Medication Adherence and Outcomes Among Patients in United States With HIV (CHANGE)

University of Pennsylvania

Status: Completed

Conditions: Human Immunodeficiency Virus; Medication Adherence

Treatments: Behavioral: Medication adherence and financial incentives

Study type: Interventional

Funder types: Other

Identifiers

NCT03995745

831689

Details and patient eligibility

About

With support from the NIH, this pilot study will assess the feasibility of using wireless devices and financial incentives to motivate medication adherence among HIV-positive adults in the U.S., focusing on those with non-suppressed viral loads.

While daily lotteries using wireless devices may have great potential for improving adherence to ART regimens, substantial questions exist as to whether it is: 1) possible to achieve high rates of uptake for a pilot offering wireless devices to high-risk populations; 2) achieve high rates of sustained engagement.

Full description

The goal of this study is to explore the feasibility of using wireless devices and financial incentives to motivate medication adherence among high-risk HIV positive patients. By partnering with the Drexel Partnership Comprehensive Care Clinic at Drexel University, the investigators will be able to identify such patients using clinic patient data, use clinic and physician communication channels to enroll them, and maintain high levels of ongoing participation through the use of incentives. The aim is to improve antiretroviral medication adherence among high-risk HIV positive patients by providing patients with a AdhereTech device (electronic pill bottle), daily adherence notifications tracked by the Way to Health platform, as well as daily lotteries and financial incentives. Upon completion, this study will answer questions important to the feasibility of conducting well-powered randomized controlled trials to improve adherence among HIV patients within the U.S. who have sub-optimal adherence.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of HIV, established in 2017 or earlier
• Patients at least 18 years of age or older
• Currently prescribed first or second line ART medications
• Non-suppressed viral loads, with two consecutive non-suppressed viral loads (VL>400 copies/ml) for the past two lab readings.

Exclusion criteria

• Pregnant
• Prescribed Maraviroc or Fuzeon
• More than 5 additional medications
• Diagnosed with insulin dependent diabetes
• Unable to provide consent
• Non-English speaker
• Cognitive impairment, per PI discretion
• Does not have stable residence

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

adherence based financial incentives

Experimental group

Description:

Participants randomized to this arm will receive an electronic pill bottle, AdhereTech. The AdhereTech bottle will be remotely monitored by the Way to Health platform. Participants will be randomly assigned a 2-digit number to be used as part of the lottery-based engagement incentives in which eligibility to win will be conditional on medication adherence. Participants will also be eligible for a financial bonus if participant's viral load is suppressed at the end of the intervention period. Participants will also receive an enrollment incentive and an incentive to complete a lab visit at the end of the intervention period.

Treatment:

Behavioral: Medication adherence and financial incentives

control

No Intervention group

Description:

Of the 20 participants randomized to the control arm, 10 will be randomly assigned to receive an electronic pill bottle, AdhereTech. The AdhereTech bottle will be remotely monitored by the Way to Health platform. Participants will also receive an enrollment incentive and an incentive to complete a lab visit at the end of the intervention period.