Mobile Health Interventions for Medication Adherence Among PLWH

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

Interventions

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

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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Duke University

  lead OTHER

Principal Investigators

• Lauren R Pacek, PhD · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-30

Primary Completion

2022-07-31

Completion

2022-07-31

FDA Drug

Yes