Table 2.

Problems and needs as identified by participants.

Identified problem	Identified need
Complex language	Clear language
Unclear scientific content	More background on the specifics e.g., how a virus can cause cancer, how vaccines work, reasons for reactions, reasons for children requiring vaccination at an age when most are not sexually active, and reasons for the mention of contraception (required for participation if sexually active)
Unclear study purpose	Explanation of who the researchers are Better explanation of the aim
Unclear process, particularly: • Recruitment method • Role of the child • Study withdrawal • Data access, storage time and anonymization	Description of who the study is targeted at and how the individual was selected • Clear information about the process for both the parent and child • Detailed information about the withdrawal process • More details on the practicalities: when and how data can be accessed by the participant, how long it will be used, sharing with third parties, and how data could potentially be linked back to participants
Insufficient information about alternatives to trial participation	More explicit details about the other options available outside of the study (for example other HPV vaccines available in Italy).
Insufficient information about risks, particularly: • Vaccine side effects and how long they may last • Allergies, particularly unknown ones • Any potential risks to fertility	More, and clearer information about risks, and about allergies including if and how symptoms for any unknown allergies may have presented previously
Unbalanced information (i.e., too much information about privacy)	Balance the sections of the informed consent form in line with the patients concerns (less privacy, more health risks)
Coercion through guilt (altruism was noted as a reason for study participation in the invitation letter)	Clearer, more balanced information about benefits and risks (including separation of individual and societal)
The need to seek information from other sources was expressed	Guidance to good sources of information
Difficult conversations to have in the family unit	Provide materials for communicating with a child on the topic; or communicating with other family members (e.g., husband)