DisinformationNCT07543081
Correcting Disinformation About Menthol Cigarettes and Flavored Cigars
A study testing Individual delivery of anti-disinformation messaging and Community delivery of anti-disinformation messaging in people with Disinformation and Menthol Cigarettes, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
Our study tests a multi-level anti- disinformation message (ADM) campaign on knowledge and beliefs about menthol cigarette and flavored cigar policies in Black adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disinformation, Menthol Cigarettes, Flavored Cigars
- What is being tested?
- Individual delivery of anti-disinformation messaging and Community delivery of anti-disinformation messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American or Black adults
- Aged 18+
- U.S citizen or U.S. Legal Permanent Resident
- 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
- Have access to a digital device, laptop, or desktop with internet access to complete online surveys and watch online videos
Who cannot join
- Do not identify as African American or Black
- Children aged 17 years and younger
- Adults who are not a U.S. Citizen or U.S. Legal Permanent Resident
- Do not reside in Atlanta, GA or Birmingham, AL
- Do not have access to a digital device, laptop, or desktop with internet access o Unwilling or unable to engage in online study activities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rutgers University
New Brunswick, New Jersey, 08901
Study Coordinator, 732-331-0626, unvarnished@ints.rutgers.edu
Andrea C Villanti, PhD, MPH
About this study
Official title: 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 knowledge and beliefs about menthol cigarette and flavored cigar policies in Black adults.
Read the 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 (Intervention-I) or control condition. Participants in the Intervention-I condition 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 (Intervention-C), while Birmingham serves as the control community. Community partners in Atlanta, our Intervention Community, 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.
- Conditions
- Disinformation, Menthol Cigarettes, Flavored Cigars
- Being tested
- Individual delivery of anti-disinformation messaging, Community delivery of anti-disinformation messaging
- Medical subject headings
- Disinformation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual delivery of anti-disinformation messagingBehavioural
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.
Community delivery of anti-disinformation messagingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Individual-level intervention + Community-level intervention | Experimental | Not described Receives: Behavioral: Individual delivery of anti-disinformation messaging; Behavioral: Community delivery of anti-disinformation messaging |
| Individual-level control + Community-level intervention | Experimental | Not described Receives: Behavioral: Community delivery of anti-disinformation messaging |
| Individual-level intervention + Community-level control | Experimental | Not described Receives: Behavioral: Individual delivery of anti-disinformation messaging |
| Individual-level control + Community-level control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with specific tobacco industry beliefs
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.
Measured: 3, 6, 9, 12 months
Knowledge about menthol cigarettes and flavored cigars
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.
Measured: 3, 6, 9, 12 months
Knowledge of flavored tobacco policies
Items address the public health purpose and limits of flavored tobacco policies.
Measured: 3, 6, 9, 12 months
Secondary outcomes (1)
Intention to support flavored tobacco policies
Items address plans to support local, state, and federal policies regarding flavored tobacco products.
Measured: 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DisinformationStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Andrea Villanti, PhD, MPH, Rutgers, The State University of New Jersey
- Investigators
- Andrea C Villanti, PhD, MPH, Principal investigator, Rutgers UniversityKymberle L Sterling, DrPH, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543081
- Sponsor's protocol ID
- Pro2023001258
- Other IDs
- R01MD018728
- Status last verified
- Oct 2026
- First submitted
- 15 Apr 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified survey responses from participants enrolled in the clinical trial.
Publications
Ganz O, Villanti AC, Altunbilek A, Johnson A, Garmon J, Wackowski OA, Sterling KL. Tobacco Company Efforts to Persuade Consumers to Fight the Proposed Federal Menthol Cigarette and Flavored Cigar Bans in the United States. Am J Public Health. 2025 Aug;115(8):1206-1210. doi: 10.2105/AJPH.2025.308116. No abstract available.
PubMed 40633013Wackowski OA, Garmon J, Altunbilek A, Johnson A, Ganz O, Ntansah CA, Fryer CS, Villanti AC, Sterling KL. News coverage of the proposed menthol cigarette ban in the United States (2022-2024): a content analysis. Nicotine Tob Res. 2026 Jul 22;28(8):1449-1454. doi: 10.1093/ntr/ntag036.
PubMed 41705314Garmon J, Sterling K, Wackowski OA, Ganz O, Allem JP, Villanti AC. Funding without transparency? Tobacco company support of Black-owned businesses in the USA. Tob Control. 2024 Nov 19:tc-2024-058721. doi: 10.1136/tc-2024-058721. Online ahead of print. No abstract available.
PubMed 39561998Sterling KL, Ganz O, Wackowski OA, Glasser AM, Villanti AC. Widespread Misperceptions Among U.S. Adults About Tobacco Company Engagement in Black and African American Communities. Nicotine Tob Res. 2025 Mar 24;27(4):741-747. doi: 10.1093/ntr/ntae066.
PubMed 38692654
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Unvarnished Truth: Pursuing Health Equity by Correcting Disinformation Targeting African Americans About the FDA's Proposed Ban on Menthol Cigarettes and Flavored Cigars
- ClinicalTrials.gov ID
- NCT07543081
- Acronym / sponsor ID
- Pro2023001258
- Conditions
- Disinformation, Menthol Cigarettes, Flavored Cigars
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our study tests a multi-level anti- disinformation message (ADM) campaign on knowledge and beliefs about menthol cigarette and flavored cigar policies in Black adults.
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 (Intervention-I) or control condition. Participants in the Intervention-I condition 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 (Intervention-C), while Birmingham serves as the control community. Community partners in Atlanta, our Intervention Community, 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Individual-level intervention + Community-level intervention | Experimental | Behavioral: Individual delivery of anti-disinformation messaging, Behavioral: Community delivery of anti-disinformation messaging |
| Individual-level control + Community-level intervention | Experimental | Behavioral: Community delivery of anti-disinformation messaging |
| Individual-level intervention + Community-level control | Experimental | Behavioral: Individual delivery of anti-disinformation messaging |
| Individual-level control + Community-level control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- African American or Black adults
- Aged 18+
- U.S citizen or U.S. Legal Permanent Resident
- Reside in Atlanta, GA or Birmingham, AL
- Able to read and speak English
Key exclusion criteria (5 listed)
- Do not identify as African American or Black
- Children aged 17 years and younger
- Adults who are not a U.S. Citizen or U.S. Legal Permanent Resident
- Do not reside in Atlanta, GA or Birmingham, AL
- Do not have access to a digital device, laptop, or desktop with internet access o Unwilling or unable to engage in online study activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual delivery of anti-disinformation messagingParticipants 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. | Behavioural | Individual-level intervention + Community-level control, Individual-level intervention + Community-level intervention |
| Community delivery of anti-disinformation messagingOur 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. | Behavioural | Individual-level control + Community-level intervention, Individual-level intervention + Community-level intervention |
Primary outcome
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.
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.
Knowledge of flavored tobacco policies
Time frame: 3, 6, 9, 12 months
Items address the public health purpose and limits of flavored tobacco policies.
1 secondary outcome
Intention to support flavored tobacco policies
Time frame: 3, 6, 9, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Background: PubMed 40633013Ganz O, Villanti AC, Altunbilek A, Johnson A, Garmon J, Wackowski OA, Sterling KL. Tobacco Company Efforts to Persuade Consumers to Fight the Proposed Federal Menthol Cigarette and Flavored Cigar Bans in the United States. Am J Public Health. 2025 Aug;115(8):1206-1210. doi: 10.2105/AJPH.2025.308116. No abstract available.
- Background: PubMed 41705314Wackowski OA, Garmon J, Altunbilek A, Johnson A, Ganz O, Ntansah CA, Fryer CS, Villanti AC, Sterling KL. News coverage of the proposed menthol cigarette ban in the United States (2022-2024): a content analysis. Nicotine Tob Res. 2026 Jul 22;28(8):1449-1454. doi: 10.1093/ntr/ntag036.
- Background: PubMed 39561998Garmon J, Sterling K, Wackowski OA, Ganz O, Allem JP, Villanti AC. Funding without transparency? Tobacco company support of Black-owned businesses in the USA. Tob Control. 2024 Nov 19:tc-2024-058721. doi: 10.1136/tc-2024-058721. Online ahead of print. No abstract available.
- Background: PubMed 38692654Sterling KL, Ganz O, Wackowski OA, Glasser AM, Villanti AC. Widespread Misperceptions Among U.S. Adults About Tobacco Company Engagement in Black and African American Communities. Nicotine Tob Res. 2025 Mar 24;27(4):741-747. doi: 10.1093/ntr/ntae066.
- The Disinformation Project WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified survey responses from participants enrolled in the clinical trial.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea C Villanti, PhD, MPH principal investigator
Rutgers University
Kymberle L Sterling, DrPH principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual delivery of anti-disinformation messaging and Community delivery of anti-disinformation messaging in people with Disinformation and Menthol Cigarettes, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (732-331-0626, unvarnished@ints.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with specific tobacco industry beliefs (time frame: 3, 6, 9, 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07543081, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.