Smoking CessationNCT04808609
Smoking Cessation Pilot for People Living With HIV (PLWH)
A study testing Lumme mobile phone application in people with Smoking Cessation and Smoking, run by Columbia University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Smoking, Smoking Behaviors
- What is being tested?
- Lumme mobile phone application
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2020to 16 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PLWH
- ≥ 18 years old
- own an Android smartphone
- understand and read English
- not pregnant or breastfeeding
- permanent contact information
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking Cessation, Smoking, Smoking Behaviors, Smoking Reduction, Smoking, Tobacco, Smoking, Cigarette
- Being tested
- Lumme mobile phone application, Standard of Care
- Keywords
- Smoking, Smoking Cessation, Smoking Behaviors, Smoking Reduction, Tobacco, Cigarette, PLWH, HIV, HIV/AIDS, mHealth, Mobile Health, Lumme, Pilot
- Medical subject headings
- Smoking Cessation, Smoking, Smoking Reduction, Tobacco Smoking, Cigarette Smoking, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumme mobile phone applicationDevice
Lumme mobile phone app provides smoking cessation support and tracks smoking behaviors
Standard of CareBehavioural
Smoking cessation counseling and nicotine replacement therapy
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Device: Lumme mobile phone application; Behavioral: Standard of Care |
| Control | Other | The Control group receives standard smoking cessation counseling and nicotine replacement therapy Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence
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.
Measured: Baseline, 12 weeks follow up
Secondary outcomes (5)
Percentage of Participants With Self-reported 7-day Point Prevalence Abstinence at 12 Weeks
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.
Measured: Baseline, 12 weeks follow up
Change in eCO in Ppm From 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.
Measured: Baseline to 12-week Follow-up
Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score
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.
Measured: Baseline, 12-week Follow-up
Self-reported Number of Cigarettes Smoked Daily at Baseline
During baseline visit, participants were asked to report how many cigarettes they smoked daily during the past 30 days.
Measured: Baseline
CAGE Substance Abuse Screening Tool Score at 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start6 Oct 2020
- Primary completion16 Jul 2021
- Study completion16 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Schnall, RN, MPH, PhD, Columbia University
- Investigators
- Rebecca Schnall, PhD, RN, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808609
- Sponsor's protocol ID
- AAAS6990
- Status last verified
- Feb 2023
- First submitted
- 18 Mar 2021
- Last updated
- 23 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Schnall R, Liu J, Alvarez G, Porras T, Ganzhorn S, Boerner S, Huang MC, Trujillo P, Cioe P. A Smoking Cessation Mobile App for Persons Living With HIV: Preliminary Efficacy and Feasibility Study. JMIR Form Res. 2022 Aug 18;6(8):e28626. doi: 10.2196/28626.
PubMed 35980739
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of a Smoking Cessation App in People Living With HIV (PLWH)
- ClinicalTrials.gov ID
- NCT04808609
- Acronym / sponsor ID
- AAAS6990
- Conditions
- Smoking Cessation, Smoking, Smoking Behaviors, Smoking Reduction, Smoking, Tobacco, Smoking, Cigarette
- Keywords
- Smoking, Smoking Cessation, Smoking Behaviors, Smoking Reduction, Tobacco, Cigarette, PLWH, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 16 Jul 2021 (actual)
- Study completion
- 16 Jul 2021 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Posted 18 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Lumme mobile phone application, Behavioral: Standard of CareThe 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. |
| Control | Other | Behavioral: Standard of CareThe Control group receives standard smoking cessation counseling and nicotine replacement therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- PLWH
- ≥ 18 years old
- own an Android smartphone
- understand and read English
- not pregnant or breastfeeding
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumme mobile phone applicationLumme mobile phone app provides smoking cessation support and tracks smoking behaviors | Device | Intervention |
| Standard of CareSmoking cessation counseling and nicotine replacement therapy | Behavioural | Control, Intervention |
Primary outcome
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.
5 secondary outcomes
Percentage of Participants With Self-reported 7-day Point Prevalence Abstinence at 12 Weeks
Time frame: 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
Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score
Time frame: Baseline, 12-week Follow-up
Self-reported Number of Cigarettes Smoked Daily at Baseline
Time frame: Baseline
CAGE Substance Abuse Screening Tool Score at Baseline
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35980739Schnall R, Liu J, Alvarez G, Porras T, Ganzhorn S, Boerner S, Huang MC, Trujillo P, Cioe P. A Smoking Cessation Mobile App for Persons Living With HIV: Preliminary Efficacy and Feasibility Study. JMIR Form Res. 2022 Aug 18;6(8):e28626. doi: 10.2196/28626.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Schnall, PhD, RN principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumme mobile phone application in people with Smoking Cessation and Smoking, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence (time frame: Baseline, 12 weeks follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04808609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.