An observational study in Overdose and Harm Reduction, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by NYU Langone Health · Observational
The proposed study will use mixed methods research to examine overdose and other health-related impacts of harm reduction initiatives in NYC homeless shelters.
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.
104 studies on the registry are indexed under Drug Overdose; 22 are open to participants now.
This study's planned enrollment of 80 is below the median of 450 across 26 observational studies indexed under Drug Overdose.
Browse Drug Overdose studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
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:
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:
Exclusion Criteria:
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 .
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigators will conduct an analysis of administrative data on the population of individuals in the NYC single-adult homeless services system during 2021-2026.
Qualitative interviews and focus group sessions will be held with homeless services providers and administrators who have delivered the HRSP interventions.
Qualitative interviews and focus group sessions will be held with homeless clients who have received one or more of the HRSP interventions.
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.
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)
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)
Plan to share: 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.
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Mar 2027, 20 months after the start.
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