UnityPhilly Response App for Overdose Reversal

NCT ID: NCT06466005

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2028-07-31

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.

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.

Conditions

Opioid Overdose

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Study Groups

Active non-medical opioid user

Person who has used an opioid, e.g., heroin, fentanyl, non-medically in the past 30 days.

UnityPhilly app

Intervention Type: OTHER

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.

UnityPhilly app

Intervention Type: OTHER

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.

UnityPhilly app

Intervention Type: OTHER

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.

UnityPhilly app

Intervention Type: OTHER

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.

UnityPhilly app

Intervention Type: OTHER

UnityPhilly automatically connects bystanders and victims of opioid overdose with nearby community members who can respond immediately with naloxone.

Interventions

UnityPhilly app

UnityPhilly automatically connects bystanders and victims of opioid overdose with nearby community members who can respond immediately with naloxone.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: collaborator

Bar Ilan University

UNKNOWN

Sponsor Role: collaborator

Drexel University

OTHER

Sponsor Role: lead

Responsible Party

Stephen Lankenau

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen Lankenau, PhD

Role: PRINCIPAL_INVESTIGATOR

Drexel University

Locations

Drexel University

Philadelphia, Pennsylvania, United States

Countries

United States

Central Contacts

Stephen Lankenau, PhD

Role: CONTACT

sel59@drexel.edu

323-326-6438

Kushal Naik, MPH

Role: CONTACT

kun24@drexel.edu

References

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.

Reference Type: BACKGROUND

PMID: 38015602 (View on PubMed)

Ataiants 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.

Reference Type: BACKGROUND

PMID: 33887699 (View on PubMed)

Marcu 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.

Reference Type: BACKGROUND

PMID: 33568966 (View on PubMed)

Schwartz 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.

Reference Type: BACKGROUND

PMID: 32954238 (View on PubMed)

Marcu 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.

Reference Type: BACKGROUND

PMID: 32607487 (View on PubMed)

Related Links

https://www.unityphilly.org/

UnityPhilly website

Other Identifiers

2401010340

Identifier Type: -

Identifier Source: org_study_id