Using Digital Technologies in Clinical HIV Research: Real-World Applications and Considerations for Future Work

Abstract

BackgroundDigital technologies, especially if used in novel ways, provide a number of potential advantages to clinical research in trials related to human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) and may greatly facilitate operations as well as data collection and analysis. These technologies may even allow answering questions that are not answerable with older technologies. However, they come with a variety of potential concerns for both the participants and the trial sponsors. The exact challenges and means for alleviation depend on the technology and on the population in which it is deployed, and the rapidly changing landscape of digital technologies presents a challenge for creating future-proof guidelines for technology application.ObjectiveThe aim of this study was to identify and summarize some common themes that are frequently encountered by researchers in this context and highlight those that should be carefully considered before making a decision to include these technologies in their research.MethodsIn April 2016, the Global HIV Vaccine Enterprise surveyed the field for research groups with recent experience in novel applications of digital technologies in HIV clinical research and convened these groups for a 1-day meeting. Real-world uses of various technologies were presented and discussed by 46 attendees, most of whom were researchers involved in the design and conduct of clinical trials of biomedical HIV prevention and treatment approaches. After the meeting, a small group of organizers reviewed the presentations and feedback obtained during the meeting and categorized various lessons-learned to identify common themes. A group of 9 experts developed a draft summary of the findings that was circulated via email to all 46 attendees for review. Taking into account the feedback received, the group finalized the considerations that are presented here.ResultsMeeting presenters and attendees discussed the many successful applications of digital technologies to improve research outcomes, such as those for recruitment and enrollment, participant identification, informed consent, data collection, data quality, and protocol or treatment adherence. These discussions also revealed unintended consequence of technology usage, including risks to study participants and risks to study integrity.ConclusionsKey lessons learned from these discussions included the need to thoroughly evaluate systems to be used, the idea that early success may not be sustained throughout the study, that some failures will occur, and considerations for study-provided devices. Additionally, taking these key lessons into account, the group generated recommendations on how to move forward with the use of technology in HIV vaccine and biomedical prevention trials.

A mixed methods investigation of implementation barriers and facilitators to a daily mobile phone sexual risk assessment for young women in Soweto, South Africa

“…Participants in our study suggested more entertaining technological approaches to stay relevant to their demographic, such as the use of gaming and social networking applications to collect sexual risk information. Most social networking sites are not private or secure, and due consideration would need to be given to balance the need for privacy and security of participant data with the preference for young people to interact through accessible technology [57].…”

Development and Application of Direct Data Capture for Monitoring Medication Compliance in Clinical Trials

“…Regulatory authorities may be reluctant to allow the use of new technologies in clinical trials due to concerns regarding data security [ 5 ]. However, these problems will be overcome, and new technologies will be implemented in future clinical trials.…”

“…Electronic data capture (EDC) is defined as the collection of clinical trial data on paper (e.g., case report forms, patient diaries, and patient reports) into electronic form. EDC using mobile digital technologies enables clinical trials to be performed more rapidly and at a lower cost [ 4 5 ]. Real time direct data capture in clinical trials enhances EDC by increasing the data accuracy and reducing costs [ 6 7 ].…”

“…Real time direct data capture in clinical trials enhances EDC by increasing the data accuracy and reducing costs [ 6 7 ]. The use of novel digital technologies in clinical research trials reportedly improves research outputs [ 5 ]. Various digital technologies can be used from participant recruitment to data analysis.…”

Increasing access to clinical research using an innovative mobile recruitment approach: The (MoRe) concept

“…Technological revolution has provided opportunities for integrating digital resources into clinical research activities [ 1 , 24 , 26 ]. Some studies have incorporated electronic technologies into research using internet and mobile services for clinical research recruitment and retention, electronic consent processes, internet-based interventions, and for web-based data collection and study result dissemination [ 26 ].…”