Clinical trial NCT05560243: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Tobacco Use Cessation
Keywords: HIV, tobacco cessation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Universidade Estadual de Londrina
First posted: 2022-09-29
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility of a tobacco cessation program tailored to patients living with HIV
Primary purpose: TREATMENT

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.

Detailed description: This study aims at developing and examining 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. It consists of three phases: formative assessments with patients and health care providers to inform relevant components of the intervention, pretesting of the intervention components, and pilot testing of the intervention (feasibility).

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.

Primary outcomes:
measure: Number of Participants With a 7-day Prevalence Abstinence of Tobacco Use
timeFrame: 6-month follow-up
Secondary outcomes:
measure: Participants With Tobacco Use Abstinence Based on Salivary Cotinine at 7-month Follow-up.
timeFrame: 7 months
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: Universidade Estadual de Londrina
state: Paraná
Study officials:
affiliation: University of Alabama at Birmingham
name: Isabel C Scarinci, PhD
role: PRINCIPAL_INVESTIGATOR
References: