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://clinicaltrials.gov/ct2/show/NCT01900236 (Archived by WebCite at http://www.webcitation.org/6qAa8ld7v)
[1]
Hans-Ulrich Prokosch,et al.
Concept and implementation of a study dashboard module for a continuous monitoring of trial recruitment and documentation
,
2016,
J. Biomed. Informatics.
[2]
Gloria M. Miele,et al.
Using e-technologies in clinical trials.
,
2015,
Contemporary clinical trials.
[3]
A. Westfall,et al.
Early Retention in HIV Care and Viral Load Suppression: Implications for a Test and Treat Approach to HIV Prevention
,
2012,
Journal of acquired immune deficiency syndromes.
[4]
Simon S. Cross,et al.
How to design and use a research database
,
2009
.
[5]
Binny Krishnankutty,et al.
Data management in clinical research: An overview
,
2012,
Indian journal of pharmacology.
[6]
Prashant C. Palvia,et al.
Developing and validating an instrument for measuring user-perceived web quality
,
2002,
Inf. Manag..
[7]
J. Efird,et al.
Blocked Randomization with Randomly Selected Block Sizes
,
2010,
International journal of environmental research and public health.
[8]
A. Westfall,et al.
Missed visits and mortality among patients establishing initial outpatient HIV treatment.
,
2009,
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.
[9]
Richard D Moore,et al.
A low-effort, clinic-wide intervention improves attendance for HIV primary care.
,
2012,
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.
[10]
Lei Wang,et al.
Prevention of HIV-1 infection with early antiretroviral therapy.
,
2011,
The New England journal of medicine.
[11]
J Dunbar,et al.
Organization and management of recruitment.
,
1982,
Circulation.
[12]
D Elbourne,et al.
Recruitment to randomised trials: strategies for trial enrollment and participation study. The STEPS study.
,
2007,
Health technology assessment.
[13]
C. Oatis,et al.
Tailored System to Deliver Behavioral Intervention and Manage Data in Randomized Trials
,
2013,
Journal of medical Internet research.