Early-phase Studies of a Tailored Evidence-Based Smoking Cessation mHealth App for Persons Living With HIV
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Duke University
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Participant Attrition at Three Months
Study Overview
Brief Summary
The study team will conduct a feasibility, acceptability, and preliminary efficacy trial comparing Learn to Quit-HIV (n=30) to an app based on U.S. Clinical Practice Guidelines only (NCI QuitGuide; n=30) among HIV-positive smokers. Both apps will be integrated with NRT and ongoing HIV clinical care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •HIV-positive
- •Currently engaged with an HIV care provider
- •Self-report smoking 5 cigarettes or more per day during the past 30 days
- •Age 18 years or older
- •Current interest in quitting smoking
- •Currently own a functioning Android or Apple smartphone
Exclusion Criteria
- •No desire to quit smoking
- •Inability to attend study sessions
- •Inability to provide informed consent
- •Any medical condition or concomitant medication that could compromise subject safety or treatment, as determined by the Principal Investigators and/or Study Physician
- •Presence of contraindications for nicotine patch
- •Previous allergic reaction or hypersensitivity to nicotine patch (lifetime)
- •Current use of nicotine replacement therapy or other smoking cessation treatment (e.g., bupropion, varenicline)
- •Pregnant, planning to become pregnant, nursing, or becoming pregnant during the study
- •Current untreated and unstable diagnosis of alcohol/substance abuse or dependence (eligible if past abuse/dependence and if receiving treatment and stable for >30 days)
Arms & Interventions
Learn to Quit-HIV
A smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches, along with technical smartphone coaching for the first 4 weeks of the study.
Intervention: Learn to Quit-HIV (Device)
Learn to Quit-HIV
A smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches, along with technical smartphone coaching for the first 4 weeks of the study.
Intervention: Nicotine patch (Drug)
Learn to Quit-HIV
A smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches, along with technical smartphone coaching for the first 4 weeks of the study.
Intervention: Smartphone coaching (Behavioral)
QuitGuide
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS (United States Department of Health and Human Services) Clinical Practice Guidelines. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches, along with technical smartphone coaching for the first 4 weeks of the study.
Intervention: QuitGuide (Behavioral)
QuitGuide
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS (United States Department of Health and Human Services) Clinical Practice Guidelines. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches, along with technical smartphone coaching for the first 4 weeks of the study.
Intervention: Nicotine patch (Drug)
QuitGuide
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS (United States Department of Health and Human Services) Clinical Practice Guidelines. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches, along with technical smartphone coaching for the first 4 weeks of the study.
Intervention: Smartphone coaching (Behavioral)
Outcomes
Primary Outcomes
Participant Attrition at Three Months
Time Frame: 3 month
Number of participants lost-to-follow-up at three months.
Frequency of App Use as Measured by Interactions Per Day
Time Frame: 3 months
Average frequency of app use per arm over participants' 3 months of study participation.
App Usability as Measured by the Systems Usability Scale
Time Frame: 1 month or next available time point if participant completed the measure at 3 months.
Average app usability scores as measured by the Systems Usability Scale. The scale has a score range of 0 to 100 with higher scores representing better outcomes.
Participant Attrition at One Month
Time Frame: 1 month
Number of participants lost to follow-up at one month.
Participant Attrition at Two Months
Time Frame: 2 months
Number of participants lost-to-follow-up at two months.
Recruitment as Measured by the Proportion of Goal Participants Consented
Time Frame: 1 year
Number of participants consented divided by goal of consenting 60 participants.
Duration of Daily App Use
Time Frame: 3 months
Average duration of app use per arm over participants' 3 months of study participation
Secondary Outcomes
- Reduction in Cigarettes Smoked Per Day(3 months)
- Number of Quit Attempts(3 months)
- 7-day Point Prevalence Abstinence(3 months)
- Number of Participants With at Least One Adverse Event Determined to be Related to the Study Interventions(3 months)
- Overall Adherence to Nicotine Replacement Therapy(baseline to 3 months)