After you are determined eligible, a research nurse or another member of the study team will explain an informed consent form. After signing this form, you will have a normal diagnostic colposcopy exam and we will collect additional samples from you.
We will first collect urine to be used as point-of-care pregnancy test. If positive, you will be unable to continue the study.
The clinician will exam you and take several samples from you, including from the vagina, rectum, and blood. With these, we can determine your vaginal pH, and identify sexually transmitted infections and the presence of different types of HPV. We will also collect bacteria for culture and to characterize your microbiome. Lastly, several cervical biopsies will be taken for diagnostic and research purposes.
Two to four weeks later, during a post-enrolment visit, you will receive your results about the HPV test. Women who either test HPV-negative or are infected with only low-risk HPV strains will be given our clinical recommendations. Women with cervical carcinoma will be immediately referred for treatment. The study will end for these women. If you have a high risk HPV strain infection but do not have carcinoma, you will be followed for up to 3 years to determine the bacterial or host factors that contribute to either regression (abnormal cells that go back to normal due to natural immunity) or progress to cervical cancer and need to be treated.
During your enrolment examination, you will fill out a questionnaire that will be used to collect demographics and other information such as medical history, substance use, sexual practices, past pregnancy, and other factors related to the microbiome and reproductive health. You will also be instructed on how to use an online food diary, which will collect information about your diet in the three days following your enrolment visit, as well as the three days prior to your follow up visits.
Over the next three years, once every 4-6 months you will come into the clinic for regular scheduled clinical visits where we will also collect more research samples. The samples taken will mirror the enrolment study, including several swabs of the vagina and the rectum, as well as a blood draw and several cervical biopsies. After these visits, the study will end and you can complete an exit questionnaire.
Thank you very much for considering to participate in the THRIVE HPV study!