TA Intervention for Overdose Prevention

(POP-2 Trial)

Overseen By Kelly Doran, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new support system, the TA Intervention, to help housing agencies prevent tenant overdoses and improve tenant health. It involves supportive housing agencies in New York and New Jersey, focusing on those with tenants who have experienced overdoses in the past year. The trial explores different phases: a control period, an intervention period, and a sustainment period. Agencies with at least 40 tenants and concerns about tenant overdoses might be a good fit for this trial. As an unphased trial, it offers a unique opportunity to contribute to innovative solutions for tenant health and safety.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this technical assistance intervention is safe for overdose prevention?

Research has shown that technical assistance programs are usually easy for people to manage. These programs aim to improve organizational operations rather than using physical treatments or medications, resulting in fewer risks of direct physical side effects.

Studies have found that these programs can help organizations enhance health outcomes, such as reducing overdoses. However, these studies typically do not focus on specific side effects in individuals. Since technical assistance involves offering guidance and support, it is generally considered safe for participants.

The goal of these programs is to help organizations better prevent overdoses, indicating a low safety risk. Participants are more likely to notice changes in how their housing agency operates than any direct health-related effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TA Intervention for overdose prevention because it takes a novel approach to tackling this critical issue. Unlike traditional treatments that often focus solely on immediate overdose reversal, like naloxone, this intervention is designed to provide a comprehensive, phased approach. Participants first experience a control phase, then move into an intervention phase aimed at reducing risk behaviors, and finally enter a sustainment phase to ensure long-term success. This method not only aims to prevent overdoses but also supports ongoing behavioral change, making it a holistic solution that could significantly impact public health.

What evidence suggests that this trial's TA Intervention could be effective for overdose prevention?

Research has shown that technical assistance (TA) programs play a crucial role in preventing overdoses. These programs often involve collaboration and information sharing to enhance public health efforts. For example, one study found that local health departments successfully implemented various activities to prevent overdoses, resulting in improved health outcomes. Another study highlighted that TA aids in collecting and using high-quality data to track and manage overdose cases effectively. Although exact effectiveness numbers may not be available, these programs are based on proven methods, suggesting a positive impact on overdose prevention. Participants in this trial will experience different phases, including control, intervention, and sustainment, to evaluate the TA intervention's effectiveness in various settings. ^{1 6 7 8 9}

Who Is on the Research Team?

Kelly Doran, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for agencies that manage permanent supportive housing, aiming to implement strategies to prevent tenant overdose and promote health. Specific eligibility criteria are not provided.

Inclusion Criteria

Supportive Housing Agencies/Individuals who Work at Supportive Housing Agencies must serve at least 40 tenants in New York and/or New Jersey

Supportive Housing Agencies/Individuals who Work at Supportive Housing Agencies must have a significant concern for overdose (as demonstrated by past year tenant overdose)

Supportive Housing Agencies/Individuals who Work at Supportive Housing Agencies must be willing to complete all activities required for participation in the trial

Exclusion Criteria

See inclusion criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control

Participants receive the control condition

6-27 months

Intervention

Technical assistance intervention to implement overdose prevention practices

6 months

Sustainment

Sustainment phase to maintain intervention practices

12-26 months

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TA Intervention

Trial Overview The study is testing a 'Technical Assistance Intervention' designed to assist housing agencies in adopting practices proven to prevent overdoses among tenants.

How Is the Trial Designed?

Group I: Wave 4: Control, Intervention, Sustainment Experimental Treatment 1 Intervention

Participants at agencies assigned to wave 4 will receive the control condition from months 1-27; intervention for months 27-33; and sustainment from months 33-45.

Group II: Wave 3: Control, Intervention, Sustainment Experimental Treatment 1 Intervention

Participants at agencies assigned to wave 3 will receive the control condition from months 1-20; intervention for months 20-26; and sustainment from months 26-45.

Group III: Wave 2: Control, Intervention, Sustainment Experimental Treatment 1 Intervention

Participants at agencies assigned to wave 2 will receive the control condition from months 1-13; intervention for months 13-19; and sustainment from months 19-45.

Group IV: Wave 1: Control, Intervention, Sustainment Experimental Treatment 1 Intervention

Participants at agencies assigned to wave 1 will receive the control condition from months 1-6; intervention for months 6-12; and sustainment from months 12-45.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. cdc.gov cdc.gov/overdose-prevention/media/pdfs/OD2A_EvalProfile_TechincalAssistance_508.pdf

Technical Assistance to Disproportionately Affected ... This resource is meant to demonstrate how to conduct evaluations, in many cases using existing programmatic data, to produce actionable and timely findings.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11149216/

Overdose prevention activities led by local public health ... Most of the activities were coded as coordination, collaboration, and integration (n=52, 23.6%), harm reduction (n=51, 23.1%), data and evidence ...

3. substanceabusepolicy.biomedcentral.com substanceabusepolicy.biomedcentral.com/articles/10.1186/s13011-024-00612-y

Overdose prevention activities led by local public health ... This paper aims to: 1) describe the overdose prevention activities that LHDs implemented during the four eighteen-month funding cycles; 2) identify ...

4. astho.org astho.org/4a4b1d/globalassets/resources/od2a-cooperative-agreements-recipient-orientation-handbook.pdf

Overdose Data to Action (OD2A) State and LOCAL ... Overdose Data to Action (OD2A) supports jurisdictions in collecting high-quality, comprehensive, and timely data on nonfatal and fatal overdoses and in using ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S037687162301116X

Electronic harm reduction interventions for drug overdose ... Per-protocol analysis showed that of 164 patients contacted, 67% were reached (n = 109) and 80 patients accepted naloxone, corresponding to a 73 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10993074/

Public Health Interventions and Overdose-Related ... This decision analytical model estimates the projected 3-year association between public health interventions and opioid overdose-related outcomes

7. health.state.mn.us health.state.mn.us/communities/opioids/mnresponse/ofrphastguide.pdf

Overdose Fatality Reviews for Public Health and Safety ... In 2022, preliminary data showed an average of three Minnesotans died each day from a drug overdose with a total number of 1,343 deaths. Of ...

8. cdc.gov cdc.gov/overdose-prevention/php/od2a/prevention.html

Overdose Data to Action: Prevention Strategies OD2A prevention strategies rely on strong, multisectoral partnerships, such as those between public health, public safety, harm reduction, ...

9. hhs.gov hhs.gov/overdose-prevention/primary-prevention

Primary Prevention | Overdose Prevention Strategy This program aims to prevent opioid misuse and use disorder through investments in research on risk identification; intervention development; social ...