||1R21CA261199-01 Interpret this number
||Kaiser Foundation Research Institute
||Design and Testing of a Mhealth App for Ambivalent Smokers Living with Hiv: a Randomized Pilot Study
Reducing smoking among PLWH is a recognized public health priority. Smoking rates are up to 2-3 times
higher among PLWH than in the general population and with the widespread adoption of antiretroviral therapy,
more smokers living with HIV (SLWH) now die from tobacco-related diseases than HIV. However, available
scientific evidence suggests that standard, evidence-based cessation treatments may not be adequate for
SLWH. Novel intervention strategies appear needed. Hence, NCI’s call for research proposals (RFA-CA-20-
036) “to develop and test adaptations of evidence-based smoking cessation interventions among people living
with HIV (PLWH).” This proposal is responsive to this call and will test two adaptions to standard, evidence-
based care. First, standard care will be augmented with information and design elements targeted to SLWH, to
better address their unique needs and concerns and increase the intervention appeal. Second, the intervention
will target SLWH who want to quit smoking someday, but who are not yet ready to quit. These “ambivalent
smokers” make up ~ 70% of all smokers, but they are typically excluded from treatment because they are not
ready to commit to quitting. However, there is sound theoretical and empirical support for intervening with
these smokers, particularly using disseminable strategies with low cost and wide-reach, such as mHealth apps.
The proposed study will build on our programmatic work developing motivational interventions, digital
health programs, and working with SLWH. The proposed experimental intervention combines evidence-based
treatment recommended by the US PHS Nicotine Dependence Treatment Guidelines (e.g., advice to quit,
referral to counseling, self-help guidance and nicotine replacement therapy) with theoretically-grounded and
empirically-based content tailored to ambivalent SLWH. This includes HIV-specific information about the risks
of smoking and benefits of quitting, tailored narrative testimonials, and a series of discrete behavioral
experiments designed to help ambivalent smokers clarify their goals for smoking reduction/quitting; build and
strengthen their motivation, confidence, and outcome expectations for quitting; and teach them the basic skills
necessary to cut back and quit smoking. Using user-centered (UX) design methodologies, we will iteratively
refine the proposed content and intervention design in collaboration with SLWH (n~20) who are ambivalent
about quitting. We will then partner with Kaiser Permanente developers to build the experimental app (for
Android and iOS) and assess its feasibility, acceptability, and potential efficacy compared to standard
evidence-based cessation treatment also delivered via mHealth app in a rigorous, parallel, two-arm,
randomized pilot study (n=50). Pilot participants will be recruited nationwide and followed for 3 months. If
ultimately effective, this novel intervention could be widely disseminated and promoted through health plans,
tobacco quitlines, AIDS service organizations and other public health agencies with access to ambivalent
SLWH, expanding intervention reach to this high-risk and often overlooked smoking population.
Commentary on Graham et al.: Biochemical verification of abstinence in remotely conducted smoking cessation trials should not be a universal design requirement for rigor.
, McClure J.B.
Addiction (Abingdon, England), 2022 Apr; 117(4), p. 1047-1048.