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Learn to Quit-HIV Pilot Study

Primary Purpose

HIV/AIDS, Smoking Cessation, Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Learn to Quit-HIV
QuitGuide
Nicotine patch
Smartphone coaching
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV/AIDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Duke University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Learn to Quit-HIV

QuitGuide

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Duration of Daily App Use
Average duration of app use per arm over participants' 3 months of study participation
Frequency of App Use as Measured by Interactions Per Day
Average frequency of app use per arm over participants' 3 months of study participation.
Participant Attrition at One Month
Number of participants lost to follow-up at one month.
Participant Attrition at Two Months
Number of participants lost-to-follow-up at two months.
Participant Attrition at Three Months
Number of participants lost-to-follow-up at three months.
Recruitment as Measured by the Proportion of Goal Participants Consented
Number of participants consented divided by goal of consenting 60 participants.
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.

Secondary Outcome Measures

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.
Number of Quit Attempts
Quit attempts defined as self-reported no smoking at all for 24 hours; assessed via a Timeline Followback procedure.
Number of Quit Attempts
Quit attempts defined as self-reported no smoking at all for 24 hours; assessed via a Timeline Followback procedure.
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.
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.
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.
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.

Full Information

First Posted
October 22, 2020
Last Updated
October 17, 2023
Sponsor
Duke University
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04609514
Brief Title
Learn to Quit-HIV Pilot Study
Official Title
Early-phase Studies of a Tailored Evidence-Based Smoking Cessation mHealth App for Persons Living With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
June 2, 2022 (Actual)
Study Completion Date
June 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Smoking Cessation, Tobacco Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Learn to Quit-HIV
Arm Type
Experimental
Arm Description
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.
Arm Title
QuitGuide
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Learn to Quit-HIV
Other Intervention Name(s)
LTQ-H, LTQ-HIV
Intervention Description
A smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation.
Intervention Type
Behavioral
Intervention Name(s)
QuitGuide
Other Intervention Name(s)
NCI QuitGuide
Intervention Description
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines.
Intervention Type
Drug
Intervention Name(s)
Nicotine patch
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Smartphone coaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Duration of Daily App Use
Description
Average duration of app use per arm over participants' 3 months of study participation
Time Frame
3 months
Title
Frequency of App Use as Measured by Interactions Per Day
Description
Average frequency of app use per arm over participants' 3 months of study participation.
Time Frame
3 months
Title
Participant Attrition at One Month
Description
Number of participants lost to follow-up at one month.
Time Frame
1 month
Title
Participant Attrition at Two Months
Description
Number of participants lost-to-follow-up at two months.
Time Frame
2 months
Title
Participant Attrition at Three Months
Description
Number of participants lost-to-follow-up at three months.
Time Frame
3 month
Title
Recruitment as Measured by the Proportion of Goal Participants Consented
Description
Number of participants consented divided by goal of consenting 60 participants.
Time Frame
1 year
Title
App Usability as Measured by the Systems Usability Scale
Description
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.
Time Frame
1 month or next available time point if participant completed the measure at 3 months.
Secondary Outcome Measure Information:
Title
Reduction in Cigarettes Smoked Per Day
Description
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.
Time Frame
3 months
Title
Number of Quit Attempts
Description
Quit attempts defined as self-reported no smoking at all for 24 hours; assessed via a Timeline Followback procedure.
Time Frame
1 month
Title
Number of Quit Attempts
Description
Quit attempts defined as self-reported no smoking at all for 24 hours; assessed via a Timeline Followback procedure.
Time Frame
3 months
Title
7-day Point Prevalence Abstinence
Description
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.
Time Frame
1 month
Title
7-day Point Prevalence Abstinence
Description
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.
Time Frame
3 months
Title
Overall Adherence to Nicotine Replacement Therapy
Description
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.
Time Frame
baseline to 3 months
Title
Number of Participants With at Least One Adverse Event Determined to be Related to the Study Interventions
Description
Adverse events reported here will only include those that are determined to be related to the study interventions.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Pacek, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Learn to Quit-HIV Pilot Study

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