Methods for Authenticating Participants in Fully Web-Based Mobile App Trials from the iReach Project: Cross-sectional...

Area of Science:

• Digital Health
• Public Health Interventions
• Clinical Trial Methodology

Background:

• Mobile health (mHealth) apps are crucial for scaling HIV prevention services like testing, PrEP, and education.
• Web-based intervention trials require robust methods to prevent fraudulent or duplicate participant enrollment.
• Ensuring data validity and reliability is critical for the integrity of mHealth trial results.

Purpose of the Study:

• To discuss electronic and manual authentication strategies used in the iReach randomized controlled trial.
• To detail methods for monitoring and preventing fraudulent enrollment in a web-based HIV prevention study.

Main Methods:

• The iReach trial focused on same-sex attracted, cisgender males aged 13-18 in the US, prioritizing people of color and rural residents.
• Data evaluation involved identifying duplicate enrollments and fraudulent participants via data inconsistencies and completion times.
• Electronic flagging of suspicious enrollment was supplemented by manual verification of age, IP addresses, email, social media, and survey completion times.

Main Results:

• Combined electronic and manual strategies prevented 624 cases of fraudulent, duplicative, or ineligible enrollment.
• Electronic strategies identified 79% (493/624) of problematic enrollments, significantly reducing manual authentication burden.
• A case study illustrating a specific authentication scenario and resolution was included.

Conclusions:

• Developing effective methods to handle suspicious enrollments is increasingly vital for web-based trials.
• These authentication strategies are essential for maintaining data quality and ensuring reliable trial outcomes.
• Implementing robust enrollment monitoring protects the integrity of research findings in digital health interventions.