Advances in the last decade have transformed HIV-1 infection into a chronic disease through the use of highly active antiretroviral (ARV) therapy. Recent studies suggest the ARVs used as pre-exposure prophylaxis (PrEP) to prevent HIV infection have the potential to transform the HIV pandemic. However, the success of ARVs in both the treatment and prevention of HIV is critically dependent on taking medications exactly as prescribed (adherence). To date, no reliable, accurate measurement for ARV adherence exists. This proposal will evaluate the use of a novel sensor platform termed the Digital Health Feedback System (DHFS) for real- time adherence monitoring in HIV-infected persons starting ARVs and in persons at high risk for HIV infection starting PrEP.
Aim 1 : Develop selected digitized ARVs for use within the DHFS. We will combine an edible sensor with commonly used ARVs within a gelcap to allow the DHFS to detect when a person takes their medication. Outcomes will include successful development of a `digitized' panel of ARVs to use with the DHFS, which are tested against USP guidelines and safe for use in clinical settings.
Aim 2 : Evaluate the use, acceptability, validity, and utility of the DHFS for longitudinal monitoring of adherence during initial ARV therapy. We will assess if the DHFS is acceptable to persons living with HIV that are initiating ARV treatment for the first time. Outcomes include acceptabilit as measured through validated questionnaires and persistence of use by participants, positive detection accuracy of the DHFS as measured by directly observed ingestions at study visits, and medication adherence as measured by DHFS.
Aim 3 : Evaluate the acceptability, validity, and utility of the DHFS for longitudinal monitoring of ARVs used in HIV pre-exposure prophylaxis (PrEP). We will assess if the DHFS is acceptable to persons at high risk for HIV infection that are initiating PrEP. Outcomes include acceptability as measured through validated questionnaires and persistence of use by participants, positive detection accuracy of the DHFS as measured by directly observed ingestions at study visits, and medication adherence as measured by DHFS.

Public Health Relevance

Adherence to antiretroviral therapy is critical to the successful management of HIV and to the efficacy of pre-exposure prophylaxis (PrEP) in the prevention of HIV infection. This project investigates a novel medication adherence monitoring tool, the Digital Health Feedback System (DHFS), in HIV-infected persons initiating antiretroviral therapy and in persons at high risk for HIV infection initiating PrEP. The overarching goals of this proposal include evaluation of the use, validity, and acceptability of the DHFS.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
5R01MH110057-04
Application #
9524742
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Stirratt, Michael J
Project Start
2015-09-20
Project End
2020-07-31
Budget Start
2018-08-01
Budget End
2019-07-31
Support Year
4
Fiscal Year
2018
Total Cost
Indirect Cost
Name
University of California, San Diego
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
804355790
City
La Jolla
State
CA
Country
United States
Zip Code
92093
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Karris, Maile Young (2017) Short Communication: Resolution of Tenofovir Disoproxil Fumarate Induced Fanconi Syndrome with Switch to Tenofovir Alafenamide Fumarate in a HIV-1 and Hepatitis B Coinfected Patient. AIDS Res Hum Retroviruses 33:718-722
Browne, Sara H; Behzadi, Yashar; Littlewort, Gwen (2015) Let Visuals Tell the Story: Medication Adherence in Patients with Type II Diabetes Captured by a Novel Ingestion Sensor Platform. JMIR Mhealth Uhealth 3:e108