Mobile Health Interventions for Medication Adherence Among PLWH (HIVSMART)
Primary Purpose
HIV/AIDS, Smoking, Smoking Cessation
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Varenicline
Mobile phone application
Contingency management
Sponsored by
About this trial
This is an interventional treatment trial for HIV/AIDS focused on measuring Smoking, mHealth, Chantix, Varenicline, HIV
Eligibility Criteria
Inclusion Criteria:
- Between the ages of 18-65
- HIV-positive
- Currently engaged with an HIV care provider
- Interested in quitting smoking within the next 30 days
- Has an Android (v5.x.x or Lollipop) or iOS (v6.0) smartphone (interested participants without a compatible smartphone will be provided one, with costs offset by the study team)
- English-speaking
- Capable of giving written informed consent
Exclusion Criteria:
- Inability to attend study sessions
- Any medical condition or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator, Study Physician, and/or participant's HIV care provider
- Current use of nicotine replacement therapy or other smoking cessation treatment (e.g., bupropion)
- Pregnant, planning to become pregnant, nursing, or becoming pregnant during the study
- BAL >0.000 at screening.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Varenicline
Varenicline + mobile app
Varenicline + mobile app + contingency management
Arm Description
An α4β2 nicotinic acetylcholine receptor partial agonist
An α4β2 nicotinic acetylcholine receptor partial agonist + a mobile phone application designed to improve adherence to medications
An α4β2 nicotinic acetylcholine receptor partial agonist + a mobile phone application designed to improve adherence to medications + monetary reinforcers for being adherent to medication
Outcomes
Primary Outcome Measures
The average number of times per day that participants initiate an interaction with mobile app
The average number of times per day that participants initiate an interaction with the app, as measured by background analytics
The average number of times per day participants respond to a prompt from mobile app
The average number of times per day that participants respond to prompts from the app, as measured by background analytics
Technical issues with using the mobile app
Average number of technical issues reported by participants throughout the course of the study
Perceived usefulness of mSMART app
Participants will be asked to respond to the following: "Overall, I find the mSMART app useful for remembering to take my varenicline." Response options include: Strongly disagree; Somewhat disagree; neither agree nor disagree; somewhat agree; strongly agree.
Perceived ease of use of mSMART app
Participants will be asked to respond to the following: "Overall, I find the mSMART app easy to use." Response options include: Strongly disagree; Somewhat disagree; neither agree nor disagree; somewhat agree; strongly agree.
Secondary Outcome Measures
Adherence to varenicline
Percentage of varenicline pills taken as directed, as measured via pill counts
Concentration of expired breath carbon monoxide
Participants will provide an expired breath carbon monoxide sample at each study visit, measured in parts per million. Smoking cessation will be defined as a measured carbon monoxide sample that is ≤50% lower than their expired breath carbon monoxide that was measured at baseline
Concentration of cotinine in urine sample
Participants will provide a urine sample at each study visit. These samples will be tested with a rapid urinary cotinine strip that indicates whether or not the participant has been abstinent from smoking (measured in ng of cotinine per mL of urine).
Full Information
NCT ID
NCT04191278
First Posted
November 27, 2019
Last Updated
August 31, 2021
Sponsor
Duke University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT04191278
Brief Title
Mobile Health Interventions for Medication Adherence Among PLWH
Acronym
HIVSMART
Official Title
Mobile Health Interventions for Varenicline Adherence Among HIV-positive Smokers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Why Stopped
COVID prevented study initiation
Study Start Date
November 2021 (Anticipated)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cigarette smoking remains highly prevalent among persons living with HIV (PLWH). Quitting smoking can have important health benefits for this population. However, PLWH have historically had a difficult time quitting smoking. This is likely due, at least in part, to poor medication adherence.
Poor adherence to medication is a well-documented issue among PLWH. Research shows that not taking smoking cessation medications as prescribed can limit their treatment effectiveness. Improving adherence to smoking cessation medications will likely increase smoking cessation attempt success.
Mobile phone applications and behavioral interventions show promise for improving adherence to smoking cessation medications and cessation outcomes among PLWH. Therefore, this trial will assess 1) whether a mobile phone application is a feasible and acceptable intervention for improving medication adherence; 2) whether use of the mobile phone app improves adherence to varenicline; and 3) smoking cessation outcomes.
Detailed Description
Cigarette smoking is a significant public health problem among persons living with HIV (PLWH). The prevalence of smoking among PLWH is 40-75%, compared to approximately 15% in the general population. In PLWH, smoking confers increased risk of cardiovascular disease, respiratory conditions, lung cancer, poor adherence to antiretroviral (ARV) therapy, poor HIV treatment outcomes, and all-cause mortality. Approximately 24% of deaths among PWLH on ARV are attributable to tobacco use. Moreover, smokers with HIV lose more life years to smoking than to HIV itself (13 versus 5 years).
Smoking cessation is a challenge for smokers with HIV. Smokers with HIV are interested in quitting, yet most quit attempts end in relapse. Poor cessation outcomes are likely attributable, in part, to poor adherence to smoking cessation medications. Not taking varenicline as prescribed significantly limits treatment effectiveness. Adherence to varenicline in smokers with HIV is poor, with only 56-62% of individuals in clinical trials taking the medication as prescribed. Putatively, real world adherence is expected to be lower. Medication adherence is a well-documented issue in HIV: only 62% achieve optimal adherence to ARV. Interventions are needed to improve smoking cessation medication adherence among smokers with HIV. Such interventions will improve cessation and reduce the burden of smoking in this population.
Mobile phone-delivered interventions show promise for improving cessation outcomes in smokers living with HIV. However, an intervention that provided text message medication reminders and motivational cessation messages with or without phone-delivered counseling, as compared to a control group, yielded no group differences for varenicline adherence. Thus, it is possible that more intensive, and multi-component, interventions are required to improve the effectiveness of mobile-phone-based interventions.
This trial will: 1) assess the feasibility and acceptability of a mobile phone app that aims to increase medication adherence; 2) whether use of the app and/or contingency management increases adherence to varenicline over varenicline treatment as usual; and 3) monitor smoking cessation outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Smoking, Smoking Cessation, HIV
Keywords
Smoking, mHealth, Chantix, Varenicline, HIV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned to one of three study conditions: 1) varenicline alone; 2) varenicline + mobile health app; 3) varenicline + mobile health app + contingency management
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Varenicline
Arm Type
Active Comparator
Arm Description
An α4β2 nicotinic acetylcholine receptor partial agonist
Arm Title
Varenicline + mobile app
Arm Type
Experimental
Arm Description
An α4β2 nicotinic acetylcholine receptor partial agonist + a mobile phone application designed to improve adherence to medications
Arm Title
Varenicline + mobile app + contingency management
Arm Type
Experimental
Arm Description
An α4β2 nicotinic acetylcholine receptor partial agonist + a mobile phone application designed to improve adherence to medications + monetary reinforcers for being adherent to medication
Intervention Type
Drug
Intervention Name(s)
Varenicline
Other Intervention Name(s)
Chantix
Intervention Description
All participants will receive a standard 12-week course of varenicline tartrate. Participants will receive 0.5 mg tablets per oral (PO) once daily for days 1-3, 0.5 mg tablets PO twice daily for days 4-7, and 1 mg tablets PO twice daily for days 8-84
Intervention Type
Device
Intervention Name(s)
Mobile phone application
Intervention Description
Participants randomized to 2 of the 3 study groups will receive a mobile phone application designed to improve adherence to medication. The app has a number of functions, including: a) reminders to take medication; b) information about coping strategies for dealing with side effects and withdrawal symptoms; c) provision of a personalized graphical display of treatment progress (e.g., adherence, side effects); d) camera-based verification of having taken medication.
Intervention Type
Behavioral
Intervention Name(s)
Contingency management
Intervention Description
Participants randomized to 1 of the 3 study groups will receive monetary reinforcement contingent upon verified medication adherence behaviors. Participants in the other 2 groups will be yoked to a participant in the CM group so that they also have a chance of earning monetary reinforcers, though not contingent upon their own behaviors.
Primary Outcome Measure Information:
Title
The average number of times per day that participants initiate an interaction with mobile app
Description
The average number of times per day that participants initiate an interaction with the app, as measured by background analytics
Time Frame
Daily throughout study duration (12 weeks)
Title
The average number of times per day participants respond to a prompt from mobile app
Description
The average number of times per day that participants respond to prompts from the app, as measured by background analytics
Time Frame
Daily throughout study duration (12 weeks)
Title
Technical issues with using the mobile app
Description
Average number of technical issues reported by participants throughout the course of the study
Time Frame
Weekly throughout study (once every week for 12 weeks)
Title
Perceived usefulness of mSMART app
Description
Participants will be asked to respond to the following: "Overall, I find the mSMART app useful for remembering to take my varenicline." Response options include: Strongly disagree; Somewhat disagree; neither agree nor disagree; somewhat agree; strongly agree.
Time Frame
Week 12
Title
Perceived ease of use of mSMART app
Description
Participants will be asked to respond to the following: "Overall, I find the mSMART app easy to use." Response options include: Strongly disagree; Somewhat disagree; neither agree nor disagree; somewhat agree; strongly agree.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Adherence to varenicline
Description
Percentage of varenicline pills taken as directed, as measured via pill counts
Time Frame
Weekly throughout study duration (once a week, over the course of 12 weeks)
Title
Concentration of expired breath carbon monoxide
Description
Participants will provide an expired breath carbon monoxide sample at each study visit, measured in parts per million. Smoking cessation will be defined as a measured carbon monoxide sample that is ≤50% lower than their expired breath carbon monoxide that was measured at baseline
Time Frame
Baseline and Weekly throughout study (once every week for 12 weeks)
Title
Concentration of cotinine in urine sample
Description
Participants will provide a urine sample at each study visit. These samples will be tested with a rapid urinary cotinine strip that indicates whether or not the participant has been abstinent from smoking (measured in ng of cotinine per mL of urine).
Time Frame
Weekly throughout study (once every week for 12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between the ages of 18-65
HIV-positive
Currently engaged with an HIV care provider
Interested in quitting smoking within the next 30 days
Has an Android (v5.x.x or Lollipop) or iOS (v6.0) smartphone (interested participants without a compatible smartphone will be provided one, with costs offset by the study team)
English-speaking
Capable of giving written informed consent
Exclusion Criteria:
Inability to attend study sessions
Any medical condition or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator, Study Physician, and/or participant's HIV care provider
Current use of nicotine replacement therapy or other smoking cessation treatment (e.g., bupropion)
Pregnant, planning to become pregnant, nursing, or becoming pregnant during the study
BAL >0.000 at screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren R Pacek, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Mobile Health Interventions for Medication Adherence Among PLWH
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