Smoking Cessation in a Cohort HIV+ Rio de Janeiro, Brazil.

Smoking Cessation is Associated With Short-term Improvement of Vascular Health in a Cohort of People Living With HIV in Rio de Janeiro, Brazil.

The study was carried out within a large, urban prospective cohort of PLHIV at the Instituto Nacional de Infectologia Evandro Chagas (INI). Located in Rio de Janeiro, Brazil, INI is a national public referral center for PLWHA receiving primary care since 1998. From December 2019, adults who had attitudes toward quitting smoking and had no contraindications to study pharmacotherapy were enrolled by active site searching

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Nicotine Replacement Therapy; Brachial Flow Mediated Dilatation
• Intervention / Treatment: Drug: Nicotine replacement

• Study Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 22210-080
    • Instituto Nacional de Infectologia Evandro Chagas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Adults HIV positive who had attitudes toward quitting smoking and had no contraindications to study pharmacotherapy

Description

Inclusion Criteria:

• individuals were deemed as regular smokers, defined as the consumption of one or more pack (20 cigarettes) per week in the past 6 months, and expired carbon monoxide (CO) measurement > 10 ppm at the screening visit.

Exclusion Criteria:

• previous use of transdermal nicotine patches or bupropion in the last 6 months; (ii) contraindication to nicotine patches; (iii). Pregnancy; (iv) breastfeeding

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Relapse	Drug: Nicotine replacement; Nicotine patches
Group 2; Smoking cessation	Drug: Nicotine replacement; Nicotine patches

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FMD	Flow mediated brachial artery dilatation	12 months

Collaborators and Investigators

• Sponsor: Instituto Fernandes Figueira

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Actual): April 15, 2022
• Study Completion (Actual): April 15, 2023

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 3.171.692

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Upon request data will be shared , anonimyzed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No