UnityPhilly Response App for Overdose Reversal

May 7, 2026 updated by: Stephen Lankenau, Drexel University

UnityPhilly Response App for Overdose Reversal: Assessing Citywide Effectiveness and Sustainability

The goal of this clinical trial is to discover if an overdose prevention app (UnityPhilly) can encourage citizen responders to respond and prevent opioid overdoses using the UnityPhilly app. The main hypotheses to answer are:

Hypothesis 1: UnityPhilly signal rates relative to EMS calls will increase over time. The primary outcome will be assessed as the total number of overdoses signaled by participants relative to all overdose-related EMS calls, per year.

Hypothesis 2: The number of cases where a nearby UnityPhilly participant successfully reverses an overdose with naloxone will increase over time. The primary outcome will be assessed as the number of successful reversals relative to the total number of responder arrivals, per year.

Participants will be supplied with the UnityPhilly app, training on how to use the app and respond to an opioid overdose using naloxone, and respond to follow up surveys about their experiences.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a behavioral clinical trial, which is has been developed to evaluate and compare ways that people respond to a drug overdose using the UnityPhilly overdose response app. The UnityPhilly app, along with training participants how to use the app, the provision of naloxone, and overdose prevention training, is the intervention in this study. All individuals enrolled in this study are prospectively assigned to use the UnityPhilly app so that there is no control or placebo group - all receive the intervention. By enrolling five different types of individuals into the study, e.g., person who uses opioids, person in recovery, we will be evaluate the effectiveness of the UnityPhilly app in these different groups in responding to and reducing opioid overdose in Philadelphia. Aim 1 of the study will redevelop the UnityPhilly app previously tested in an earlier R34 study so that the app is easy to use among different groups of users in different overdose environments. Aim 2 of the study will enroll 450 study participants from 3 different neighborhoods in Philadelphia over a period of 9 months and who will be studied for an additional 12 month period to assess the effectiveness of the app. Participants will self-identify into the following 5 subgroups: (1) Active non-medical opioid user; (2) Active prescription medical opioid user; (3) Person in recovery from opioid misuse; (4) Caregiver/family member of (1), (2), or (3); or (5) Concerned community member. All 450 persons will be prospectively assigned to use of the UnityPhilly app into this longitudinal study. Effectiveness of the app, including such outcomes as overdoses signaled, willingness to respond to an app signal, and first to scene of an overdose, will be assessed among the five groups overtime using a mix of quantitative assessments (baseline, follow up, incident, log data) and qualitative interviews. Multivariate and qualitative analyses will assess a series of five hypotheses linked to key effectiveness outcomes. Aim 3 of the study will enroll an additional 3,000 resident volunteers to determine the sustainability of UnityPhilly using the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) Model. These 3,000 individuals, who will be exposed to the UnityPhilly app by the 450 study participants and/or other social media/community outreach during the study, will download/use the UnityPhilly app and will be assessed over a two-year period. Sustainability of the app, including reasons to join UnityPhilly, equity in diffusion of the app, network density of the app, will be assessed using a mix of quantitative assessments (baseline, log) and quantitative interviews from both the study participants (n=450) and resident volunteers (n=3,000). Multivariate and qualitative analyses (n=60) will assess a series of six research questions linked to key sustainability outcomes.

Study Type

Observational

Enrollment (Estimated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Stephen Lankenau, PhD
  • Phone Number: 323-326-6438
  • Email: sel59@drexel.edu

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Drexel University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Key study enrollment criteria will include: owning a smartphone with a data package; living or working in one of three identified Philadelphia neighborhoods, i.e., Kensington, South Philadelphia, West Philadelphia; aged 18 or older. Furthermore, participants will be placed into one of the five subgroups based upon 30-day self-report of non-medical opioid use, medical opioid use, abstinence or recovery from any opioid use, family member or community self-affiliation (see subgroups 1-5 above). The study will enroll 450 participants and all will be assigned the intervention, i.e., UnityPhilly app.

Description

Inclusion Criteria:

  • owning a smartphone with a data package;
  • living or working in one of three identified Philadelphia neighborhoods;
  • aged 18 or older.

Exclusion Criteria:

  • persons aged under 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Active non-medical opioid user
Person who has used an opioid, e.g., heroin, fentanyl, non-medically in the past 30 days.
Other: UnityPhilly app
UnityPhilly automatically connects bystanders and victims of opioid overdose with nearby community members who can respond immediately with naloxone.
Active prescription medical opioid user
Person who has used an opioid, e.g., hydrocodone, with a medical prescription in the past 30 days.
Other: UnityPhilly app
UnityPhilly automatically connects bystanders and victims of opioid overdose with nearby community members who can respond immediately with naloxone.
Person in recovery from opioid misuse
Person who formerly used opioids non-medically and/or is on opioid replacement therapy.
Other: UnityPhilly app
UnityPhilly automatically connects bystanders and victims of opioid overdose with nearby community members who can respond immediately with naloxone.
Caregiver/family members of groups 1, 2, 3
Person who is caring for or a family member of active non-medical user, medical user, or person in recovery.
Other: UnityPhilly app
UnityPhilly automatically connects bystanders and victims of opioid overdose with nearby community members who can respond immediately with naloxone.
Concerned community member
Person in the community who is concerned about the opioid overdose crisis and is interested addressing the problem.
Other: UnityPhilly app
UnityPhilly automatically connects bystanders and victims of opioid overdose with nearby community members who can respond immediately with naloxone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Overdoses Signaled
Time Frame: 2 year period
# events signaled by participants vs. # all overdose-related EMS calls, per year
2 year period
Rate of Overdoses Reversed
Time Frame: 2 year period
# successful opioid reversals vs. # all arrivals, per year
2 year period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Drexel University

Collaborators

University of Michigan

Investigators

  • Principal Investigator: Stephen Lankenau, PhD, Drexel University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

June 14, 2024

First Submitted That Met QC Criteria

June 14, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2401010340

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Even though the final datasets will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects based on advanced location analytics. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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