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HIV/AIDSPhase 4HIVSMARTNCT04191278

Mobile Health Interventions for Medication Adherence Among PLWH

A Phase 4 study testing Varenicline, Mobile phone application and Contingency management in people with HIV/AIDS and Smoking, run by Duke University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
HIV/AIDS, Smoking, Smoking Cessation
What is being tested?
Varenicline, Mobile phone application and Contingency management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Nov 2021to Jul 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

About this study

Official title: 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.

Read the 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.

Being tested
Varenicline, Mobile phone application, Contingency management
Keywords
Smoking, mHealth, Chantix, Varenicline, HIV
Medical subject headings
Acquired Immunodeficiency Syndrome, Smoking, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VareniclineDrug

    Also called Chantix

    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

  • Mobile phone applicationDevice

    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.

  • Contingency managementBehavioural

    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.

Study groups in NCT04191278
Study groupRoleWhat they receive
VareniclineActive comparatorAn α4β2 nicotinic acetylcholine receptor partial agonist
Receives: Drug: Varenicline
Varenicline + mobile appExperimentalAn α4β2 nicotinic acetylcholine receptor partial agonist + a mobile phone application designed to improve adherence to medications
Receives: Drug: Varenicline; Device: Mobile phone application
Varenicline + mobile app + contingency managementExperimentalAn α4β2 nicotinic acetylcholine receptor partial agonist + a mobile phone application designed to improve adherence to medications + monetary reinforcers for being adherent to medication
Receives: Drug: Varenicline; Device: Mobile phone application; Behavioral: Contingency management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Daily throughout study duration (12 weeks)

  2. 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

    Measured: Daily throughout study duration (12 weeks)

  3. Technical issues with using the mobile app

    Average number of technical issues reported by participants throughout the course of the study

    Measured: Weekly throughout study (once every week for 12 weeks)

  4. 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.

    Measured: Week 12

  5. 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.

    Measured: Week 12

Secondary outcomes (3)

  1. Adherence to varenicline

    Percentage of varenicline pills taken as directed, as measured via pill counts

    Measured: Weekly throughout study duration (once a week, over the course of 12 weeks)

  2. 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

    Measured: Baseline and Weekly throughout study (once every week for 12 weeks)

  3. 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).

    Measured: Weekly throughout study (once every week for 12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2019
  2. Study startNov 2021 (estimated)
  3. Primary completionJul 2022 (estimated)
  4. Study completionJul 2022 (estimated)

Why it stopped: COVID prevented study initiation

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04191278
Sponsor's protocol ID
Pro00100107
Other IDs
K01DA043413
Acronym
HIVSMART
Status last verified
Sep 2020
First submitted
27 Nov 2019
Last updated
5 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Varenicline, Mobile phone application and Contingency management in people with HIV/AIDS and Smoking, run by Duke University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The average number of times per day that participants initiate an interaction with mobile app (time frame: Daily throughout study duration (12 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04191278.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.

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