Effects of Using E-Cigarettes on Lungs in People With HIV (HBS Ancillary)

NCT ID: NCT04794543

Last Updated: 2024-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-12-04

Brief Summary

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This is an ancillary study, thus participants will be recruited from participants in the HBS Study. This project acutely assesses the role of the e-cigarettes and vaping on lung health. The proposed work will inform the design of future studies to better understand vaping's health consequences and to test novel interventions to mitigate vaping's contribution to acute and/or chronic lung injury.

Detailed Description

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Conditions

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Hiv Lung Injury

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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e-cigarettes and/or e-liquid vaping smokers

actively use e-cigarettes or vape

No interventions assigned to this group

cigarette smokers

actively smoke combustible tobacco and/or marijuana (cannabis)

No interventions assigned to this group

Non-smokers

no use of e-cigarettes or vape or active smoking in the past 5 years (and less than a total of 10 pack-years lifetime use)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* documented HIV-infection
* in care at an HIV specialty clinic
* age ≥ 18 years.

Exclusion Criteria

* a pacemaker or other implanted electronic device
* pregnant women, prisoners, cognitively-impaired subjects.

For this ancillary, the experimental group must actively use at least one of the following: e-cigarettes, e-liquid vapes, burning leaf tobacco cigarettes, or inhaled burning leaf marijuana (cannabis). The control group will have no use of e-cigarettes or vape or active smoking in the past year.

Participants must be willing to archive data and biological samples for future use.

Exclusion from the ancillary are:

* overt respiratory or oral cavity disease
* acute illness in the past 4 weeks
* active cancer
* active weight loss program
* any other medical, psychiatric or behavioral factors that, in the judgment of the PI may interfere with study participation or ability to follow the protocol
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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John Apolzan

Assistant Professor, Director Clinical Nutrition and Metabolism Lab

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Apolzan, PhD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Lsuhsc-No

New Orleans, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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U54GM104940

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PBRC 2020-028

Identifier Type: -

Identifier Source: org_study_id

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