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

NCT03999411 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20190181
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Smoking Cessation; HIV

Keywords

nicotine replacement therapy; antiretroviral; smartphone

Outcome Measures

Primary Outcomes (6)

• Number of Participants With Smoking Cessation

  Participants who self-report seven days of non-smoking.

  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

• 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: 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

  At screening through study completion (up to 3 months)

Secondary Outcomes (2)

• Number of Participants With Reported Relapse

  Up to 3 months

• Number of Cigarettes Smoked Per Day

  At baseline and at 3 months

Study Arms (3)

Usual Care

PLACEBO COMPARATOR

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; Behavioral: Adherence to Antiretroviral Therapy Counseling

Smoking cessation only intervention

ACTIVE COMPARATOR

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; Behavioral: Adherence to Antiretroviral Therapy Counseling; Behavioral: Behavioral Smoking Cessation Counseling; Behavioral: "Crave-to-Quit" app

Combined smoking cessation and HIV intervention

EXPERIMENTAL

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; Behavioral: Adherence to Antiretroviral Therapy Counseling; Behavioral: Behavioral Smoking Cessation Counseling; Behavioral: "Crave-to-Quit" app; Behavioral: vDOT "emocha" app

Interventions

Nicoderm C-Q Transdermal Product DRUG

6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)

Also known as: NRT

Combined smoking cessation and HIV intervention; Smoking cessation only intervention; Usual Care

Adherence to Antiretroviral Therapy Counseling BEHAVIORAL

Brief counseling on adhering to antiretroviral therapy with self-help materials.

Combined smoking cessation and HIV intervention; Smoking cessation only intervention; Usual Care

Behavioral Smoking Cessation Counseling BEHAVIORAL

One time face-to-face smoking cessation counseling and 2 follow-up phone calls.

Combined smoking cessation and HIV intervention; Smoking cessation only intervention

"Crave-to-Quit" app BEHAVIORAL

Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.

Combined smoking cessation and HIV intervention; Smoking cessation only intervention

vDOT "emocha" app BEHAVIORAL

Video Directly Observed Therapy (vDOT) smartphone app ("emocha") that allows participants to take a video of themselves taking medication to ensure adherence.

Combined smoking cessation and HIV intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Smoking; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Results Point of Contact

• Title: Dr. Taghrid Asfar
• Organization: University of Miami

tasfar@med.miami.edu

305-243-3826

Study Officials

• Taghrid Asfar, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 26, 2019
• Study Start: September 9, 2019
• Primary Completion: October 14, 2020
• Study Completion: October 14, 2020
• Last Updated: March 28, 2024
• Results First Posted: December 2, 2021

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)