1. Baseline Medical and Menstrual History The ins, outs, ups, and downs of collecting a relevant and complete baseline medical/menstrual history MTN 020 Training

2. Timing and Purpose Medical/Menstrual History will be obtained and documented starting at the Screening Visit – Updated at enrollment visit, prior to randomization Purpose is to establish eligibility and document relevant baseline medical history and conditions, for comparison during follow-up

3. Obtaining a Complete Medical/Menstrual History Two main sources of information: 1.The Participant Things we would never know if the ppt didn’t tell us 2.Study observations Things we would never know if we didn’t look clinician-observed

4. Participant report Study evaluations Baseline History

5. Collecting Ppt Reported Baseline Medical/Menstrual History Ask the ppt about – Past medical history, including but not limited to: – Past problems, including those where medication was taken for an extended period of time – Previous surgeries – Gynecologic history – Allergies (drugs, latex, seasonal) – Any current symptoms/conditions she is having Optional tool to document questions that were asked to ppt = Baseline Medical History Questions Sheet

7. Pre-existing Conditions CRF serves as the “starting point” or baseline form from which study clinician must determine whether conditions identified during follow- up are adverse events Baseline Med/Menstrual History Documentation: Pre-existing Conditions CRF

8. Purpose of PRE CRF Provides in one place a “snapshot” of the ppt’s medical status at point of randomization, as well as important medical events from her history

10. Case 1 23 year old presents for a screening visit In the process of taking her medical/menstrual history, you learn that she – Had an appendectomy when she was 8 – Has had a rash on her right arm for one week – Has periodic headaches, but none today What type of additional details would you want to collect and document about each of these events?

11. Case 1 - continued Probing questions – How often do you get headaches? – When did they start? – Do you take medication for them? – How long do they last? – Do you need to miss work or school because of them? – Do you have associated symptoms when you get your headache? – Have you had a rash like this in the past? – Can you think of something (new drug, food, etc.) that may have brought the rash on?

12. Case 2 A 22 year old woman presents for her screening visit. During her medical/menstrual history interview she reveals that has the following medical issues – Intermittent spotting since starting DMPA one year ago – Hospitalized at age 3 for measles – Mild upper respiratory infection last month, now resolved

13. Case 2 - continued You conduct her screening visit physical exam and notice a scar on her abdomen. She explains that she had her gallbladder removed three years ago because it was infected. You also notice a large scar on her knee measuring 6 cm. She explains that she fell off a motorcycle 4 years ago but did not require surgery or medical treatment. On pelvic exam you notice a 5 mm genital wart on the left labia. She is unaware of it. Thoughts on additional information needed?

14. Case 3 28 year old presents for screening. During the medical history interview she identifies the following medical problems – Hypertension, controlled on a beta blocker – Eczema on her elbows – History of a cesarean section – Chronic low back pain – Vaginal itching Thoughts on additional details needed? Will you need to wait for evaluation of any of the above?

15. Case 4 A 24 year old woman presents for screening visit. She denies any medical problems except – She has been told that she is anemic because of her vegetarian diet – She was diagnosed with a urinary tract infection last year Thoughts on additional details needed, or how you would document this as part of her history?

16. Case 4 - continued Her physical exam and pelvic exam are completely unremarkable except for a birthmark on her back. At the end of her visit, you draw her screening labs and schedule an enrollment visit when you think her labs will be back. You receive her screening labs for review – Hemoglobin is Grade 1 – RPR is positive How will you update her history?

17. QUESTIONS?