Learn to Quit-HIV Pilot Study

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other Names: LTQ-H; LTQ-HIV; Drug: 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.; Behavioral: 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.
Active Comparator: 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.	Drug: 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.; Behavioral: 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.; Behavioral: QuitGuide; A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines.; Other Names: NCI QuitGuide

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Lauren Pacek, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Actual): June 2, 2022
• Study Completion (Actual): June 2, 2022

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: October 28, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: Pro00104423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No