Mobile Health Interventions for Medication Adherence Among PLWH (HIVSMART)

Mobile Health Interventions for Varenicline Adherence Among HIV-positive Smokers

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.

Study Overview

• Status: Withdrawn
• Conditions: Smoking; Smoking Cessation; HIV/AIDS; HIV
• Intervention / Treatment: Drug: Varenicline; Device: Mobile phone application; Behavioral: Contingency management

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.

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Varenicline; An α4β2 nicotinic acetylcholine receptor partial agonist	Drug: Varenicline; 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; Other Names: Chantix
Experimental: Varenicline + mobile app; An α4β2 nicotinic acetylcholine receptor partial agonist + a mobile phone application designed to improve adherence to medications	Drug: Varenicline; 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; Other Names: Chantix; Device: Mobile phone application; 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.
Experimental: Varenicline + mobile app + contingency management; An α4β2 nicotinic acetylcholine receptor partial agonist + a mobile phone application designed to improve adherence to medications + monetary reinforcers for being adherent to medication	Drug: Varenicline; 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; Other Names: Chantix; Device: Mobile phone application; 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.; Behavioral: Contingency management; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Daily throughout study duration (12 weeks)
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	Daily throughout study duration (12 weeks)
Technical issues with using the mobile app	Average number of technical issues reported by participants throughout the course of the study	Weekly throughout study (once every week for 12 weeks)
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.	Week 12
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.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to varenicline	Percentage of varenicline pills taken as directed, as measured via pill counts	Weekly throughout study duration (once a week, over the course of 12 weeks)
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	Baseline and Weekly throughout study (once every week for 12 weeks)
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).	Weekly throughout study (once every week for 12 weeks)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Lauren R Pacek, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: December 6, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: HIV; Smoking; mHealth; Varenicline; Chantix
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: Pro00100107; K01DA043413 (U.S. NIH Grant/Contract)

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