EQQUAL-NM for the Promotion of Smoking Cessation in Sexual and Gender Minority Young Adults in New Mexico

Culturally-Tailored, Avatar-Led MHealth Intervention to Aid Smoking Cessation Among Sexual and Gender Minority Young Adults in New Mexico

This clinical trial assesses the acceptability and efficacy of Empowered, Queer, Quitting, and Living--New Mexico (EQQUAL-NM), a smoking cessation intervention for sexual and gender minority young adults in New Mexico. Smoking prevalence among sexual and gender minority (SGM) adults in New Mexico is more than twice as high as non-SGM adults. Helping young adult tobacco users to quit is critical, yet there have been few efforts to develop tailored treatments specifically for this population. EQQUAL-NM is a digital smoking cessation intervention designed specifically for SGM young adult smokers in New Mexico and may help them quit smoking.

Study Overview

• Status: Withdrawn
• Conditions: Cigarette Smoking-Related Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Behavioral: Smartphone App-delivered Smoking Cessation Intervention; Behavioral: Smartphone App-delivered Smoking Cessation Intervention; Other: Health Promotion and Education; Other: Health Promotion and Education; Other: Biospecimen Collection

Detailed Description

OUTLINE:

Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive access to a self-guided, smartphone app-delivered quit smoking program, called EQQUAL-NM (Program A) that helps explore personal values and teaches participants about smoking triggers and skills to help them manage cravings and accept thoughts and feelings related to smoking. Participants receive text message reminders and prompts on study. Some participants also undergo collection of a saliva sample during follow-up.

GROUP II: Participants receive access to a self-guided, smartphone app-delivered quit smoking program, called EQQUAL-NM (Program B) that is based on current clinical practice guidelines for tobacco cessation to help them quit smoking. This program helps with quit advice, tracking progress on quitting smoking, and managing cravings. Participants receive text message reminders and prompts on study. Some participants also undergo collection of a saliva sample during follow-up.

After completion of study intervention, patients are followed up at 3 months.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Self-identify being between 18 and 30 years of age
• Self-identify as a sexual and/or gender minority (i.e., a sexual orientation other than straight and/or gender that doesn't match sex assigned at birth)
• Currently reside in New Mexico, with a New Mexico mailing address, and anticipate remaining in New Mexico for the duration of the study (3 months)
• Self-report smoking at least 1 cigarette per week in the 30 days prior to screening
• Own an Android phone or iPhone
• Have at least weekly internet access for the next three months
• Willing and able to stream audio and video for this study
• Current use of a personal email account
• Current use of text messaging
• Interested in participating in the study for themselves (versus [vs] someone else)
• Self-report that they have not participated in one of Fred Hutch's/NMSU's prior smoking cessation studies
• Understand and agree to the conditions of compensation
• Currently not incarcerated
• Participants must be willing to use the assigned intervention program, complete the study assessments, and agree to the online consent form in English

Exclusion Criteria:

• Current use of other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (but initiating these treatments during the study is allowed)
• Member of the same household as another research participant
• Previous use of the National Cancer Institute (NCI) QuitGuide app
• Google voice number as sole phone number
• Does not pass study fraud prevention protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (EQQUAL-NM, Program A); Participants receive self-guided smartphone app-delivered EQQUAL-NM (Program A) intervention on study. Participants also receive motivational messages, reminders and smoking cessation information via text messages. Some participants also complete at-home saliva sample collection during follow-up.	Other: Questionnaire Administration; Ancillary studies; Behavioral: Smartphone App-delivered Smoking Cessation Intervention; Receive access to EQQUAL-NM (Program A) intervention; Other Names: Smoking and Tobacco Use Cessation Intervention; Behavioral: Smartphone App-delivered Smoking Cessation Intervention; Receive access to EQQUAL-NM (Program B) intervention; Other Names: Smoking and Tobacco Use Cessation Intervention; Other: Health Promotion and Education; Receive text message reminders, motivational messages and prompts via SMS text messages (Program A); Other Names: Text Message-Based Intervention; Other: Health Promotion and Education; Receive text message reminders, motivational messages and prompts via SMS text messages (Program B); Other Names: Text Message-Based Intervention; Other: Biospecimen Collection; Complete at-home saliva sample collection; Other Names: Saliva Sample Collection
Active Comparator: Arm II (EQQUAL-NM, Program B); Participants receive self-guided smartphone app-delivered EQQUAL-NM (Program B) intervention on study. Participants also receive motivational messages, reminders and smoking cessation information via text messages. Some participants also complete at-home saliva sample collection during follow-up.	Other: Questionnaire Administration; Ancillary studies; Behavioral: Smartphone App-delivered Smoking Cessation Intervention; Receive access to EQQUAL-NM (Program A) intervention; Other Names: Smoking and Tobacco Use Cessation Intervention; Behavioral: Smartphone App-delivered Smoking Cessation Intervention; Receive access to EQQUAL-NM (Program B) intervention; Other Names: Smoking and Tobacco Use Cessation Intervention; Other: Health Promotion and Education; Receive text message reminders, motivational messages and prompts via SMS text messages (Program A); Other Names: Text Message-Based Intervention; Other: Health Promotion and Education; Receive text message reminders, motivational messages and prompts via SMS text messages (Program B); Other Names: Text Message-Based Intervention; Other: Biospecimen Collection; Complete at-home saliva sample collection; Other Names: Saliva Sample Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant satisfaction	Self-report of satisfaction overall and with specific program components will be rated on a 5-point Likert-type scale. Higher scale scores indicate higher satisfaction with the app.	At 3-month follow-up
Number of logins to the assigned application	Server-recorded number of app openings over 3 months	Up to 3-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported 7-day point prevalence abstinence (PPA) from all nicotine and tobacco products	Self-report of no nicotine/tobacco product use over the previous 7 days, with the exception of FDA-approved medications	At 3 months
Biochemically confirmed 7-day point prevalence abstinence (PPA) from all nicotine/tobacco products	Self-report of no nicotine/tobacco product use over the previous 7 days, with the exception of FDA-approved medications, biochemically confirmed via saliva cotinine	At 3 months
Self-reported 30-day PPA from all nicotine/tobacco products	Self-report of no nicotine/tobacco product use over the previous 30 days, with the exception of FDA-approved medications	At 3 months
Biochemically confirmed 30-day PPA from all nicotine/tobacco products	Self-report of no nicotine/tobacco product use over the previous 30 days, with the exception of FDA-approved medications, biochemically confirmed via saliva cotinine	At 3 months
Self-reported 7-day PPA from cigarette smoking	Self-report of no cigarette smoking over the previous 7 days	At 3 months
Self-reported 30-day PPA from cigarette smoking	Self-report of no cigarette smoking over the previous 30 days	At 3 months
Change in Contemplation Ladder scores	Contemplation Ladder scores will be used to assess readiness to quit using cigarettes. Ladder scores are on a 0 to 10 scale, with higher change scores meaning greater increases readiness to quit.	At baseline and at 3-month follow-up
Change in acceptance of tobacco-use triggers	Change in acceptance of tobacco-use triggers will be measured using the Avoidance and Inflexibility Scale. Higher change scores indicate greater improvement in acceptance of tobacco use triggers.	At baseline and at 3-month follow-up
Change in values-guided action	Change in values-guided action measured using the Values Questionnaire. Higher change scores indicate greater improvement in values-guided action.	At baseline and at 3-month follow-up

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI); New Mexico State University; National Cancer Institute Center to Reduce Cancer Health Disparities
• Investigators: Principal Investigator: Jaimee Heffner, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Estimated): October 8, 2025
• Last Update Submitted That Met QC Criteria: October 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Manufactured Materials; Technology, Industry, and Agriculture; Health Education; Educational Status; Health Promotion; Smoking Devices
• Other Study ID Numbers: RG1124189 (Fred Hutch/University of Washington Cancer Consortium); NCI-2024-02453 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); U54CA132381 (U.S. NIH Grant/Contract); FHIRB0020404 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No