Development and Pilot Testing of the Sense2Quit App

NCT ID: NCT05609032

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-06
• Study Completion Date: 2024-01-12

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.

Conditions

Smoking Cessation; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention (App Arm)

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.

Group Type: EXPERIMENTAL

Sense2Quit App

Intervention Type: BEHAVIORAL

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

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sense2Quit App

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

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Western Reserve University

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Schnall, RN, MPH, PhD

Mary Dickey Lindsay Professor of Disease Prevention and Health Promotion

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca Schnall, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center

New York, New York, United States

Countries

United States

References

Schnall R, Huang MC, Brin M, Cioe PA, Liu J, Das A, Fontalvo S, Xu W. Feasibility and Acceptability of the Sense2Quit App for Improving Smoking Cessation in PWH. AIDS Behav. 2025 Jun;29(6):1920-1929. doi: 10.1007/s10461-025-04659-1. Epub 2025 Feb 25.

Reference Type: DERIVED

PMID: 40000581 (View on PubMed)

Brin M, Trujillo P, Jia H, Cioe P, Huang MC, Chen H, Qian X, Xu W, Schnall R. Pilot Testing of an mHealth App for Tobacco Cessation in People Living With HIV: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Oct 19;12:e49558. doi: 10.2196/49558.

Reference Type: DERIVED

PMID: 37856173 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R21CA265961-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAT7031

Identifier Type: -

Identifier Source: org_study_id