NCT06308081

Brief Summary

The investigators long-term goal is to reduce tobacco use and tobacco-related health disparities among SGM populations. The objective of Project SMART (Social Media Anti-Vaping Messages to Reduce ENDS Use Among Sexual and Gender Minority Teens) is to evaluate the effectiveness of an sexual gender minority (SGM) -tailored social media intervention to prevent vaping initiation among SGM youth ages 13-20 years. The investigators central hypothesis is that SGM-tailored anti-vaping social media messages will be more effective than existing non-tailored messages to prevent vaping initiation among SGM youth. The scientific premise for this work is based on principles of cultural tailoring in health communication for vulnerable populations, the Health Equity Promotion Model, and the Message Impact Framework. The investigators are developing and evaluating a social media intervention because SGM youth have a high rate of social media use and are more likely to go online for health information than non-SGM youth. Social media, moreover, are increasingly used for health promotion to address health disparities and well-being of SGM populations. The investigators will conduct rapid-cycle feedback with stakeholders including SGM organization leaders to provide input on the message design, testing, and intervention implementation to ensure feasibility and acceptability of the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

February 21, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

October 7, 2025

Status Verified

October 1, 2025

Enrollment Period

1.5 years

First QC Date

January 3, 2024

Last Update Submit

October 2, 2025

Conditions

Keywords

Communication interventionsLGBTQ+ youth

Outcome Measures

Primary Outcomes (1)

  • Susceptibility to vaping

    We will measure susceptibility to vaping using four items previously used on PATH Wave 7 youth questionnaire and NYTS 2022 Questionnaire: 1. Have you ever been curious about using an e-cigarette or other electronic nicotine products? (1 = Not at all curious; 2 = A little curious; 3 = Somewhat curious; 4 = Very curious) 2. Do you think you will use an e-cigarette or an electronic nicotine product in the next year? (1 = Definitely not; 2 = Probably not; 3 = Probably yes; 4 = Definitely yes) 3. Do you think you will use an e-cigarette or an electronic nicotine product soon? (1 = Definitely not; 2 = Probably not; 3 = Probably yes; 4 = Definitely yes) 4. If one of your best friends were to offer you an e-cigarette or an electronic nicotine product, would you use it? (1 = Definitely not; 2 = Probably not; 3 = Probably yes; 4 = Definitely yes) The responses to these items will be averaged to create a score of vaping susceptibility.

    One week, Two weeks, Three weeks, and One month

Secondary Outcomes (1)

  • Vaping initiation

    One week, Two weeks, Three weeks, and One month

Study Arms (2)

Tailored

EXPERIMENTAL

Participants in the tailored arm will receive SGM-tailored anti-vaping health messages delivered via text message

Other: Tailored

Non-Tailored

NO INTERVENTION

Participants in the non-tailored arm will receive non-tailored anti-vaping health messages delivered via text message

Interventions

Messages will be in the form of high-quality English-language anti-vaping messages comprising static text and imagery designed to resemble social media posts (e.g., image and a caption). We will create 24 messages based on the top-ranked tailoring features and belief themes tested in Aim 2 to comprise SGM-tailored messages. For the non-tailored message condition, we will create 24 anti-vaping social media messages that mirror the SGM-tailored messages but do not contain SGM identity cues. We will match the belief themes used in the tailored and non-tailored messages such that they represent a range of belief targets (e.g., addiction, physical health effects, mental health effects) as indicated in Aims 1 and 2. We do not utilize a social media platform for the delivery of the message to avoid potential contamination across randomized conditions.

Also known as: SGM tailored messages
Tailored

Eligibility Criteria

Age13 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Identify as SGM
  • ages 13-20
  • not vaped or used other tobacco products in the past 30 days
  • have access to a smartphone
  • Able to read and speak in English
  • willing to receive messages via texting for the study
  • susceptible to e-cigarette use at intake (i.e., those do not state "definitely not" to all three susceptibility questions).

You may not qualify if:

  • Current vapers
  • Non-SGM youth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (35)

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MeSH Terms

Conditions

VapingAdolescent Behavior

Condition Hierarchy (Ancestors)

SmokingBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomized to 1 of 2 conditions: SGM-tailored anti-vaping messages versus non-tailored messages. Block randomization will achieve balance across the two conditions based on age group, gender identity, sexual orientation, race, ethnicity, and prior use. Both conditions will receive repeated exposure of messages within their assigned condition daily for 4, up to a total of 24 messages over the course of the study. Messages will be delivered using texting to participants mobile phones. We will record participants' self-reported engagement to the messages at the follow-up survey (after measuring the study outcomes). Participants will be asked to complete a baseline survey comprising vaping susceptibility and characteristics, surveys at 1-, 2-, 3-, and 4-weeks follow-up to measure vaping susceptibility.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Communication

Study Record Dates

First Submitted

January 3, 2024

First Posted

March 13, 2024

Study Start

February 21, 2024

Primary Completion

August 15, 2025

Study Completion

August 15, 2025

Last Updated

October 7, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations