Testing the Integrated mHealth App Intervention "SiS-H"

NCT05886621 | Completed

• 2 other identifiers: 2023P001360R21CA261458
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is a pilot randomized controlled trial (RCT) that seeks to test the feasibility, acceptability, process outcomes, and exploratory outcomes of a newly integrated, app-based smoking cessation treatment (SiS-H, which stands for "Smiling instead of Smoking for people with HIV") for people with HIV who smoke. This treatment will be compared to onboarding to the National Cancer Institute's smartphone app "QuitGuide" (QG). Persons with HIV who smoke and are engaged in HIV clinical care (n=64) will be randomized (1:1) to smoking cessation support via SiS-H vs. "QuitGuide".

Conditions

Smoking Cessation

Keywords

smoking; smartphone app; smoking cessation; QuitGuide; Smiling instead of Smoking; SiS-H; positive psychology; mHealth; QUIT; Life Steps

Outcome Measures

Primary Outcomes (1)

• App usage

  Number of days participants used the assigned app during the prescribed period of app use (i.e., 8 weeks for both apps). App usage is passively recorded by the app, which time-stamps every interaction with the app.

  Continuously logged in the app from baseline (2 weeks pre-quit) to end of treatment (6 weeks post-quit).

Secondary Outcomes (16)

• Time spent applying content

  Measured at week 4 (2 weeks post-quit) and week 8 (6-weeks post-quit)

• Expected app usage

  Assessed at end of treatment (6 weeks post-quit)

• Use of smoking cessation strategies

  Assessed at end of treatment (6 weeks post-quit)

• Satisfaction with smoking cessation support

  Assessed at end of treatment (6 weeks post-quit)

• App usability rating, System Usability Scale (SUS)

  Assessed at end of treatment (6 weeks post-quit)

Other Outcomes (3)

• 30-day point prevalence abstinence (PPA) - self-reported

  Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)

• 30-day point prevalence abstinence (PPA) - biochemically verified

  Measured at baseline and week 20 (3 months after end of treatment)

• HIV Medication Adherence

  Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)

Study Arms (2)

Smiling instead of Smoking - HIV

EXPERIMENTAL

Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.

Behavioral: Smiling instead of Smoking - HIV

QuitGuide

ACTIVE COMPARATOR

Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.

Behavioral: QuitGuide

Interventions

Smiling instead of Smoking - HIV BEHAVIORAL

Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and will be asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.

Also known as: SiS-H

Smiling instead of Smoking - HIV

QuitGuide BEHAVIORAL

Participants will be onboarded to the NCI smartphone app QuitGuide(QG) and will be asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).

Also known as: QG

QuitGuide

Eligibility Criteria

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

You may qualify if:

• + years of age
• current smoker, who has smoked at least 100 cigarettes lifetime, and smokes at least weekly
• HIV positive, by self-report
• currently engaged in HIV clinical care (i.e., saw an HIV care provider within the last year)
• willing to let study staff look at medical record to extract HIV-relevant information (e.g., CD4 T cell count)
• willing to make a quit attempt as part of this study
• willing to give permission to study staff to look at app usage for the assigned smoking cessation app
• willing and able to comply with study procedures

You may not qualify if:

• does not own a smartphone
• does not have daily access to the owned smartphone

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Behavioral Medicine Program (BMED)

Boston, Massachusetts, 02114, United States

Location

Related Publications (10)

• Brooke, J. (1996). SUS: A 'quick and dirty' usability scale. In P. W. Jordan, B. Thomas, I. L. McClelland, & B. Weerdmeester (Eds.), Usability evaluation in industry (1st ed., Vol. 189, pp. 4-7). CRC Press.

  BACKGROUND

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  PMID: 11260806 BACKGROUND

• Etter JF, Bergman MM, Humair JP, Perneger TV. Development and validation of a scale measuring self-efficacy of current and former smokers. Addiction. 2000 Jun;95(6):901-13. doi: 10.1046/j.1360-0443.2000.9569017.x.

  PMID: 10946439 BACKGROUND

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  PMID: 10829336 BACKGROUND

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  PMID: 21852891 BACKGROUND

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  PMID: 10245370 BACKGROUND

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  PMID: 3397865 BACKGROUND

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  PMID: 27098408 BACKGROUND

MeSH Terms

Conditions

Smoking Cessation; Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Bettina Hoeppner, PhD, MS

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 2-group pilot randomized controlled trial

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 2, 2023
• Study Start: November 7, 2023
• Primary Completion: May 5, 2025
• Study Completion: July 7, 2025
• Last Updated: February 10, 2026

Record last verified: 2024-09

Locations

US (1)