Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602076
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Developing an SGM Smoking Cessation Intervention With Community Partners
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Developing an Empowerment Theory-Based Smoking Cessation Intervention for Sexual andor Gender Minority People With Community Partners
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECHO
Brief Summary:
Problem Tobacco-related inequities among sexual andor 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 ie 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 N20 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
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 ie 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 N20 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 N60 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 eg 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 N12 SGM adults and volunteer activity facilitators in OK and SJV These will form the basis of ECHOs 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 N50 SGM adults willing to quit smoking from OK and SJV will be randomized to receive either the NCIs QuitGuide smoking cessation smartphone app and free nicotine replacement therapy NRT control n25 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
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 N60 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 eg 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 N12 SGM adults and volunteer activity facilitators in OK and SJV These will form the basis of ECHOs 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 N50 SGM adults willing to quit smoking from OK and SJV will be randomized to receive either the NCIs QuitGuide smoking cessation smartphone app and free nicotine replacement therapy NRT control n25 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None