Trial Information

Gardasil Vaccination as Therapy in Low Grade Cervical Abnormalities

This study is looking for additional clinical outcomes in women who are already getting the
Gardasil vaccination. We are not giving the vaccination as part of the research protocol.
This point will be stressed to patients. Their participation or non-participation will not
impact their ability to receive the vaccine series. Their participation only impacts
whether or not we will contact them in the future and whether or not we will review their
medical records.

Subjects will be enrolled into the study at the time of their presentation for colposcopy in
the EAMC Family Medicine Clinic. Subjects will be screened for inclusion and exclusion
criteria. Those found eligible will be consented for enrollment by one of the study
investigators. Colposcopy records will also be searched for patients seen in the
colposcopy clinic between the availability of Gardasil and the beginning of this study. Any
patients who meet enrollment criteria will be contacted by phone and invited to participate
in the study. These patients will be followed in the exact same way as patients enrolled
upon presenting for the first time to the colposcopy clinic.

Patients will be given their first vaccination at the time of their colposcopy appointment
unless they have already begun the vaccine series. Phone and email will be used to remind
patients when they are due for their second and third vaccinations. Any study subject that
does not receive the their 2nd or 3rd vaccine will be considered "partially vaccinated".
They will not be removed from the protocol, however, because an intention-to-treat analysis
is planned.

Study subjects will be followed prospectively for up to 15 months. 15 months was chosen
because some patients may be late getting their one-year follow ups. AHLTA records and
colposcopy clinic convenience files will be reviewed for each patient periodically.
Patients who meet criteria to return to routine annual Pap smear, based on ASCCP guidelines,
during the next 11 to 15 months will be considered as "reversion". Those patients who have
ASCUS, + HPV, LGSIL, or HGSIL on Pap smear at 11 to 15 months past their original Pap smear
will be considered "persistent". Historical control subjects will also be grouped into
"reversion" and "persistent" using the same criteria.