Abstract
BackgroundMeticulous 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.ObjectiveThis 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.MethodsIn 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).ResultsThe 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.ConclusionsThe 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 RegistrationClinicaltrials.gov NCT01900236; (https://clinicaltrials.gov/ct2/show/NCT01900236 (Archived by WebCite at http://www.webcitation.org/6qAa8ld7v)
Highlights
In multisite behavioral intervention trials, participant enrollment, randomization, data collection, security, storage and access, and intervention fidelity are all components critical to the success of a study [1,2]
In order to support the implementation of the National Institute of Allergy and Infectious Diseases (NIAID)-funded trial Integrating ENGagement and Adherence Goals upon Entry (iENGAGE), we developed software to deploy a 4-site behavioral intervention for new clinic patients with HIV/AIDS
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
Summary
In multisite behavioral intervention trials, participant enrollment, randomization, data collection, security, storage and access, and intervention fidelity are all components critical to the success of a study [1,2]. Central study coordinators are typically tasked with tracking and documenting participant activities [3,4]. There are several electronic data capture systems available for the conduct of randomized clinical trials, and while there are some examples of behavioral sciences research being supported by software [2], this practice is much less common than in the clinical trials space. Like most randomized clinical trials, in behavioral intervention trials, participants typically complete several study procedures at different time points. With limited literature available on multisite behavioral intervention trials supported by custom software, there is little opportunity for such investigators to learn how this technology could facilitate the accomplishment of their research goals. Participants typically complete several study procedures at different time points. To scale our intervention strategy homogenously across sites, we developed software that would function as a behavioral sciences research platform
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