Smoking Cessation in a Cohort HIV+ Rio de Janeiro, Brazil.
Sponsor
Instituto Fernandes Figueira (Other)
Overall Status
Completed
CT.gov ID
NCT05873738
Collaborator
(none)
115
1
40.1
2.9
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
115 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Smoking Cessation is Associated With Short-term Improvement of Vascular Health in a Cohort of People Living With HIV in Rio de Janeiro, Brazil.
Actual Study Start Date
:
Dec 10, 2019
Actual Primary Completion Date
:
Apr 15, 2022
Actual Study Completion Date
:
Apr 15, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group 1 Relapse |
Drug: Nicotine replacement
Nicotine patches
|
| Group 2 Smoking cessation |
Drug: Nicotine replacement
Nicotine patches
|
Outcome Measures
Primary Outcome Measures
- FMD [12 months]
Flow mediated brachial artery dilatation
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Instituto Nacional de Infectologia Evandro Chagas | Rio de Janeiro | Brazil | 22210-080 |
Sponsors and Collaborators
- Instituto Fernandes Figueira
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Rodrigo de Carvalho Moreira,
Dr,
Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier:
NCT05873738
Other Study ID Numbers:
- 3.171.692
First Posted:
May 24, 2023
Last Update Posted:
May 24, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms: