What is expected of me?
Participation
After you have been determined eligible for participation in the study, you will first be required to review and sign a consent form. This will be done in the presence of a nurse who will be able to answer any questions you may have regarding the study.
You will then fill out an extensive questionnaire at the clinic, which you will be able to fill out in privacy. The nurses will be available if you have any questions or concerns regarding the questionnaire. The questionnaire will take about 15-20 minutes to fill out.
During your first visit, as well as after one month and six months after your first visit, you will have a physical exam where the clinician will take vaginal, rectal and blood samples from you. Normally these exams will take about 10 mins.
If you have bacterial vaginosis, you will be prescribed treatment which you will be expected to take and record in your dairy by filling in the appropriate circles for each date (see example picture below). If at any time during the study you have recurring bacterial vaginosis, you will be treated again and asked to record this in your diary.
You will be sent home with a month's supply of swabs which you will use to take daily vaginal swabs (even when menstruating) which you will date and record on your diary. A nurse will explain the procedure for taking the swab, and you will be sent home with detailed instructions on the procedure.
You will be provided with a cooler bag and an icepack which you can use to store your used swabs in a freezer and also use to transport your samples to the clinic each month.
When you come to the clinic to drop off your monthly samples and collect fresh swabs for the following month, you will be required to fill out a monthly questionnaire similar to the initial questionnaire.
Your last day of participation will be your 6 month clinical visit, where you will have your final physical exam and questionnaire.
If you are interested, we will contact you at the end of the study with your results.
Thank you very much for considering to participate in the THRIVE BV study!
Summary
The THRIVE study requires you to participate for 6 months. You will come to the clinic 3 times to have comprehensive sampling. You will be required to take daily self-collected vaginal swabs, and store these in a freezer in between monthly visits. You will be asked to fill out a daily diary to keep track of any days missed, when you take medication for BV, and when you are menstruating. You will be required to fill out monthly questionnaires. If you have any further questions about the THRIVE study please feel free to contact us and we will be happy to clarify any concerns you may have.