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

University of Alabama at Birmingham56 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infections

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of Participants With a 7-day Prevalence Abstinence of Tobacco Use

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.

Time frame: 6-month follow-up

Secondary Outcomes

Participants With Tobacco Use Abstinence Based on Salivary Cotinine at 7-month Follow-up.

Tobacco use abstinence based on salivary cotinine was assessed at 7-month follow-up

Time frame: 7 months