Shelter HArm Reduction Evaluation

NCT07170072 | Recruiting

• 2 other identifiers: 24-01708R01CE003699
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overdose; Harm Reduction

Outcome Measures

Primary Outcomes (2)

• Incidence of Fatal Overdose (OD)

  Day 0 (Administrative Analysis of Data)

• Incidence of Non-Fatal Overdose (OD)

  Day 0 (Administrative Analysis of Data)

Secondary Outcomes (2)

• Incidence of Substance Use Disorder (SUD) Treatment Initiation

  Day 0 (Administrative Analysis of Data)

• Incidence of Health Services Utilization

  Day 0 (Administrative Analysis of Data)

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• 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:
• 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:
• years of age or older
• Speak English

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Drug Overdose; Harm Reduction

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Bennett Allen, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bennett Allen, PhD

CONTACT

646-501-3708; Bennett.Allen@nyulangone.org

Kelly Doran, MD

CONTACT

212-263-5850; kelly.doran@nyulangone.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 12, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)