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

NCT05560243 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2024-12-11

Study results available
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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.

Conditions

  • HIV Infections
  • Tobacco Use Cessation

Interventions

BEHAVIORAL

Tobacco cessation

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

Sponsors & Collaborators

  • Universidade Estadual de Londrina

    collaborator OTHER

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Isabel C Scarinci, PhD · University of Alabama at Birmingham

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2023-08-31
Completion
2023-08-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05560243 on ClinicalTrials.gov