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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03999411
• Other study ID #: 20190181
• Status: Completed
• Phase: Phase 4
• Start date: September 9, 2019
• Est. completion date: October 14, 2020

Study information

• Verified date: March 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 14, 2020
• Est. primary completion date: October 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Smoking
• Smoking Cessation

Intervention

Drug:
• Nicoderm C-Q Transdermal Product
6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)

Behavioral:
• Adherence to Antiretroviral Therapy Counseling
Brief counseling on adhering to antiretroviral therapy with self-help materials.
• Behavioral Smoking Cessation Counseling
One time face-to-face smoking cessation counseling and 2 follow-up phone calls.
• "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.
• 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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Smoking Cessation	Participants who self-report seven days of non-smoking.	Up to 3 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Secondary	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
Secondary	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