A Web-Based Data Collection Platform for Multisite Randomized Behavioral Intervention Trials: Development, Key Software Features, and Results of a User Survey

Riddhi A Modi, Michael J Mugavero, Rivet K Amico, Jeanne Keruly, Evelyn Byrd Quinlivan, Heidi M Crane, Alfredo Guzman, Anne Zinski, Solange Montue, Katya Roytburd, Anna Church, James H Willig, Riddhi A Modi, Michael J Mugavero, Rivet K Amico, Jeanne Keruly, Evelyn Byrd Quinlivan, Heidi M Crane, Alfredo Guzman, Anne Zinski, Solange Montue, Katya Roytburd, Anna Church, James H Willig

Abstract

Background: Meticulous tracking of study data must begin early in the study recruitment phase and must account for regulatory compliance, minimize missing data, and provide high information integrity and/or reduction of errors. In behavioral intervention trials, participants typically complete several study procedures at different time points. Among HIV-infected patients, behavioral interventions can favorably affect health outcomes. In order to empower newly diagnosed HIV positive individuals to learn skills to enhance retention in HIV care, we developed the behavioral health intervention Integrating ENGagement and Adherence Goals upon Entry (iENGAGE) funded by the National Institute of Allergy and Infectious Diseases (NIAID), where we deployed an in-clinic behavioral health intervention in 4 urban HIV outpatient clinics in the United States. To scale our intervention strategy homogenously across sites, we developed software that would function as a behavioral sciences research platform.

Objective: This manuscript aimed to: (1) describe the design and implementation of a Web-based software application to facilitate deployment of a multisite behavioral science intervention; and (2) report on results of a survey to capture end-user perspectives of the impact of this platform on the conduct of a behavioral intervention trial.

Methods: In order to support the implementation of the NIAID-funded trial iENGAGE, we developed software to deploy a 4-site behavioral intervention for new clinic patients with HIV/AIDS. We integrated the study coordinator into the informatics team to participate in the software development process. Here, we report the key software features and the results of the 25-item survey to evaluate user perspectives on research and intervention activities specific to the iENGAGE trial (N=13).

Results: The key features addressed are study enrollment, participant randomization, real-time data collection, facilitation of longitudinal workflow, reporting, and reusability. We found 100% user agreement (13/13) that participation in the database design and/or testing phase made it easier to understand user roles and responsibilities and recommended participation of research teams in developing databases for future studies. Users acknowledged ease of use, color flags, longitudinal work flow, and data storage in one location as the most useful features of the software platform and issues related to saving participant forms, security restrictions, and worklist layout as least useful features.

Conclusions: The successful development of the iENGAGE behavioral science research platform validated an approach of early and continuous involvement of the study team in design development. In addition, we recommend post-hoc collection of data from users as this led to important insights on how to enhance future software and inform standard clinical practices.

Trial registration: Clinicaltrials.gov NCT01900236; (https://ichgcp.net/clinical-trials-registry/NCT01900236 (Archived by WebCite at http://www.webcitation.org/6qAa8ld7v).

Keywords: HIV; Web application; behavioral research; iENGAGE; software design; survey; user perspective.

Conflict of interest statement

Conflicts of Interest: JHW has received research support from the Bristol-Myers Squibb Virology Fellows Research Program for the 2006 to 2008 academic years, Pfizer, Tibotec Therapeutics, and Definicare, and has consulted for Bristol-Myers Squibb and Gilead Sciences. AOW has received research support from Definicare. GAB has received research support from the Bristol-Myers Squibb Virology Fellows Research Training Program for the 2010 to 2012 academic years. MJM has received support from Bristol-Myers Squibb and personal fees from Gilead Sciences, Jansen Therapeutics, and Bristol-Myers Squibb, unrelated to the submitted work.

©Riddhi A Modi, Michael J Mugavero, Rivet K Amico, Jeanne Keruly, Evelyn Byrd Quinlivan, Heidi M Crane, Alfredo Guzman, Anne Zinski, Solange Montue, Katya Roytburd, Anna Church, James H Willig. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 16.06.2017.

Figures

Figure 1
Figure 1
Patient registration.
Figure 2
Figure 2
Worklist.

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Source: PubMed

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