Table 1.
Participants | Inclusion (V 1) | Results (V 2) | Return (Vi, with i>2) | |
All | All | HPV+ | HPV- | |
Time | Day 0 | +4 weeks | +8 weeks | +16 weeks |
Eligibility | ¤ | |||
Consent | ¤ | |||
Gynaecological consult | ¤ | ¤ | ¤ | ¤ |
Vaginal pH cotton swab | ¤ | ¤ | ¤ | ¤ |
two vaginal swab samples (Copan ESwab) | ¤ | ¤ | ¤ | ¤ |
One ophthalmological sponge sample | ¤ | ¤ | ¤ | |
One cervical smear in PreservCyt (cytology) | ¤ | + | ||
One cervical smear in PBS (Phosphate Buffered Saline) | ¤ | + | ¤ | |
Blood sampling (HPV antibodies) | ¤ | ¤ | ||
Blood sampling (sequencing) | ¤ | |||
Blood sampling (immunophenotyping) | ¤ | ⊲ | ||
Other STI detection | ⋆ | ⋆ | ⋆ | ⋆ |
Questionnaire #1 (inclusion) | ¤ | |||
Questionnaire #2 (visit) | ¤ | ¤ | ¤ | |
Questionnaire #3 (home) | ¤ | ¤ | ¤ | ¤ |
Returning self-sampling samples | ¤ | ¤ | ¤ | |
Serious adverse event collection | ¤ | ¤ | ¤ |
The cross-sectional study only includes the first two columns (V 1 and V 2). ¤ S amples taken at visits. + P articipants infected by a HR-HPV for 12 month will have one PBS smear replaced by a Thinprep smear to perform a cytology and check for lesions. ⊲ T his sample is only taken at the first HPV + visit of a formerly HPV- participant. ⋆ STI detection will be performed at inclusion unless the participant has been tested within the last 3 months and during the study every 6 months if a new partner has been reported or request. HPV, human papillomavirus; STI, sexually transmitted infection.