Learn to Quit-HIV Pilot Study

Not Applicable

Completed

• Conditions: Tobacco Use Disorder; HIV/AIDS; Smoking Cessation
• Interventions: Device: Learn to Quit-HIV; Behavioral: QuitGuide; Drug: Nicotine patch; Behavioral: Smartphone coaching

• Registration Number: NCT04609514
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-10-28
• Study First Posted: 2020-10-30
• Study Start: 2021-01-25
• Primary Completion: 2022-06-02
• Study Completion: 2022-06-02
• Results First Submitted: 2023-06-01
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-17
• Last Update Submitted: 2023-10-17
• Results First Posted: 2023-10-19
• Last Update Posted: 2023-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QuitGuide	Nicotine patch	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.
Learn to Quit-HIV	Nicotine patch	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	Smartphone coaching	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	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.
QuitGuide	QuitGuide	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.
QuitGuide	Smartphone coaching	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.

Primary Outcome Measures

Name	Time	Method
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.
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.
Participant Attrition at One Month	1 month	Number of participants lost to follow-up at one month.
Recruitment as Measured by the Proportion of Goal Participants Consented	1 year	Number of participants consented divided by goal of consenting 60 participants.
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.
Duration of Daily App Use	3 months	Average duration of app use per arm over participants' 3 months of study participation

Secondary Outcome Measures

Name	Time	Method
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.
Number of Quit Attempts	3 months	Quit attempts defined as self-reported no smoking at all for 24 hours; assessed via a Timeline Followback procedure.
7-day Point Prevalence Abstinence	3 months	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.
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.
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.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States