Clinical trial NCT06602076: Developing an SGM Smoking Cessation Intervention With Community Partners
Official title: Developing an Empowerment Theory-Based Smoking Cessation Intervention for Sexual and/or Gender Minority People With Community Partners
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Smoking Cessation
Keywords: LGBT
tobacco use
smoking cessation
sexual and gender minorities
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 Oklahoma (OK) and the San Joaquin Valley (SJV) in California 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion/exclusion criteria (All Aims):

* Sexual and/or gender minority (SGM)-identified
* Adults (i.e., ≥ 18 years old)
* Currently smoking cigarettes
* Living in a high stigma environment in the U.S.
* Able to read English at \&gt; 6th-grade level

Individuals with serious psychological distress (i.e., score of 13 ≥ 18 on the Kessler PD Scale-6 19) will be excluded from all Aims because of likelihood of functional impairments that substantially interfere with one or more major life activities.

Aim 3 (Pilot RCT) inclusion criteria will be:

* (1) ≥ 18 years old
* (2) sexual and/or gender minority-identified (see definition above)
* (3) living in Oklahoma or one of the 8 counties in San Joaquin Valley, California (verified by address)
* (4) a current cigarette smoker (see definition above)
* (5) willing to quit smoking within 30 days of enrollment (see definition above)
* (6) own a smartphone
* (7) ability to read English at \&gt; 6th-grade level (see definition above)
* have no NRT contraindications
* (8) ≥ weekly internet access
* (9) willing and able to participate in SGM-serving volunteer activities.

Aim 3 (Pilot RCT) exclusion criteria: Individuals will be excluded if currently using other smoking cessation treatments.

Sexual minority identity will be indicated by selecting any non-heterosexual response option(s) from: Heterosexual (Straight); Gay or Lesbian; Bisexual; Something else (please state)." Participants will indicate the sex assigned on their birth certificate (i.e., natal sex). Gender minority identity will be indicated by "Trans male/Trans man;" "Trans female/Trans woman;" "Gender queer/Gender non-conforming;" "Different identity (please state)" or a binary identity (male or female) non-concordant with natal sex. Current cigarette smoking will be indicated by ≥100 lifetime cigarettes and currently smoking cigarettes "every day" or "some days". High SGM stigma states are defined as the 22 states wherein ˂60% of the population 'thinks that homosexuality should be accepted'.21 High SGM stigma municipalities are defined as one of the 246 U.S. municipalities (out of the 496 scored from all U.S. states) that scored below the median (71) on the HRC Municipal Equality Index. Willingness to quit smoking will be assessed with a single item: "Are you willing to quit smoking cigarettes within 30 days after enrolling in this study? (yes/no)". To be classified as 'ready to quit smoking,' participants will report readiness to quit in the next 30 days and at least 1 past-year quit attempt (i.e., in the "Preparation" stage of change).

An equal number of female and male participants (i.e., natal sex) will be recruited so as to examine sex as a biological factor. Recruitment targets will aim to reflect the racial/ethnic composition of the populations from which the samples are drawn.

Primary outcomes:
measure: Retention
timeFrame: 12 weeks
measure: Intervention feasibility
timeFrame: 12 weeks
measure: Intervention acceptability
timeFrame: 12 weeks
measure: Intervention appropriateness
timeFrame: 12 weeks
Secondary outcomes:
measure: Self-reported smoking abstinence assessed at Week 12
timeFrame: 12 weeks
measure: Self-efficacy asssessed at Week 12
timeFrame: 12 weeks
measure: Motivation to quit smoking assessed at Week 12
timeFrame: 12 weeks
measure: Smoking intensity assessed at Week 12
timeFrame: 12 weeks
measure: Cessation Treatment Engagement assessed at Week 12
timeFrame: 12 weeks
Other outcomes:
measure: Self-reported smoking abstinence assessed at Week 24
timeFrame: 24 weeks
measure: Smoking intensity assessed at Week 24
timeFrame: 24 weeks
measure: Motivation to quit smoking assessed at Week 24
timeFrame: 24 weeks
measure: Self-efficacy asssessed at Week 24
timeFrame: 24 weeks
Locations:
Study officials:
affiliation: Associate Professor
name: Julia M McQuoid, PhD
role: PRINCIPAL_INVESTIGATOR
References: