Clinical trial NCT04191278: Mobile Health Interventions for Medication Adherence Among PLWH
Official title: Mobile Health Interventions for Varenicline Adherence Among HIV-positive Smokers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: HIV/AIDS
Smoking
Smoking Cessation
HIV
Keywords: Smoking
mHealth
Chantix
Varenicline
HIV
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-12-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The average number of times per day that participants initiate an interaction with mobile app
timeFrame: Daily throughout study duration (12 weeks)
measure: The average number of times per day participants respond to a prompt from mobile app
timeFrame: Daily throughout study duration (12 weeks)
measure: Technical issues with using the mobile app
timeFrame: Weekly throughout study (once every week for 12 weeks)
measure: Perceived usefulness of mSMART app
timeFrame: Week 12
measure: Perceived ease of use of mSMART app
timeFrame: Week 12
Secondary outcomes:
measure: Adherence to varenicline
timeFrame: Weekly throughout study duration (once a week, over the course of 12 weeks)
measure: Concentration of expired breath carbon monoxide
timeFrame: Baseline and Weekly throughout study (once every week for 12 weeks)
measure: Concentration of cotinine in urine sample
timeFrame: Weekly throughout study (once every week for 12 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Lauren R Pacek, PhD
role: PRINCIPAL_INVESTIGATOR
References: