Design and Testing of a mHealth App for Ambivalent Smokers Living with HIV: A Randomized Pilot Study

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PROJECT SUMMARY 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.