NCT07099287

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2025

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

July 25, 2025

Last Update Submit

July 31, 2025

Conditions

Keywords

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • 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.

    Month 3

Study Arms (1)

TRANSform your health

EXPERIMENTAL

A culturally adapted smoking cessation intervention for transgender and gender diverse individuals living in Argentina

Behavioral: TRANSform your health

Interventions

A culturally adapted smoking cessation intervention for transgender and gender diverse individuals living in Argentina

TRANSform your health

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsTransgender and gender diverse individuals
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación Huésped

Buenos Aires, Argentina

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Francisco Cartujano, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor - Department of Public Health Sciences (SMD)

Study Record Dates

First Submitted

July 25, 2025

First Posted

August 1, 2025

Study Start

September 23, 2024

Primary Completion

February 5, 2025

Study Completion

February 28, 2025

Last Updated

August 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations