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

The University of Alabama at Birmingham

Status: Completed

Conditions: Tobacco Use Cessation; HIV Infections

Treatments: Behavioral: Tobacco cessation

Study type: Interventional

Funder types: Other

Identifiers

NCT05560243

R21DA049557

Details and patient eligibility

About

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.

Full 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).

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

Intervention

Experimental group

Description:

Patients will receive a tobacco cessation intervention

Treatment:

Behavioral: Tobacco cessation