Ignite Creation Date:
2024-07-17 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466005
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-14
Brief Title:
UnityPhilly Response App for Overdose Reversal
Sponsor:
Drexel University
Organization:
Drexel University
Study Overview
Official Title:
UnityPhilly Response App for Overdose Reversal Assessing Citywide Effectiveness and Sustainability
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg 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 Caregiverfamily 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 3000 resident volunteers to determine the sustainability of UnityPhilly using the Reach Effectiveness Adoption Implementation and Maintenance RE-AIM Model These 3000 individuals who will be exposed to the UnityPhilly app by the 450 study participants andor other social mediacommunity outreach during the study will downloaduse 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 n450 and resident volunteers n3000 Multivariate and qualitative analyses n60 will assess a series of six research questions linked to key sustainability outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None