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

Behavioral Economic Incentives to Improve Medication Adherence and Outcomes Among Patients in United States With HIV: A Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Medication Adherence; Human Immunodeficiency Virus
• Intervention / Treatment: Behavioral: Medication adherence and financial incentives

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Drexel University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: adherence based financial incentives; 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.	Behavioral: Medication adherence and financial incentives; Provision of wireless devices and financial incentives to motivate medication adherence among HIV-positive adults who have not reached viral suppression.
No Intervention: control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with viral suppression	viral load less than 400	approximately 3 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
viral suppression by arm	viral load less than 400	approximately 3 months after enrollment
medication adherence by arm	electronic pill bottle openings by day	approximately 3 months after enrollment
Recruitment rates by arm		approximately 3 months after enrollment
Attrition rates by arm		approximately 3 months after enrollment
Percent of patients that use electronic pill bottle		approximately 3 months after enrollment
Completion rates of lab visit by arm		approximately 3 months after enrollment
number of clinic visits by arm		approximately 3 months after enrollment

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Drexel University

Publications and helpful links

General Publications

• Bien-Gund CH, Ho JI, Bair EF, Marcus N, Choi RJ, Szep Z, Althoff A, Momplaisir FM, Thirumurthy H. Brief Report: Financial Incentives and Real-Time Adherence Monitoring to Promote Daily Adherence to HIV Treatment and Viral Suppression Among People Living With HIV: A Pilot Study. J Acquir Immune Defic Syndr. 2021 May 1;87(1):688-692. doi: 10.1097/QAI.0000000000002628.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2019
• Primary Completion (Actual): September 27, 2019
• Study Completion (Actual): October 13, 2020

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: June 20, 2019
• First Posted (Actual): June 24, 2019

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 14, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 831689

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No