Correcting Disinformation About Menthol Cigarettes and Flavored Cigars

April 29, 2026 updated by: Andrea Villanti, PhD, MPH, Rutgers, The State University of New Jersey

The Unvarnished Truth: Pursuing Health Equity by Correcting Disinformation Targeting African Americans About the FDA's Proposed Ban on Menthol Cigarettes and Flavored Cigars

Our study tests a multi-level anti- disinformation message (ADM) campaign on menthol cigarette and flavored cigar policies in Black adults.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study uses a prospective, randomized factorial trial design to evaluate delivery of anti-disinformation messaging (ADM) on Black adults' receptivity to flavored tobacco policies, beliefs about the tobacco industry, and beliefs about menthol cigarettes and flavored cigars. Eligible, consenting participants will complete the baseline survey, providing sociodemographic information and baseline measures of study outcomes. Participants will then be randomized, stratified by study site (Atlanta, GA or Birmingham, AL), in a 1:1 ratio within the survey platform to either the individually-delivered ADM intervention or control condition. Participants in the intervention condition (Intervention-I) will receive their first exposure to the ADM intervention at the end of baseline survey. At follow-up assessments (3-months, 6-months, 9-months, 12-months), all participants will complete study measures and at 3-, 6-, and 9-month follow-up assessments, Intervention-I participants will be exposed to the ADM intervention at the end of the survey. Six months after our first enrollment in the trial, Atlanta will receive the community-delivered ADM intervention, while Birmingham serves as the control community. Community partners in Atlanta, our Intervention Community (Intervention-C), will disseminate our ADM intervention messages through their community networks for 12 months, overlapping at least six months with the delivery of the individual-level intervention (Intervention-I) in our enrolled participants. Upon completion of the final assessment (12-month follow-up), all participants will be exposed to the ADM intervention within the survey platform and asked to complete measures on perceived message effectiveness and credibility of the study messages.

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers University
        • Contact:
        • Principal Investigator:
          • Andrea C Villanti, PhD, MPH
        • Principal Investigator:
          • Kymberle L Sterling, DrPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • African American or Black adults
  • Aged 18+
  • Reside in Atlanta, GA or Birmingham, AL
  • Able to read and speak English
  • Willing to engage in all online study activities including online quarterly surveys over a 12-month period.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individual-level intervention + Community-level intervention
Behavioral: Individual delivery of anti-disinformation messaging
Participants in this condition will be exposed to anti-disinformation messages (ADM) designed to increase correct beliefs about menthol cigarettes, flavored cigars, the purpose, and limits of flavored tobacco policies. The delayed intervention control condition in this study will receive the ADM intervention after outcome measures are collected at the last assessment.
Behavioral: Community delivery of anti-disinformation messaging
Our community-level campaign will distribute our ADM messages to our Intervention Community via social media, print ads and posters, radio ads, and community events. These messages will be delivered over 1 year, with monthly delivery activities led by EAB members in the Intervention Community.
Experimental: Individual-level control + Community-level intervention
Behavioral: Community delivery of anti-disinformation messaging
Our community-level campaign will distribute our ADM messages to our Intervention Community via social media, print ads and posters, radio ads, and community events. These messages will be delivered over 1 year, with monthly delivery activities led by EAB members in the Intervention Community.
Experimental: Individual-level intervention + Community-level control
Behavioral: Individual delivery of anti-disinformation messaging
Participants in this condition will be exposed to anti-disinformation messages (ADM) designed to increase correct beliefs about menthol cigarettes, flavored cigars, the purpose, and limits of flavored tobacco policies. The delayed intervention control condition in this study will receive the ADM intervention after outcome measures are collected at the last assessment.
No Intervention: Individual-level control + Community-level control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge about menthol cigarettes and flavored cigars
Time Frame: 3, 6, 9, 12 months
Items address prevalence of menthol cigarette and flavored cigar use in Black and African Americans and role of menthol/flavors in tobacco initiation, progression, and cessation.
3, 6, 9, 12 months
Knowledge of flavored tobacco policies
Time Frame: 3, 6, 9, 12 months
Items address the public health purpose and limits of flavored tobacco policies.
3, 6, 9, 12 months
Proportion of participants with specific tobacco industry beliefs
Time Frame: 3, 6, 9, 12 months
Beliefs items address tobacco industry behaviors, including funding Black community organizations, paying Black lobbyists to oppose public health policies, and targeting Black and African American communities with menthol cigarette and flavored cigar marketing.
3, 6, 9, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intention to support flavored tobacco policies
Time Frame: 3, 6, 9, 12 months
Items address plans to support local, state, and federal policies regarding flavored tobacco products.
3, 6, 9, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Andrea C Villanti, PhD, MPH, Rutgers University
  • Principal Investigator: Kymberle L Sterling, DrPH, Rutgers University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

April 15, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2023001258
  • R01MD018728 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified survey responses from participants enrolled in the clinical trial.

IPD Sharing Time Frame

IPD and supporting information will be available approximately 12 months following the end of data collection or publication of the main study outcomes.

IPD Sharing Access Criteria

Study data will be deposited in the NAHDAP data repository hosted at the ICPSR and will be available to the research community in perpetuity. Datasets underlying methodological publications will be shared at or prior to initial publication date.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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