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Completed

NCT Number: NCT03995745

Medication Adherence and Outcomes Among Patients in United States With HIV

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.

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Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Medication Adherence Patient Acceptance of Health Care Patient Compliance RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Treatment Adherence and Compliance Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Drexel University

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medication adherence and financial incentives

Behavioral

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

Primary outcomes

  1. Number of patients with viral suppression

    Time frame: approximately 3 months after enrollment

    viral load less than 400

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Drexel University

Registry information

Official study title

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

Acronym: CHANGE

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jun 24, 2019
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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