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Completed

NCT Number: NCT03999411

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

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.

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Key information

Conditions

Smoking Behavior HIV Health Behavior Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami

Miami, Florida, 33136, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicoderm C-Q Transdermal Product

Drug

6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)

Other names: NRT

Adherence to Antiretroviral Therapy Counseling

Behavioral

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

Behavioral Smoking Cessation Counseling

Behavioral

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

"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.

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.

Primary outcomes

  1. Number of Participants With Smoking Cessation

    Time frame: Up to 3 months

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

  2. Number of Participants With ≥ 95% Adherence to ART Medication Based on the Visual Analogue Scale

    Time frame: 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.

  3. Usability of Intervention Questionnaire Score

    Time frame: 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.

  4. Acceptability of Intervention Questionnaire Scores

    Time frame: 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.

  5. Number of Participants Reporting Engagement With the Intervention

    Time frame: 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.

  6. Feasibility of Delivery

    Time frame: At screening through study completion (up to 3 months)

    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

Secondary outcomes

  1. Number of Participants With Reported Relapse

    Time frame: Up to 3 months

    Number of participants who have smoked at least once per week on two consecutive weeks after smoking cessation was confirmed.

  2. Number of Cigarettes Smoked Per Day

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 26, 2019
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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