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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Aug 22, 2023
Date Accepted: Feb 14, 2024

The final, peer-reviewed published version of this preprint can be found here:

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

Bizier A, Jones A, Businelle M, Kezbers K, Hoeppner B, Giordano T, Gallagher M, Zvolensky M, Garey L

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

JMIR Res Protoc 2024;13:e52090

DOI: 10.2196/52090

PMID: 38657227

PMCID: 11079772

Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

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

  • Andre Bizier; 
  • Arielle Jones; 
  • Michael Businelle; 
  • Krista Kezbers; 
  • Bettina Hoeppner; 
  • Thomas Giordano; 
  • Matthew Gallagher; 
  • Michael Zvolensky; 
  • Lorra Garey

ABSTRACT

Background:

Black adults who smoke and have HIV face significant stressors (e.g., racial discrimination, HIV stigma) that impede successful smoking cessation attempts and perpetuate smoking-related health disparities. These stressors place Black adults who smoke and have HIV at increased risk of elevated interoceptive stress (e.g., anxiety, bodily sensations) and smoking to manage symptoms. In turn, this population experiences worse HIV-related outcomes. Yet, no specialized treatment exists to address smoking cessation and HIV disease management for Black smokers with HIV.

Objective:

The aim of this study is to test a culturally adapted, novel, mobile intervention that targets smoking outcomes, HIV treatment engagement/adherence, and anxiety sensitivity (AS; a proxy for difficulty and responsivity to interoceptive stress) among Black smokers with HIV (i.e., Mobile Anxiety Sensitivity Program for Smoking and HIV; MASP+). Various culturally tailored components of the app will be evaluated for their ability to help users to quit smoking, manage physiological stress, and improve healthcare management.

Methods:

The current study is a pilot randomized controlled trial in which Black smokers with HIV (N = 72) will be recruited from an HIV clinic and randomly assigned to use either: (1) the National Cancer Institute’s (NCI) QuitGuide app, or (2) MASP+. Study procedures include an online pre-screener, smartphone-based assessments, including daily app-based ecological momentary assessments (EMAs) for 6 weeks (4 EMAs each day), a phone-based qualitative interview 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 post-baseline (26 weeks post-quit).

Results:

Primary outcomes include biochemically-verified 7-day point prevalence abstinence, increased use of antiretroviral therapy, and improved attendance at HIV-related health appointments at 26 weeks post-quit. Qualitative data will also be collected and assessed to obtain feedback that will guide further tailoring of app content and evaluation of efficacy.

Conclusions:

Results of the present study will determine whether the MASP+ app serves as a successful aid for smoking cessation, treatment engagement, and physiological stress outcomes among Black people with HIV. 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 results prove promising, 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. Clinical Trial: This trial has been registered at clinicaltrials.gov (NCT: NCT05709002; Protocol ID: QKWEF8XLMTT3).


 Citation

Please cite as:

Bizier A, Jones A, Businelle M, Kezbers K, Hoeppner B, Giordano T, Gallagher M, Zvolensky M, Garey L

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

JMIR Res Protoc 2024;13:e52090

DOI: 10.2196/52090

PMID: 38657227

PMCID: 11079772

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