Learn to Quit-HIV Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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Early-phase Studies of a Tailored Evidence-Based Smoking Cessation mHealth App for Persons Living With HIV

Conditions
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HIV/AIDS, Smoking Cessation, Tobacco Use Disorder

Intervention / Treatment
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* Device: Learn to Quit-HIV
* Behavioral: QuitGuide
* Drug: Nicotine patch
* Behavioral: Smartphone coaching


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Learn to Quit-HIV<br>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. | Device: Learn to Quit-HIV<br>* A smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation.<br>* Other names: LTQ-HIV;Drug: Nicotine patch<br>* 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.<br>Behavioral: Smartphone coaching<br>* 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.<br>|
| Active Comparator: QuitGuide<br>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. | Behavioral: QuitGuide<br>* A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines.<br>* Other names: NCI QuitGuide;Drug: Nicotine patch<br>* 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.<br>Behavioral: Smartphone coaching<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Daily App Use | Average duration of app use per arm over participants' 3 months of study participation | 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. | 3 months | 
| Participant Attrition at One Month | Number of participants lost to follow-up at one month. | 1 month | 
| Participant Attrition at Two Months | Number of participants lost-to-follow-up at two months. | 2 months | 
| Participant Attrition at Three Months | Number of participants lost-to-follow-up at three months. | 3 month | 
| Recruitment as Measured by the Proportion of Goal Participants Consented | Number of participants consented divided by goal of consenting 60 participants. | 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. | 1 month or next available time point if participant completed the measure at 3 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 3 months |