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.