Developing an SGM Smoking Cessation Intervention With Community Partners
- Conditions
- Smoking Cessation
- Interventions
- Behavioral: ECHO (Empowering Our Community & Health Outcomes)
- Registration Number
- NCT06602076
- Lead Sponsor
- University of Oklahoma
- Brief Summary
Problem: Tobacco-related inequities among sexual and/or gender minoritized (SGM) people persist, especially in places with high SGM stigma. Tobacco is a leading cause of preventable disease and death among SGM individuals, ≥35% of whom live in places with high structural stigma. High-stigma places have more negative aggregate attitudes about SGM people, weaker policy protections, and are more likely to expose SGM people to minority stressors and lack SGM community participation outlets. Existing SGM-tailored smoking cessation interventions overwhelmingly focus on within-person processes of behavior change rather than the adverse sociopolitical factors driving smoking inequities.
Hypothesis: The hypothesis of this study is that when SGM people in high-stigma environments participate in SGM-serving volunteer activities that empower their communities, they may also experience cognitive and behavioral changes that support smoking cessation (i.e., social support, minority stress coping, SGM identity pride, prosociality).
Importance: Empowerment Theory-informed health behavior change approaches have worked for SGM HIV prevention and youth tobacco interventions. The pretest in Oklahoma (N=20) demonstrated the feasibility and acceptability of an additive intervention design wherein SGM people received remotely-delivered standard smoking cessation support and did SGM-serving volunteer activities. Building on this work, this project was developed with community partners in Oklahoma and California to (1) inform, (2) develop, and (3) pilot test protocol for ECHO (Empowering Our Community and Health Outcomes) a smoking cessation intervention tailored for SGM people living in high-stigma places. Conducted remotely to increase scalability and accessibility, this project lays the ground work of a future R01 application to scale-up the intervention across the country.
- Detailed Description
Specific Aims
Aim 1 (Inform): Prioritize factors associated with SGM smoking cessation in high stigma places to inform volunteer activity protocol development for the ECHO intervention. Smartphone-administered ecological momentary assessment (EMA) will observe a 28-day naturalistic cessation attempt with N=60 SGM adults, recruited nationally from high SGM stigma states and municipalities. This aim will assess daily cessation-related experiences and behaviors, including evidence-based SGM-specific cessation factors (e.g., minority stress coping). These factors likely fluctuate within and across days, requiring EMA.
Hypothesis: Social support, SGM identity pride, minority stress coping, and prosociality will be associated with within- and day-level smoking abstinence, with largest effect sizes for social support and SGM identity pride.
Aim 2 (Develop): Develop volunteer activity protocols likely to maximize SGM smoking cessation success. With findings on prioritized cessation factors from Aim 1, the community partners, and the pretesting experience, a set of online volunteer activities will be developed that support local SGM communities and harness key evidence-based cessation-promoting factors. Activities will be iteratively tested and refined with feedback from N=12 SGM adults and volunteer activity facilitators in OK and SJV. These will form the basis of ECHO's refined core protocol that can be readily adapted in future intervention iterations.
Aim 3 (Pilot): Determine the feasibility, acceptability, and associations with quit self-efficacy and motivation of the developed ECHO intervention protocol in two pilot sites. In a 2-arm, 12-week pilot randomized controlled trial (RCT) with Week 24 follow up, N=50 SGM adults willing to quit smoking from OK and SJV will be randomized to receive either the NCI's QuitGuide smoking cessation smartphone app and free nicotine replacement therapy (NRT; control, n=25), or QuitGuide and NRT plus ECHO, which includes online SGM-serving volunteer activities (≥4 sessions) and a digital hub (Facebook) to foster social support across sites. Key feasibility outcomes assessed at Week 12 include: intervention acceptability, QuitGuide app engagement, NRT adherence, quit self-efficacy and motivation, smoking behavior, and cessation-promoting factors that we aim to activate with the volunteer activity protocols. Community partner outcomes will include volunteer hours and organizational visibility as assessed by participant records and key informant interviews. Characteristics will be identified across volunteer activity protocols that best activated cessation-related factors.
This remotely-delivered, SGM-tailored smoking cessation intervention uses an innovative, theory-based, local-yet-scalable approach to enhance individual outcomes through community empowerment. This project will advance efforts to understand and address SGM tobacco use disparities and will inform a future R01 application for a fully-powered, multi-site intervention RCT aiming to end SGM tobacco-related inequities in high stigma places.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment ECHO (Empowering Our Community & Health Outcomes) Receive standard smoking cessation treatment in the form of the NCI's QuitGuide smoking cessation smartphone app and free over-the-counter nicotine replacement therapy provided by mail, plus participate in online SGM-serving volunteer activities (≥4 sessions) and a digital hub (Facebook) to foster social support across sites.
- Primary Outcome Measures
Name Time Method Retention 12 weeks BENCHMARK:
Retention at week 12 (minimum 80%)Intervention feasibility 12 weeks The following post-intervention outcome will be assessed at Week 12: Overall intervention feasibility will be assessed by the Weiner scale (2017), which has four 5-point Likert-scale questions; higher score indicates greater feasibility.
BENCHMARK:
Intervention feasibility at Week 12 (70% or more of participants with an average score of 4 or greater on each scale).Intervention acceptability 12 weeks The following post-intervention outcome will be assessed at Week 12: Overall intervention acceptability will be assessed by the Weiner scale (2017), which has four 5-point Likert-scale questions; higher score indicates greater acceptability.
BENCHMARK:
Intervention acceptability at Week 12 (70% or more of participants with an average score of 4 or greater on each scale).Intervention appropriateness 12 weeks The following post-intervention outcome will be assessed at Week 12: Overall intervention appropriateness will be assessed by the Weiner scale (2017), which has four 5-point Likert-scale questions; higher score indicates greater appropriateness.
BENCHMARK:
Intervention appropriateness at Week 12 (70% or more of participants with an average score of 4 or greater on each scale).
- Secondary Outcome Measures
Name Time Method Self-reported smoking abstinence assessed at Week 12 12 weeks -Self-reported 7-day Point Prevalence Abstinence (PPA)
Self-efficacy asssessed at Week 12 12 weeks -Self-Efficacy Scale/Confidence (SESC)
Motivation to quit smoking assessed at Week 12 12 weeks -Motivation to change (Stages of Change \[SoC\] scale)
Smoking intensity assessed at Week 12 12 weeks -Smoking intensity will be assessed by past-week smoking days and past-week cigarettes per smoking day.
Cessation Treatment Engagement assessed at Week 12 12 weeks -Engagement with smoking cessation treatment will be the number of days the participant opened the QuitGuide app during the 12-week intervention period according to objective -tracking of app feature use. Greater number of days indicates greater engeagement.