Randomized Pilot Study of a mHealth App for Ambivalent Smokers Living With HIV

March 28, 2024 updated by: Jennifer McClure, Kaiser Permanente

Design and Testing of a mHealth App for Ambivalent Smokers Living With HIV: A Randomized Pilot Study

This pilot study will assess the acceptability and feasibility a novel mHealth app designed for smokers who are ambivalent about quitting and have been diagnosed with HIV.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will use a randomized, parallel, two-arm trial to compare outcomes between people assigned to use a "standard care" mHealth app versus a similar app with additional content targeted to people living with HIV. A total of up to 50 people will be enrolled and followed for three months to assess outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98101
        • Kaiser Permanente WA Health Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria Include:

  • 18 years of age or older;
  • Comfortable speaking and reading in English;
  • Smoked at least 100 cigarettes in their lifetime;
  • Smoked, even a puff, in the past 7 days;
  • Smoked at least 5 cigarettes a day;
  • Are interested in quitting smoking someday, but not in the next month;
  • Have an iPhone Operating System (iOS) or Android smart phone which they use at least weekly;
  • Are willing to upgrade their phone operating system, if needed;
  • Agree to download and try the app;
  • Do not use Virtual Private Network (VPN) on their smart phone;
  • Live in the United States and have a valid U.S.-based mailing address and phone number;
  • Have been diagnosed with HIV

Exclusion Criteria Include:

  • Refusing to answer all screening questions
  • History of dementia or psychosis
  • Visual impairments that preclude their ability to view content on their smart phone and lack adaptive devices to view content
  • Contraindications for nicotine replacement therapy (NRT) use (e.g., based on medical history or daily smoking level)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control
mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.
Device: mHealth Intervention
Mobile health (mHealth) app to motivate and support quitting smoking.
Experimental: Experimental
mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.
Device: mHealth Intervention
Mobile health (mHealth) app to motivate and support quitting smoking.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intervention (App) Utilization
Time Frame: 3 months post-enrollment
Number of unique app user-sessions
3 months post-enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
App Installation and Use
Time Frame: 3 month follow-up
Number of people in each study arm who installed the assigned app and used it at least one time. These people were included in the analytic cohort used to analyze all other study outcomes.
3 month follow-up
App Utilization - Cumulative Days of Use
Time Frame: 3 month follow-up
Cumulative number of days between the first and last use of the assigned app
3 month follow-up
Self-reported 24-hour Quit Attempt
Time Frame: 3 months post-enrollment
At least one intentional smoking quit attempt lasting at least 24 hours. Missing outcomes imputed as not making a quit attempt.
3 months post-enrollment
Satisfaction With App Content and Advice
Time Frame: 1 month follow-up
Satisfaction with the overall "content and advice" of the assigned app, rated on a Likert scale from 1="not at all satisfied" to 5="extremely satisfied".
1 month follow-up
Satisfaction With App Content and Advice
Time Frame: 3 month follow-up
Satisfaction with the overall "content and advice" of the assigned app, rated on a Likert scale from 1="not at all satisfied" to 5="extremely satisfied".
3 month follow-up
Earned Nicotine Replacement Therapy (NRT)
Time Frame: 3 month follow-up
Positive indicator if participants earn minimum number of badges required to receive free nicotine replacement therapy
3 month follow-up
Not Smoking (Even a Puff) in the Last 7 Days
Time Frame: 3-months post-enrollment
7-day point prevalent abstinence: self-report of not smoking, even a puff, in the last 7 days. Missing values were imputed as smoking.
3-months post-enrollment
Proportion Who Request Nicotine Replacement Therapy
Time Frame: 3 month follow-up
Among participants eligible to receive free nicotine replacement therapy based on their app use, how many request it in each study arm.
3 month follow-up
Number of Cigarettes Smoked Per Day
Time Frame: 1 month follow-up
Self-reported average number of cigarettes smoked per day at follow-up
1 month follow-up
Number of Cigarettes Smoked Per Day
Time Frame: 3 month follow-up
Self-reported average number of cigarettes smoked per day at follow-up
3 month follow-up
Motivation for Quitting Smoking
Time Frame: 1 month follow-up
Self-reported motivation for quitting smoking or remaining quit assessed using a 10 point Likert scale from 1=not at all to 10=extremely.
1 month follow-up
Motivation for Quitting Smoking
Time Frame: 3 month follow-up
Self-reported motivation for quitting smoking or remaining quit assessed using a 10 point Likert scale from 1=not at all to 10=extremely.
3 month follow-up
Self-efficacy for Quitting Smoking
Time Frame: 1 month follow-up
Self-reported confidence in one's ability to quit smoking assessed using a 10 point Likert scale item ranging from 1=not at all to 10=extremely.
1 month follow-up
Self-efficacy for Quitting Smoking
Time Frame: 3 month follow-up
Self-reported confidence in one's ability to quit smoking assessed using a 10 point Likert scale item ranging from 1=not at all to 10=extremely.
3 month follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Utilization - Personal Experiments
Time Frame: 3 month follow-up
Number of "personal experiment" exercises completed in the experimental arm out of a maximum of 10.
3 month follow-up
Quit Guide Participation
Time Frame: 3 month follow-up
Earning at least one badge from the quit guide (one possible with each of 6 steps to the quit guide).
3 month follow-up
Quit Guide Completion
Time Frame: 3 month follow-up
Earning all 6 badges possible from the quit guide (one badge earned for each of 6 total steps completed).
3 month follow-up
Cigarette Tracker Use
Time Frame: 3 month follow-up
Use of the cigarette tracker tool (earning the badge for use).
3 month follow-up
Savings Calculator Use
Time Frame: 3 month follow-up
Use of the savings calculator tool (earning the badge for use).
3 month follow-up
Read Peer Testimonials
Time Frame: 3 month follow-up
Indication that each provided peer testimonial on how to talk back to common excuses for not quitting was opened and viewed.
3 month follow-up
Read Peer Advice
Time Frame: 3 month follow-up
Indication that each page of the peer advice and motivational support vignette was opened and viewed.
3 month follow-up
Journal Opened
Time Frame: 3 month follow-up
Indication the journal was opened at least one time.
3 month follow-up
Use of More Help Feature
Time Frame: 3 month follow-up
Indication the More Help page (with contact information for a tobacco quit-line and more resources for quitting smoking) was viewed at least one time
3 month follow-up
Completing "Just the Facts" Toolbox Component
Time Frame: 3 month follow-up
Completing and earning the badge for the "just the facts" toolbox component; only available to the experimental arm.
3 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaiser Permanente

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer McClure, PhD, Kaiser Permanente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 2, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R21CA261199 (U.S. NIH Grant/Contract)

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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