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

Primary Purpose

HIV Infections, Tobacco Use Cessation

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Tobacco cessation
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, tobacco cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Universidade Estadual de Londrina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Patients will receive a tobacco cessation intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 26, 2022
Last Updated
September 14, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
Universidade Estadual de Londrina
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1. Study Identification

Unique Protocol Identification Number
NCT05560243
Brief Title
Tobacco Cessation Tailored to Patients Living With HIV (PLWH) in Brazil
Official Title
Development, Implementation, and Evaluation of a Tobacco Cessation Intervention Tailored to Patients Living With HIV (PLWH) in Brazil: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Actual)
Study Completion Date
August 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Universidade Estadual de Londrina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Tobacco Use Cessation
Keywords
HIV, tobacco cessation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility of a tobacco cessation program tailored to patients living with HIV
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients will receive a tobacco cessation intervention
Intervention Type
Behavioral
Intervention Name(s)
Tobacco cessation
Intervention Description
Tobacco cessation program consisting of cognitive-therapy sessions and pharmacological management
Primary Outcome Measure Information:
Title
7-day prevalence abstinence of tobacco use
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabel C Scarinci, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Estadual de Londrina
City
Londrina
State/Province
Paraná
ZIP/Postal Code
86057
Country
Brazil

12. IPD Sharing Statement

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

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