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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05029362
Other study ID # HSC-SPH-20-0318 (aim 2)
Secondary ID 1K22CA237639
Status Completed
Phase N/A
First received
Last updated
Start date January 5, 2022
Est. completion date October 5, 2022

Study information

Verified date April 2024
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to pretest the design of a text-based smoking cessation program tailored to sexual minority individuals.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date October 5, 2022
Est. primary completion date October 5, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Smoke five or more cigarettes per day, has smoked at least 100 cigarettes in their lifetime and smokes everyday - Have an interest in quitting smoking in the next 15 days - Have a cellphone number with an unlimited short messaging service (SMS) plan - Have US mailing and email addresses - Positive cotinine saliva test results Exclusion Criteria: - Individuals who are found to have a prepaid cell phone - Individuals who are found to have a cellphone number that does not work or is registered to someone else - Pregnant or breastfeeding women - Contraindication for nicotine patch - Regular use of tobacco products other than cigarettes - Current use of tobacco cessation medications - Enrolled in another smoking cessation study - Non-English speakers - Having inadequate equipment/device (webcam, speakers, mic) for participating in telehealth sessions

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
SmokefreeSGM
Participants will have access to a text-based smoking cessation program tailored to sexual minority individuals (SmokefreeSGM). The text-based program will be beta-tested by these participants for a period of 2 weeks before and 10 weeks after their quit date. Messages originated from the text-based smoking cessation program will be sent by a fictitious quit coach who will offer evidence-based advice on quitting smoking based on real-life experiences of sexual minority individuals.

Locations

Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perceived Usability as Assessed by the System Usability Scale (SUS) The 10-item System Usability Scale (SUS) was used to assess the usability of the SmokefreeSGM text messaging program. Total score ranges from 0 to 100, with a higher score indicating greater acceptability and a score above 75 indicating that the program is perceived as acceptable. 1 month after quit date
Secondary Engagement as Assessed by the Number of Text Messages Sent and Received by Study Participants After Enrollment. A participant's engagement rate was determined by dividing the total number of participant responses to the bidirectional text messages (numerator) by the total number of bidirectional text messages sent by the text-based platform (denominator). Participants who had rates =33.3% were classified as having low engagement, 33.3-66.6% moderate engagement, and =66.7% high engagement. Data are reported categorically as number of participants who have low, moderate, or high engagement. 1 month after enrollment
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