UnityPhilly Response App for Overdose Reversal
2 other identifiers
interventional
450
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2024
CompletedFirst Posted
Study publicly available on registry
June 20, 2024
CompletedStudy Start
First participant enrolled
September 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
July 20, 2026
May 1, 2026
2.2 years
June 14, 2024
July 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate of Overdoses Signaled
\# events signaled by participants vs. # all overdose-related EMS calls, per year
2 year period
Rate of Overdoses Reversed
\# successful opioid reversals vs. # all arrivals, per year
2 year period
Study Arms (5)
Active non-medical opioid user
OTHERPerson who has used an opioid, e.g., heroin, fentanyl, non-medically in the past 30 days.
Active prescription medical opioid user
OTHERPerson who has used an opioid, e.g., hydrocodone, with a medical prescription in the past 30 days.
Person in recovery from opioid misuse
OTHERPerson who formerly used opioids non-medically and/or is on opioid replacement therapy.
Caregiver/family members of groups 1, 2, 3
OTHERPerson who is caring for or a family member of active non-medical user, medical user, or person in recovery.
Concerned community member
OTHERPerson in the community who is concerned about the opioid overdose crisis and is interested addressing the problem.
Interventions
UnityPhilly automatically connects bystanders and victims of opioid overdose with nearby community members who can respond immediately with naloxone.
Eligibility Criteria
You may qualify if:
- owning a smartphone with a data package;
- living or working in one of three identified Philadelphia neighborhoods;
- aged 18 or older.
You may not qualify if:
- persons aged under 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Drexel Universitylead
- University of Michigancollaborator
Study Sites (1)
Drexel University
Philadelphia, Pennsylvania, 19104, United States
Related Publications (5)
Khalemsky M, Khalemsky A, Lankenau S, Ataiants J, Roth A, Marcu G, Schwartz DG. Predictive Dispatch of Volunteer First Responders: Algorithm Development and Validation. JMIR Mhealth Uhealth. 2023 Nov 28;11:e41551. doi: 10.2196/41551.
PMID: 38015602BACKGROUNDAtaiants J, Reed MK, Schwartz DG, Roth A, Marcu G, Lankenau SE. Decision-making by laypersons equipped with an emergency response smartphone app for opioid overdose. Int J Drug Policy. 2021 Sep;95:103250. doi: 10.1016/j.drugpo.2021.103250. Epub 2021 Apr 20.
PMID: 33887699BACKGROUNDMarcu G, Schwartz DG, Ataiants J, Roth A, Yahav I, Cocchiaro B, Khalemsky M, Lankenau S. Empowering communities with a smartphone-based response network for opioid overdoses. IEEE Pervasive Comput. 2020 Oct-Dec;19(4):42-47. doi: 10.1109/mprv.2020.3019947. Epub 2020 Nov 17.
PMID: 33568966BACKGROUNDSchwartz DG, Ataiants J, Roth A, Marcu G, Yahav I, Cocchiaro B, Khalemsky M, Lankenau S. Layperson reversal of opioid overdose supported by smartphone alert: A prospective observational cohort study. EClinicalMedicine. 2020 Aug 3;25:100474. doi: 10.1016/j.eclinm.2020.100474. eCollection 2020 Aug.
PMID: 32954238BACKGROUNDMarcu G, Aizen R, Roth AM, Lankenau S, Schwartz DG. Acceptability of smartphone applications for facilitating layperson naloxone administration during opioid overdoses. JAMIA Open. 2019 Dec 4;3(1):44-52. doi: 10.1093/jamiaopen/ooz068. eCollection 2020 Apr.
PMID: 32607487BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Lankenau, PhD
Drexel University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 14, 2024
First Posted
June 20, 2024
Study Start
September 16, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
July 1, 2028
Last Updated
July 20, 2026
Record last verified: 2026-05