Mobile Health Interventions for Medication Adherence Among PLWH

NCT04191278 | Withdrawn Phase 4 FDA Drug

• 2 other identifiers: Pro00100107K01DA043413
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV/AIDS; Smoking; Smoking Cessation; HIV

Keywords

Smoking; mHealth; Chantix; Varenicline; HIV

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Adherence to varenicline

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

• Concentration of expired breath carbon monoxide

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

• Concentration of cotinine in urine sample

  Weekly throughout study (once every week for 12 weeks)

Study Arms (3)

Varenicline

ACTIVE COMPARATOR

An α4β2 nicotinic acetylcholine receptor partial agonist

Drug: Varenicline

Varenicline + mobile app

EXPERIMENTAL

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

Drug: Varenicline; Device: Mobile phone application

Varenicline + mobile app + contingency management

EXPERIMENTAL

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; Device: Mobile phone application; Behavioral: Contingency management

Interventions

Varenicline DRUG

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

Also known as: Chantix

Varenicline; Varenicline + mobile app; Varenicline + mobile app + contingency management

Mobile phone application DEVICE

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.

Varenicline + mobile app; Varenicline + mobile app + contingency management

Contingency management BEHAVIORAL

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.

Varenicline + mobile app + contingency management

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Smoking; Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Lauren R Pacek, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 9, 2019
• Study Start: November 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: September 5, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share