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

Not Applicable

Completed

• Conditions: HIV Infections; Tobacco Use Cessation

• Registration Number: NCT05560243
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

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 Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-29
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Results First Submitted: 2024-09-04
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Results First Posted: 2024-12-11
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants With a 7-day Prevalence Abstinence of Tobacco Use	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 Outcome Measures

Name	Time	Method
Participants With Tobacco Use Abstinence Based on Salivary Cotinine at 7-month Follow-up.	7 months	Tobacco use abstinence based on salivary cotinine was assessed at 7-month follow-up

Trial Locations

Locations (1)

Universidade Estadual de Londrina; 🇧🇷 Londrina, Paraná, Brazil