Development and Pilot Testing of the Sense2Quit App

HIV Infections Clinical Trial

Official title:

Development and Pilot Testing of the Sense2Quit App

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05609032
• Other study ID #: AAAT7031
• Secondary ID: 1R21CA265961-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 6, 2023
• Est. completion date: November 2024

Study information

• Verified date: October 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• HIV Infections
• Smoking Cessation

Intervention

Behavioral:
• Sense2Quit App
Participants in the intervention arm will receive access to Sense2Quit, a smartphone app that links to a smartwatch.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Case Western Reserve University, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks after baseline (or quit date if later than baseline visit)