SBIR-STTR Award

Remote Assistance For HIV Antiretroviral Adherence
Award last edited on: 10/27/14

Sponsored Program
SBIR
Awarding Agency
NIH : NIMH
Total Award Amount
$1,086,944
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Jorge Luis Piovesan

Company Information

K & A Wireless LLC (AKA: K&A Wireless, LLC)

2350 Alamo Avenue SE Suite 301
Albuquerque, NM 87112
   (505) 338-2380
   sales@ka-wireless.com
   www.ka-wireless.com
Location: Single
Congr. District: 01
County: Bernalillo

Phase I

Contract Number: 1R43MH089810-01A1
Start Date: 8/1/10    Completed: 1/31/11
Phase I year
2010
Phase I Amount
$99,927
This SBIR project seeks to develop a system capable of remotely monitoring, in real-time, the adherence of an HIV patient to antiretroviral therapy (ART). ART is a medication regimen that once started, needs to be followed for the rest of the patient's life. ART has been successful in improving the quality and expectancy of life of HIV patients as well as in reducing the likelihood of transmission of the disease. However, its success depends on strict adherence to the medication regimen, which is often difficult for patients to accomplish. For this reason, researchers have argued that real-time monitoring of adherence could have a positive impact on adherence rates. This project proposes to accomplish real-time monitoring of adherence using a system that integrates sensors, wireless communications, and Internet technologies. The proposed system will be capable of acquiring information about patient's medication consumption and communicating such information to the appropriate personnel for real-time monitoring of adherence. The proposed system addresses several usability and sensing limitations of competing products on the market. In particular, it will be capable of measuring partial dosing, and may also contribute to measuring pocketing, which are parameters that can only be measured through patient reporting today. This system will be designed and tested by the research team that K&A Wireless has put together for this project, which involves experts on sensors, electronic design, wireless and Internet communications, and ART adherence. This Phase 1 effort will be focused on: 1) designing the electronic hardware capable of acquiring, processing, and transmitting the medication consumption information; 2) designing and evaluating the processing software that will estimate the medication consumption based on the sensor information; and 3) designing the communication and computing system to implement the remote real-time monitoring of adherence. The information obtained from the completion of these objectives will provide the hardware and software design for the device that will estimate the medication consumption, and a system-level design for communications of the complete monitoring system. Phase 2 will then be focused on the full development of the system, and on the performance of a clinical trial to evaluate the impact of the proposed system in ART adherence. In this form K&A Wireless expects to deliver by the end of this SBIR effort a working system with demonstrated impact on ART adherence, which is a major concern in today's HIV healthcare.

Public Health Relevance:
The success of antiretroviral therapy in improving the life of HIV patients depends on strict adherence to the medication regimen [2, 3]. Since such adherence requirements are challenging for the patient, researchers have suggested that real-time monitoring of adherence could positively impact adherence rates [2]. This motivates the development of a system capable of keeping track of the patient's medication consumption through sensing technology and reporting such information to the provider in real-time.

Thesaurus Terms:
"0-11 Years Old; Aids Virus; Acquired Immune Deficiency Syndrome Virus; Acquired Immunodeficiency Syndrome Virus; Address; Adherence; Adherence (Attribute); Affect; Algorithms; Anti-Retroviral Agents; Antiretroviral Agents; Birth; Boxing; Care, Health; Cell Phone; Cellular Phone; Child; Child Youth; Children (0-21); Clinical Trials; Clinical Trials, Unspecified; Communication; Complex; Compliance Behavior; Computer Interface; Computer Programs; Computer Systems; Computer Systems Development; Computer Software; Computers; Consumption; Designing Computer Software; Detection; Development; Development, Computer Systems; Devices; Dose; Drugs; Electronics; Event; Flr; Failure (Biologic Function); Hiv; Htlv-Iii; Health; Healthcare; Human Immunodeficiency Viruses; Human Resources; Human T-Cell Leukemia Virus Type Iii; Human T-Cell Lymphotropic Virus Type Iii; Human T-Lymphotropic Virus Type Iii; Human, Child; Image; Internet; Investigators; Lav-Htlv-Iii; Life; Life Expectancy; Link; Lymphadenopathy-Associated Virus; Manpower; Marketing; Measures; Medication; Methods; Methods And Techniques; Methods, Other; Monitor; Mothers; Oranges; Prov; Parturition; Patient Compliance; Patient Cooperation; Patients; Pattern Recognition; Pattern Recognition/Display/Analysis; Performance; Pharmaceutic Preparations; Pharmaceutical Preparations; Phase; Pill; Process; Provider; Regimen; Reporting; Research; Research Personnel; Research Resources; Researchers; Resources; Rest; Sbir; Sbirs (R43/44); Small Business Innovation Research; Small Business Innovation Research Grant; Software; Software Design; Solutions; Source; Supervision; System; System, Loinc Axis 4; Systems Development; Techniques; Technology; Telephone, Cellular; Testing; Time; Transmission; Treatment Compliance; Update; Viral; Virus-Hiv; Www; Wireless Technology; Work; Anti-Retroviral; Antiretroviral; Antiretroviral Therapy; Base; Children; Clinical Investigation; Communicable Disease Transmission; Compliance Cooperation; Computer Program/Software; Design; Designing; Disease Transmission; Drug/Agent; Experience; Failure; Image Processing; Imaging; Improved; Infectious Disease Transmission; Innovate; Innovation; Innovative; Mathematical Ability; Number Sense; Numerousy; Patient Adherence; Personnel; Pill (Pharmacologic); Prevent; Preventing; Public Health Relevance; Sensor; Success; Therapy Adherence; Therapy Compliance; Therapy Cooperation; Transmission Process; Usability; Web; Wireless; World Wide Web; Youngster"

Phase II

Contract Number: 2R44MH089810-02A1
Start Date: 12/14/09    Completed: 8/31/14
Phase II year
2012
(last award dollars: 2013)
Phase II Amount
$987,017

This SBIR project is developing a system capable of remotely monitoring, in real-time, the adherence of an HIV patient to Antiretroviral therapy (ART). ART is a medication regimen that once started, needs to be followed for the rest of the patient's life. ART has been successful in improving the quality and expectancy of life of HIV patients as well as in reducing the likelihood of transmission of the disease. However, its success depends on high levels of adherence to the medication regimen, which is often difficult for patients to accomplish. For this reason, researchers have argued that real-time monitoring of adherence could have a positive impact on their ability to measure adherence and on patients'adherence performance. This project proposes to accomplish real-time monitoring of adherence using a system that integrates sensors, wireless communications, and Internet technologies. The proposed system will be capable of acquiring information about patient's medication consumption and communicating such information to the appropriate personnel for real-time monitoring of adherence. The proposed system addresses several usability and sensing limitations of competing approaches. In particular, it will be capable of measuring partial dosing, which can only be measured through patient reporting today. This system will be designed and tested by the research team that K&A Wireless has put together for this project, which involves experts on sensing, electronic design, wireless and Internet communications, and HIV ART adherence. The Phase 1 effort of this SBIR has proven that the proposed technology is feasible: 1) The sensing and processing approach used to estimate the pill-taking have been successfully developed and tested. 2) The electronics capable of acquiring, processing, and transmitting the medication consumption information have been designed and shown to be portable;and 3) The communication system to implement the remote real- time monitoring of adherence has been specified in detail taking usability, reliability, and information privacy into account. The information obtained from the completion of these milestones has been used to determine the target configuration of all the components of the system and to plan the proposed Phase 2. This Phase 2 will be focused on the full development of the proposed system and on the validation of the usability and accuracy of the system in the field. For this purpose, this Phase 2 effort has th following milestones: 1) Assemble each of the components of the proposed system;2) Integrate all the components into a fully working system;3) Evaluate the acceptability of the developed system with providers and patients;and 4) Conduct a validation trial to evaluate the accuracy of the proposed system in the field. In this form K&A Wireless expects to deliver by the end of this Phase 2 effort a working system with demonstrated adherence measuring accuracy, which can then be used to monitor, and even improve ART adherence.

Public Health Relevance:
The success of antiretroviral therapy in improving the life of HIV patients depends on high levels of adherence to the medication regimen [3, 4, 5]. Since such adherence requirements are challenging for the patient, researchers have suggested that real-time monitoring of adherence could positively impact adherence measurement accuracy and adherence rates [6]. This motivates the development of a system capable of keeping track of the patient's medication consumption through sensing technology and reporting such information to the provider in real-time.