Recruitment of adolescents to virtual clinical trials: experiences from the Health4Me clinical trial (Preprint)

Abstract

BACKGROUND Preventive interventions are needed to provide targeted health support to adolescents to improve health behaviors. Engaging adolescents in preventive interventions remains a challenge, highlighting the need for innovative recruitment strategies. Given adolescents’ lives are intertwined with digital technologies, attention should be focused on these avenues for recruitment. The evolving nature of clinical trials, including the emergence of virtual clinical trials, require new recruitment approaches, which must be evaluated. OBJECTIVE To examine the effectiveness and cost of various digital recruitment strategies for recruiting adolescents to a virtual clinical trial, and to evaluate the progression of participants from screening to enrolment and explore factors associated with non-participation. We do this using the example of the Health4Me Study, a preventive digital health intervention to improve physical activity and nutrition behaviors among adolescents 12-18 years old. METHODS Participants were recruited into the Health4Me Study via social media advertisements on various contemporary platforms, emails to schools, emails to contacts within known networks and emails to relevant youth organizations. Data was collected from social media advertisements, screening, and recruitment logs. Data analysis included summary and descriptive statistics, as well as Chi-Squared tests to explore factors associated with non-participation. RESULTS From 2369 expressions of interest, 390 (16.4%) participants were enrolled. A total of 19 advertisements were placed on social media, and 385 promotional emails were sent to schools, contacts within known networks, and relevant youth organizations. Social media advertisements reached 408,077 unique accounts. Advertisements mostly reached those living in populous states in Australia (75% of unique accounts [306,489/408,077]) and those identifying as female (43.5% of unique accounts [177,698/408,077]). 25% of advertisements were delivered to accounts with uncategorised genders (101,907/408,077). Total cost per participant enrolled was AUD $3.89 (USD $2.58). Most participants (85.9%, 1980/2305) found out about the study through Instagram. Differences in screening characteristics between eligible participants who did and did not enrol were found to be statistically significant for gender (P=.02) with fewer males and more individuals reporting their gender as 'Other' enrolling than expected than by chance alone. Recruitment method also differed (P<.001), with fewer participants enrolling through Instagram and more enrolling through other methods (e.g. known networks, word of mouth) than expected by chance alone. CONCLUSIONS In this study we show that virtual clinical trial recruitment was found to be low-cost with the potential to increase trial participation. Social media was the most effective recruitment method, reaching all states and territories, including hard-to-reach populations. Future action is needed to explore recruitment methods which are more effective for males and to build trust among adolescents regarding clinical trial recruitment via social media.