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:
To test the feasibility and acceptability of the SiS-H integrated treatment to
support people with HIV in quitting smoking.
To test the efficacy of the integrated SiS-H treatment to have a positive impact on
variables relevant to the process of quitting smoking.
(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.
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.
Feasibility (secondary outcomes): The investigators hypothesize that SiS-H treatment
will be feasible, as measured in the following ways:
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
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)
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
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:
Satisfaction with smoking cessation support (Client Satisfaction Questionnaire
(CSQ-8))
App system usability (System Usability Scale (SUS))
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:
Smoking cessation self-efficacy as measured by the Smoking Self-Efficacy
Questionnaire (SEQ-12); higher self-efficacy is considered 'better'
Craving, as measured by the Brief Questionnaire of Smoking Urges (QSU-Brief); lower
craving is considered 'better'
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.