Medication Adherence and Outcomes Among Patients in United States With HIV

Human Immunodeficiency Virus Clinical Trial

— CHANGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03995745
• Other study ID #: 831689
• Status: Completed
• Phase: N/A
• Start date: May 16, 2019
• Est. completion date: October 13, 2020

Study information

• Verified date: October 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 13, 2020
• Est. primary completion date: September 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Medication Adherence

Intervention

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.

Locations

Country	Name	City	State
United States	Drexel University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Drexel University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with viral suppression	viral load less than 400	approximately 3 months after enrollment
Secondary	viral suppression by arm	viral load less than 400	approximately 3 months after enrollment
Secondary	medication adherence by arm	electronic pill bottle openings by day	approximately 3 months after enrollment
Secondary	Recruitment rates by arm		approximately 3 months after enrollment
Secondary	Attrition rates by arm		approximately 3 months after enrollment
Secondary	Percent of patients that use electronic pill bottle		approximately 3 months after enrollment
Secondary	Completion rates of lab visit by arm		approximately 3 months after enrollment
Secondary	number of clinic visits by arm		approximately 3 months after enrollment