Clinical trial NCT05609032: Development and Pilot Testing of the Sense2Quit App
Official title: Development and Pilot Testing of the Sense2Quit App
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
HIV Infections
Keywords: Sense2Quit
Tobacco Use
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
name: National Cancer Institute (NCI)
First posted: 2022-11-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* PLWH confirmed through medical records or pill bottles for antiretroviral therapy (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).

Primary outcomes:
measure: Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence at 12 Weeks
timeFrame: 12 weeks after baseline (or quit date if later than baseline visit)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Rebecca Schnall, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: