Medication Adherence and Outcomes Among Patients in United States With HIV

NCT ID: NCT03995745

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-16
• Study Completion Date: 2020-10-13

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.

Conditions

Human Immunodeficiency Virus; Medication Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Medication adherence and financial incentives

Intervention Type: BEHAVIORAL

Provision of wireless devices and financial incentives to motivate medication adherence among HIV-positive adults who have not reached viral suppression.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Drexel University

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Drexel University

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33470727 (View on PubMed)

Other Identifiers

831689

Identifier Type: -

Identifier Source: org_study_id