - Low Intensity, Homeless Overdose Prevention- Expansion (HOPE) - High Intensity
- Keywords
- Veterans, Risk Mitigation, Unstably Housed, Social Work, Implementation Science
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homeless Overdose Prevention- Expansion (HOPE) - Low IntensityBehavioural
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.
Homeless Overdose Prevention- Expansion (HOPE) - High IntensityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Homeless Overdose Prevention- Expansion (HOPE) - High Intensity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach - VA administrative data
Reach 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.
Measured: 12 months
Adoption - VA administrative data
Adoption will be measured in terms of the proportion of VHA pharmacy and other prescriber staff who delivered OEND, using VA administrative data.
Measured: 12 months
Implementation - Electronic Data Capture
Implementation will be measured in terms of adherence of sites to tailored implementation. Implementation fidelity will be captured using electronic data capture.
Measured: 12 months
Maintenance - Rapid Qualitative Interviews
Maintenance 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.
Measured: 6-12 months
Secondary outcomes (1)
Effectiveness
Among 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start15 Oct 2026 (estimated)
- Primary completion31 Jul 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HomelessnessStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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).
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Amanda M. Midboe, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716202
- Sponsor's protocol ID
- QUX 26-003
- Acronym
- HOPE
- Status last verified
- Sep 2026
- First submitted
- 2 Jul 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homeless Overdose Prevention- Expansion (HOPE) (QUE 25-014)
- ClinicalTrials.gov ID
- NCT07716202
- Acronym / sponsor ID
- HOPE / QUX 26-003
- Keywords
- Veterans, Risk Mitigation, Unstably Housed, Social Work, Implementation Science
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Low-Intensity (LI) | Active comparator | Behavioral: Homeless Overdose Prevention- Expansion (HOPE) - Low IntensityThe 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. |
| High-Intensity (HI) | Active comparator | Behavioral: Homeless Overdose Prevention- Expansion (HOPE) - High IntensityThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Not flagged by existing HOPE algorithms
- Not currently enrolled in HUD-VASH
- Is not a patient at a participating site of the implementation trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Homeless Overdose Prevention- Expansion (HOPE) - Low IntensityHomeless 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. | Behavioural | Low-Intensity (LI) |
| Homeless Overdose Prevention- Expansion (HOPE) - High IntensityHomeless 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. | Behavioural | High-Intensity (HI) |
Primary outcome
Reach - VA administrative data
Time frame: 12 months
Reach 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 data
Time frame: 12 months
Adoption 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 Capture
Time frame: 12 months
Implementation will be measured in terms of adherence of sites to tailored implementation. Implementation fidelity will be captured using electronic data capture.
Maintenance - Rapid Qualitative Interviews
Time frame: 6-12 months
Maintenance 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.
1 secondary outcome
Effectiveness
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amanda M. Midboe, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Homeless Overdose Prevention- Expansion (HOPE) - Low Intensity and Homeless Overdose Prevention- Expansion (HOPE) - High Intensity in people with Homelessness and Opioid Education and Naloxone Distribution (OEND), run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda M Midboe, PhD ((650) 493-5000 ext. 27829, Amanda.Midboe@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach - VA administrative data (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.