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Completed

NCT Number: NCT05560243

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

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.

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Key information

Conditions

HIV Infections Behavior Blood-Borne Infections Communicable Diseases Genital Diseases Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tobacco Use Cessation Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Estadual de Londrina

Londrina, Paraná, 86057, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tobacco cessation

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Universidade Estadual de Londrina

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 29, 2022
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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