Tobacco Cessation Tailored to Patients Living With HIV (PLWH) in Brazil

Study Overview
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Brief Summary
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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.

Official Title
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Development, Implementation, and Evaluation of a Tobacco Cessation Intervention Tailored to Patients Living With HIV (PLWH) in Brazil: A Feasibility Study

Conditions
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HIV Infections, Tobacco Use Cessation

Intervention / Treatment
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* Behavioral: Tobacco cessation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility of a tobacco cessation program tailored to patients living with HIV
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients will receive a tobacco cessation intervention | Behavioral: Tobacco cessation<br>* Tobacco cessation program consisting of cognitive-therapy sessions and pharmacological management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, tobacco cessation