Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients

Phase 4

Completed

• Conditions: Smoking; Smoking Cessation; HIV
• Interventions: Drug: Nicoderm C-Q Transdermal Product; Behavioral: Adherence to Antiretroviral Therapy Counseling; Behavioral: Behavioral Smoking Cessation Counseling; Behavioral: "Crave-to-Quit" app; Behavioral: vDOT "emocha" app

• Registration Number: NCT03999411
• Lead Sponsor: University of Miami

Brief Summary

The purpose of this study is to learn if a mindfulness-based smoking cessation smartphone app can help people quit smoking and stay on antiretroviral therapies.

Detailed Description

The current study aims to test the feasibility of a three-arm randomized clinical trial testing the combined mindfulness training + Emocha apps intervention versus the mindfulness training app only with brief advice to improve ART adherence and usual care (UC; brief advice to quit and improve ART adherence). Our primary hypothesis is that the combination of mindfulness training + Emocha apps would be superior to the mindfulness training app with brief advice to improve ART adherence, and these two interventions would be superior to the UC in terms of the feasibility, acceptability, and potential efficacy (3-month smoking cessation; improvement in adherence to ART).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-06-24
• Study First Submitted QC: 2019-06-24
• Study First Posted: 2019-06-26
• Study Start: 2019-09-09
• Primary Completion: 2020-10-14
• Study Completion: 2020-10-14
• Results First Submitted: 2021-10-05
• Results First Submitted QC: 2021-11-05
• Results First Posted: 2021-12-02
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• ≥ 18 years old
• Diagnosed with HIV
• Have been prescribed ART medication in the prior 6 months
• Have smoked ≥ 5 cigarettes/day in the past year
• Be interested in making a quit attempt in the next 30 days
• Own a smartphone (apple/android)and plan to keep it active for the following 3 months
• Read/speak English
• Be able to provide consent
• Have no plans to move in the next 3 months
• Not pregnant or planning to be pregnant in the following 3 months

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Exclusion Criteria

• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners
• Have contraindication to NRT (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder)
• Currently being treated for a psychiatric condition
• Currently being treated for smoking cessation, alcoholism, or illicit drug use

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Nicoderm C-Q Transdermal Product	Participants will receive brief advice to adhere to ART brief advice to quit smoking, 6-week supplies of nicotine-replacement therapy (NRT), and self-help materials to quit smoking and adhere to ART.
Usual Care	Adherence to Antiretroviral Therapy Counseling	Participants will receive brief advice to adhere to ART brief advice to quit smoking, 6-week supplies of nicotine-replacement therapy (NRT), and self-help materials to quit smoking and adhere to ART.
Smoking cessation only intervention	Nicoderm C-Q Transdermal Product	Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the "Crave-to-Quit" app, and two brief follow-up phone calls.
Smoking cessation only intervention	Adherence to Antiretroviral Therapy Counseling	Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the "Crave-to-Quit" app, and two brief follow-up phone calls.
Smoking cessation only intervention	Behavioral Smoking Cessation Counseling	Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the "Crave-to-Quit" app, and two brief follow-up phone calls.
Smoking cessation only intervention	"Crave-to-Quit" app	Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the "Crave-to-Quit" app, and two brief follow-up phone calls.
Combined smoking cessation and HIV intervention	Nicoderm C-Q Transdermal Product	Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication.
Combined smoking cessation and HIV intervention	Adherence to Antiretroviral Therapy Counseling	Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication.
Combined smoking cessation and HIV intervention	Behavioral Smoking Cessation Counseling	Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication.
Combined smoking cessation and HIV intervention	"Crave-to-Quit" app	Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication.
Combined smoking cessation and HIV intervention	vDOT "emocha" app	Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Smoking Cessation	Up to 3 months	Participants who self-report seven days of non-smoking.
Number of Participants With ≥ 95% Adherence to ART Medication Based on the Visual Analogue Scale	3 months	Number of participants with ≥ 95% Adherence to ART Medication Based on the Visual Analogue Scale ranging from 0 to 100%. The ART medication visual analogue scale is an instrument for patients to rate their dose taken percentages (≥ 95% of doses taken will be regarded as good adherence). Higher score (0 to 100%) indicates higher adherence to ART.
Usability of Intervention Questionnaire Score	3 months	The usability of the Craving-to Quit and Emocha apps will be assessed via a questionnaire with scores ranging from 0-10 with the higher score indicating increased comfortability with using the app.
Acceptability of Intervention Questionnaire Scores	3 months	The acceptability is be assessed by 3 items "How satisfied were you with the intervention?", "How likely are you to recommend this intervention to a friend?" and "How useful was the intervention?" Each question is scored from 0-10 with the higher score indicating increased acceptability.
Number of Participants Reporting Engagement With the Intervention	Up to 3 months	Participant engagement is evaluated via self-reported use of the Craving-to-Quit and Emocha apps. Participants will complete a questionnaire indicating how often they used the apps. The response categories include: Everyday, often, some days, not often, not at all. We report the number of participants in each category or combination of categories.
Feasibility of Delivery	At screening through study completion (up to 3 months)	The feasibility of delivery will be assessed via evaluating the: 1. eligible, defined as number of participants eligible out of total screened; 2. recruitment rate, defined as number of participants enrolled out of total screened; 3. total completing all study activities, defined as the number of participants completing all activities out of total enrolled

Secondary Outcome Measures

Name	Time	Method
Number of Cigarettes Smoked Per Day	At baseline and at 3 months	Self-reported number of cigarettes smoked per day by each participant (Q. On average, how many cigarettes do you smoke per day?) at baseline assessment and at 3-month assessment.
Number of Participants With Reported Relapse	Up to 3 months	Number of participants who have smoked at least once per week on two consecutive weeks after smoking cessation was confirmed.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States