University of Oklahoma
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.
Smoking Cessation
ECHO (Empowering Our Community & Health Outcomes)
EARLY_PHASE1
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 50 participants |
| Masking : | DOUBLE |
| Masking Description : | Blinding participants will not be possible because participants will be able to tell if they are in the treatment group versus control group due to the volunteer activities in the treatment group and absence of such activities in the control group. Investigators will remain blinded to the group assignments. Randomization will use a centralized and automated system to ensure allocation concealment from outcomes analysts. If manual allocation is required, sequentially numbered, opaque, sealed envelopes will be utilized to maintain allocation concealment and managed internally at OU. Additionally, the following blinded outcome assessment procedures are planned: Outcome assessors will be a separate and unique team from those managing allocation and tracking of participants during the research activities; Participants will be assigned unique codes that do not reveal their identity and group to the outcome assessors. |
| Primary Purpose : | TREATMENT |
| Official Title : | Developing an Empowerment Theory-Based Smoking Cessation Intervention for Sexual and/or Gender Minority People With Community Partners |
| Actual Study Start Date : | 2025-09 |
| Estimated Primary Completion Date : | 2027-11-30 |
| Estimated Study Completion Date : | 2027-11-30 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 100 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
No Location Found