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PACE Vape Messaging Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04450537
Recruitment Status : Recruiting
First Posted : June 29, 2020
Last Update Posted : June 29, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Andrea Villanti, University of Vermont

Brief Summary:
The purpose of this study is to examine the effect of exposure to vape education messages on beliefs, perceptions, norms, and behaviors related to electronic vapor product use.

Condition or disease Intervention/treatment Phase
Vaping E-cigarette Use Electronic Cigarette Use Behavioral: Vape Messaging Intervention Not Applicable

Detailed Description:

Using content developed from the formative research phase, participants in this randomized controlled trial will either be exposed to ten vape education messages or to ten messages on sun safety, with all messages formatted for social media.

This study will take place over a 1-month period. Individuals who complete the screening survey and are eligible to participate will be invited to complete a 10-15 minute baseline survey at the start of the study. This survey will ask questions about tobacco and electronic vapor product use, and beliefs about and perceptions of vape products. This survey will also ask about exposure to tobacco and e-cigarette marketing, exposure to prevention messaging on vaping and tobacco use, and peer and family influences on tobacco use. During the survey, participants will be presented with and be asked to provide feedback for short health-related messages.

One month after completing this survey, participants will be sent an invitation to the follow-up survey. This survey will again ask about tobacco and electronic vapor product use, and beliefs about and perceptions of vape products.

All study procedures will take place remotely, with surveys conducted online. At the end of the first survey, participants will be eligible to receive a $10 online gift card. Upon completion of the follow-up survey, participants will be eligible to receive a $15 online gift card. In total, participants will be eligible to receive up to $25 for completing both surveys. Those who are ineligible will not be asked to complete the baseline survey and will not be compensated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 604 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Anti-JUUL-type Messages on Beliefs, Perceived Harms, and Behavioral Intentions Among Young Adults
Actual Study Start Date : June 23, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Experimental: Vape Messaging Intervention
Participants will be exposed to 10 vape education messages
Behavioral: Vape Messaging Intervention
Participants will be exposed to 10 vape education messages

No Intervention: Sun Safety Control
Participants will be exposed 10 sun safety messages



Primary Outcome Measures :
  1. Nicotine/e-cigarette beliefs [ Time Frame: Assessed at 1-month follow-up ]
    True/false/don't know questions about nicotine and electronic vapor/tobacco products

  2. Vape harm perceptions [ Time Frame: Assessed at 1-month follow-up ]
    Harm perception questions about use of electronic vapor/vape products

  3. Vaping-related norms [ Time Frame: Assessed at 1-month follow-up ]
    Questions (5-point Likert scale: 1=Very negative, 5 = Very positive) about others' opinion of using electronic vapor/vape products like JUUL


Secondary Outcome Measures :
  1. Behavioral intentions [ Time Frame: Assessed at 1-month follow-up ]
    Questions about intent to use electronic vapor/vape products in the next 12 months



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 18-24
  • Vermont resident
  • Access to a smartphone with internet
  • Use of one or more social media site(s) at least weekly

Exclusion Criteria:

  • Aged 25 years or older
  • Not Vermont resident
  • No access to a smartphone with internet
  • Use of one or more social media site(s) less than weekly

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04450537


Contacts
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Contact: Elisha LePine, BA (802) 391-0610 pace.vermont@gmail.com

Locations
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United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05405
Contact: Elisha LePine, BA    802-391-0610    pace.vermont@gmail.com   
Sponsors and Collaborators
University of Vermont
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Andrea C Villanti, PhD, MPH University of Vermont
Additional Information:
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Responsible Party: Andrea Villanti, Associate Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT04450537    
Other Study ID Numbers: 00000693
U54DA036114 ( U.S. NIH Grant/Contract )
First Posted: June 29, 2020    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrea Villanti, University of Vermont:
surveys
vaping