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Development and Pilot Testing of the Sense2Quit App

Primary Purpose

Smoking Cessation, HIV Infections

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sense2Quit App
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smoking Cessation focused on measuring Sense2Quit, Tobacco Use

Eligibility Criteria

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

Inclusion Criteria: PLWH confirmed through medical records or pill bottes for ART medications. ≥ 18 years of age; Own an Android smartphone; Understand and read English; Not pregnant or breastfeeding (due to contraindications for Nicotine Replacement Therapy [NRT]); Permanent contact information; Smokes ≥5 cigarettes per day for the past 30 days; Interested in quitting smoking within 30 days; Blows ≥5 ppm eCO into a breath analyzer at baseline. Exclusion Criteria: Use of tobacco products other than cigarettes (i.e. cigars, piped tobacco, chew, snuff) Planning to move within 3 months of enrollment; Positive history of a medical condition that precludes nicotine patch use; Current use of NRT or other smoking cessation medications (e.g., Chantix or Zyban); Current enrollment in another smoking cessation program. Alcohol dependence measured through the AUDIT-C A household member is also participating in the Sense2Quit study (due to study contamination).

Sites / Locations

  • Columbia University Irving Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention (App Arm)

Control

Arm Description

Participants randomized to the intervention arm will receive access to the Sense2Quit App (A multi-component intervention that links a smartphone app to a smartwatch to provide real-time quit reminders to curtail relapses and avoid potential triggers), standard smoking cessation counseling, and nicotine replacement therapy.

Participants randomized to the control arm will receive standard smoking cessation counseling and referral to quitline.

Outcomes

Primary Outcome Measures

Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence
7-day point prevalence abstinence is calculated as the percentage of participants who reported no smoking/tobacco use in the 7 days prior to their 12-week follow-up visits biochemically verified by exhaled Carbon Monoxide (eCO) collected at 4 and 12 weeks via breathalyzer (Micro+TM basic Smokerlyzer®). At each of the 2 follow-up timepoints, participants with eCO levels <5 parts per million (ppm) will be classified as abstinent while participants with eCO levels ≥5ppm will be classified as not abstinent.

Secondary Outcome Measures

Full Information

First Posted
July 14, 2022
Last Updated
August 3, 2023
Sponsor
Columbia University
Collaborators
Case Western Reserve University, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05609032
Brief Title
Development and Pilot Testing of the Sense2Quit App
Official Title
Development and Pilot Testing of the Sense2Quit App
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Case Western Reserve University, National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a pilot randomized controlled trial to examine the feasibility, acceptability and preliminary efficacy of the Sense2Quit App in a sample of 60 PLWH who smoke.
Detailed Description
The estimated 40-70% of persons living with HIV (PLWH) who smoke cigarettes experience substantial tobacco-related morbidity and mortality. For PLWH, apart from achieving and maintaining a suppressed viral load, tobacco cessation is the most important health behavior they can undertake to maximize both quality of life and life expectancy. However, the currently available evidence for improving tobacco cessation among PLWH is inadequate. Few tobacco cessation interventions have been tested among PLWH, and of those which have, there is 'very low' quality evidence that they were effective in the short-term and 'moderate' quality evidence indicating similar outcomes to controls in the long-term. Thus, it is critical to develop evidence-based tobacco cessation interventions to address the complex and unique needs of PLWH. In response to this need, the investigators propose to develop a mobile intervention for PLWH who smoke building on Sense2Quit, a multi-component intervention that links a smartphone app to a smartwatch to provide real-time quit reminders to curtail relapses and avoid potential trigger. This real-time feedback is critical especially in the first few weeks of a quit attempt. The proposed Sense2Quit intervention for PLWH who smoke cigarettes is a novel and evidence-driven intervention using mobile technology to improve tobacco cessation. This will be the first study to develop and pilot test an innovative tobacco cessation intervention for PLWH. The final product of this study will be the basis for an R01 application to conduct a large-scale efficacy study for this population. The investigators are confident that the proposed intervention will be a high impact intervention for improving tobacco cessation among PLWH and have long-term implications for overall improvement in the public's health.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, HIV Infections
Keywords
Sense2Quit, Tobacco Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Intervention assignment will be masked to participants only
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention (App Arm)
Arm Type
Experimental
Arm Description
Participants randomized to the intervention arm will receive access to the Sense2Quit App (A multi-component intervention that links a smartphone app to a smartwatch to provide real-time quit reminders to curtail relapses and avoid potential triggers), standard smoking cessation counseling, and nicotine replacement therapy.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants randomized to the control arm will receive standard smoking cessation counseling and referral to quitline.
Intervention Type
Behavioral
Intervention Name(s)
Sense2Quit App
Intervention Description
Participants in the intervention arm will receive access to Sense2Quit, a smartphone app that links to a smartwatch.
Primary Outcome Measure Information:
Title
Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence
Description
7-day point prevalence abstinence is calculated as the percentage of participants who reported no smoking/tobacco use in the 7 days prior to their 12-week follow-up visits biochemically verified by exhaled Carbon Monoxide (eCO) collected at 4 and 12 weeks via breathalyzer (Micro+TM basic Smokerlyzer®). At each of the 2 follow-up timepoints, participants with eCO levels <5 parts per million (ppm) will be classified as abstinent while participants with eCO levels ≥5ppm will be classified as not abstinent.
Time Frame
12 weeks after baseline (or quit date if later than baseline visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: PLWH confirmed through medical records or pill bottes for ART medications. ≥ 18 years of age; Own an Android smartphone; Understand and read English; Not pregnant or breastfeeding (due to contraindications for Nicotine Replacement Therapy [NRT]); Permanent contact information; Smokes ≥5 cigarettes per day for the past 30 days; Interested in quitting smoking within 30 days; Blows ≥5 ppm eCO into a breath analyzer at baseline. Exclusion Criteria: Use of tobacco products other than cigarettes (i.e. cigars, piped tobacco, chew, snuff) Planning to move within 3 months of enrollment; Positive history of a medical condition that precludes nicotine patch use; Current use of NRT or other smoking cessation medications (e.g., Chantix or Zyban); Current enrollment in another smoking cessation program. Alcohol dependence measured through the AUDIT-C A household member is also participating in the Sense2Quit study (due to study contamination).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Schnall, PhD, MPH
Phone
212-342-6886
Email
rb897@columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Maeve Brin
Phone
212-342-6988
Email
mb4953@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Schnall, PhD, MPH
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Schnall, PhD, MPH
Phone
212-342-6886
Email
rb897@columbia.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Development and Pilot Testing of the Sense2Quit App

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