JMIR Publications

ABSTRACT

Background:

Electronic health records are a cost-effective approach to providing necessary foundations for clinical trial research. The ability to utilize electronic health records in real-world clinical settings allows for pragmatic approaches to intervention studies with the emerging adult HIV population within these settings, however the regulatory components related to the utilization of electronic health records data, in multi-site clinical trials poses unique challenges.

Objective:

As part of the larger ATN162b study that evaluated clinic level outcomes of an HIV treatment and PrEP services intervention to improve retention within the emerging adult HIV population, the objective of this paper is to highlight the regulatory process and challenges in the implementation of a multi-site pragmatic trial utilizing electronic health records.

Methods:

Four sites were selected from subject recruitment venues as part of the Adolescent Trials Network. One prevention site and one treatment site received the intervention and one prevention comparison site and one treatment comparison site did not in a quasi-experimental design. An additional four sites were engaged in research activities (data management and analysis). The ATN162b protocol team worked with site personnel to establish the necessary regulatory infrastructure in order to collect electronic health record data to evaluate retention in care and viral suppression, as well as paradata on the intervention component to assess feasibility and acceptability of the mHealth intervention. Methods to develop this infrastructure included site-specific training activities and the development of data use and reliance agreements to ensure regulatory compliance.

Results:

Due to variations in site-specific activities, and the associated regulatory implications, the overall study's timeline was impacted, resulting in a phased approach with the data extraction sites as phase 1 and intervention sites as phase 2. This phased approach was intended to address the unique regulatory needs of all participating sites in order to ensure that all sites were properly onboarded and all regulatory components were in place. Across all sites, the regulatory process spanned 6 months for the four data extraction and intervention sites, and up to 10 months for the data management and analysis sites.

Conclusions:

The process for engaging in multi-site clinical trial studies utilizing electronic health record data is a multi-step, collaborative effort. Considerations surrounding the necessity of data use agreements, reliance agreements, external IRB review and engagement with clinical sites were a foremost consideration to ensure successful implementation and adherence to pragmatic trial timelines and outcomes.