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

December 9, 2024 updated by: Isabel Scarinci, University of Alabama at Birmingham

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Paraná
      • Londrina, Paraná, Brazil, 86057
        • Universidade Estadual de Londrina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With a 7-day Prevalence Abstinence of Tobacco Use
Time Frame: 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.
6-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants With Tobacco Use Abstinence Based on Salivary Cotinine at 7-month Follow-up.
Time Frame: 7 months
Tobacco use abstinence based on salivary cotinine was assessed at 7-month follow-up
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Universidade Estadual de Londrina

Investigators

  • Principal Investigator: Isabel C Scarinci, PhD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

September 26, 2022

First Submitted That Met QC Criteria

September 26, 2022

First Posted (Actual)

September 29, 2022

Study Record Updates

Last Update Posted (Estimated)

December 11, 2024

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21DA049557 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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