NCT06386432

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 26, 2024

Completed
1.6 years until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

October 8, 2025

Status Verified

April 1, 2025

Enrollment Period

4 months

First QC Date

April 23, 2024

Last Update Submit

October 3, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • Self-reported 7-day point prevalence abstinence (PPA) from all nicotine and tobacco products

    At 3 months

  • Biochemically confirmed 7-day point prevalence abstinence (PPA) from all nicotine/tobacco products

    At 3 months

  • Self-reported 30-day PPA from all nicotine/tobacco products

    At 3 months

  • Biochemically confirmed 30-day PPA from all nicotine/tobacco products

    At 3 months

  • Self-reported 7-day PPA from cigarette smoking

    At 3 months

  • +4 more secondary outcomes

Study Arms (2)

Arm I (EQQUAL-NM, Program A)

EXPERIMENTAL

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.

Behavioral: Smartphone App-delivered Smoking Cessation InterventionOther: Health Promotion and EducationOther: Biospecimen CollectionOther: Questionnaire Administration

Arm II (EQQUAL-NM, Program B)

ACTIVE COMPARATOR

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.

Behavioral: Smartphone App-delivered Smoking Cessation InterventionOther: Health Promotion and EducationOther: Biospecimen CollectionOther: Questionnaire Administration

Interventions

Receive access to EQQUAL-NM (Program A) intervention

Also known as: Smoking and Tobacco Use Cessation Intervention
Arm I (EQQUAL-NM, Program A)

Receive text message reminders, motivational messages and prompts via SMS text messages (Program A)

Also known as: Text Message-Based Intervention
Arm I (EQQUAL-NM, Program A)

Complete at-home saliva sample collection

Also known as: Saliva Sample Collection
Arm I (EQQUAL-NM, Program A)Arm II (EQQUAL-NM, Program B)

Ancillary studies

Arm I (EQQUAL-NM, Program A)Arm II (EQQUAL-NM, Program B)

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Smoking DevicesHealth PromotionEducational Status

Intervention Hierarchy (Ancestors)

Manufactured MaterialsTechnology, Industry, and AgricultureHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Jaimee Heffner

    Fred Hutch/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Any outcome evaluator who has contact with participants will remain blinded to treatment group assignment until the final set of questions regarding acceptability of specific program components is asked.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2024

First Posted

April 26, 2024

Study Start

December 1, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

October 8, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations