Smoking CessationNCT07099287
Advancing Smoking Cessation Among Transgender
A study testing TRANSform your health in people with Smoking Cessation, run by University of Rochester at 1 site in Argentina.
Trial summary
In partnership with a Community Advisory Board, the investigators developed TRANSformá tu salud (Spanish for TRANSform your health), a culturally adapted smoking cessation intervention for transgender and gender diverse individuals living in Argentina. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- TRANSform your health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteArgentina
- Study dates
- 23 Sep 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Eligible individuals self-identified as transgender and gender diverse individuals, were 18 years old or older, smoked at least three days per week, were interested in quitting smoking within the next 30 days, had an active cellphone with WhatsApp®, and were willing to complete two study visits.
Who cannot join
- Use of other tobacco products (including e-cigarettes), pregnancy or breast-feeding, plans to move from their current residence in the next six months, and shared residence with a current study participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TRANSformá tu Salud Dejando de Fumar: Advancing Smoking Cessation Among Transgender
In partnership with a Community Advisory Board, the investigators developed TRANSformá tu salud (Spanish for TRANSform your health), a culturally adapted smoking cessation intervention for transgender and gender diverse individuals living in Argentina. This was a single-arm pilot study with 40 TGD individuals who smoke and received TRANSformá tu salud. The investigators assessed the feasibility, acceptability, and preliminary impact of TRANSformá tu salud.
Read the detailed description
In partnership with a Community Advisory Board, the investigators developed TRANSformá tu salud (Spanish for TRANSform your health), a culturally adapted smoking cessation intervention for transgender and gender diverse individuals living in Argentina. This was a single-arm pilot study with 40 TGD individuals who smoke and received TRANSformá tu salud. The investigators assessed the feasibility, acceptability, and preliminary impact of TRANSformá tu salud.
- Conditions
- Smoking Cessation
- Being tested
- TRANSform your health
- Keywords
- Smoking Cessation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRANSform your healthBehavioural
A culturally adapted smoking cessation intervention for transgender and gender diverse individuals living in Argentina
| Study group | Role | What they receive |
|---|---|---|
| TRANSform your health | Experimental | A culturally adapted smoking cessation intervention for transgender and gender diverse individuals living in Argentina Receives: Behavioral: TRANSform your health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Reporting 7-Day Point Prevalence Smoking Abstinence at Month 3
Seven-day point prevalence smoking abstinence is defined as no cigarette smoking, not even a puff, during the 7 days prior to the Month 3 assessment. Abstinence will be assessed as a binary outcome (yes or no), and the result will be reported as the percentage of participants who meet this criterion at Month 3.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start23 Sep 2024
- Primary completion5 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Fundación Huésped
- Responsible party
- Principal investigator, Francisco Cartujano, MD, University of Rochester
- Investigators
- Francisco Cartujano, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099287
- Sponsor's protocol ID
- FH-077
- Other IDs
- R21CA284313
- Status last verified
- Jul 2025
- First submitted
- 25 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRANSformá tu Salud Dejando de Fumar: Advancing Smoking Cessation Among Transgender
- ClinicalTrials.gov ID
- NCT07099287
- Acronym / sponsor ID
- FH-077
- Conditions
- Smoking Cessation
- Keywords
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Fundación Huésped
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 1 Aug 2025 (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.
In partnership with a Community Advisory Board, the investigators developed TRANSformá tu salud (Spanish for TRANSform your health), a culturally adapted smoking cessation intervention for transgender and gender diverse individuals living in Argentina. This was a single-arm pilot study with 40 TGD individuals who smoke and received TRANSformá tu salud. The investigators assessed the feasibility, acceptability, and preliminary impact of TRANSformá tu salud.
Detailed description
In partnership with a Community Advisory Board, the investigators developed TRANSformá tu salud (Spanish for TRANSform your health), a culturally adapted smoking cessation intervention for transgender and gender diverse individuals living in Argentina. This was a single-arm pilot study with 40 TGD individuals who smoke and received TRANSformá tu salud. The investigators assessed the feasibility, acceptability, and preliminary impact of TRANSformá tu salud.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRANSform your health | Experimental | Behavioral: TRANSform your healthA culturally adapted smoking cessation intervention for transgender and gender diverse individuals living in Argentina |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible individuals self-identified as transgender and gender diverse individuals, were 18 years old or older, smoked at least three days per week, were interested in quitting smoking within the next 30 days, had an active cellphone with WhatsApp®, and were willing to complete two study visits.
Key exclusion criteria (1 listed)
- Use of other tobacco products (including e-cigarettes), pregnancy or breast-feeding, plans to move from their current residence in the next six months, and shared residence with a current study participant
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 |
|---|---|---|
| TRANSform your healthA culturally adapted smoking cessation intervention for transgender and gender diverse individuals living in Argentina | Behavioural | TRANSform your health |
Primary outcome
Percentage of Participants Reporting 7-Day Point Prevalence Smoking Abstinence at Month 3
Time frame: Month 3
Seven-day point prevalence smoking abstinence is defined as no cigarette smoking, not even a puff, during the 7 days prior to the Month 3 assessment. Abstinence will be assessed as a binary outcome (yes or no), and the result will be reported as the percentage of participants who meet this criterion at Month 3.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Smoking Cessation
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Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
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Using Smartwatches to Monitor Smoking in Real-life Situations
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Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
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Smoking Cessation
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. This study is not recruiting at the moment.
Francisco Cartujano, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRANSform your health in people with Smoking Cessation, run by University of Rochester at 1 site in Argentina.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Aug 2025. 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 Argentina. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Reporting 7-Day Point Prevalence Smoking Abstinence at Month 3 (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2025.