Clinical trial NCT03995745: Medication Adherence and Outcomes Among Patients in United States With HIV
Official title: Behavioral Economic Incentives to Improve Medication Adherence and Outcomes Among Patients in United States With HIV: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Medication Adherence
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Drexel University
First posted: 2019-06-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of patients with viral suppression
timeFrame: approximately 3 months after enrollment
Secondary outcomes:
measure: viral suppression by arm
timeFrame: approximately 3 months after enrollment
measure: medication adherence by arm
timeFrame: approximately 3 months after enrollment
measure: Recruitment rates by arm
timeFrame: approximately 3 months after enrollment
measure: Attrition rates by arm
timeFrame: approximately 3 months after enrollment
measure: Percent of patients that use electronic pill bottle
timeFrame: approximately 3 months after enrollment
measure: Completion rates of lab visit by arm
timeFrame: approximately 3 months after enrollment
measure: number of clinic visits by arm
timeFrame: approximately 3 months after enrollment
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
References:
citation: 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.