Testing the Integrated mHealth App Intervention "SiS-H"

Smoking Cessation Clinical Trial

Official title: Pilot RCT to Test the Integrated mHealth App Intervention (SiS-H) for Smoking Cessation for People With HIV

Status Recruiting

Clinical Trial 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".

Clinical Trial Description

The team recently developed an mHealth intervention that integrates (1) the "Smiling instead of Smoking" (SiS) app, a conceptually-grounded, iteratively developed smoking cessation smartphone app, (2) a successful face-to-face smoking cessation treatment for smokers with HIV, called QUIT, and (3) Life Steps, an efficacious brief intervention to promote adaptive engagement in HIV care. The new integrated treatment emphasizes protecting the experience of positive emotions among smokers with HIV as they navigate the process of quitting smoking and supports smoking self-efficacy by engaging participants in app-based activities. Guidance and support for engaging with the app are provided through two face-to-face sessions.

The present study is a pilot randomized controlled trial (RCT) that seeks to test the feasibility, acceptability, process outcomes and exploratory outcomes of this new treatment, called SiS-H, compared to onboarding to the National Cancer Institute's smartphone app "QuitGuide" (QG). Smokers with HIV engaged in HIV clinical care (n=64) will be randomized (1:1) to smoking cessation support via SiS-H vs. the National Cancer Institute's smartphone app "QuitGuide" (QG).

Smoking cessation support will last 8 weeks and will consist of face-to-face interactions with study staff about navigating their assigned smoking cessation app and brief smoking cessation information. Participants will be offered nicotine replacement patches but will not be required to use them.

Study assessments will consist of online surveys (baseline, 2, 6, and 12 weeks post-quit), and biochemical tests of smoking status (baseline, 12 weeks post-quit). Data will be extracted from the medical record, with participants' permission.

The aims of the study are:

1. To test the feasibility and acceptability of the SiS-H integrated treatment to support people with HIV in quitting smoking.

2. To test the efficacy of the integrated SiS-H treatment to have a positive impact on variables relevant to the process of quitting smoking.

3. (EXPLORATORY) To examine differences in 30-day point prevalence smoking abstinence (biologically verified), other smoking outcomes, and HIV medication adherence between both app groups.

Below are specifics on the Specific Aims of this study, and the investigators' hypotheses:

Specific Aim 1: In this pilot randomized-controlled trial, the investigators will test the feasibility and acceptability of the SiS-H integrated treatment to support people with HIV in quitting smoking.

1. Feasibility (primary outcome): App use of the assigned app, as measured by the number of days participants used the app during the treatment period (8 weeks) will be significantly higher in SiS-H compared to QG. App use will be calculated based on passively collected app usage data.

2. Feasibility (secondary outcomes): The investigators hypothesize that SiS-H treatment will be feasible, as measured in the following ways:

1. Self-reported time spent applying content; the investigators' hypothesis is that "time spent" (i.e., as measured by this self-report item: "During the past week, how much time did participants spend applying or contemplating the content of the [Smiling Instead of Smoking app / QuitGuide app (logic-branched by treatment group)]? ______________ (in minutes, total for the week)") will be equal or higher in SiS-H than QG

2. Achieving expected app use (i.e., 75% of participants using the app at least once 6 out of 8 weeks of the prescribed treatment week)

3. Use of smoking cessation strategies (see attached instrument); the investigators' hypothesis is that "use of strategies" will be equal or higher in SiS-H than QG

3. Acceptability (secondary outcomes): The investigators hypothesize that SiS-H treatment will be acceptable (i.e., equal or higher scores compared to the control group), as measured at treatment end in the following ways:

1. Satisfaction with smoking cessation support (Client Satisfaction Questionnaire (CSQ-8))

2. App system usability (System Usability Scale (SUS))

3. User app rating (User Mobile Application Rating Scale (uMARS))

Specific Aim 2: In this pilot RCT, the investigators will test the efficacy of the integrated SiS-H treatment to have a positive impact on variables relevant to the process of quitting smoking. Specifically, the investigators hypothesize outcomes will be better for the SiS-H group compared to the QG group at the end of treatment on the following measures:

1. Smoking cessation self-efficacy as measured by the Smoking Self-Efficacy Questionnaire (SEQ-12); higher self-efficacy is considered 'better'

2. Craving, as measured by the Brief Questionnaire of Smoking Urges (QSU-Brief); lower craving is considered 'better'

3. Positive affect, as measured by the positive affect subscale of the PANAS Positive and Negative Affect Schedule (PANAS); higher positive affect is considered 'better'

Exploratory Aim 3: Although not statistically powered, the investigators will examine differences in 30-day point prevalence abstinence (biologically verified), other smoking outcomes, and 30-day self-reported ART adherence, as measured by the Medication Adherence scale, between both app groups. ;

Related Conditions & MeSH terms

• Smoking Cessation

• NCT number: NCT05886621
• Study type: Interventional
• Source: Massachusetts General Hospital
• Contact: Bettina Hoeppner, Ph.D., M.S.
• Phone: 617-643-1988
• Email: bhoeppner@mgh.harvard.edu
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2023
• Completion date: October 2024