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

NCT05560243 | Completed Results DMC

• 1 other identifier: R21DA049557
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Tobacco Use Cessation

Keywords

HIV, tobacco cessation

Outcome Measures

Primary Outcomes (1)

• 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.

  6-month follow-up

Secondary Outcomes (1)

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

  7 months

Study Arms (1)

Intervention

EXPERIMENTAL

Patients will receive a tobacco cessation intervention

Behavioral: Tobacco cessation

Interventions

Tobacco cessation BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PLWH (that is, patients with a confirmed HIV diagnosis) receiving care at the reference center in Londrina
• 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.

You may not qualify if:

• History of hypertension
• History of angina
• History of asthma
• On medication for depression.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Universidade Estadual de Londrina: collaborator

Study Sites (1)

Universidade Estadual de Londrina

Londrina, Paraná, 86057, Brazil

Location

MeSH Terms

Conditions

HIV Infections; Tobacco Use Cessation

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Isabel Scarinci, Principal Investigator
• Organization: University of Alabama at Birmingham

scarinci@uab.edu

2059757177

Study Officials

• Isabel C Scarinci, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Feasibility of a tobacco cessation program tailored to patients living with HIV

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: September 1, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: December 11, 2024
• Results First Posted: December 11, 2024

Record last verified: 2024-12

Locations

BR (1)