Clinical trial NCT06820034: Empowering Cessation ACS South Region
Official title: Empowering Smoking Cessation for Sexual And/or Gender Minoritized (SGM) People in Oklahoma and the American Cancer Society (ACS) South Region
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Smoking Cessation
Keywords: smoking cessation
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sexual and/or gender minority (SGM) people face a disproportionate burden of cancer risk, and tobacco use is a key modifiable risk factor. SGM tobacco-related disparities are especially pronounced in places with high levels of stigma against SGM people. This community-engaged and remotely-delivered Research Scholar Grant project will evaluate an empowerment-based smoking cessation intervention tailored for SGM people in high-stigma places. In partnership with Freedom Oklahoma (OK) and a Community Advisory Board from Arkansas (AR) and Texas (TX) this projects aims to: (1) Adapt SGM-serving volunteer activities from the Oklahoma intervention pilot study for delivery in nearby states; (2) Test intervention efficacy among SGM adults in OK, AR, and TX; (3) Identify treatment mechanisms.


Eligibility criteria: Exclusion criteria:

* Currently using other smoking cessation treatments.
* Unable or unwilling to use Nicotine Replacement Therapy (NRT)
* Serious psychological distress (i.e., score of 13 ≥ 18 on the Kessler Psychological Distress (PD) Scale-6 19)

Inclusion criteria will be:

1. ≥ 18 years old
2. sexual and/or gender minority-identified (SGM) (see definition below)
3. living in Oklahoma, Texas, or Arkansas (verified by address)
4. a current cigarette smoker (see definition)
5. willing to quit smoking within 30 days of enrollment (see definition)
6. ability to read and speak English 'well' or 'very well'
7. ≥ weekly internet access
8. willing and able to participate in SGM-serving volunteer activities.
9. own a smartphone

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'. 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).

Primary outcomes:
measure: Biochemically-verified 7-day Point Prevalence Abstinence (PPA) at 26 weeks
timeFrame: 26 weeks post-quit-date
Secondary outcomes:
measure: Social Support
timeFrame: Week 0; Week 12
measure: Smoking intensity
timeFrame: Week 0, Week 12, Week 26
measure: Adaptive coping with minority stress
timeFrame: Week 0; Week 12
measure: Self-efficacy
timeFrame: Week 0, Week 12, Week 26
measure: Motivation to quit smoking
timeFrame: Week 0, Week 12, Week 26
measure: Internalized transphobia
timeFrame: Week 0; Week 12
measure: Prosociality
timeFrame: Week 0; Week 12
measure: Nicotine Replacement Therapy (NRT) Adherence
timeFrame: Weeks 1, 3, 5, 7, 9, 11
measure: Smoking cessation app engagement
timeFrame: Weeks 3, 5, 7, 9, 11
measure: Intervention satisfaction
timeFrame: Weeks 3, 5, 7, 9, 12
measure: Sexual Orientation Identity Pride
timeFrame: Week 0, Week 12
measure: Gender identity and expression pride
timeFrame: Week 0, Week 12
Other outcomes:
Locations:
Study officials:
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