HIV/AIDS, Smoking Cessation, Tobacco Use Disorder
Conditions
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.
Interventions
DEVICELearn 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.
BEHAVIORALQuitGuide
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines.
DRUGNicotine patch
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.
BEHAVIORALSmartphone coaching
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.
Sponsors
National Institutes of Health (NIH)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| App Usability as Measured by the Systems Usability Scale | 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. |
| Frequency of App Use as Measured by Interactions Per Day | 3 months | Average frequency of app use per arm over participants' 3 months of study participation. |
| Participant Attrition at One Month | 1 month | Number of participants lost to follow-up at one month. |
| Participant Attrition at Two Months | 2 months | Number of participants lost-to-follow-up at two months. |
| Participant Attrition at Three Months | 3 month | Number of participants lost-to-follow-up at three months. |
| Recruitment as Measured by the Proportion of Goal Participants Consented | 1 year | Number of participants consented divided by goal of consenting 60 participants. |
| Duration of Daily App Use | 3 months | Average duration of app use per arm over participants' 3 months of study participation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Quit Attempts | 1 month | Quit attempts defined as self-reported no smoking at all for 24 hours; assessed via a Timeline Followback procedure. |
| 7-day Point Prevalence Abstinence | 1 month | 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. |
| Overall Adherence to Nicotine Replacement Therapy | baseline to 3 months | 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. |
| Number of Participants With at Least One Adverse Event Determined to be Related to the Study Interventions | 3 months | Adverse events reported here will only include those that are determined to be related to the study interventions. |
| Reduction in Cigarettes Smoked Per Day | 3 months | 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. |
Countries
United States
Participant flow
Recruitment details
51 subjects completed the informed consent process at the screening visit. Eight of these subjects did not pass screen. Therefore, only 43 of these subjects had passed screen and started the study protocol by being assigned to one of the two condition arms.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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.
Nicotine patch: 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.
Smartphone coaching: 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. | 22 |
| QuitGuide A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS 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.
QuitGuide: A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines.
Nicotine patch: 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.
Smartphone coaching: 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. | 21 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 4 |
| Overall Study | Withdrawal by PI | 0 | 2 |
Baseline characteristics
| Characteristic | Learn to Quit-HIV | Total | QuitGuide |
|---|---|---|---|
| Age, Continuous | 48.59 years STANDARD_DEVIATION 11.12 | 50.60 years STANDARD_DEVIATION 10.29 | 52.91 years STANDARD_DEVIATION 8.97 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 41 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 20 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 22 Participants | 11 Participants |
| Region of Enrollment United States | 22 Participants | 43 Participants | 21 Participants |
| Sex: Female, Male Female | 5 Participants | 12 Participants | 7 Participants |
| Sex: Female, Male Male | 17 Participants | 31 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 21 |
| other Total, other adverse events | 6 / 22 | 5 / 21 |
| serious Total, serious adverse events | 0 / 22 | 0 / 21 |
Outcome results
Primary
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.
Population: Two participants from the LTQ arm did not complete the week 4 visit, thus this measure was not obtained. Two participants were withdrawn from Quit Guide after randomization. Three participants from the NCI Quit Guide arm did not complete the week 4 visit, thus this measure was not obtained.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit-HIV | App Usability as Measured by the Systems Usability Scale | 73 score on a scale | Standard Deviation 16.3 |
| QuitGuide | App Usability as Measured by the Systems Usability Scale | 78 score on a scale | Standard Deviation 15.6 |
p-value: 0.39Robust Yuen's test
Primary
Duration of Daily App Use
Average duration of app use per arm over participants' 3 months of study participation
Time frame: 3 months
Population: 7 participants from LTQ arm were excluded from the dataset due to technical/mechanical failure to provide Firebase data. 2 participants were removed from the NCI Quit guide arm due to PI withdrawal.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Learn to Quit-HIV | Duration of Daily App Use | 12 minutes |
| QuitGuide | Duration of Daily App Use | 1.05 minutes |
p-value: 0.51Wilcoxon Rank Sum Test
Primary
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
Population: 7 participants from LTQ arm were excluded from the dataset due to technical/mechanical failure to provide Firebase data. 2 participants were removed from the NCI Quit guide arm due to PI withdrawal.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit-HIV | Frequency of App Use as Measured by Interactions Per Day | 1.91 interactions per day | Standard Deviation 5.3 |
| QuitGuide | Frequency of App Use as Measured by Interactions Per Day | 1.21 interactions per day | Standard Deviation 5.26 |
p-value: <0.001Wilcoxon Rank Sum Test
Primary
Participant Attrition at One Month
Number of participants lost to follow-up at one month.
Time frame: 1 month
Population: Two participants were withdrawn from QuitGuide after randomization.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit-HIV | Participant Attrition at One Month | 2 Participants |
| QuitGuide | Participant Attrition at One Month | 5 Participants |
Primary
Participant Attrition at Three Months
Number of participants lost-to-follow-up at three months.
Time frame: 3 month
Population: Two participants were withdrawn from QuitGuide after randomization.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit-HIV | Participant Attrition at Three Months | 7 Participants |
| QuitGuide | Participant Attrition at Three Months | 7 Participants |
Primary
Participant Attrition at Two Months
Number of participants lost-to-follow-up at two months.
Time frame: 2 months
Population: Two participants were withdrawn from QuitGuide after randomization.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit-HIV | Participant Attrition at Two Months | 4 Participants |
| QuitGuide | Participant Attrition at Two Months | 7 Participants |
Primary
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
Population: Target sample size represents the numerator which allows us to calculate the proportion of enrolled participants (n=51) relative to the target goal (N=60). Enrolled participants are those who were consented, however not all consented participants progressed to the next step of study procedure where they would be randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Learn to Quit-HIV | Recruitment as Measured by the Proportion of Goal Participants Consented | 0.85 proportion of goal participants |
Secondary
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
Population: The Intention to Treat sample was utilized for this outcome. Two participants were withdrawn from QuitGuide after randomization. Lost to follow up participants were assumed to have maintained their smoking status.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit-HIV | 7-day Point Prevalence Abstinence | 18.2 percentage of participants | Standard Deviation 0.395 |
| QuitGuide | 7-day Point Prevalence Abstinence | 15.8 percentage of participants | Standard Deviation 0.375 |
p-value: 0.839295% CI: [0.23, 6.119]Regression, Logistic
Secondary
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
Population: Data not collected.
Secondary
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
Population: Two participants were withdrawn from QuitGuide after randomization. All participants who were randomized were included in the analysis as total population that could have reported adverse events related to the study during their enrollment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit-HIV | Number of Participants With at Least One Adverse Event Determined to be Related to the Study Interventions | 3 Participants |
| QuitGuide | Number of Participants With at Least One Adverse Event Determined to be Related to the Study Interventions | 2 Participants |
Secondary
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
Population: Participants who completed a Timeline Followback were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit-HIV | Number of Quit Attempts | 1.86 quit attempts | Standard Deviation 1.68 |
| QuitGuide | Number of Quit Attempts | 2.50 quit attempts | Standard Deviation 1.38 |
p-value: 0.51Wilcoxon rank sum test
Secondary
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
Population: Participants who completed a Timeline Followback were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit-HIV | Number of Quit Attempts | 1.89 quit attempts | Standard Deviation 1.45 |
| QuitGuide | Number of Quit Attempts | 1.30 quit attempts | Standard Deviation 0.82 |
p-value: 0.478Wilcoxon rank sum test
Secondary
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
Population: Two participants from LTQ arm did not complete the measure. Two participants were withdrawn from QuitGuide after randomization. Four participants from QuitGuide arm did not complete the measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Learn to Quit-HIV | Overall Adherence to Nicotine Replacement Therapy | 31.8 percentage of participants |
| QuitGuide | Overall Adherence to Nicotine Replacement Therapy | 31.6 percentage of participants |
p-value: 1Pearson's Chi-squared test
Secondary
Reduction in Cigarettes Smoked Per Day
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
Population: Two participants were withdrawn from QuitGuide after randomization. From the LTQ arm, one participant did not complete the measure. From the NCI QuitGuide arm, two participants did not complete the measure and one participant's responses were unusable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit-HIV | Reduction in Cigarettes Smoked Per Day | 11.1 reduction in cigarettes per day | Standard Deviation 4.91 |
| QuitGuide | Reduction in Cigarettes Smoked Per Day | 9.2 reduction in cigarettes per day | Standard Deviation 5.92 |
p-value: 0.4Robust Yuen's test