Pilot Randomized Controlled Trial of an Intervention to Promote HPV Uptake Among Young Women Who Attend Subsidized Clinics

Objective: To evaluate the preliminary efficacy, acceptability, and feasibility of Step Up to Prevention, a technology- enhanced intervention to promote human papillomavirus (HPV) vaccination uptake among young minority and lowincome women. Design: A pilot randomized controlled trial. Setting: Two federally supported outpatient clinics in a large city in the northeastern United States. Participants: Women who were 18 to 26 years of age (N 1 / 4 60). Methods: We randomized participants into four groups: computer information, in-person tailored, combined, and usual care. We administered computer-assisted self-interview surveys before the intervention (baseline), immediately after the intervention (postintervention), and after their clinic visit (post-clinic visit). We conducted a descriptive analysis of participant characteristics. For preliminary efficacy, we used logistic regression-assessed HPV vaccine initiation uptake rates, and we used descriptive statistics to compare theoretical mediators. We used conventional content analysis to assess participant feedback about intervention acceptability. We assessed feasibility through recruitment and retention rates and our ability to deliver the intervention. Results: We observed significant differences in initial HPV vaccine uptake between the intervention groups and the usual care group. Participant feedback indicated that the intervention was acceptable, empowering, and informative. We met our recruitment target, maintained a high retention rate (98%), and delivered the complete intervention to all participants. Conclusion: We report the preliminary efficacy, acceptability, and feasibility of this intervention to promote HPV vaccine initiation among young women in federally subsided health care settings by advancing favorable views and improving knowledge about HPV vaccination.