Firearm Secure Storage Device Distribution RCT

Comparative Effectiveness of Firearm Secure Storage Device Distribution Strategies: A Hybrid Type 1 Effectiveness-Implementation Randomized Clinical Trial

This study aims to learn how to best promote safe firearm storage in the community. Firearm injuries are a major public health concern, and securely storing firearms can help prevent accidental injuries, suicide, and unauthorized access. This research will test whether providing people with a choice of firearm storage devices improves safe storage practices compared to providing standard cable locks alone. Adults who are patients, visitors, or employees at participating Penn Medicine community health centers may choose to enroll by scanning a QR code displayed at the site. After reviewing study information and providing consent, participants will complete a short online survey about firearm ownership and storage practices. Participants will then be randomly assigned to receive either cable locks or a choice of storage devices such as a lock box and/or cable locks, which will be mailed to their home at no cost. Participants will receive firearm safety educational materials and will be asked to complete brief follow-up surveys by text message about one month and three months later. Some participants and health center staff may also be invited to participate in interviews about their experiences with the program. The goal of this research is to identify practical and acceptable ways for health systems to support safe firearm storage and reduce firearm-related injuries in diverse communities.

Study Overview

• Status: Recruiting
• Conditions: Firearm Safety; Firearm Safety Storage
• Intervention / Treatment: Device: Cable locks; Device: Lock box; Device: Lock box and cable locks

• Study Type: Interventional
• Enrollment (Estimated): 1858
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Trauma Injury Prevention Coordinator; Phone Number: 215-746-0149; Email: InjuryPrevention@pennmedicine.upenn.edu
• Study Contact Backup: Name: Senior Project Manager; Email: laurentn@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Penn Medicine
      • Contact: Senior Project Manager, MSW; Phone Number: 609-248-0229; Email: nathalie.laurent@pennmedicine.upenn.edu
      • Contact: Trauma Injury Prevention Coordinator, RN; Phone Number: 609-248-0229; Email: sunny.vespico@pennmedicine.upenn.edu
      • Principal Investigator: Mucio (Kit) Delgado, MD, MS
      • Principal Investigator: Elinore Kaufman, MD, MSHP, FACS
      • Sub-Investigator: Katelin Hoskins, PhD, MBE
      • Sub-Investigator: Renee Betancourt, MD
      • Sub-Investigator: Michael Harhay, PhD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient, visitor, or employee at enrollment site
• Can access QR code survey at enrollment site via smartphone and have access to text messaging
• Have a residential [U.S.] mailing address
• Report a firearm at home
• Request a secure storage device

Exclusion Criteria:

• Prior enrollment from same household address (needed to preserve independence of study observations)
• Inability to complete study consent and assessments in English or Spanish

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cable lock distribution (usual practice); Up to 5 cable locks	Device: Cable locks; Participants assigned to this intervention will receive up to five firearm cable locks at no cost. The cable locks will be mailed to the participant's home along with firearm safety educational materials.
Active Comparator: Choice of a lock box and/or cable locks (choice of preferred devices); Preferred device option, with choices of: (A) up to 5 cable locks; (B) lock box only; or (C) lock box plus up to 4 cable locks	Device: Cable locks; Participants assigned to this intervention will receive up to five firearm cable locks at no cost. The cable locks will be mailed to the participant's home along with firearm safety educational materials.; Device: Lock box; Participants assigned to this intervention will receive one firearm lock box at no cost. The lock box will be mailed to the participant's home along with firearm safety educational materials.; Device: Lock box and cable locks; Participants assigned to this intervention will receive one firearm lock box and up to four firearm cable locks at no cost. The storage devices will be mailed to the participant's home along with firearm safety educational materials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Reporting All Firearms Stored Securely at 30 Days	Proportion of participants reporting that all firearms in or around their home are stored securely (vs. some or none) on the 30-day follow-up survey. Secure storage will be assessed through participant self-report using the following response options: Yes, all of them (1); Yes, some of them (2); None of them (3); Not sure (4); No guns in or around home (5); and Prefer not to answer (6).	30 days after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with all firearms stored securely at 3 months	Proportion of participants reporting that all firearms in the household are stored securely (vs. some or none) on the 3-month follow-up survey.	3 months after enrollment
Proportion of participants changing from no firearms stored securely to some or all firearms stored securely at 1 month	Participants reporting that some household firearms are stored securely (vs. none) on 1 month follow-up survey after device distribution.	30 days after enrollment
Proportion of participants changing from no firearms stored securely to some or all firearms stored securely at 3 months	Participants reporting that some household firearms are stored securely (vs. none) on 3 month follow-up survey after device distribution.	3 months after enrollment
Number of preferred firearm storage devices requested	Among patients randomized to the preferred device arm, the number of firearm storage devices requested by participants will be assessed.	Baseline (enrollment)
Incremental intervention cost per participant	Incremental cost of delivering the intervention, including the cost of firearm storage devices and associated shipping costs. Costs will be calculated in US dollar per participant	Baseline (enrollment)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants by Cable Lock Frequency at 30 Days	Frequency of cable lock use among participants reporting use of cable locks on firearms at the 30-day follow-up assessment. Participants will report how often cable locks are used using the following response options: Always (1); More than half the time (2); Less than half the time (3)	30 days after enrollment
Number of Participants by Cable Lock Frequency at 90 Days	Frequency of cable lock use among participants reporting use of cable locks on firearms at the 90-day follow-up assessment. Participants will report how often cable locks are used using the following response options: Always (1); More than half the time (2); Less than half the time (3)	90 days after enrollment
Number of Participants by Cable Lock Frequency at 180 Days	Frequency of cable lock use among participants reporting use of cable locks on firearms at the 180-day follow-up assessment. Participants will report how often cable locks are used using the following response options: Always (1); More than half the time (2); Less than half the time (3)	180 days after enrollment
Number of Cable Locks by Recipient Type at 30 Days	Number of cable locks reported as being held by the participant (self), family members, friends, or other individuals at the 30-day follow-up assessment. Participants will report the number of cable locks held by each recipient type.	30 days after enrollment
Number of Cable Locks by Recipient Type at 90 Days	Number of cable locks reported as being held by the participant (self), family members, friends, or other individuals at the 90-day follow-up assessment. Participants will report the number of cable locks held by each recipient type.	90 days after enrollment
Number of Cable Locks by Recipient Type at 180 Days	Number of cable locks reported as being held by the participant (self), family members, friends, or other individuals at the 180-day follow-up assessment. Participants will report the number of cable locks held by each recipient type.	180 days after enrollment
Number of Participants by Lock Box Usage Category at 30 Days	Lock box usage will be assessed through participant self-report at the 30-day follow-up. Participants will report whether the lock box is being used to secure a previously unlocked firearm, replace an existing firearm lock, or is not being used for a firearm. The number of participants selecting each response category will be reported.	30 days after enrollment
Number of Participants by Lock Box Usage Category at 90 Days	Lock box usage will be assessed through participant self-report at the 90-day follow-up. Participants will report whether the lock box is being used to secure a previously unlocked firearm, replace an existing firearm lock, or is not being used for a firearm. The number of participants selecting each response category will be reported.	90 days after enrollment
Number of Participants by Lock Box Usage Category at 180 Days	Lock box usage will be assessed through participant self-report at the 180-day follow-up. Participants will report whether the lock box is being used to secure a previously unlocked firearm, replace an existing firearm lock, or is not being used for a firearm. The number of participants selecting each response category will be reported.	180 days after enrollment
Number of Participants by Lock Box Recipient Type at 30 Days	Lock box possession will be assessed through participant self-report at the 30-day follow-up. Participants will identify who has the lock box using the following response categories: self, family member, friend, or other individual. The number of participants selecting each response category will be reported.	30 days after enrollment
Number of Participants by Lock Box Recipient Type at 90 Days	Lock box possession will be assessed through participant self-report at the 90-day follow-up. Participants will identify who has the lock box using the following response categories: self, family member, friend, or other individual. The number of participants selecting each response category will be reported.	90 days after enrollment
Number of Participants by Lock Box Recipient Type at 180 Days	Lock box possession will be assessed through participant self-report at the 180-day follow-up. Participants will identify who has the lock box using the following response categories: self, family member, friend, or other individual. The number of participants selecting each response category will be reported.	180 days after enrollment
Number of Participants by Lock Box Frequency at 30 Days	Frequency of lock box use will be assessed through participant self-report at the 30-day follow-up. Participants will report how often the lock box is used using the following response categories: Always (1), More than half the time (2), and Less than half the time (3). The number of participants selecting each response category will be reported.	30 days after enrollment
Number of Participants by Lock Box Frequency at 90 Days	Frequency of lock box use will be assessed through participant self-report at the 90-day follow-up. Participants will report how often the lock box is used using the following response categories: Always (1), More than half the time (2), and Less than half the time (3). The number of participants selecting each response category will be reported.	90 days after enrollment
Number of Participants by Lock Box Frequency at 180 Days	Frequency of lock box use will be assessed through participant self-report at the 180-day follow-up. Participants will report how often the lock box is used using the following response categories: Always (1), More than half the time (2), and Less than half the time (3). The number of participants selecting each response category will be reported.	180 days after enrollment
Number of Participants by Cable Lock Usage Category at 30 Days	Cable lock usage will be assessed through participant self-report at the 30-day follow-up. Participants will report whether the cable lock is being used to secure a previously unlocked firearm, replace an existing firearm lock, or is not being used for a firearm. The number of participants selecting each response category will be reported.	30 days after enrollment
Number of Participants by Cable Lock Usage Category at 90 Days	Cable lock usage will be assessed through participant self-report at the 90-day follow-up. Participants will report whether the cable lock is being used to secure a previously unlocked firearm, replace an existing firearm lock, or is not being used for a firearm. The number of participants selecting each response category will be reported.	90 days after enrollment
Number of Participants by Cable Lock Usage Category at 180 Days	Cable lock usage will be assessed through participant self-report at the 180-day follow-up. Participants will report whether the cable lock is being used to secure a previously unlocked firearm, replace an existing firearm lock, or is not being used for a firearm. The number of participants selecting each response category will be reported.	180 days after enrollment
Number of Participants Who Reported Using Injury Prevention Resources at 30 days	Assessed via a 3-item self-reported follow-up questionnaire evaluating participant engagement with provided injury prevention resources. The questionnaire assesses whether participants accessed the texted gun safety webpage, whether they spoke with the Injury Prevention Coordinator (including reasons for contact), and whether they have unmet gun safety resource needs.	30 days after enrollment
Number of Participants Who Reported Using Injury Prevention Resources at 90 days	Assessed via a 3-item self-reported follow-up questionnaire evaluating participant engagement with provided injury prevention resources. The questionnaire assesses whether participants accessed the texted gun safety webpage, whether they spoke with the Injury Prevention Coordinator (including reasons for contact), and whether they have unmet gun safety resource needs.	90 days after enrollment
Number of Participants Who Reported Using Injury Prevention Resources at 180 days	Assessed via a 3-item self-reported follow-up questionnaire evaluating participant engagement with provided injury prevention resources. The questionnaire assesses whether participants accessed the texted gun safety webpage, whether they spoke with the Injury Prevention Coordinator (including reasons for contact), and whether they have unmet gun safety resource needs.	180 days after enrollment

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Mucio (Kit) Delgado, MD, MS, University of Pennsylvania; Principal Investigator: Elinore Kaufman, MD, MSHP, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: October 1, 2026
• First Submitted That Met QC Criteria: October 19, 2026
• First Posted (Actual): October 21, 2026

Study Record Updates

• Last Update Posted (Actual): November 5, 2026
• Last Update Submitted That Met QC Criteria: November 2, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: Firearm safety; Storage outcomes; Firearm safety storage
• Other Study ID Numbers: 26-6055

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No