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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03995745
Recruitment Status : Active, not recruiting
First Posted : June 24, 2019
Last Update Posted : May 11, 2020
Sponsor:
Collaborator:
Drexel University
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE May 23, 2019
First Posted Date  ICMJE June 24, 2019
Last Update Posted Date May 11, 2020
Actual Study Start Date  ICMJE May 16, 2019
Actual Primary Completion Date September 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
Number of patients with viral suppression [ Time Frame: approximately 3 months after enrollment ]
viral load less than 400
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • viral suppression by arm [ Time Frame: approximately 3 months after enrollment ]
    viral load less than 400
  • medication adherence by arm [ Time Frame: approximately 3 months after enrollment ]
    electronic pill bottle openings by day
  • Recruitment rates by arm [ Time Frame: approximately 3 months after enrollment ]
  • Attrition rates by arm [ Time Frame: approximately 3 months after enrollment ]
  • Percent of patients that use electronic pill bottle [ Time Frame: approximately 3 months after enrollment ]
  • Completion rates of lab visit by arm [ Time Frame: approximately 3 months after enrollment ]
  • number of clinic visits by arm [ Time Frame: approximately 3 months after enrollment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Medication Adherence and Outcomes Among Patients in United States With HIV
Official Title  ICMJE Behavioral Economic Incentives to Improve Medication Adherence and Outcomes Among Patients in United States With HIV: A Feasibility Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE
  • Human Immunodeficiency Virus
  • Medication Adherence
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Medication adherence and financial incentives
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 20, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2020
Actual Primary Completion Date September 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03995745
Other Study ID Numbers  ICMJE 831689
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Drexel University
Investigators  ICMJE Not Provided
PRS Account University of Pennsylvania
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP