UnityPhilly Response App for Overdose Reversal

Opioid Overdose Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06466005
• Other study ID #: 2401010340
• Status: Not yet recruiting
• Start date: October 2024
• Est. completion date: July 2028

Study information

• Verified date: June 2024
• Source: Drexel University
• Contact: Lyric Kleber, MPH
• Phone: (215) 490-8259
• Email: lqk23[@]drexel.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: July 2028
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Overdose
• Opiate Overdose
• Opioid Overdose

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Drexel University	Bar Ilan University, University of Michigan

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Overdoses Signaled	# events signaled by participants vs. # all overdose-related EMS calls, per year	2 year period
Primary	Rate of Overdoses Reversed	# successful opioid reversals vs. # all arrivals, per year	2 year period

External Links

•   UnityPhilly website