HIV/AIDSNCT04609514
Learn to Quit-HIV Pilot Study
A study testing Learn to Quit-HIV, QuitGuide and Nicotine patch in people with HIV/AIDS and Smoking Cessation, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, Smoking Cessation, Tobacco Use Disorder
- What is being tested?
- Learn to Quit-HIV, QuitGuide and Nicotine patch
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2021to 2 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early-phase Studies of a Tailored Evidence-Based Smoking Cessation mHealth App for Persons Living With HIV
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.
- Conditions
- HIV/AIDS, Smoking Cessation, Tobacco Use Disorder
- Being tested
- Learn to Quit-HIV, QuitGuide, Nicotine patch, Smartphone coaching
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Smoking Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learn to Quit-HIVDevice
Also called LTQ-H, LTQ-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.
QuitGuideBehavioural
Also called NCI QuitGuide
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines.
Nicotine patchDrug
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 coachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Learn to Quit-HIV | Experimental | 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. Receives: Device: Learn to Quit-HIV; Drug: Nicotine patch; Behavioral: Smartphone coaching |
| QuitGuide | Active comparator | 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. Receives: Behavioral: QuitGuide; Drug: Nicotine patch; Behavioral: Smartphone coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Daily App Use
Average duration of app use per arm over participants' 3 months of study participation
Measured: 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.
Measured: 3 months
Participant Attrition at One Month
Number of participants lost to follow-up at one month.
Measured: 1 month
Participant Attrition at Two Months
Number of participants lost-to-follow-up at two months.
Measured: 2 months
Participant Attrition at Three Months
Number of participants lost-to-follow-up at three months.
Measured: 3 month
Recruitment as Measured by the Proportion of Goal Participants Consented
Number of participants consented divided by goal of consenting 60 participants.
Measured: 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.
Measured: 1 month or next available time point if participant completed the measure at 3 months.
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start25 Jan 2021
- Primary completion2 Jun 2022
- Study completion2 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Lauren Pacek, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609514
- Sponsor's protocol ID
- Pro00104423
- Status last verified
- Oct 2023
- First submitted
- 22 Oct 2020
- Last updated
- 19 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early-phase Studies of a Tailored Evidence-Based Smoking Cessation mHealth App for Persons Living With HIV
- ClinicalTrials.gov ID
- NCT04609514
- Acronym / sponsor ID
- Pro00104423
- Conditions
- HIV/AIDS, Smoking Cessation, Tobacco Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 30 Oct 2020 (actual)
- Results
- Posted 19 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Learn to Quit-HIV | Experimental | Device: Learn to Quit-HIV, Drug: Nicotine patch, Behavioral: Smartphone coachingA 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. |
| QuitGuide | Active comparator | Behavioral: QuitGuide, Drug: Nicotine patch, Behavioral: Smartphone coachingA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Learn to Quit-HIVAlso: LTQ-H, LTQ-HIVA smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation. | Device | Learn to Quit-HIV |
| QuitGuideAlso: NCI QuitGuideA smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. | Behavioural | QuitGuide |
| Nicotine patchAll 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. | Drug | Learn to Quit-HIV, QuitGuide |
| Smartphone coachingAll 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. | Behavioural | Learn to Quit-HIV, QuitGuide |
Primary outcome
Duration of Daily App Use
Time frame: 3 months
Average duration of app use per arm over participants' 3 months of study participation
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.
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.
Participant Attrition at Three Months
Time frame: 3 month
Number of participants lost-to-follow-up at three 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.
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.
7 secondary outcomes
Reduction in Cigarettes Smoked Per Day
Time frame: 3 months
Number of Quit Attempts
Time frame: 1 month
Number of Quit Attempts
Time frame: 3 months
7-day Point Prevalence Abstinence
Time frame: 1 month
7-day Point Prevalence Abstinence
Time frame: 3 months
Overall Adherence to Nicotine Replacement Therapy
Time frame: baseline to 3 months
Number of Participants With at Least One Adverse Event Determined to be Related to the Study Interventions
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Pacek, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Learn to Quit-HIV, QuitGuide and Nicotine patch in people with HIV/AIDS and Smoking Cessation, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Daily App Use (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.