Project RESIST: Increasing Resistance to Tobacco Marketing Among Young Adult Sexual Minority Women Using Inoculation Message Approaches (RESIST)

• ClinicalTrials.gov Identifier: NCT04812795
• Recruitment Status: Active, not recruiting
• First Posted: March 24, 2021
• Last Update Posted: June 30, 2022
• Sponsor: Abramson Cancer Center at Penn Medicine
• Collaborators: National Cancer Institute (NCI); Michigan State University; Harvard School of Public Health (HSPH); Stanford University; Dana-Farber Cancer Institute; Fenway Community Health
• Information provided by (Responsible Party): Andy Tan, Abramson Cancer Center at Penn Medicine

Study Description

Brief Summary:

Project RESIST is an R01 study funded by NCI focused on determining the effects of using culturally tailored inoculation approaches to increase resilience to tobacco marketing influences among young adult sexual minority women ages 18-30 and incorporates critical stakeholder inputs that support later adoption and implementation. The study team is utilizing formative research to design and pre-test anti-smoking messages and two national longitudinal online survey experiments.

Condition or disease	Intervention/treatment	Phase
Cigarette Smoking Behavior	Other: Culturally tailored anti-smoking messages; Other: Non-culturally tailored interventions	Not Applicable

Detailed Description:

This study will recruit 2000 young adult sexual minority women (SMW), ages 18-30 years, current smokers (n = 1000) and not current smokers (n=1000). The study team will randomly assign participants to a condition in which they will be exposed to either culturally tailored anti-smoking messages or non-tailored. Participants will receive these messages at baseline and 1, 2, and 3 weeks post baseline. They will be asked to complete a follow-up survey one month post baseline. Intentions to quit smoking as well as intention (among current smokers) and intention to purchase cigarettes (among current nonsmokers) will be measured at baseline and one-month post baseline.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2214 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants will be randomly assigned to the tailored or non-tailored arms using random assignment function within survey software.
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Project RESIST: Increasing Resistance to Tobacco Marketing Among Young Adult Sexual Minority Women Using Inoculation Message Approaches
• Actual Study Start Date: September 8, 2021
• Actual Primary Completion Date: May 20, 2022
• Estimated Study Completion Date: December 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Culturally tailored; The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult SMW. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3.	Other: Culturally tailored anti-smoking messages; Anti-smoking messages that are culturally tailored for sexual minority women.
Active Comparator: Non-culturally tailored; The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3.	Other: Non-culturally tailored interventions; Anti-smoking messages that are not culturally tailored for sexual minority women.

Outcome Measures

Primary Outcome Measures :

1. Change in intention to quit smoking [ Time Frame: Days 0, 30 ]
   Change in intention to quit smoking will be measured using the Burkhalter intention to quit smoking four item scale that measures readiness to cut down or quit smoking in the next 30 days. This will only be measured among current smokers. Lowest mean score is 1 and highest mean score is 7. Higher scores indicate increased intention to quit smoking.
2. Change in intention to purchase cigarettes [ Time Frame: Days 0, 30 ]
   Change in intention to purchase cigarettes will be measured using the Juster single item consumer buying intention scale to measure how likely participants who are not current smokers are to purchase cigarettes. Response options range from 0 to 10 with 10 indicating a higher likelihood of purchasing cigarettes.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 30 Years (Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Anyone who identifies as a woman, whether they are cisgender or transgender, would meet the gender-based eligibility requirement.
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Ages 18-30
• Woman
• Identifies as a sexual minority (any sexual orientation other than heterosexual)
• Lives in the United States
• Able to take surveys in English

Exclusion Criteria:

• Under 18 or older than 30
• Men
• Heterosexual
• Lives outside the United States
• Unable to take survey in English

Contacts and Locations

Locations

United States, California

Stanford University

Stanford, California, United States, 94305

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Abramson Cancer Center at Penn Medicine

National Cancer Institute (NCI)

Michigan State University

Harvard School of Public Health (HSPH)

Stanford University

Dana-Farber Cancer Institute

Fenway Community Health

More Information

• Responsible Party: Andy Tan, Associate Professor, Abramson Cancer Center at Penn Medicine
• ClinicalTrials.gov Identifier: NCT04812795
• Other Study ID Numbers: 843579; R01CA237670 ( U.S. NIH Grant/Contract )
• First Posted: March 24, 2021
• Last Update Posted: June 30, 2022
• Last Verified: June 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No