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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

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.


Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Medication Adherence Behavioral: Medication adherence and financial incentives Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Official Title: Behavioral Economic Incentives to Improve Medication Adherence and Outcomes Among Patients in United States With HIV: A Feasibility Study
Actual Study Start Date : May 16, 2019
Actual Primary Completion Date : September 27, 2019
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.



Primary Outcome Measures :
  1. Number of patients with viral suppression [ Time Frame: approximately 3 months after enrollment ]
    viral load less than 400


Secondary Outcome Measures :
  1. viral suppression by arm [ Time Frame: approximately 3 months after enrollment ]
    viral load less than 400

  2. medication adherence by arm [ Time Frame: approximately 3 months after enrollment ]
    electronic pill bottle openings by day

  3. Recruitment rates by arm [ Time Frame: approximately 3 months after enrollment ]
  4. Attrition rates by arm [ Time Frame: approximately 3 months after enrollment ]
  5. Percent of patients that use electronic pill bottle [ Time Frame: approximately 3 months after enrollment ]
  6. Completion rates of lab visit by arm [ Time Frame: approximately 3 months after enrollment ]
  7. number of clinic visits by arm [ Time Frame: approximately 3 months after enrollment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995745


Locations
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United States, Pennsylvania
Drexel University
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Drexel University
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03995745    
Other Study ID Numbers: 831689
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases