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

A Novel Smartphone-based Intervention to Support Smoking Cessation and Adherence to Antiretroviral Therapy Among People Living With HIV: A Pilot Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Smoking Cessation; HIV
• Intervention / Treatment: 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

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).

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Usual Care; 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.	Drug: Nicoderm C-Q Transdermal Product; 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT); Other Names: NRT; Behavioral: Adherence to Antiretroviral Therapy Counseling; Brief counseling on adhering to antiretroviral therapy with self-help materials.
Active Comparator: Smoking cessation only intervention; 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.	Drug: Nicoderm C-Q Transdermal Product; 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT); Other Names: NRT; Behavioral: Adherence to Antiretroviral Therapy Counseling; Brief counseling on adhering to antiretroviral therapy with self-help materials.; Behavioral: Behavioral Smoking Cessation Counseling; One time face-to-face smoking cessation counseling and 2 follow-up phone calls.; Behavioral: "Crave-to-Quit" app; Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.
Experimental: Combined smoking cessation and HIV intervention; 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.	Drug: Nicoderm C-Q Transdermal Product; 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT); Other Names: NRT; Behavioral: Adherence to Antiretroviral Therapy Counseling; Brief counseling on adhering to antiretroviral therapy with self-help materials.; Behavioral: Behavioral Smoking Cessation Counseling; One time face-to-face smoking cessation counseling and 2 follow-up phone calls.; Behavioral: "Crave-to-Quit" app; Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.; Behavioral: vDOT "emocha" app; Video Directly Observed Therapy (vDOT) smartphone app ("emocha") that allows participants to take a video of themselves taking medication to ensure adherence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Smoking Cessation	Participants who self-report seven days of non-smoking.	Up to 3 months
Usability of Intervention Questionnaire Score	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.	3 months
Acceptability of Intervention Questionnaire Scores	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.	3 months
Number of Participants Reporting Engagement With the Intervention	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.	Up to 3 months
Feasibility of Delivery	The feasibility of delivery will be assessed via evaluating the: eligible, defined as number of participants eligible out of total screened; recruitment rate, defined as number of participants enrolled out of total screened; total completing all study activities, defined as the number of participants completing all activities out of total enrolled	At screening through study completion (up to 3 months)
Number of Participants With ≥ 95% Adherence to ART Medication Based on the Visual Analogue Scale	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Reported Relapse	Number of participants who have smoked at least once per week on two consecutive weeks after smoking cessation was confirmed.	Up to 3 months
Number of Cigarettes Smoked Per Day	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.	At baseline and at 3 months

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Taghrid Asfar, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Actual): October 14, 2020
• Study Completion (Actual): October 14, 2020

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: June 24, 2019
• First Posted (Actual): June 26, 2019

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: smartphone; nicotine replacement therapy; antiretroviral
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Antiviral Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine; Anti-Retroviral Agents
• Other Study ID Numbers: 20190181

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No