Firearm Secure Storage Device Distribution RCT

NCT07886983 | Not Yet Recruiting

• 1 other identifier: 26-6055
• Study Type: interventional
• Target: 1,858
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Firearm Safety; Firearm Safety Storage

Keywords

Storage outcomes; Firearm safety; Firearm safety storage

Outcome Measures

Primary Outcomes (1)

• 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 at the 30-day follow-up assessment. 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 Outcomes (5)

• Number of firearm storage devices requested

  Baseline (enrollment)

• Proportion of participants with all firearms stored securely at 3 months

  3 months after enrollment

• Proportion of participants changing from no firearms stored securely to some or all firearms stored securely at 1 month

  Baseline and 1 month

• Proportion of participants changing from no firearms stored securely to some or all firearms stored securely at 3 months

  Baseline and 3 months

• Incremental intervention cost per participant

  Up to 3 months after enrollment

Other Outcomes (21)

• Number of Participants by Cable Lock Usage Frequency at 30 Days

  30 days after enrollment

• Number of Participants by Cable Lock Usage Frequency at 90 Days

  90 days after enrollment

• Number of Participants by Cable Lock Usage Frequency at 180 Days

  180 days after enrollment

Study Arms (3)

Up to 5 cable locks

ACTIVE COMPARATOR

Choice of preferred device

Device: Cable locks

Lock box only

ACTIVE COMPARATOR

Choice of preferred device

Device: Lock box

Lock box and cable locks

ACTIVE COMPARATOR

Choice of preferred device

Device: Lock box and cable locks

Interventions

Cable locks DEVICE

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.

Up to 5 cable locks

Lock box DEVICE

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.

Lock box only

Lock box and cable locks DEVICE

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.

Lock box and cable locks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Officials

• Mucio (Kit) Delgado, MD, MS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Elinore Kaufman, MD, MSHP

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trauma Injury Prevention Coordinator

CONTACT

215-746-0149; InjuryPrevention@pennmedicine.upenn.edu

Senior Project Manager

CONTACT

laurentn@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized into one of three interventions: 1. Up to 5 cable locks; 2. Lock box only; 3. Lock box + up to 4 cable locks

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 21, 2026
• Study Start: October 21, 2026
• Primary Completion (Estimated): August 20, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 21, 2026

Record last verified: 2026-10