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A Web-Based Data Collection Platform for Multisite Randomized Behavioral Intervention Trials: Development, Key
Riddhi A Modi1, Michael J Mugavero1, Rivet K Amico2
1University of Alabama at Birmingham, Birmingham, AL, United States.
JMIR Research Protocols
|June 18, 2017
Summary
A new software platform, Integrating ENGagement and Adherence Goals upon Entry (iENGAGE), was developed to support a multisite behavioral intervention for HIV patients. User feedback highlighted ease of use and data integration as key benefits for improving clinical trial conduct.
Area of Science:
- Behavioral Science
- Health Informatics
- Clinical Trials
Background:
- Meticulous data tracking is crucial for regulatory compliance and data integrity in behavioral intervention trials.
- Behavioral interventions can improve health outcomes for HIV-infected patients, enhancing retention in care.
- The iENGAGE intervention was developed to empower newly diagnosed HIV-positive individuals.
Purpose of the Study:
- To describe the design and implementation of a Web-based software application for multisite behavioral science interventions.
- To report on end-user perspectives regarding the software's impact on a behavioral intervention trial.
Main Methods:
- Developed a software platform to deploy a 4-site behavioral intervention for new HIV/AIDS clinic patients.
- Integrated a study coordinator into the informatics team for software development.
- Conducted a 25-item survey with 13 users to evaluate perspectives on the iENGAGE trial platform.
Main Results:
- Key features included study enrollment, randomization, real-time data collection, longitudinal workflow, reporting, and reusability.
- 100% user agreement that database participation improved understanding of roles and responsibilities.
- Users found ease of use, color flags, longitudinal workflow, and centralized data storage most useful.
Conclusions:
- Early and continuous study team involvement in design development validated the iENGAGE platform's approach.
- Post-hoc data collection from users provided insights for enhancing future software and informing clinical practices.
- The platform successfully supported a multisite behavioral intervention for HIV patients.
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