Clinical trial NCT05886621: Testing the Integrated mHealth App Intervention "SiS-H"
Official title: Pilot RCT to Test the Integrated mHealth App Intervention (SiS-H) for Smoking Cessation for People With HIV
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Keywords: smoking
smartphone app
smoking cessation
QuitGuide
Smiling instead of Smoking
SiS-H
positive psychology
mHealth
QUIT
Life Steps
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-06-02
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-group pilot randomized controlled trial
Primary purpose: OTHER

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".

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 18+ 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

Exclusion Criteria:

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

Primary outcomes:
measure: App usage
timeFrame: Continuously logged in the app from baseline (2 weeks pre-quit) to end of treatment (6 weeks post-quit).
Secondary outcomes:
measure: Time spent applying content
timeFrame: Measured at week 4 (2 weeks post-quit) and week 8 (6-weeks post-quit)
measure: Expected app usage
timeFrame: Assessed at end of treatment (6 weeks post-quit)
measure: Use of smoking cessation strategies
timeFrame: Assessed at end of treatment (6 weeks post-quit)
measure: Satisfaction with smoking cessation support
timeFrame: Assessed at end of treatment (6 weeks post-quit)
measure: App usability rating, System Usability Scale (SUS)
timeFrame: Assessed at end of treatment (6 weeks post-quit)
measure: User mobile application rating (uMARS)
timeFrame: Assessed at end of treatment (6 weeks post-quit)
measure: Smoking Self-Efficacy Questionnaire (SEQ-12)
timeFrame: Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)
measure: Positive affect - Positive and Negative Affect Schedule (PANAS)
timeFrame: Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)
measure: Negative affect - Positive and Negative Affect Schedule (PANAS)
timeFrame: Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)
measure: Brief Questionnaire of Smoking Urges (QSU)
timeFrame: Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)
measure: Attitudes Towards Smoking Scale (ATS) - adverse effects of smoking sub-scale
timeFrame: Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)
measure: Attitudes Towards Smoking Scale (ATS) - psychoactive benefits of smoking sub-scale
timeFrame: Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)
measure: Attitudes Towards Smoking Scale (ATS) - pleasure of smoking sub-scale
timeFrame: Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)
measure: Decisional Balance Inventory (DBI) for Smoking - negative expectancies sub-scale
timeFrame: Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)
measure: Decisional Balance Inventory (DBI) for Smoking - positive expectancies subscale
timeFrame: Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)
measure: Modified version of the Twenty Statements Test
timeFrame: Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)
Other outcomes:
measure: 30-day point prevalence abstinence (PPA) - self-reported
timeFrame: Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)
measure: 30-day point prevalence abstinence (PPA) - biochemically verified
timeFrame: Measured at baseline and week 20 (3 months after end of treatment)
measure: HIV Medication Adherence
timeFrame: Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)
Locations:
city: Boston
country: United States
facility: Behavioral Medicine Program (BMED)
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Bettina Hoeppner, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Cox LS, Tiffany ST, Christen AG. Evaluation of the brief questionnaire of smoking urges (QSU-brief) in laboratory and clinical settings. Nicotine Tob Res. 2001 Feb;3(1):7-16. doi: 10.1080/14622200020032051.
citation: 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.
citation: Etter JF, Humair JP, Bergman MM, Perneger TV. Development and validation of the Attitudes Towards Smoking Scale (ATS-18). Addiction. 2000 Apr;95(4):613-25. doi: 10.1046/j.1360-0443.2000.95461312.x.
citation: Fredrickson BL, Branigan C. Positive emotions broaden the scope of attention and thought-action repertoires. Cogn Emot. 2005 May 1;19(3):313-332. doi: 10.1080/02699930441000238.
citation: Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.
citation: Stoyanov SR, Hides L, Kavanagh DJ, Wilson H. Development and Validation of the User Version of the Mobile Application Rating Scale (uMARS). JMIR Mhealth Uhealth. 2016 Jun 10;4(2):e72. doi: 10.2196/mhealth.5849.
citation: Ward RM, Velicer WF, Rossi JS, Fava JL, Prochaska JO. Factorial invariance and internal consistency for the decisional balance inventory--short form. Addict Behav. 2004 Jul;29(5):953-8. doi: 10.1016/j.addbeh.2004.02.042.
citation: Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
citation: Wilson IB, Lee Y, Michaud J, Fowler FJ Jr, Rogers WH. Validation of a New Three-Item Self-Report Measure for Medication Adherence. AIDS Behav. 2016 Nov;20(11):2700-2708. doi: 10.1007/s10461-016-1406-x.