Facilitated By

San Antonio Medical Foundation

Real World Adoption of an OUD Digital Health Therapeutic

Biomedical Development Corporation

For more than 25 years, Biomedical Development Corporation has been bringing commercially-viable products to market by linking promising technologies with vital sources of research funding.

Principal Investigator(s)
Gregg Siegel
Funded by
Research Start Date

The overall goal of this Fast-Track SBIR project is to evaluate the real-world adoption of KIOS, a patient-centered digital therapeutic / mobile app to assist in the effective self-management of Opioid Use Disorder (OUD). Previous work demonstrated that KIOS could chart the trajectories of patients with OUD by tracking concurrent changes in multiple clinical measures as they interact. KIOS makes it possible to process patient-entered data and provide responsive behavioral advice to patients specific to their condition in real time. KIOS is an adjunctive tool to MOUD and counseling that gives patients 24/7 access to behavioral intervention strategies that can significantly augment and improve response to routine clinic-based counseling interventions.

Phase I of this application examines barriers and facilitators to payor and other non-patient stakeholder adoption, and incorporates the results into the software and trial design accordingly.

It has three Specific Aims:
Aim 1. Perform Rapid Qualitative Analysis to Define Stakeholder Needs
Aim 2. Implement Applicable Software Changes
Aim 3. Finalize Clinical Trial Design for Phase II

Phase II evaluates the effectiveness of KIOS in clinical studies using a hybrid type 2 design. The Phase II effort is comprised of three Specific Aims:
Aim 1. Optimize Implementation Program
Aim 2. Demonstrate Effectiveness in a Randomized Clinical Trial
Aim 3. Examine Implementation of KIOS in a Real World Context

Collaborative Project
Medical Devices
Behavioral Health