Human Immunodeficiency Virus, Medication Adherence
Conditions
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.
Interventions
BEHAVIORALMedication 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.
Sponsors
Drexel University
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with viral suppression | approximately 3 months after enrollment | viral load less than 400 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| medication adherence by arm | approximately 3 months after enrollment | electronic pill bottle openings by day |
| Recruitment rates by arm | approximately 3 months after enrollment | — |
| Attrition rates by arm | approximately 3 months after enrollment | — |
| viral suppression by arm | approximately 3 months after enrollment | viral load less than 400 |
| Completion rates of lab visit by arm | approximately 3 months after enrollment | — |
| number of clinic visits by arm | approximately 3 months after enrollment | — |
| Percent of patients that use electronic pill bottle | approximately 3 months after enrollment | — |
Countries
United States
Outcome results
None listed