Smoking Cessation Pilot for People Living With HIV (PLWH)

Back to results

Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lumme mobile phone application

Standard of Care

About this trial

This is an interventional supportive care trial for Smoking Cessation focused on measuring Smoking, Smoking Cessation, Smoking Behaviors, Smoking Reduction, Tobacco, Cigarette, PLWH, HIV, HIV/AIDS, mHealth, Mobile Health, Lumme, Pilot

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Columbia University Irving Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Control

Arm Description

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.

The Control group receives standard smoking cessation counseling and nicotine replacement therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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

Full Information

NCT ID

NCT04808609

First Posted

March 18, 2021

Last Updated

February 21, 2023

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT04808609

Brief Title

Smoking Cessation Pilot for People Living With HIV (PLWH)

Official Title

A Pilot Trial of a Smoking Cessation App in People Living With HIV (PLWH)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

October 6, 2020 (Actual)

Primary Completion Date

July 16, 2021 (Actual)

Study Completion Date

July 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

4. Oversight

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

Data Monitoring Committee

No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Smoking Cessation, Smoking, Smoking Behaviors, Smoking Reduction, Smoking, Tobacco, Smoking, Cigarette, Hiv, HIV/AIDS

Keywords

Smoking, Smoking Cessation, Smoking Behaviors, Smoking Reduction, Tobacco, Cigarette, PLWH, HIV, HIV/AIDS, mHealth, Mobile Health, Lumme, Pilot

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

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.

Arm Title

Control

Arm Type

Other

Arm Description

The Control group receives standard smoking cessation counseling and nicotine replacement therapy

Intervention Type

Device

Intervention Name(s)

Lumme mobile phone application

Intervention Description

Lumme mobile phone app provides smoking cessation support and tracks smoking behaviors

Intervention Type

Behavioral

Intervention Name(s)

Standard of Care

Intervention Description

Smoking cessation counseling and nicotine replacement therapy

Primary Outcome Measure Information:

Title

Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence

Description

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.

Time Frame

Baseline, 12 weeks follow up

Secondary Outcome Measure Information:

Title

Percentage of Participants With Self-reported 7-day Point Prevalence Abstinence at 12 Weeks

Description

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.

Time Frame

Baseline, 12 weeks follow up

Title

Change in eCO in Ppm From Baseline to 12-week Follow-up

Description

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.

Time Frame

Baseline to 12-week Follow-up

Title

Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score

Description

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.

Time Frame

Baseline, 12-week Follow-up

Title

Self-reported Number of Cigarettes Smoked Daily at Baseline

Description

During baseline visit, participants were asked to report how many cigarettes they smoked daily during the past 30 days.

Time Frame

Baseline

Title

CAGE Substance Abuse Screening Tool Score at Baseline

Description

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

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rebecca Schnall, PhD, RN

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Irving Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35980739

Citation

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.

Results Reference

derived

Smoking Cessation, Smoking, Smoking Behaviors

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial