N/A
Completed N=56
Tobacco Cessation Tailored to Patients Living With HIV (PLWH) in Brazil
HIV · Tobacco Use Cessation
Source: ClinicalTrials.gov NCT05560243 ↗
Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Number of Participants With a 7-day Prevalence Abstinence of Tobacco Use — 27 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a 7-day Prevalence Abstinence of Tobacco Use |
27 | — |
| SECONDARY Participants With Tobacco Use Abstinence Based on Salivary Cotinine at 7-month Follow-up. |
18 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05560243). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.