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

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Recruiting

CT.gov ID

NCT05560243

Collaborator

Universidade Estadual de Londrina (Other)

Enrollment

Location

Arm

23.9

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Tobacco Use Cessation	Behavioral: Tobacco cessation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Feasibility of a tobacco cessation program tailored to patients living with HIVFeasibility of a tobacco cessation program tailored to patients living with HIV

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Aug 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Patients will receive a tobacco cessation intervention	Behavioral: Tobacco cessation Tobacco cessation program consisting of cognitive-therapy sessions and pharmacological management

Arm

Intervention/Treatment

Experimental: Intervention

Patients will receive a tobacco cessation intervention

Behavioral: Tobacco cessation

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidade Estadual de Londrina	Londrina	Paraná	Brazil	86057

Sponsors and Collaborators

University of Alabama at Birmingham
Universidade Estadual de Londrina

Investigators

Principal Investigator: Isabel C Scarinci, PhD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Isabel Scarinci, Professor, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT05560243

Other Study ID Numbers:

R21DA049557

First Posted:

Sep 29, 2022

Last Update Posted:

Dec 15, 2022

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Isabel Scarinci, Professor, University of Alabama at Birmingham

HIV, tobacco cessation

Additional relevant MeSH terms:

HIV Infections

Study Results

No Results Posted as of Dec 15, 2022