MTN-036/ IPM 047 Informed Consent Comprehension Assessment (TRUE/FALSE)
No. / Question / True / False1 / If you decide to join this research study, you will be in the study for about 13 weeks. / /
2 / The primary purpose of this study is to test how effective three different vaginal rings are at preventing HIV. / /
3 / You will be asked to insert a vaginal ring either three times for 4-5 weeks at a time, or once for 13 weeks depending on random assignment to one of these study groups. / /
4 / If you take part in the research study, you will have physical and pelvic exams, be tested for HIV and other health problems, and answer questions about your experience wearing the vaginal ring. / /
5 / You will be asked to abstain from receptive vaginal sex for the duration of study participation. / /
6 / The study ring will prevent you from getting pregnant, so you may choose not to use another form of contraception during your study participation. / /
7 / If the study staff determines that you have any medical problems, they will treat you or refer you to available sources of medical care for those problems. / /
8 / The vaginal ring could cause some bad effects like causing some discomfort or discharge from the vagina. / /
9 / If you decide not to join this research study, this decision will not impact your regular medical care. / /
10 / If you do not agree to future specimen storage, you cannot be in this research study. / /
11 / Your personal information may be accessed by anyone at the clinic, even if they are not part of the study staff. / /
PTID / DATE
Staff Signature / Staff Date
Version 1.0, 14 July 2017