Procedure
After the screening questionnaire was completed by the study staff
member, the participant was asked to self-collect a vaginal swab in the
privacy of their homes or in a private space near the mobile clinic. The
study participant was provided instruction with visuals on how to
perform the self-collection. Briefly, the woman was instructed to insert
the swab two inches into her vagina, swirl three times along the upper
vaginal wall, then to remove and place the swab into the provided
collection tube and return to the research staff. Swab insertion and
removal was not witnessed by the research staff member. The
cervicovaginal sample was collected using a broom-type collection device
(Digene HC2 NA Collection Device) and then placed in a 1ml of specimen
transport medium (STM) containing PreservCyt solution to prevent drying
of the sample. At the time of receipt, the study interviewer verified if
the swab was completely submerged into the solution and the collection
bottle was closed correctly.
As part of the standard of care for cervical cancer screening, a
clinician performed a pelvic examination. Lubricant was not applied to
the speculum prior to insertion. After speculum placement, the cervical
os was visualized and a cotton-tipped swab was used to remove any excess
secretions. An endocervical specimen was collected by inserting the
brush-like collection device into the cervical os and rotating five
times. This was placed in the collection device which was then sent to
PHRII laboratory by maintaining cold/refrigerated condition for further
testing for HPV. After the completion of the examination, the research
interviewer administered an acceptability questionnaire about the
woman’s experiences with the pelvic exam and self-collection processes.
The questionnaire was a Likert scale, that ranged from 1 (least
favorable) to 5 (most favorable), to evaluate experiences related to
perception of care, comfort, privacy, embarrassment, and pain for both
collection methods individually. Measures used in the acceptability
questionnaire have been previously used in other HPV self-sampling
studies. The questionnaire also assessed difficulties encountered during
self-collection and questions regarding the ability to perform the
self-collection.