Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 26, 2021
Date Accepted: Sep 3, 2021
Evaluating the Efficacy of Automated Smoking Treatment for People with HIV: Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
Smoking prevalence rates among people with HIV are nearly 3 times higher than rates in the general population. Nevertheless, few smoking cessation trials targeting smokers with HIV appear in the literature. Efforts to develop and evaluate sustainable, low-cost, and evidence-based cessation interventions for people with HIV are needed. Given the widespread proliferation of mobile phones, the potential of using mHealth apps to improve the reach and efficacy of cessation interventions is promising, but evidence of efficacy is lacking, particularly among people with HIV.
Objective:
This study will consist of a 2-group randomized controlled trial to evaluate a fully-automated smartphone intervention for people with HIV seeking cessation treatment.
Methods:
Participants (N=500) will be randomized to receive either Standard Treatment (ST, n=250) or Automated Treatment (AT, n=250). ST participants will be connected to the Florida Quitline and will receive nicotine replacement therapy (NRT) in the form of transdermal patches and lozenges. This approach, referred to as Ask Advise Connect (AAC), was developed by our team and has been implemented in numerous health systems. ST will be compared to AT, a fully-automated behavioral treatment approach. AT participants will receive NRT and an interactive smartphone-based intervention that comprises individually-tailored audio/video and text content. The major goal is to determine whether AT performs better—in terms of facilitating long-term smoking abstinence—than the more resource-intensive ST approach. Our primary aim is to evaluate the efficacy of AT for facilitating smoking cessation among people with HIV. As secondary aims, we will explore potential mediators and moderators and conduct economic evaluations to assess the cost and cost-effectiveness of AT compared to ST.
Results:
The intervention content has been developed and finalized. Recruitment and enrollment will begin in the summer of 2021.
Conclusions:
There is a critical need for efficacious, cost-effective, and sustainable cessation treatments for people with HIV who smoke. The AT intervention was designed to help fill this need. If efficacy is established, the AT approach will be readily adoptable by HIV clinics and community-based organizations, and it will offer an efficient way to allocate limited public health resources to tobacco control interventions. Clinical Trial: NCT05014282
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