Lay health worker research personnel for home-based data collection in clinical and translational research: Qualitative and quantitative findings from two trials in hard-to-reach populations.

Aims: The role of lay health workers in data collection for clinical and translational research studies is not well described. We explored lay health workers as data collectors in clinical and translational research studies. We also present several methods for examining their work, i.e., qualitative interviews, fidelity checklists, and rates of unusable/missing data. Methods: We conducted 2 randomized, controlled trials that employed lay health research personnel (LHR) who were employed by community-based organizations. In one study, Results: Independent observers reported a very high degree of fidelity to technical data collection protocols (>95%) and low rates of missing/unusable data (1.5%-11%). Qualitative results show that trust, training, communication, and supervision are key and that LHR report feeling empowered by their role. LHR training included various content areas over several weeks with special attention to LHR and participant safety. Training and supervision from both the academic researchers and the staff at the community-based organizations were necessary and had to be well-coordinated. Conclusions: Carefully selected, trained, and supervised LHRs can collect sophisticated data for community-based clinical and translational research.