NCT06644664

Brief Summary

This clinical trial evaluates the effect of message framing on smoking behaviors among lesbian, gay, bisexual, transgender, queer (LGBTQ+) young adults who use nicotine and/or tobacco. Tobacco regulation has contributed to a steady decline in tobacco products designed to be smoked (combustible), but there has been an increase in the use of new tobacco products, such as electronic nicotine delivery systems (ENDS). The use of more than one tobacco product (polytobacco) is high in LGBTQ+ populations. Both LGBTQ+ people and people who engage in polytobacco use are less likely to view tobacco as harmful, which may reinforce tobacco use. Message framing includes culturally targeted messages to communicate the absolute risks (AR) and relative risks (RR) of polytobacco use. Using message framing may increase quit rates or change smoking behaviors in LGBTQ+ young adults who use nicotine and/or tobacco products.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
292

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 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

Study Start

First participant enrolled

September 24, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2026

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

October 15, 2024

Last Update Submit

March 24, 2026

Conditions

Keywords

Sexual and Gender MinoritiesHealth CommunicationTobacco ProductsCigarettesElectronic Nicotine Delivery SystemsE-cigarettesyoung adulttext messaging

Outcome Measures

Primary Outcomes (3)

  • Total tobacco cessation

    2 items. Asks for current use of nicotine vapes and combustible cigarettes Every day, Some days, or Not at all.

    At 12 weeks post-baseline

  • Acceptability of multimedia messaging service (MMS) anti-polytobacco messages

    In a qualitative interview, Participants will be asked the following question: How did you find participating in a study with images sent via text message? How smoothly would you say it went?

    At 6-week post-enrollment

  • Feasibility of MMS anti-polytobacco messages

    6 items per study arm. Experimental arms 1 and 2: 6 Yes/No questions (1 per week) checking for engagement with the study content, specifically regarding nicotine and tobacco use. Control Group: 6 Yes/No questions (1 per week) checking for engagement with the study content, specifically regarding sun safety.

    At 6-weeks post-enrollment

Secondary Outcomes (4)

  • Switching to exclusive electronic nicotine delivery system (ENDS) use

    At 6- and 12-weeks post-baseline

  • Risk perceptions

    At 6- and 12-weeks post-baseline

  • Behavioral intentions

    Difference between conditions in behavioral intentions from screener, and at 6 and 12-week post baseline

  • Serious quit attempts

    Difference between conditions in quit attempts from screener, and at 6 and 12-week post baseline

Study Arms (3)

Arm I (Absolute Risk messages)

EXPERIMENTAL

Participants receive AR anti-polytobacco MMS messages TIW and a check-in text message QW for a total of 6 weeks. Participants also receive smoking cessation resources via email during follow up.

Other: InterviewBehavioral: Smoking Cessation InterventionOther: Survey AdministrationOther: Text Message-Based Navigation Intervention

Arm II (Relative Risk messages)

EXPERIMENTAL

Participants receive RR anti-polytobacco MMS messages TIW and a check-in text message QW for a total of 6 weeks. Participants also receive smoking cessation resources via email during follow up.

Other: InterviewBehavioral: Smoking Cessation InterventionOther: Survey AdministrationOther: Text Message-Based Navigation Intervention

Arm III (control messages)

ACTIVE COMPARATOR

Participants receive control MMS messages on health risks of UV/sun exposure TIW and a check-in text message QW for a total of 6 weeks. Participants also receive smoking cessation resources via email during follow up.

Behavioral: Health EducationBehavioral: Smoking Cessation InterventionOther: Survey AdministrationOther: Text Message-Based Navigation Intervention

Interventions

Receive control MMS messages

Arm III (control messages)

Ancillary studies

Arm I (Absolute Risk messages)Arm II (Relative Risk messages)

Receive AR MMS messages

Also known as: Smoking and Tobacco Use Cessation Interventions
Arm I (Absolute Risk messages)

Ancillary studies

Arm I (Absolute Risk messages)Arm II (Relative Risk messages)Arm III (control messages)

Receive check-in text message

Also known as: Automated Text Message-Based Navigation, Text Message-Based Navigation
Arm I (Absolute Risk messages)Arm II (Relative Risk messages)Arm III (control messages)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • Self-identify as LGBTQ+
  • Able to speak English fluently
  • An ever user of ENDS and combustible tobacco who currently use ENDS, combustible cigarettes, or both ENDS and combustible cigarettes
  • Currently reside in the United States (US)
  • Have a mobile phone through a U.S. carrier with MMS messaging and can send and receive text messages for study participation
  • Access to the internet with Zoom capabilities

You may not qualify if:

  • Have a landline or Voice Over Internet Protocol (VOIP) phone number

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Conditions

CoitusVaping

Interventions

Interviews as TopicSmoking Devices

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorSmoking

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Joanne G Patterson

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are blinded to their randomization category (absolute risks, relative risks, or control)
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 15, 2024

First Posted

October 16, 2024

Study Start

September 24, 2024

Primary Completion

February 2, 2026

Study Completion

February 2, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations