Learn to Quit-HIV Pilot Study

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04609514
• Other study ID #: Pro00104423
• Status: Completed
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: June 2, 2022

Study information

• Verified date: October 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 2, 2022
• Est. primary completion date: June 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• HIV/AIDS
• Smoking Cessation
• Tobacco Use Disorder

Intervention

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.

Behavioral:
• QuitGuide
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines.

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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Daily App Use	Average duration of app use per arm over participants' 3 months of study participation	3 months
Primary	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
Primary	Participant Attrition at One Month	Number of participants lost to follow-up at one month.	1 month
Primary	Participant Attrition at Two Months	Number of participants lost-to-follow-up at two months.	2 months
Primary	Participant Attrition at Three Months	Number of participants lost-to-follow-up at three months.	3 month
Primary	Recruitment as Measured by the Proportion of Goal Participants Consented	Number of participants consented divided by goal of consenting 60 participants.	1 year
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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