Trial Outcomes & Findings for Tobacco Cessation Tailored to Patients Living With HIV (PLWH) in Brazil (NCT NCT05560243)

Last Updated: 2024-12-11

Results Overview

7-day point prevalence abstinence (defined as no tobacco use in the past 7 days and verified through measurement of salivary cotinine and exhaled carbon monoxide (CO) levels) at 6-month follow-up.

Recruitment status

COMPLETED

Study phase

Target enrollment

56 participants

Primary outcome timeframe

6-month follow-up

Results posted on

2024-12-11

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Patients will receive a tobacco cessation intervention Tobacco cessation: Tobacco cessation program consisting of cognitive-therapy sessions and pharmacological management
Overall Study STARTED	56
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Patients will receive a tobacco cessation intervention Tobacco cessation: Tobacco cessation program consisting of cognitive-therapy sessions and pharmacological management
Overall Study 11 did not start the intervention, and 14 were lost to follow-up	25

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=45 Participants Patients will receive a tobacco cessation intervention Tobacco cessation: Tobacco cessation program consisting of cognitive-therapy sessions and pharmacological management
Age, Continuous	46 years STANDARD_DEVIATION 11.7 • n=45 Participants
Sex: Female, Male Female	17 Participants n=45 Participants
Sex: Female, Male Male	28 Participants n=45 Participants
Region of Enrollment Brazil	45 participants n=45 Participants
Educational attainment - completed at least high school	25 participants n=45 Participants
Number of cigarettes/day	18.4 cigarettes/day STANDARD_DEVIATION 11.4 • n=45 Participants
Fagerstrom Score - moderate to very high	28 participants n=45 Participants
Depressive symptomatology (CES-D)	25.8 units on a scale STANDARD_DEVIATION 15.8 • n=45 Participants
Social Support	4.5 units on a scale STANDARD_DEVIATION 1.6 • n=45 Participants

PRIMARY outcome

Timeframe: 6-month follow-up

7-day point prevalence abstinence (defined as no tobacco use in the past 7 days and verified through measurement of salivary cotinine and exhaled carbon monoxide (CO) levels) at 6-month follow-up.

Outcome measures

Outcome measures
Measure	Intervention n=45 Participants Tobacco cessation intervention - pharmacological management and cognitive behavioral therapy
Number of Participants With a 7-day Prevalence Abstinence of Tobacco Use	27 participants

SECONDARY outcome

Timeframe: 7 months

Tobacco use abstinence based on salivary cotinine was assessed at 7-month follow-up

Outcome measures

Outcome measures
Measure	Intervention n=45 Participants Tobacco cessation intervention - pharmacological management and cognitive behavioral therapy
Participants With Tobacco Use Abstinence Based on Salivary Cotinine at 7-month Follow-up.	18 participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Isabel Scarinci, Principal Investigator

University of Alabama at Birmingham

Phone: 2059757177

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place