Trial Outcomes & Findings for Learn to Quit-HIV Pilot Study (NCT NCT04609514)
NCT ID: NCT04609514
Last Updated: 2023-10-19
Results Overview
Average duration of app use per arm over participants' 3 months of study participation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
3 months
Results posted on
2023-10-19
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
|
Overall Study
Per Protocol Week 4
|
20
|
14
|
|
Overall Study
Per Protocol Week 8
|
18
|
12
|
|
Overall Study
Per Protocol Week 12
|
15
|
12
|
|
Overall Study
Survey or Text Per Protocol Week 12
|
2
|
3
|
|
Overall Study
COMPLETED
|
17
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
|
Overall Study
Withdrawal by PI
|
0
|
2
|
Baseline Characteristics
Learn to Quit-HIV Pilot Study
Baseline characteristics by cohort
| Measure |
Learn to Quit-HIV
n=22 Participants
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.
|
QuitGuide
n=21 Participants
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.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.59 years
STANDARD_DEVIATION 11.12 • n=99 Participants
|
52.91 years
STANDARD_DEVIATION 8.97 • n=107 Participants
|
50.60 years
STANDARD_DEVIATION 10.29 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 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.
Average duration of app use per arm over participants' 3 months of study participation
Outcome measures
| Measure |
Learn to Quit-HIV
n=15 Participants
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.
|
QuitGuide
n=19 Participants
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.
|
|---|---|---|
|
Duration of Daily App Use
|
12 minutes
Interval 0.0 to 260.45
|
1.05 minutes
Interval 0.0 to 472.0
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 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.
Average frequency of app use per arm over participants' 3 months of study participation.
Outcome measures
| Measure |
Learn to Quit-HIV
n=15 Participants
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.
|
QuitGuide
n=19 Participants
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.
|
|---|---|---|
|
Frequency of App Use as Measured by Interactions Per Day
|
1.91 interactions per day
Standard Deviation 5.30
|
1.21 interactions per day
Standard Deviation 5.26
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Two participants were withdrawn from QuitGuide after randomization.
Number of participants lost to follow-up at one month.
Outcome measures
| Measure |
Learn to Quit-HIV
n=22 Participants
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.
|
QuitGuide
n=19 Participants
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.
|
|---|---|---|
|
Participant Attrition at One Month
|
2 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: Two participants were withdrawn from QuitGuide after randomization.
Number of participants lost-to-follow-up at two months.
Outcome measures
| Measure |
Learn to Quit-HIV
n=22 Participants
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.
|
QuitGuide
n=19 Participants
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.
|
|---|---|---|
|
Participant Attrition at Two Months
|
4 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 3 monthPopulation: Two participants were withdrawn from QuitGuide after randomization.
Number of participants lost-to-follow-up at three months.
Outcome measures
| Measure |
Learn to Quit-HIV
n=22 Participants
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.
|
QuitGuide
n=19 Participants
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.
|
|---|---|---|
|
Participant Attrition at Three Months
|
7 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 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.
Number of participants consented divided by goal of consenting 60 participants.
Outcome measures
| Measure |
Learn to Quit-HIV
n=60 Participants
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.
|
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.
|
|---|---|---|
|
Recruitment as Measured by the Proportion of Goal Participants Consented
|
0.85 proportion of goal participants
|
—
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Learn to Quit-HIV
n=20 Participants
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.
|
QuitGuide
n=14 Participants
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.
|
|---|---|---|
|
App Usability as Measured by the Systems Usability Scale
|
73 score on a scale
Standard Deviation 16.3
|
78 score on a scale
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Learn to Quit-HIV
n=16 Participants
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.
|
QuitGuide
n=11 Participants
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.
|
|---|---|---|
|
Reduction in Cigarettes Smoked Per Day
|
11.1 reduction in cigarettes per day
Standard Deviation 4.91
|
9.2 reduction in cigarettes per day
Standard Deviation 5.92
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Participants who completed a Timeline Followback were included in the analysis.
Quit attempts defined as self-reported no smoking at all for 24 hours; assessed via a Timeline Followback procedure.
Outcome measures
| Measure |
Learn to Quit-HIV
n=9 Participants
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.
|
QuitGuide
n=10 Participants
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.
|
|---|---|---|
|
Number of Quit Attempts
|
1.89 quit attempts
Standard Deviation 1.45
|
1.30 quit attempts
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants who completed a Timeline Followback were included in the analysis.
Quit attempts defined as self-reported no smoking at all for 24 hours; assessed via a Timeline Followback procedure.
Outcome measures
| Measure |
Learn to Quit-HIV
n=7 Participants
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.
|
QuitGuide
n=6 Participants
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.
|
|---|---|---|
|
Number of Quit Attempts
|
1.86 quit attempts
Standard Deviation 1.68
|
2.50 quit attempts
Standard Deviation 1.38
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Data not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Learn to Quit-HIV
n=22 Participants
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.
|
QuitGuide
n=19 Participants
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.
|
|---|---|---|
|
7-day Point Prevalence Abstinence
|
18.2 percentage of participants
Standard Deviation 0.395
|
15.8 percentage of participants
Standard Deviation 0.375
|
SECONDARY outcome
Timeframe: baseline to 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Learn to Quit-HIV
n=20 Participants
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.
|
QuitGuide
n=15 Participants
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.
|
|---|---|---|
|
Overall Adherence to Nicotine Replacement Therapy
|
31.8 percentage of participants
|
31.6 percentage of participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
Adverse events reported here will only include those that are determined to be related to the study interventions.
Outcome measures
| Measure |
Learn to Quit-HIV
n=22 Participants
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.
|
QuitGuide
n=19 Participants
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.
|
|---|---|---|
|
Number of Participants With at Least One Adverse Event Determined to be Related to the Study Interventions
|
3 Participants
|
2 Participants
|
Adverse Events
Learn to Quit-HIV
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
QuitGuide
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Learn to Quit-HIV
n=22 participants at risk
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.
|
QuitGuide
n=21 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Cough
|
9.1%
2/22 • 12 weeks
|
0.00%
0/21 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.5%
1/22 • 12 weeks
|
0.00%
0/21 • 12 weeks
|
|
Infections and infestations
COVID
|
4.5%
1/22 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
|
Endocrine disorders
Diabetes Diagnosis
|
4.5%
1/22 • 12 weeks
|
0.00%
0/21 • 12 weeks
|
|
Infections and infestations
Infection (dermis)
|
4.5%
1/22 • 12 weeks
|
0.00%
0/21 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Ache
|
4.5%
1/22 • 12 weeks
|
0.00%
0/21 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
9.1%
2/22 • 12 weeks
|
0.00%
0/21 • 12 weeks
|
|
Psychiatric disorders
Depression
|
4.5%
1/22 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
|
Psychiatric disorders
Anxiety
|
4.5%
1/22 • 12 weeks
|
0.00%
0/21 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Sweating
|
4.5%
1/22 • 12 weeks
|
0.00%
0/21 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
COPD Diagnosis
|
0.00%
0/22 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
|
General disorders
Headache
|
0.00%
0/22 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
|
Injury, poisoning and procedural complications
Muscle Pain
|
0.00%
0/22 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
|
Infections and infestations
Nasal congestion
|
0.00%
0/22 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
|
Nervous system disorders
Numbness/Tingling
|
0.00%
0/22 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
|
Surgical and medical procedures
Procedure
|
0.00%
0/22 • 12 weeks
|
4.8%
1/21 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place