HIV Infections, Tobacco Use Cessation
Conditions
Keywords
HIV, tobacco cessation
Brief summary
The overall goal of this feasibility study is to make adaptations to these evidence-based approaches in collaboration with PLWH and health care providers working with this population, and develop, implement, and evaluate the feasibility and scalability of a theory-based, culturally relevant tobacco cessation intervention for PLWH receiving care through the public health system in a southern town in Brazil (Londrina). This proposal will focus on the intervention development, pretesting, and feasibility testing. The primary outcome will be a 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 levels) at 6-month follow-up. We will also conduct detailed treatment fidelity and scalability assessments (acceptability, feasibility, potential reach and adoption, alignment with the strategic context) to inform a full-scale efficacy trial.
Detailed description
This study aims at developing and examining feasibility and scalability of a theory-based, culturally relevant tobacco cessation intervention for PLWH receiving care through the public health system in a southern town in Brazil. It consists of three phases: formative assessments with patients and health care providers to inform relevant components of the intervention, pretesting of the intervention components, and pilot testing of the intervention (feasibility).
Interventions
BEHAVIORALTobacco cessation
Tobacco cessation program consisting of cognitive-therapy sessions and pharmacological management
Sponsors
Universidade Estadual de Londrina
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Feasibility of a tobacco cessation program tailored to patients living with HIV
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* PLWH (that is, patients with a confirmed HIV diagnosis) receiving care at the reference center in Londrina * 18 years of age and older; (c) smoke at least 5 cigarettes (industrialized or hand-rolled) per day Smoked within the past seven days. * No intent to move from the area served by reference center in Londrina within the next 12 months.
Exclusion criteria
* History of hypertension * History of angina * History of asthma * On medication for depression.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a 7-day Prevalence Abstinence of Tobacco Use | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Tobacco Use Abstinence Based on Salivary Cotinine at 7-month Follow-up. | 7 months | Tobacco use abstinence based on salivary cotinine was assessed at 7-month follow-up |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Patients will receive a tobacco cessation intervention
Tobacco cessation: Tobacco cessation program consisting of cognitive-therapy sessions and pharmacological management | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | 11 did not start the intervention, and 14 were lost to follow-up | 25 |
Baseline characteristics
| Characteristic | Intervention | — |
|---|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 11.7 | — |
| Depressive symptomatology (CES-D) | 25.8 units on a scale STANDARD_DEVIATION 15.8 | — |
| Educational attainment - completed at least high school | 25 participants | — |
| Fagerstrom Score - moderate to very high | 28 participants | — |
| Number of cigarettes/day | 18.4 cigarettes/day STANDARD_DEVIATION 11.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Brazil | 45 participants | — |
| Sex: Female, Male Female | 17 Participants | — |
| Sex: Female, Male Male | 28 Participants | — |
| Social Support | 4.5 units on a scale STANDARD_DEVIATION 1.6 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 45 |
| other Total, other adverse events | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
Primary
Number of Participants With a 7-day Prevalence Abstinence of Tobacco Use
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.
Time frame: 6-month follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Number of Participants With a 7-day Prevalence Abstinence of Tobacco Use | 27 participants |
Secondary
Participants With Tobacco Use Abstinence Based on Salivary Cotinine at 7-month Follow-up.
Tobacco use abstinence based on salivary cotinine was assessed at 7-month follow-up
Time frame: 7 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Participants With Tobacco Use Abstinence Based on Salivary Cotinine at 7-month Follow-up. | 18 participants |