OverdoseSHARENCT07170072
Shelter HArm Reduction Evaluation
An observational study of Overdose and Harm Reduction, run by NYU Langone Health at 1 site in United States.
Trial summary
The proposed study will use mixed methods research to examine overdose and other health-related impacts of harm reduction initiatives in NYC homeless shelters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overdose, Harm Reduction
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2025to 31 Mar 2027
- Phase
- Observational
- 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
Study population: Aims 1a, 1b, and 2: Analysis of administrative data will include the population of individuals in the NYC single-adult homeless services system during 2021-2026. Aim 3: Qualitative interview and focus group participants will include homeless clients who have received one or more of the HRSP interventions and homeless services providers and administrators who have delivered the HRSP interventions.
Who may be able to join
- For Aims 1a, 1b, and 2: There will be no participant enrollment or direct contact with individuals as these aims will involve the use of an analytic dataset comprised of linked administrative NYC homeless services, Medicaid, and vital records. The dataset will include records for individuals who entered the NYC DHS single-adult shelter system during calendar years 2021-2026, as well as a matched comparison group(s) (as identified through Medicaid data) during the same years. The matched comparison group will be comprised of individuals age 18 and older with active Medicaid coverage at the time of observation.
- For Aim 3 Homeless Services Client participant group: To be eligible for participation in this study, an individual must meet all of the following criteria:
- Adult 18 year of age or older
- Speak English
- Is staying or has stayed in an NYC single-adult shelter that has implemented HRSP interventions
- Report past-year drug use
Show all 17Show fewer
- Able and willing to provide consent
- For Aim 3 Homeless Services Staff participant group: To be eligible for participation in this study, an individual must meet all of the following criteria:
- 18 years of age or older
- Speak English
- Works at an adult shelter service provider agency that implemented HRSP or received HRSP interventions (role may include case manager, security staff, shelter director, medical staff, organizational leadership)
- Able and willing to provide consent
- For Aim 3 Homeless Services Stakeholder participant group: To be eligible for participation in this study, an individual must meet all of the following criteria:
- 18 years of age or older
- Speak English
- Works in a role in which they have key insight to the HRSP interventions, including planning and implementation (role may include homeless services administrator or other key stakeholder)
- Able and willing to provide consent
Who cannot join
- Aims 1a, 1b, and 2: Children under age 18 years of age will be excluded.
- Aim 3: Under age 18 years old, currently a prisoner (we are not sampling from locations where we expect to encounter prisoners), unable to communicate in English (because the interview and focus group guides will not be validated for use in other languages), and unable to provide informed consent.
- For Aim 3 Homeless Services Client participant group: those who are not staying or have not stayed at a shelter with HRSP interventions and those who do not report past-year drug use will not be excluded.
- For Aim 3 Homeless Services Staff participant group: those who have not been employed in a shelter with the HRSP interventions will be excluded. In alignment with standard techniques of purposeful sampling and the study goal of ensuring a range of experiences is captured in the qualitative interviews, additional targeting or exclusion criteria might be set by investigators as needed to ensure that a diverse range of experiences is included among qualitative interview participants.
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, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: Community-based Evaluation of a Novel, System-wide Harm Reduction Strategic Plan for People Experiencing Homelessness in New York City
The proposed study will use mixed methods research to examine overdose and other health-related impacts of harm reduction initiatives in NYC homeless shelters.
Read the detailed description
Mixed-methods study using analyses of administrative homeless services and Medicaid data (Aims 1a, 1b, and 2) and in-depth qualitative interviews (Aim 3). This study will examine the implementation and impact of a Harm Reduction Strategic Plan (HRSP) portfolio of interventions in the NYC single-adult shelter system. The study will be conducted using administrative data (Aims 1a, 1b, and 2) and in-depth interviews and focus groups about client and staff experiences with the HRSP.
- Conditions
- Overdose, Harm Reduction
- Medical subject headings
- Drug Overdose, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Aims 1a, 1b, and 2: Individuals in the NYC Single-Adult Homeless Services | Investigators will conduct an analysis of administrative data on the population of individuals in the NYC single-adult homeless services system during 2021-2026. | |
| Aim 3: Homeless Services Clients Staff | Qualitative interviews and focus group sessions will be held with homeless services providers and administrators who have delivered the HRSP interventions. | |
| Aim 3: Homeless Services Clients | Qualitative interviews and focus group sessions will be held with homeless clients who have received one or more of the HRSP interventions. | |
| Aim 3: Homeless Services Stakeholders | Qualitative interviews and focus group sessions will be held with stakeholders, who work in a role in which they have key insight to the HRSP interventions, including planning and implementation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Fatal Overdose (OD)
Measured: Day 0 (Administrative Analysis of Data)
Incidence of Non-Fatal Overdose (OD)
Measured: Day 0 (Administrative Analysis of Data)
Secondary outcomes (2)
Incidence of Substance Use Disorder (SUD) Treatment Initiation
Measured: Day 0 (Administrative Analysis of Data)
Incidence of Health Services Utilization
Measured: Day 0 (Administrative Analysis of Data)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start23 Jul 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Bennett Allen, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170072
- Sponsor's protocol ID
- 24-01708
- Other IDs
- R01CE003699
- Acronym
- SHARE
- Status last verified
- Aug 2026
- First submitted
- 5 Sep 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is not a clinical trial and is not subject to data sharing requirements. The study involves qualitative interviews with sensitive information and data will not be shared outside of the research team in line with confidentiality agreements and restrictions outlined in our IRB approval.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Evaluation of a Novel, System-wide Harm Reduction Strategic Plan for People Experiencing Homelessness in New York City
- ClinicalTrials.gov ID
- NCT07170072
- Acronym / sponsor ID
- SHARE / 24-01708
- Conditions
- Overdose, Harm Reduction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 12 Sep 2025 (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.
The proposed study will use mixed methods research to examine overdose and other health-related impacts of harm reduction initiatives in NYC homeless shelters.
Detailed description
Mixed-methods study using analyses of administrative homeless services and Medicaid data (Aims 1a, 1b, and 2) and in-depth qualitative interviews (Aim 3). This study will examine the implementation and impact of a Harm Reduction Strategic Plan (HRSP) portfolio of interventions in the NYC single-adult shelter system. The study will be conducted using administrative data (Aims 1a, 1b, and 2) and in-depth interviews and focus groups about client and staff experiences with the HRSP.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aims 1a, 1b, and 2: Individuals in the NYC Single-Adult Homeless Services | – | –Investigators will conduct an analysis of administrative data on the population of individuals in the NYC single-adult homeless services system during 2021-2026. |
| Aim 3: Homeless Services Clients Staff | – | –Qualitative interviews and focus group sessions will be held with homeless services providers and administrators who have delivered the HRSP interventions. |
| Aim 3: Homeless Services Clients | – | –Qualitative interviews and focus group sessions will be held with homeless clients who have received one or more of the HRSP interventions. |
| Aim 3: Homeless Services Stakeholders | – | –Qualitative interviews and focus group sessions will be held with stakeholders, who work in a role in which they have key insight to the HRSP interventions, including planning and implementation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Aims 1a, 1b, and 2: Analysis of administrative data will include the population of individuals in the NYC single-adult homeless services system during 2021-2026. Aim 3: Qualitative interview and focus group participants will include homeless clients who have received one or more of the HRSP interventions and homeless services providers and administrators who have delivered the HRSP interventions.
Key inclusion criteria (17 listed)
- For Aims 1a, 1b, and 2: There will be no participant enrollment or direct contact with individuals as these aims will involve the use of an analytic dataset comprised of linked administrative NYC homeless services, Medicaid, and vital records. The dataset will include records for individuals who entered the NYC DHS single-adult shelter system during calendar years 2021-2026, as well as a matched comparison group(s) (as identified through Medicaid data) during the same years. The matched comparison group will be comprised of individuals age 18 and older with active Medicaid coverage at the time of observation.
- For Aim 3 Homeless Services Client participant group: To be eligible for participation in this study, an individual must meet all of the following criteria:
- Adult 18 year of age or older
- Speak English
- Is staying or has stayed in an NYC single-adult shelter that has implemented HRSP interventions
Key exclusion criteria (4 listed)
- Aims 1a, 1b, and 2: Children under age 18 years of age will be excluded.
- Aim 3: Under age 18 years old, currently a prisoner (we are not sampling from locations where we expect to encounter prisoners), unable to communicate in English (because the interview and focus group guides will not be validated for use in other languages), and unable to provide informed consent.
- For Aim 3 Homeless Services Client participant group: those who are not staying or have not stayed at a shelter with HRSP interventions and those who do not report past-year drug use will not be excluded.
- For Aim 3 Homeless Services Staff participant group: those who have not been employed in a shelter with the HRSP interventions will be excluded. In alignment with standard techniques of purposeful sampling and the study goal of ensuring a range of experiences is captured in the qualitative interviews, additional targeting or exclusion criteria might be set by investigators as needed to ensure that a diverse range of experiences is included among qualitative interview participants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Fatal Overdose (OD)
Time frame: Day 0 (Administrative Analysis of Data)
Incidence of Non-Fatal Overdose (OD)
Time frame: Day 0 (Administrative Analysis of Data)
2 secondary outcomes
Incidence of Substance Use Disorder (SUD) Treatment Initiation
Time frame: Day 0 (Administrative Analysis of Data)
Incidence of Health Services Utilization
Time frame: Day 0 (Administrative Analysis of Data)
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 25 Aug 2026.
- Individual participant dataSharing planned: No. This study is not a clinical trial and is not subject to data sharing requirements. The study involves qualitative interviews with sensitive information and data will not be shared outside of the research team in line with confidentiality agreements and restrictions outlined in our IRB approval.
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Not yet recruiting
Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Opioid Overdose (Trial 3 of 3)
Remote vs. In-Person, Remote Visits
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.
Bennett Allen, PhD 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?
An observational study of Overdose and Harm Reduction, 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 17 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 25 Aug 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 Bennett Allen, PhD (646-501-3708, Bennett.Allen@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Fatal Overdose (OD) (time frame: Day 0 (Administrative Analysis of Data)). The study lists 2 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 25 Aug 2026.