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

Primary Purpose

Human Immunodeficiency Virus, Medication Adherence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medication adherence and financial incentives
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Drexel University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

adherence based financial incentives

control

Arm 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.

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.

Outcomes

Primary Outcome Measures

Number of patients with viral suppression
viral load less than 400

Secondary Outcome Measures

viral suppression by arm
viral load less than 400
medication adherence by arm
electronic pill bottle openings by day
Recruitment rates by arm
Attrition rates by arm
Percent of patients that use electronic pill bottle
Completion rates of lab visit by arm
number of clinic visits by arm

Full Information

First Posted
May 23, 2019
Last Updated
October 14, 2020
Sponsor
University of Pennsylvania
Collaborators
Drexel University
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1. Study Identification

Unique Protocol Identification Number
NCT03995745
Brief Title
Medication Adherence and Outcomes Among Patients in United States With HIV
Acronym
CHANGE
Official Title
Behavioral Economic Incentives to Improve Medication Adherence and Outcomes Among Patients in United States With HIV: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 16, 2019 (Actual)
Primary Completion Date
September 27, 2019 (Actual)
Study Completion Date
October 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Drexel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus, Medication Adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
HIV-positive patients in Philadelphia with non-suppressed viral loads will be randomly assigned to receive the intervention (electronic-pill bottle with adherence based daily financial incentives, and incentive for reaching viral suppression) or control. About 40 patients will be enrolled in the study, 20 in each arm.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
adherence based financial incentives
Arm Type
Experimental
Arm 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.
Arm Title
control
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Medication adherence and financial incentives
Intervention Description
Provision of wireless devices and financial incentives to motivate medication adherence among HIV-positive adults who have not reached viral suppression.
Primary Outcome Measure Information:
Title
Number of patients with viral suppression
Description
viral load less than 400
Time Frame
approximately 3 months after enrollment
Secondary Outcome Measure Information:
Title
viral suppression by arm
Description
viral load less than 400
Time Frame
approximately 3 months after enrollment
Title
medication adherence by arm
Description
electronic pill bottle openings by day
Time Frame
approximately 3 months after enrollment
Title
Recruitment rates by arm
Time Frame
approximately 3 months after enrollment
Title
Attrition rates by arm
Time Frame
approximately 3 months after enrollment
Title
Percent of patients that use electronic pill bottle
Time Frame
approximately 3 months after enrollment
Title
Completion rates of lab visit by arm
Time Frame
approximately 3 months after enrollment
Title
number of clinic visits by arm
Time Frame
approximately 3 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33470727
Citation
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.
Results Reference
derived

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Medication Adherence and Outcomes Among Patients in United States With HIV

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