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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
A smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines.
All participants will receive an 8-week course of nicotine patches. They will start off with 4 weeks of 21mg/24 hours patches, then move to 2 weeks of 14mg/24 hours patches, and finally end with 2 weeks of 7mg/24 hours patches.
Duke University
Durham, North Carolina, United States
Duration of Daily App Use
Average duration of app use per arm over participants' 3 months of study participation
Time frame: 3 months
Frequency of App Use as Measured by Interactions Per Day
Average frequency of app use per arm over participants' 3 months of study participation.
Time frame: 3 months
Participant Attrition at One Month
Number of participants lost to follow-up at one month.
Time frame: 1 month
Participant Attrition at Two Months
Number of participants lost-to-follow-up at two months.
Time frame: 2 months
Participant Attrition at Three Months
Number of participants lost-to-follow-up at three months.
Time frame: 3 month
Recruitment as Measured by the Proportion of Goal Participants Consented
Number of participants consented divided by goal of consenting 60 participants.
Time frame: 1 year
App Usability as Measured by the Systems Usability Scale
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.
Time frame: 1 month or next available time point if participant completed the measure at 3 months.
Reduction in Cigarettes Smoked Per Day
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
All participants will partake in over-the-phone smartphone coaching lead by the PI or a research assistant. This will be a time for participants to bring up any technical issues they are experiencing with the study smartphone or app.
Change in cigarettes smoked per day from baseline to the 12-week follow up. Cigarettes smoked per day are measured with a self-report item at baseline and at the 3-month follow up. This outcome is calculated as the difference between cigarettes smoked per day at baseline and the cigarettes smoked per day at the 3 month timepoint. A positive and large values in this outcome indicate larger reductions in cigarettes smoked per day per group, indicating a more positive outcome. A negative and large value indicate an increase in cigarettes smoked per day per group, indicating a clinically negative outcome.
Time frame: 3 months
Number of Quit Attempts
Quit attempts defined as self-reported no smoking at all for 24 hours; assessed via a Timeline Followback procedure.
Time frame: 1 month
Number of Quit Attempts
Quit attempts defined as self-reported no smoking at all for 24 hours; assessed via a Timeline Followback procedure.
Time frame: 3 months
7-day Point Prevalence Abstinence
Percent of subjects in each group reporting 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking any tobacco product at all during the corresponding time frame period, AND by a result of less than 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, or if they do not provide data at the time-point they are not considered abstinent.
Time frame: 1 month
7-day Point Prevalence Abstinence
Percent of subjects in each group reporting 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking any tobacco product at all during the corresponding time frame period, AND by a result of less than 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, or if they do not provide data at the time-point they are not considered abstinent.
Time frame: 3 months
Overall Adherence to Nicotine Replacement Therapy
Reported as percent of participants who used the patch at least 80% of the days of the required 8 weeks. Adherence determined by timeline follow back interview.
Time frame: baseline to 3 months
Number of Participants With at Least One Adverse Event Determined to be Related to the Study Interventions
Adverse events reported here will only include those that are determined to be related to the study interventions.
Time frame: 3 months