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

NCT ID: NCT05560243

Last Updated: 2024-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-08-31

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.

Detailed Description

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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).

Conditions

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HIV Infections Tobacco Use Cessation

Keywords

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HIV, tobacco cessation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Feasibility of a tobacco cessation program tailored to patients living with HIV
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Patients will receive a tobacco cessation intervention

Group Type EXPERIMENTAL

Tobacco cessation

Intervention Type BEHAVIORAL

Tobacco cessation program consisting of cognitive-therapy sessions and pharmacological management

Interventions

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Tobacco cessation

Tobacco cessation program consisting of cognitive-therapy sessions and pharmacological management

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Estadual de Londrina

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Isabel Scarinci

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Isabel C Scarinci, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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Universidade Estadual de Londrina

Londrina, Paraná, Brazil

Site Status

Countries

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Brazil

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R21DA049557

Identifier Type: NIH

Identifier Source: org_study_id

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