Mobile Health Interventions for Medication Adherence Among PLWH (HIVSMART)

Duke University

Status and phase: Withdrawn; Phase 4

Conditions: HIV; Smoking; Smoking Cessation; HIV/AIDS

Treatments: Drug: Varenicline; Behavioral: Contingency management; Device: Mobile phone application

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04191278

K01DA043413 (U.S. NIH Grant/Contract)

Pro00100107

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Varenicline

Active Comparator group

Description:

An α4β2 nicotinic acetylcholine receptor partial agonist

Treatment:

Drug: Varenicline

Varenicline + mobile app

Experimental group

Description:

An α4β2 nicotinic acetylcholine receptor partial agonist + a mobile phone application designed to improve adherence to medications

Treatment:

Device: Mobile phone application

Drug: Varenicline

Varenicline + mobile app + contingency management

Experimental group

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

Treatment:

Behavioral: Contingency management

Device: Mobile phone application

Drug: Varenicline