Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT07170072

Conditions

Overdose

Harm Reduction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07170072

Start date

Jul 23, 2025

Status verified date

Aug, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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:

  • 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

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 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.

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-08-25.