OverdosePOPNCT05786222
Permanent Supportive Housing Overdose Prevention
A study testing CSH-Delivered Overdose Prevention Support in people with Overdose, run by NYU Langone Health at 1 site in United States.
Trial summary
Permanent supportive housing (PSH), the gold standard intervention for ending chronic homelessness, has expanded rapidly across the U.S. in recent years. Due to a confluence of individual and environmental risk factors, PSH tenants face heightened risk for overdose. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overdose
- What is being tested?
- CSH-Delivered Overdose Prevention Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,350 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2023to 31 Jan 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Tenant surveys: To be eligible to participate in the tenant survey part of this study, an individual must:
- Be a supportive housing tenant in a participating building
- Be at least 18 years old
- Be able to read and respond to a survey in English or Spanish
- Staff surveys: To be eligible to participate in the staff survey part of this study, an individual must work for a participating PSH building (or have worked for one in the past 6 months). All PSH building staff are at least 18 years old and are able to read and respond to a survey in English. Staff surveys will begin with a question confirming eligibility.
- Qualitative interviews: To be eligible to participate in the qualitative interview part of this study, an individual must:
Show all 11Show fewer
- Work for or live in a participating PSH building
- Serve as staff (including leaders) or tenant implementation champion
- Be at least 18 years old
- Speak and understand English
- Medicaid data analysis: Identifying information for all tenants in participating buildings (to be provided to the study team by buildings as described in a bilaterally signed information sharing agreement) will be used to conduct a match with Medicaid administrative data.
Who cannot join
- Children under the age of 18 years old will be excluded, including from the Medicaid data analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Permanent Supportive Housing Overdose Prevention (POP) Study: A Hybrid Type 3 Stepped Wedge Randomized Controlled Trial
Permanent supportive housing (PSH), the gold standard intervention for ending chronic homelessness, has expanded rapidly across the U.S. in recent years. Due to a confluence of individual and environmental risk factors, PSH tenants face heightened risk for overdose. While evidence-based practices to prevent overdose exist, they have not been broadly implemented in PSH settings. This study will address this research to practice gap by studying the implementation of evidence-based practices to prevent overdose in 20 PSH buildings in New York. In a community-partnered stepped wedge randomized controlled trial, the investigators will study a package of implementation strategies that includes an implementation toolkit, tenant and staff implementation champions, limited practice facilitation, and learning collaboratives. Outcomes will be examined using surveys and qualitative interviews with PSH tenants and staff; observation; and analysis of Medicaid claims data.
Read the detailed description
This single-center study is a hybrid type 3 trial with a stepped wedge cluster randomized controlled trial design, with primary objectives of studying implementation of overdose prevention practices in PSH and secondary objectives of examining effectiveness on clinically relevant outcomes and multilevel factors influencing implementation. Twenty participating PSH building sites will be randomized into four intervention clusters of five buildings each. With the stepped wedge design, all clusters of study PSH buildings will begin in the control condition. Clusters are randomly assigned to receive the intervention at different times, with all eventually receiving the six-month implementation strategy package intervention from Corporation for Supportive Housing (CSH). Study investigators will survey PSH building tenants and staff; conduct observation of building policies and procedures; analyze tenant Medicaid data; and interview staff and tenants.
- Conditions
- Overdose
- Being tested
- CSH-Delivered Overdose Prevention Support
- Medical subject headings
- Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSH-Delivered Overdose Prevention SupportBehavioural
Corporation for Supportive Housing (CSH) will deliver technical support for overdose (OD) prevention in the participating PSH buildings using a package of core implementation strategies: PSH Overdose Prevention (POP) Toolkit (an implementation manual/blueprint for overdose prevention practices); Implementation Champions (staff and tenants in each PSH building will be selected as implementation champions who support implementation and sustainment of OD prevention practices in their buildings); practice facilitation (the practice facilitator [a trained CSH employee] will work with the tenant and staff champions in small group workshops and coaching sessions, building their capacity and supporting their work toward implementation of building OD prevention practices); learning collaboratives (PSH buildings starting the intervention at the same time will attend learning collaborative meetings).
| Study group | Role | What they receive |
|---|---|---|
| Cluster 1 | Experimental | Buildings randomized to Cluster 1 will receive the CSH-delivered intervention at Months 2-7. Tenant surveys will be administered 1 month prior to and 12 months following the start of the intervention period.
At all clusters, an all-staff survey will be administered at Months 1, 8, 15, 22, and 29. A sustainment survey will be administered to selected staff-leaders in the 8th month following the end of the intervention period. Receives: Behavioral: CSH-Delivered Overdose Prevention Support |
| Cluster 2 | Experimental | Buildings randomized to Cluster 2 will receive the CSH-delivered intervention at Months 9-14. Tenant surveys will be administered 1 month prior to and 12 months following the start of the intervention period.
At all clusters, an all-staff survey will be administered at Months 1, 8, 15, 22, and 29. A sustainment survey will be administered to selected staff-leaders in the 8th month following the end of the intervention period. Receives: Behavioral: CSH-Delivered Overdose Prevention Support |
| Cluster 3 | Experimental | Buildings randomized to Cluster 3 will receive the CSH-delivered intervention at Months 16-21. Tenant surveys will be administered 1 month prior to and 12 months following the start of the intervention period.
At all clusters, an all-staff survey will be administered at Months 1, 8, 15, 22, and 29. A sustainment survey will be administered to selected staff-leaders in the 8th month following the end of the intervention period. Receives: Behavioral: CSH-Delivered Overdose Prevention Support |
| Cluster 4 | Experimental | Buildings randomized to Cluster 3 will receive the CSH-delivered intervention at Months 23-28. Tenant surveys will be administered 1 month prior to and 12 months following the start of the intervention period.
At all clusters, an all-staff survey will be administered at Months 1, 8, 15, 22, and 29. A sustainment survey will be administered to selected staff-leaders in the 8th month following the end of the intervention period. Receives: Behavioral: CSH-Delivered Overdose Prevention Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fidelity Checklist Score
Buildings will receive a fidelity checklist score of 0 (not implemented), 1 (partial implementation), or 2 (full implementation) for each overdose prevention practice. The primary outcome is total summed score, with higher scores indicating greater fidelity.
Measured: Month 1
Fidelity Checklist Score
Buildings will receive a fidelity checklist score of 0 (not implemented), 1 (partial implementation), or 2 (full implementation) for each overdose prevention practice. The primary outcome is total summed score, with higher scores indicating greater fidelity.
Measured: Month 8
Fidelity Checklist Score
Buildings will receive a fidelity checklist score of 0 (not implemented), 1 (partial implementation), or 2 (full implementation) for each overdose prevention practice. The primary outcome is total summed score, with higher scores indicating greater fidelity.
Measured: Month 15
Fidelity Checklist Score
Buildings will receive a fidelity checklist score of 0 (not implemented), 1 (partial implementation), or 2 (full implementation) for each overdose prevention practice. The primary outcome is total summed score, with higher scores indicating greater fidelity.
Measured: Month 22
Fidelity Checklist Score
Buildings will receive a fidelity checklist score of 0 (not implemented), 1 (partial implementation), or 2 (full implementation) for each overdose prevention practice. The primary outcome is total summed score, with higher scores indicating greater fidelity.
Measured: Month 29
Secondary outcomes (57)
Intervention Appropriateness Measure (IAM) Score
1-item assessment of intervention appropriateness (adapted from Weiner, et al.) for each of three overdose prevention categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).
Measured: Month 1
Intervention Appropriateness Measure (IAM) Score
1-item assessment of intervention appropriateness (adapted from Weiner, et al.) for each of three overdose prevention categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).
Measured: Month 8
Intervention Appropriateness Measure (IAM) Score
1-item assessment of intervention appropriateness (adapted from Weiner, et al.) for each of three overdose prevention categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).
Measured: Month 15
Intervention Appropriateness Measure (IAM) Score
1-item assessment of intervention appropriateness (adapted from Weiner, et al.) for each of three overdose prevention categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).
Measured: Month 22
Intervention Appropriateness Measure (IAM) Score
1-item assessment of intervention appropriateness (adapted from Weiner, et al.) for each of three overdose prevention categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).
Measured: Month 29
Feasibility of Intervention Measure (FIM) Score
1-item assessment of intervention feasibility (adapted from Weiner, et al.) for each of the three overdose prevention practice categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).
Measured: Month 1
Feasibility of Intervention Measure (FIM) Score
1-item assessment of intervention feasibility (adapted from Weiner, et al.) for each of the three overdose prevention practice categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).
Measured: Month 8
Feasibility of Intervention Measure (FIM) Score
1-item assessment of intervention feasibility (adapted from Weiner, et al.) for each of the three overdose prevention practice categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).
Measured: Month 15
Feasibility of Intervention Measure (FIM) Score
1-item assessment of intervention feasibility (adapted from Weiner, et al.) for each of the three overdose prevention practice categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).
Measured: Month 22
Feasibility of Intervention Measure (FIM) Score
1-item assessment of intervention feasibility (adapted from Weiner, et al.) for each of the three overdose prevention practice categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).
Measured: Month 29
Brief Opioid Overdose Knowledge (BOOK) Survey Score
BOOK is a 12-item assessment of opioid overdose knowledge (Dunn, et al.) administered to staff. For each item, staff select either "True" or "False." The total score ranges from 0-12; higher scores indicate greater opioid overdose knowledge.
Measured: Month 1
Brief Opioid Overdose Knowledge (BOOK) Survey Score
BOOK is a 12-item assessment of opioid overdose knowledge (Dunn, et al.) administered to staff. For each item, staff select either "True" or "False." The total score ranges from 0-12; higher scores indicate greater opioid overdose knowledge.
Measured: Month 8
Brief Opioid Overdose Knowledge (BOOK) Survey Score
BOOK is a 12-item assessment of opioid overdose knowledge (Dunn, et al.) administered to staff. For each item, staff select either "True" or "False." The total score ranges from 0-12; higher scores indicate greater opioid overdose knowledge.
Measured: Month 15
Brief Opioid Overdose Knowledge (BOOK) Survey Score
BOOK is a 12-item assessment of opioid overdose knowledge (Dunn, et al.) administered to staff. For each item, staff select either "True" or "False." The total score ranges from 0-12; higher scores indicate greater opioid overdose knowledge.
Measured: Month 22
Brief Opioid Overdose Knowledge (BOOK) Survey Score
BOOK is a 12-item assessment of opioid overdose knowledge (Dunn, et al.) administered to staff. For each item, staff select either "True" or "False." The total score ranges from 0-12; higher scores indicate greater opioid overdose knowledge.
Measured: Month 29
Perceived Stigma Toward Substance Users Scale Score
8-item assessment of perceived stigma toward substance users (Luoma, et al.). Survey is administered to staff. Each item is ranked on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The score is the sum of responses (with some items reverse-scored). The total score ranges from 8-32, with higher scores indicating greater perceived stigma.
Measured: Month 1
Perceived Stigma Toward Substance Users Scale Score
8-item assessment of perceived stigma toward substance users (Luoma, et al.). Survey is administered to staff. Each item is ranked on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The score is the sum of responses (with some items reverse-scored). The total score ranges from 8-32, with higher scores indicating greater perceived stigma.
Measured: Month 8
Perceived Stigma Toward Substance Users Scale Score
8-item assessment of perceived stigma toward substance users (Luoma, et al.). Survey is administered to staff. Each item is ranked on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The score is the sum of responses (with some items reverse-scored). The total score ranges from 8-32, with higher scores indicating greater perceived stigma.
Measured: Month 15
Perceived Stigma Toward Substance Users Scale Score
8-item assessment of perceived stigma toward substance users (Luoma, et al.). Survey is administered to staff. Each item is ranked on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The score is the sum of responses (with some items reverse-scored). The total score ranges from 8-32, with higher scores indicating greater perceived stigma.
Measured: Month 22
Perceived Stigma Toward Substance Users Scale Score
8-item assessment of perceived stigma toward substance users (Luoma, et al.). Survey is administered to staff. Each item is ranked on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The score is the sum of responses (with some items reverse-scored). The total score ranges from 8-32, with higher scores indicating greater perceived stigma.
Measured: Month 29
Tenant Substance-Use-Related Emergency Department Visits
Data derived from NY Medicaid data.
Measured: Month 1
Tenant Substance-Use-Related Emergency Department Visits
Data derived from NY Medicaid data.
Measured: Month 8
Tenant Substance-Use-Related Emergency Department Visits
Data derived from NY Medicaid data.
Measured: Month 15
Tenant Substance-Use-Related Emergency Department Visits
Data derived from NY Medicaid data.
Measured: Month 22
Tenant Substance-Use-Related Emergency Department Visits
Data derived from NY Medicaid data.
Measured: Month 29
Tenant Substance-Use-Related Emergency Department Visits
Data derived from NY Medicaid data.
Measured: Month 35
Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
Data derived from NY Medicaid data.
Measured: Month 1
Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
Data derived from NY Medicaid data.
Measured: Month 8
Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
Data derived from NY Medicaid data.
Measured: Month 15
Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
Data derived from NY Medicaid data.
Measured: Month 22
Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
Data derived from NY Medicaid data.
Measured: Month 29
Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
Data derived from NY Medicaid data.
Measured: Month 35
Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.
Measured: Month 1
Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.
Measured: Month 8
Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.
Measured: Month 15
Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.
Measured: Month 22
Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.
Measured: Month 29
Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.
Measured: Month 35
Adoption Checklist Score
20-item checklist assessing building adoption of each overdose prevention practice. Checklist is included in a subset of staff surveys. Buildings will receive an adoption checklist score of 0 (not adopted) or 1 (adopted) for each of 20 overdose prevention practices. The total score is the sum of responses and ranges from 0-20, with higher scores indicating greater adoption.
Measured: Month 1
Adoption Checklist Score
20-item checklist assessing building adoption of each overdose prevention practice. Checklist is included in a subset of staff surveys. Buildings will receive an adoption checklist score of 0 (not adopted) or 1 (adopted) for each of 20 overdose prevention practices. The total score is the sum of responses and ranges from 0-20, with higher scores indicating greater adoption.
Measured: Month 8
Adoption Checklist Score
20-item checklist assessing building adoption of each overdose prevention practice. Checklist is included in a subset of staff surveys. Buildings will receive an adoption checklist score of 0 (not adopted) or 1 (adopted) for each of 20 overdose prevention practices. The total score is the sum of responses and ranges from 0-20, with higher scores indicating greater adoption.
Measured: Month 15
Adoption Checklist Score
20-item checklist assessing building adoption of each overdose prevention practice. Checklist is included in a subset of staff surveys. Buildings will receive an adoption checklist score of 0 (not adopted) or 1 (adopted) for each of 20 overdose prevention practices. The total score is the sum of responses and ranges from 0-20, with higher scores indicating greater adoption.
Measured: Month 22
Adoption Checklist Score
20-item checklist assessing building adoption of each overdose prevention practice. Checklist is included in a subset of staff surveys. Buildings will receive an adoption checklist score of 0 (not adopted) or 1 (adopted) for each of 20 overdose prevention practices. The total score is the sum of responses and ranges from 0-20, with higher scores indicating greater adoption.
Measured: Month 29
Acceptability of Intervention Measure (AIM) Score
1-item assessment of intervention acceptability (adapted from Weiner, et al.) for each of the three overdose prevention practice categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).
Measured: Month 1
Acceptability of Intervention Measure (AIM) Score
1-item assessment of intervention acceptability (adapted from Weiner, et al.) for each of the three overdose prevention practice categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).
Measured: Month 8
Acceptability of Intervention Measure (AIM) Score
1-item assessment of intervention acceptability (adapted from Weiner, et al.) for each of the three overdose prevention practice categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).
Measured: Month 15
Acceptability of Intervention Measure (AIM) Score
1-item assessment of intervention acceptability (adapted from Weiner, et al.) for each of the three overdose prevention practice categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).
Measured: Month 22
Acceptability of Intervention Measure (AIM) Score
1-item assessment of intervention acceptability (adapted from Weiner, et al.) for each of the three overdose prevention practice categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).
Measured: Month 29
Organizational Priority Measure Score
7-item assessment of organizational priority (adapted from Klein, et al.) administered to staff and rated on a Likert scale from 1 (not true) to 5 (definitely true). The total score is the sum of responses and ranges from 7 to 35; higher scores indicate higher organizational priority.
Measured: Month 1
Organizational Priority Measure Score
7-item assessment of organizational priority (adapted from Klein, et al.) administered to staff and rated on a Likert scale from 1 (not true) to 5 (definitely true). The total score is the sum of responses and ranges from 7 to 35; higher scores indicate higher organizational priority.
Measured: Month 8
Organizational Priority Measure Score
7-item assessment of organizational priority (adapted from Klein, et al.) administered to staff and rated on a Likert scale from 1 (not true) to 5 (definitely true). The total score is the sum of responses and ranges from 7 to 35; higher scores indicate higher organizational priority.
Measured: Month 15
Organizational Priority Measure Score
7-item assessment of organizational priority (adapted from Klein, et al.) administered to staff and rated on a Likert scale from 1 (not true) to 5 (definitely true). The total score is the sum of responses and ranges from 7 to 35; higher scores indicate higher organizational priority.
Measured: Month 22
Organizational Priority Measure Score
7-item assessment of organizational priority (adapted from Klein, et al.) administered to staff and rated on a Likert scale from 1 (not true) to 5 (definitely true). The total score is the sum of responses and ranges from 7 to 35; higher scores indicate higher organizational priority.
Measured: Month 29
Sustainment based on Fidelity Checklist Score
Sustainment of the overdose prevention practices will be measured using fidelity checklist score results. Buildings will receive a fidelity checklist score of 0 (not implemented), 1 (partial implementation), or 2 (full implementation) for each overdose prevention practice. The primary outcome is total summed score, with higher scores indicating greater fidelity.
Measured: Month 15
Sustainment based on Fidelity Checklist Score
Sustainment of the overdose prevention practices will be measured using fidelity checklist score results. Buildings will receive a fidelity checklist score of 0 (not implemented), 1 (partial implementation), or 2 (full implementation) for each overdose prevention practice. The primary outcome is total summed score, with higher scores indicating greater fidelity.
Measured: Month 22
Sustainment based on Fidelity Checklist Score
Sustainment of the overdose prevention practices will be measured using fidelity checklist score results. Buildings will receive a fidelity checklist score of 0 (not implemented), 1 (partial implementation), or 2 (full implementation) for each overdose prevention practice. The primary outcome is total summed score, with higher scores indicating greater fidelity.
Measured: Month 29
Sustainment based on Fidelity Checklist Score
Sustainment of the overdose prevention practices will be measured using fidelity checklist score results. Buildings will receive a fidelity checklist score of 0 (not implemented), 1 (partial implementation), or 2 (full implementation) for each overdose prevention practice. The primary outcome is total summed score, with higher scores indicating greater fidelity.
Measured: Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start26 Sep 2023
- Primary completion31 Mar 2026
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverdoseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1,350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kelly Doran, MD, MHS, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786222
- Sponsor's protocol ID
- 23-00098
- Acronym
- POP
- Status last verified
- Apr 2026
- First submitted
- 14 Mar 2023
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified staff and tenant questionnaire data will be shared beginning 3 months and ending 5 years following article publication with qualified researchers who have a research question appropriate to the data and of potential benefit to permanent supportive housing tenants. Deidentified data will only be provided in aggregate after completion of a data use agreement (DUA). Requests should be directed to Kelly.Doran@nyulangone.org. All requests for such data will be presented to the study's Advisory Board for approval. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Gaeta Gazzola M, Torsiglieri A, Blaufarb S, Velez L, Hernandez P, O'Grady MA, Shelley D, Frank D, Cleland CM, Doran KM. Understanding overdose risk and response in permanent supportive housing: results of focus groups with tenants, staff, and leaders. Addict Sci Clin Pract. 2025 Nov 28;20(1):91. doi: 10.1186/s13722-025-00616-4.
PubMed 41316389Doran KM, Torsiglieri A, Blaufarb S, Hernandez P, Melnick E, Velez L, Cleland CM, Neighbors C, O'Grady MA, Shelley D. The POP (Permanent Supportive Housing Overdose Prevention) Study: protocol for a hybrid type 3 stepped-wedge cluster randomized controlled trial. Implement Sci. 2023 Jun 7;18(1):21. doi: 10.1186/s13012-023-01278-z.
PubMed 37287026
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Permanent Supportive Housing Overdose Prevention (POP) Study: A Hybrid Type 3 Stepped Wedge Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05786222
- Acronym / sponsor ID
- POP / 23-00098
- Conditions
- Overdose
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,350 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 27 Mar 2023 (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.
Permanent supportive housing (PSH), the gold standard intervention for ending chronic homelessness, has expanded rapidly across the U.S. in recent years. Due to a confluence of individual and environmental risk factors, PSH tenants face heightened risk for overdose. While evidence-based practices to prevent overdose exist, they have not been broadly implemented in PSH settings. This study will address this research to practice gap by studying the implementation of evidence-based practices to prevent overdose in 20 PSH buildings in New York. In a community-partnered stepped wedge randomized controlled trial, the investigators will study a package of implementation strategies that includes an implementation toolkit, tenant and staff implementation champions, limited practice facilitation, and learning collaboratives. Outcomes will be examined using surveys and qualitative interviews with PSH tenants and staff; observation; and analysis of Medicaid claims data.
Detailed description
This single-center study is a hybrid type 3 trial with a stepped wedge cluster randomized controlled trial design, with primary objectives of studying implementation of overdose prevention practices in PSH and secondary objectives of examining effectiveness on clinically relevant outcomes and multilevel factors influencing implementation. Twenty participating PSH building sites will be randomized into four intervention clusters of five buildings each. With the stepped wedge design, all clusters of study PSH buildings will begin in the control condition. Clusters are randomly assigned to receive the intervention at different times, with all eventually receiving the six-month implementation strategy package intervention from Corporation for Supportive Housing (CSH). Study investigators will survey PSH building tenants and staff; conduct observation of building policies and procedures; analyze tenant Medicaid data; and interview staff and tenants.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cluster 1 | Experimental | Behavioral: CSH-Delivered Overdose Prevention SupportBuildings randomized to Cluster 1 will receive the CSH-delivered intervention at Months 2-7. Tenant surveys will be administered 1 month prior to and 12 months following the start of the intervention period. At all clusters, an all-staff survey will be administered at Months 1, 8, 15, 22, and 29. A sustainment survey will be administered to selected staff-leaders in the 8th month following the end of the intervention period. |
| Cluster 2 | Experimental | Behavioral: CSH-Delivered Overdose Prevention SupportBuildings randomized to Cluster 2 will receive the CSH-delivered intervention at Months 9-14. Tenant surveys will be administered 1 month prior to and 12 months following the start of the intervention period. At all clusters, an all-staff survey will be administered at Months 1, 8, 15, 22, and 29. A sustainment survey will be administered to selected staff-leaders in the 8th month following the end of the intervention period. |
| Cluster 3 | Experimental | Behavioral: CSH-Delivered Overdose Prevention SupportBuildings randomized to Cluster 3 will receive the CSH-delivered intervention at Months 16-21. Tenant surveys will be administered 1 month prior to and 12 months following the start of the intervention period. At all clusters, an all-staff survey will be administered at Months 1, 8, 15, 22, and 29. A sustainment survey will be administered to selected staff-leaders in the 8th month following the end of the intervention period. |
| Cluster 4 | Experimental | Behavioral: CSH-Delivered Overdose Prevention SupportBuildings randomized to Cluster 3 will receive the CSH-delivered intervention at Months 23-28. Tenant surveys will be administered 1 month prior to and 12 months following the start of the intervention period. At all clusters, an all-staff survey will be administered at Months 1, 8, 15, 22, and 29. A sustainment survey will be administered to selected staff-leaders in the 8th month following the end of the intervention period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Tenant surveys: To be eligible to participate in the tenant survey part of this study, an individual must:
- Be a supportive housing tenant in a participating building
- Be at least 18 years old
- Be able to read and respond to a survey in English or Spanish
- Staff surveys: To be eligible to participate in the staff survey part of this study, an individual must work for a participating PSH building (or have worked for one in the past 6 months). All PSH building staff are at least 18 years old and are able to read and respond to a survey in English. Staff surveys will begin with a question confirming eligibility.
Key exclusion criteria (1 listed)
- Children under the age of 18 years old will be excluded, including from the Medicaid data analysis.
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 |
|---|---|---|
| CSH-Delivered Overdose Prevention SupportCorporation for Supportive Housing (CSH) will deliver technical support for overdose (OD) prevention in the participating PSH buildings using a package of core implementation strategies: PSH Overdose Prevention (POP) Toolkit (an implementation manual/blueprint for overdose prevention practices); Implementation Champions (staff and tenants in each PSH building will be selected as implementation champions who support implementation and sustainment of OD prevention practices in their buildings); practice facilitation (the practice facilitator [a trained CSH employee] will work with the tenant and staff champions in small group workshops and coaching sessions, building their capacity and supporting their work toward implementation of building OD prevention practices); learning collaboratives (PSH buildings starting the intervention at the same time will attend learning collaborative meetings). | Behavioural | Cluster 1, Cluster 2, Cluster 3, Cluster 4 |
Primary outcome
Fidelity Checklist Score
Time frame: Month 1
Buildings will receive a fidelity checklist score of 0 (not implemented), 1 (partial implementation), or 2 (full implementation) for each overdose prevention practice. The primary outcome is total summed score, with higher scores indicating greater fidelity.
Fidelity Checklist Score
Time frame: Month 8
Buildings will receive a fidelity checklist score of 0 (not implemented), 1 (partial implementation), or 2 (full implementation) for each overdose prevention practice. The primary outcome is total summed score, with higher scores indicating greater fidelity.
Fidelity Checklist Score
Time frame: Month 15
Buildings will receive a fidelity checklist score of 0 (not implemented), 1 (partial implementation), or 2 (full implementation) for each overdose prevention practice. The primary outcome is total summed score, with higher scores indicating greater fidelity.
Fidelity Checklist Score
Time frame: Month 22
Buildings will receive a fidelity checklist score of 0 (not implemented), 1 (partial implementation), or 2 (full implementation) for each overdose prevention practice. The primary outcome is total summed score, with higher scores indicating greater fidelity.
Fidelity Checklist Score
Time frame: Month 29
Buildings will receive a fidelity checklist score of 0 (not implemented), 1 (partial implementation), or 2 (full implementation) for each overdose prevention practice. The primary outcome is total summed score, with higher scores indicating greater fidelity.
57 secondary outcomes
Intervention Appropriateness Measure (IAM) Score
Time frame: Month 1
Intervention Appropriateness Measure (IAM) Score
Time frame: Month 8
Intervention Appropriateness Measure (IAM) Score
Time frame: Month 15
Intervention Appropriateness Measure (IAM) Score
Time frame: Month 22
Intervention Appropriateness Measure (IAM) Score
Time frame: Month 29
Feasibility of Intervention Measure (FIM) Score
Time frame: Month 1
Feasibility of Intervention Measure (FIM) Score
Time frame: Month 8
Feasibility of Intervention Measure (FIM) Score
Time frame: Month 15
Feasibility of Intervention Measure (FIM) Score
Time frame: Month 22
Feasibility of Intervention Measure (FIM) Score
Time frame: Month 29
Brief Opioid Overdose Knowledge (BOOK) Survey Score
Time frame: Month 1
Brief Opioid Overdose Knowledge (BOOK) Survey Score
Time frame: Month 8
Brief Opioid Overdose Knowledge (BOOK) Survey Score
Time frame: Month 15
Brief Opioid Overdose Knowledge (BOOK) Survey Score
Time frame: Month 22
Brief Opioid Overdose Knowledge (BOOK) Survey Score
Time frame: Month 29
Perceived Stigma Toward Substance Users Scale Score
Time frame: Month 1
Perceived Stigma Toward Substance Users Scale Score
Time frame: Month 8
Perceived Stigma Toward Substance Users Scale Score
Time frame: Month 15
Perceived Stigma Toward Substance Users Scale Score
Time frame: Month 22
Perceived Stigma Toward Substance Users Scale Score
Time frame: Month 29
Tenant Substance-Use-Related Emergency Department Visits
Time frame: Month 1
Tenant Substance-Use-Related Emergency Department Visits
Time frame: Month 8
Tenant Substance-Use-Related Emergency Department Visits
Time frame: Month 15
Tenant Substance-Use-Related Emergency Department Visits
Time frame: Month 22
Tenant Substance-Use-Related Emergency Department Visits
Time frame: Month 29
Tenant Substance-Use-Related Emergency Department Visits
Time frame: Month 35
Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
Time frame: Month 1
Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
Time frame: Month 8
Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
Time frame: Month 15
Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
Time frame: Month 22
Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
Time frame: Month 29
Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
Time frame: Month 35
Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
Time frame: Month 1
Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
Time frame: Month 8
Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
Time frame: Month 15
Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
Time frame: Month 22
Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
Time frame: Month 29
Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
Time frame: Month 35
Adoption Checklist Score
Time frame: Month 1
Adoption Checklist Score
Time frame: Month 8
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 May 2026.
- Derived from this study: PubMed 41316389Gaeta Gazzola M, Torsiglieri A, Blaufarb S, Velez L, Hernandez P, O'Grady MA, Shelley D, Frank D, Cleland CM, Doran KM. Understanding overdose risk and response in permanent supportive housing: results of focus groups with tenants, staff, and leaders. Addict Sci Clin Pract. 2025 Nov 28;20(1):91. doi: 10.1186/s13722-025-00616-4.
- Derived from this study: PubMed 37287026Doran KM, Torsiglieri A, Blaufarb S, Hernandez P, Melnick E, Velez L, Cleland CM, Neighbors C, O'Grady MA, Shelley D. The POP (Permanent Supportive Housing Overdose Prevention) Study: protocol for a hybrid type 3 stepped-wedge cluster randomized controlled trial. Implement Sci. 2023 Jun 7;18(1):21. doi: 10.1186/s13012-023-01278-z.
- Individual participant dataSharing planned: Yes. De-identified staff and tenant questionnaire data will be shared beginning 3 months and ending 5 years following article publication with qualified researchers who have a research question appropriate to the data and of potential benefit to permanent supportive housing tenants. Deidentified data will only be provided in aggregate after completion of a data use agreement (DUA). Requests should be directed to Kelly.Doran@nyulangone.org. All requests for such data will be presented to the study's Advisory Board for approval. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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. This study is not recruiting at the moment.
Kelly Doran, MD, MHS principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSH-Delivered Overdose Prevention Support in people with Overdose, run by NYU Langone Health 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 11 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 5 May 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fidelity Checklist Score (time frame: Month 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05786222, which also lists 2 linked publications.
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 May 2026.