IMPORTANCE Delivery of vaccination to adolescents via a school-based program provides an opportunity to promote their involvement in health decision-making, service provision, and selfefficacy (belief in one's ability to perform a certain behavior).OBJECTIVE To examine the effect of a human papillomavirus (HPV) vaccination education and logistical intervention on adolescent psychosocial outcomes.
DESIGN, SETTING, AND PARTICIPANTSIn this cluster randomized trial and process and qualitative evaluation, adolescents aged 12 to 13 years (first year of high school) were recruited at high schools in Western Australia (WA) and South Australia (SA) in 2013 and 2014. Statistical analysis was performed from January 2016 to December 2020.
INTERVENTIONSThe complex intervention consisted of an adolescent intervention to promote knowledge and psychosocial outcomes, shared decisional support tool, and logistical strategies.
MAIN OUTCOMES AND MEASURESPrespecified secondary outcomes were assessed. The HPV Adolescent Vaccination Intervention Questionnaire (HAVIQ) was used to measure changes in adolescent knowledge (6-item subscale), fear and anxiety (6-item subscale), self-efficacy (5-item subscale), and decision-making (8-item subscale). The hypothesis was that the intervention would improve adolescent involvement in vaccine decision-making (measured before dose 1 only), improve vaccine-related self-efficacy, and reduce vaccine-related fear and anxiety (measured before doses 1, 2, and 3). Mean (SD) scores for each subscale were compared between intervention and control students. In the process evaluation, focus groups were conducted. Analyses of the HAVIQ data were conducted from 2016 to 2020. Qualitative analyses of the focus groups were undertaken from 2017 to 2020.
RESULTSThe trial included 40 schools (21 intervention and 19 control) across sectors with 6967 adolescents (mean [SD] age, 13.70 [0.45] years). There were 3805 students (1689 girls and 2116 boys) in the intervention group and 3162 students (1471 girls and 1691 boys) in the control group. The overall response rate for the HAVIQ was 55%. In WA, where parental consent was required, the response rate was 35% (1676 of 4751 students); in SA, where parental consent was not required, it was 97% (2166 of 2216 students). The mean (SD) score for decision-making in the intervention group before dose 1 was 3.50 (0.42) of 5 points and 3.40 (0.40) in the control group, a small but significant difference of 0.11 point (95% CI, 0.06 to 0.16 point; P < .001). There was a small difference in favor of the intervention group in reduced vaccination-related anxiety (pre-dose 1 difference, −0.11 point [95% CI, −0.19 to −0.02 point]; pre-dose 2 difference, −0.18 point [95% CI, −0.26 to −0.10 point]; (continued) Key Points Question Does a human papillomavirus (HPV) vaccination intervention in the school setting improve adolescent psychosocial outcomes? Findings In this analysis of secondary outcomes of a cluster randomized trial and qualitative evaluation of an education and logistical interv...