- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04808609
Smoking Cessation Pilot for People Living With HIV (PLWH)
February 21, 2023 updated by: Rebecca Schnall, RN, MPH, PhD, Columbia University
A Pilot Trial of a Smoking Cessation App in People Living With HIV (PLWH)
The overall goal of this pilot study is to evaluate the feasibility of the Lumme smartphone app for smoking cessation in people living with HIV (PLWH) and evaluate its effect on smoking cessation.
Mobile health (mHealth) technology can be used for achieving health equity in vulnerable groups because it is a widely available and relatively inexpensive tool for health behavior change and can be adapted to meet the needs of its end-users.
Therefore, a mHealth intervention such as the Lumme App proposed through this study is timely, relevant, scalable and likely to improve health outcomes in PLWH who smoke.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Of the approximately one million persons living with HIV (PLWH) in the United States (U.S.), it is estimated that between 34-47% smoke cigarettes, around three times the prevalence (12.5%) observed in the general U.S. adult population.
Consequently, PLWH experience substantial tobacco-related morbidity and mortality.
In PLWH, after achieving and maintaining a suppressed viral load, smoking cessation is the next most important health behavior to maximize both quality of life and life expectancy.
Given the high prevalence of cigarette smoking among PLWH and the benefit of smoking cessation, there is an urgent need for swift action to intervene to reduce tobacco use rates.
However, evidence to improve tobacco cessation among PLWH is inadequate.
Given the need for improving smoking cessation in PLWH, and the great promise of mHealth tools, this research study will assess smoking behaviors in people living with HIV and the subsequent efficacy of mHealth intervention for improving tobacco cessation.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10032
- Columbia University Irving Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- PLWH
- ≥ 18 years old
- own an Android smartphone
- understand and read English
- not pregnant or breastfeeding
- permanent contact information
- smokes greater than or equal to 5 cigarettes per day for the past 30 days
- interested in quitting smoking within 30 days
- blow ≥ 6 carbon monoxide (CO) into a breath analyzer at baseline
Exclusion Criteria:
- self-report being HIV-negative or unknown status
- pregnant, breastfeeding, or planning to become pregnant during the study period
- planning to move within 3 months of enrollment
- a positive history of a medical condition that precludes use of the nicotine patch
- current use of nicotine replacement therapy or other smoking cessation medications
- current enrollment in another smoking cessation program
- blows ≤ 5 CO into a breath analyzer at baseline.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
The Intervention group receives standard smoking cessation counseling and nicotine replacement therapy AND access to the Lumme app that tracks smoking behaviors and provides cessation support.
|
Lumme mobile phone app provides smoking cessation support and tracks smoking behaviors
Smoking cessation counseling and nicotine replacement therapy
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Other: Control
The Control group receives standard smoking cessation counseling and nicotine replacement therapy
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Smoking cessation counseling and nicotine replacement therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence
Time Frame: Baseline, 12 weeks follow up
|
7-day point prevalence abstinence was calculated as the percentage of participants who reported no smoking/tobacco use in the 7 days prior to their 12-week follow-up visit biochemically verified by exhaled Carbon Monoxide (eCO) collected at 12 weeks.
Participants with eCO levels <6 parts per million (ppm) at 12 weeks were classified as abstinent while participants with eCO levels ≥6ppm at 12 weeks were classified as not abstinent.
|
Baseline, 12 weeks follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Self-reported 7-day Point Prevalence Abstinence at 12 Weeks
Time Frame: Baseline, 12 weeks follow up
|
7-day point prevalence abstinence was calculated as the percentage of participants who reported no smoking/tobacco use in the 7 days prior to their 12-week follow-up visit.
|
Baseline, 12 weeks follow up
|
Change in eCO in Ppm From Baseline to 12-week Follow-up
Time Frame: Baseline to 12-week Follow-up
|
Exhaled Carbon Monoxide (eCO) was measured via Micro +TM basic Smokerlyzer® in parts per million (ppm) and collected at Baseline and at 12-week Follow-up.
Theoretically possible result values range from 0 to 150 ppm with higher values indicating more eCO.
Mean change for this study was calculated as Baseline eCO value minus 12-week Follow-up eCO value such that positive mean values indicate a decrease in eCO from Baseline to 12-week Follow-up.
|
Baseline to 12-week Follow-up
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Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score
Time Frame: Baseline, 12-week Follow-up
|
The CES-D measure contains 20 items asking respondents to rate how often over the past week they experienced depression-associated symptoms.
Response options are coded as: 0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time.
Scores are calculated by reversing scores for positive statements and adding all responses together.
Scores range from 0 to 60, with higher scores indicating greater presence of depressive symptoms.
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Baseline, 12-week Follow-up
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Self-reported Number of Cigarettes Smoked Daily at Baseline
Time Frame: Baseline
|
During baseline visit, participants were asked to report how many cigarettes they smoked daily during the past 30 days.
|
Baseline
|
CAGE Substance Abuse Screening Tool Score at Baseline
Time Frame: Baseline
|
The CAGE Substance Abuse Screening Tool contains 4 questions with binary answer options: 1 = Yes, 0 = No.
Scores are calculated by adding response values.
Scores range from 0 to 4 with higher scores indicating alcohol problems.
CAGE stands for the 4 question names: Cut down, Annoyed, Guilty, and Eye-opener
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rebecca Schnall, PhD, RN, Columbia University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 6, 2020
Primary Completion (Actual)
July 16, 2021
Study Completion (Actual)
July 16, 2021
Study Registration Dates
First Submitted
March 18, 2021
First Submitted That Met QC Criteria
March 18, 2021
First Posted (Actual)
March 22, 2021
Study Record Updates
Last Update Posted (Estimate)
February 23, 2023
Last Update Submitted That Met QC Criteria
February 21, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- AAAS6990
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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