An Integrated mHealth App for Smoking Cessation in Black Smokers With HIV: Protocol for a Randomized Controlled Trial

Abstract

Background: Black adults who smoke and have HIV experience immense stressors (eg, racial discrimination and HIV stigma) that impede smoking cessation success and perpetuate smoking-related health disparities. These stressors also place Black adults who smoke and have HIV at an increased risk of elevated interoceptive stress (eg, anxiety and uncomfortable bodily sensations) and smoking to manage symptoms. In turn, this population is more likely to smoke to manage interoceptive stress, which contributes to worse HIV-related outcomes in this group. However, no specialized treatment exists to address smoking cessation, interoceptive stress, and HIV management for Black smokers with HIV.

Objective: This study aims to test a culturally adapted and novel mobile intervention that targets combustible cigarette smoking, HIV treatment engagement and adherence, and anxiety sensitivity (a proxy for difficulty and responsivity to interoceptive stress) among Black smokers with HIV (ie, Mobile Anxiety Sensitivity Program for Smoking and HIV [MASP+]). Various culturally tailored components of the app are being evaluated for their ability to help users quit smoking, manage physiological stress, and improve health care management.

Methods: This study is a pilot randomized controlled trial in which Black combustible cigarette smokers with HIV (N=72) are being recruited and randomly assigned to use either (1) the National Cancer Institute's QuitGuide app or (2) MASP+. Study procedures include a web-based prescreener; active intervention period for 6 weeks; smartphone-based assessments, including daily app-based ecological momentary assessments for 6 weeks (4 ecological momentary assessments each day); a video-based qualitative interview using Zoom Video Communications software at week 6 for participants in all study conditions; and smartphone-based follow-up assessments at 0, 1, 2 (quit date), 3, 4, 5, 6, and 28 weeks postbaseline (26 weeks postquitting date).

Results: Primary outcomes include biochemically verified 7-day point prevalence of abstinence, HIV-related quality of life, use of antiretroviral therapy, and HIV care appointment adherence at 26 weeks postquitting date. Qualitative data are also being collected and assessed to obtain feedback that will guide further tailoring of app content and evaluation of efficacy.

Conclusions: The results of this study will determine whether the MASP+ app serves as a successful aid for combustible cigarette smoking cessation, HIV treatment engagement, and physiological stress outcomes among Black people with HIV infection. If successful, this study will provide evidence for the efficacy of a new means of addressing major mental and physical health difficulties for this high-risk population. If the results are promising, the data from this study will be used to update and tailor the MASP+ app for testing in a fully powered randomized controlled trial that will evaluate its efficacy in real-world behavioral health and social service settings.

Trial registration: ClinicalTrials.gov NCT05709002; https://clinicaltrials.gov/study/NCT05709002.

International registered report identifier (irrid): PRR1-10.2196/52090.

Keywords: Black; HIV; anxiety sensitivity; just-in-time adaptive intervention; mHealth; mobile health; mobile phone; smoking cessation.

Figure 1

Mobile Anxiety Sensitivity Program for Smoking and HIV (MASP+) participant enrollment flowchart. Note: after initial eligibility screening, participants will complete an enrollment call, baseline survey, randomization call, postrandomization survey, 6-week ecological momentary assessment (EMA) period, monthly check-ins for 5 months, and a final survey and week of EMAs at week 28. iCO: iCarbon Monoxide.

Figure 2

Mobile Anxiety Sensitivity Program for Smoking and HIV (MASP+) app home screen. Note: app features include App Instructions, Treatment Videos, Coping Toolkit, Quit Tips, Stress Management Trainings, Order Patches/Lozenges, Record Stress, Record Cigarette About to Smoke, Record Cigarette I Already Smoked, Payment, and Weekly Survey Payment.

Figure 3

Mobile Anxiety Sensitivity Program for Smoking and HIV (MASP+) quit tips feature. Note: the Quit Tips button will bring participants to a screen where they can select to receive advice on the following topics: Nicotine Medication Tips; General Help for Quitting; Benefits of Quitting; Ways to Cope with Urges; Managing Stress/Mood; Motivate Me to Stay Quit; I’ve Slipped, Now What?; Harms of Smoking; and Coping with Others Smoking.

Figure 4

Mobile Anxiety Sensitivity Program for Smoking and HIV (MASP+) coping toolkit feature. Note: the Coping Toolkit button will bring participants to a screen where they can select to receive help with the following topics: Relaxation Exercises; Challenge Unhelpful Thoughts; How to Cope With Stress; I’m Bored, Distract Me; Coping With Discrimination; How to Improve My Treatment Outcomes; and Tips on Living With a Chronic Disease.