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NCT05560243 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05560243
Other study ID # R21DA049557
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date August 31, 2023

Study information
Verified date September 2023
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Brazil Universidade Estadual de Londrina Londrina Paraná

Sponsors (2)
Lead Sponsor Collaborator
University of Alabama at Birmingham Universidade Estadual de Londrina

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 6-month follow-up
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