Trials Sponsors Conditions Drugs Pricing

Conditions

HIV Infections Smoking Cessation

Keywords

Sense2QuitTobacco 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 AppBehavioral

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

Intervention (App Arm)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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;

Sponsors & Collaborators

National Cancer Institute (NCI)
NIHcollaborator
Case Western Reserve University
Othercollaborator
Columbia University

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

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: 40000581DERIVED
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: 37856173DERIVED

MeSH Terms

Conditions

Smoking CessationHIV InfectionsTobacco Use

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital Diseases

Results Point of Contact

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

Study Officials

Rebecca Schnall, PhD, MPH
Columbia University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

60 participants (actual enrollment reported by the registry).

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

Actual (reported)

Development and Pilot Testing of the Sense2Quit App

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Intervention (App Arm)

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Intervention (App Arm)

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations