Smoking Cessation in a Cohort HIV+ Rio de Janeiro, Brazil. | NCT05873738

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

NCT05873738

Sponsor

Instituto Fernandes Figueira

Status

Completed

Last Update Posted

May 24, 2023Actual

Enrollment

115Actual

Phase

Not provided

Conditions

Smoking Cessation
Brachial Flow Mediated Dilatation
Nicotine Replacement Therapy

Interventions

Nicotine replacement

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 10, 2019Actual

Primary Completion Date

Apr 15, 2022Actual

Completion Date

Apr 15, 2023Actual

First Submitted Date

May 15, 2023

First Submission Date that Met QC Criteria

May 15, 2023

First Posted Date

May 24, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2023

Last Update Posted Date

May 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

115Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Relapse	Drug: Nicotine replacement
Group 2		Smoking cessation	Drug: Nicotine replacement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nicotine replacement	Drug	Nicotine patches	Group 1 Group 2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Nacional de Infectologia Evandro Chagas		Rio de Janeiro		22210-080	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

Upon request data will be shared , anonimyzed

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016540	Smoking Cessation

Ancestor Terms

ID	Term
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000095488	Nicotine Replacement Therapy

Ancestor Terms

ID	Term
D004358	Drug Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided