Development and Pilot Testing of the Sense2Quit App

NCT05609032 | Completed Results DMC

• 2 other identifiers: AAAT70311R21CA265961-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; HIV Infections

Keywords

Sense2Quit; Tobacco Use

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence at 12 Weeks

  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)

Study Arms (2)

Intervention (App Arm)

EXPERIMENTAL

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.

Behavioral: Sense2Quit App

Control

NO INTERVENTION

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

Interventions

Sense2Quit App BEHAVIORAL

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

Intervention (App Arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Columbia University: lead
• Case Western Reserve University: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

• 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.

  PMID: 40000581 DERIVED

• 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.

  PMID: 37856173 DERIVED

MeSH Terms

Conditions

Smoking Cessation; HIV Infections; Tobacco Use

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Rebecca Schnall, PhD, MPH, RN-BC, FAAN, FACMI
• Organization: Columbia University

rb897@cumc.columbia.edu

212-342-6886

Study Officials

• Rebecca Schnall, PhD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Intervention assignment will be masked to participants only
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mary Dickey Lindsay Professor of Disease Prevention and Health Promotion

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: November 8, 2022
• Study Start: March 6, 2023
• Primary Completion: January 12, 2024
• Study Completion: January 12, 2024
• Last Updated: November 6, 2024
• Results First Posted: November 6, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)