CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 56 enrolled
Drug / intervention
Tobacco cessationbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05560243
NCT05560243N/ACompleted

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

University of Alabama at Birmingham·interventional·Posted Sep 29, 2022·Updated Dec 11, 2024

In Brief

A clinical study evaluating Tobacco cessation for HIV Infections and Tobacco Use Cessation. Completed, enrolled 56 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

N/ACompletedFinished
20222023202420252026
First PostedSep 29, 2022
Enrollment StartSep 1, 2021
Primary CompletionAug 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 3.8 years ago

Interventions

Tobacco cessationbehavioral

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