Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT06414057
Eligibility Criteria:
Inclusion Criteria:
Individuals will be eligible for participation in components 1 and/or 2 if they:
* have a cervix
* are aged 25-45 years (inclusive)
* are able to provide informed consent for themself
And have experience of either:
* substance use/addiction
* living in custodial settings
* homelessness
* involvement in transactional sex
Exclusion Criteria:
Individuals will be excluded from participation if they:
* Do not have a cervix due to surgery or other reasons
* Are known to have completed the full vaccination schedule (as per JCVI criteria for their age and immunocompetency) (Excluded from component 1 (vaccination and HPV screening) only - still able to participate in component 2 (individual interview))
* Meet any of the vaccine exclusion criteria as set out in the local HPV PGD
* Have had a confirmed anaphylactic reaction to a previous dose of HPV vaccine.
* Have had a confirmed anaphylactic reaction to any component of the vaccine. Practitioners must check the marketing authorisation holder's SmPC for details of vaccine components.
* Have a history of severe (i.e. anaphylactic reaction) to latex where the vaccine is not latex free.
* Are known to be pregnant.
* Are suffering from an acute severe febrile illness (the presence of a minor infection is not a contraindication for immunisation).
Additionally, PGDs advise caution where a neurological condition is believed to be progressing or there is neurological deterioration and therefore, individuals meeting this criteria will be excluded (from component 1 only).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
25 Years
Maximum Age:
45 Years
Study:
NCT06414057
Study Brief:
Protocol Section:
NCT06414057