JMIR Publications

ABSTRACT

Background:

Dual use of nicotine vapes and combustible cigarettes is rising among young adults (YA), with lesbian, gay, bisexual, transgender, and queer (LGBTQ+) YA reporting substantially higher dual use prevalence than non LGBTQ+ YA. Effective, culturally relevant health communications delivered via mobile multimedia messaging (i.e. MMS texting) may increase engagement and reduce tobacco use in this high risk group, but optimal message framing (standard risk vs comparative risk) and the feasibility of MMS delivery for reducing dual use among LGBTQ+ YA remains underexplored.

Objective:

To evaluate the feasibility and preliminary efficacy of MMS-delivered, culturally relevant health communications framed as standard risk or comparative risk versus a neutral control on vaping and smoking cessation and risk perceptions among LGBTQ+ YA, and to estimate effect sizes to inform a Phase III trial.

Methods:

This is a three-arm, randomized controlled trial that will enroll up to 300 participants (target n=100/arm; N=240 after anticipated 20% attrition). Eligibility criteria include: U.S. adults, ages 18–35 years, who are fluent in English, ever used nicotine vapes and combustible cigarettes, currently use at least one product, self-identify LGBTQ+, own a U.S. carrier mobile phone with MMS capability, and have Internet/Zoom access. Recruitment used BuildClinical’s machine learning platform, listserv recontacts, and outreach. Following verification and consent, participants were randomized to standard risk (messages emphasizing harms of both products), comparative risk (messages contrasting cigarette harms relative to vapes), or sun safety control. Intervention: Condition specific MMS public education advertisements delivered three times weekly for six weeks, plus weekly MMS engagement prompts; surveys at baseline, 6 weeks, and 12 weeks. A randomly selected qualitative subsample (n=40) completed interviews. Primary outcomes include 7-day point prevalence tobacco abstinence, switching, quit attempts, and risk perceptions at 12 weeks; secondary outcomes include perceived message effectiveness, and recall at 6 weeks. Planned analyses include GLMs (logit link) for dichotomous cessation/switching outcomes and GLMMs for repeated measures of risk perceptions, intentions, and use. Power: With 240 completers, the trial has ~83% power to detect a 19-percentage point difference in 12-week quit rates between an experimental arm and control (assuming 8% control quit rate; Bonferroni corrected α=0.025).

Results:

Enrollment began September 2024 and is completed; no outcome data are finalized. The protocol includes fraud prevention procedures, IRB approval, trial registration, and a Data Safety and Monitoring oversight plan.

Conclusions:

This trial assesses the feasibility of scalable MMS delivery of culturally targeted health communications to LGBTQ+ YA, generate preliminary efficacy estimates for both standard and comparative risk approaches, and inform design and power calculations for a definitive efficacy trial aimed at reducing dual use in this underserved population. Results will guide development of evidence based, equity focused public education campaigns. Clinical Trial: The protocol for this study was registered in ClinicalTrials.gov (NCT06644664).