WIHS QxQ Form 22: Medical and Health History – 10/01/02a Page 1 of 7 WOMEN'S INTERAGENCY HIV STUDY QUESTION BY QUESTION SPECIFICATIONS FORM 22MED: MEDICATION HISTORY Guidelines for completing Form 22MED, “Medication History.” General Instructions: NOTE: If this form is being administered to the participant AFTER her physical exam, be sure to remind her that the findings from her exam conducted today do NOT apply to the questions you are as about to ask her. 1. Before beginning this section, interviewers should make sure that they have at least eight blank copies of both Drug Form 1 and Drug Form 2 available in case they are needed. 2. Use the form version dated 10/01/02. 3. Interviewers should indicate on the form whether or not the interview is associated with a participant’s regular WIHS visit or a 3-month Viral Resistance Study (VRS) visit. In the general information section at the beginning of the form, there is a place to indicate “WIHS Core Visit” or “3 Month VRS Visit.” The appropriate visit type should be selected and the corresponding number circled. If there is any confusion as to what type of visit the participant is attending, interviewers should bring this to the attention of the project director for clarification before circling the appropriate response on the form. 4. All dates should be recorded in the MM/DD/YY format unless otherwise noted. For dates that must be completed on the form, if the participant cannot remember the exact month (and day), probe for the season. Use “15” for the day if the specific day cannot be recorded. Probe for the season and assign the month as follows: Summer = July = 07 Fall = October = 10 Winter = January = 01 Spring = April = 04 Interviewers should have available an appropriate calendar to aid the participant in determining dates. Years in response to questions inquiring about occurrences “since last visit” should be 1995 and thereafter. 5. Times should be recorded in the HH:MM format. Remember to use leading zeros, e.g., 08:00. 6. For questions containing an open-ended specify box linked to the response “other,” interviewers should print responses exactly in the words of the respondent. 7. Obtain the date of the participant’s previous visit from the Visit Control Sheet (VCS). The month in this date should be used in the questions wherever (MONTH) appears. For both WIHS core visits and 3-month VRS visits, enter the date of the participant’s last completed core visit, regardless of whether she has attended an interim VRS visit. 8. Interviewers SHOULD IGNORE the three-digit numbers listed next to each box in Questions F2A, F9A–C, and F11B. These numbers are necessary for data entry, but should be ignored in the actual interview. Additionally, interviewers should ignore any markings related to data entry such as “START F22P1.” These indicators mark the beginning and end of all subforms; they have been added for data entry purposes only and will not affect how the form is completed. Follow the skip patterns as they appear on the form. READ THE INTRODUCTION TO THE PARTICIPANT.WIHS QxQ Form 22: Medical and Health History – 10/01/02a Page 2 of 7 SECTION B: MEDICATION HISTORY The time frame for questions (e.g., last three months, last six months, last three days) shifts a number of times throughout this section. The interviewer should pay particularly close attention to the time frame to which each question refers and stress this time frame to the participant while reading the questions. B1. A vaccine against HIV-1 can include vaccines which prevent infection with HIV or therapeutic vaccines (those which prevent progression of the infection). B2A. HAND THE PARTICIPANT THE CURRENT ANTIRETROVIRAL PHOTO MEDICATION CARDS. Go through each card with the participant. For EACH medication, ask the participant “Since your (MONTH) study visit, have you taken (DRUG NAME)?”. Ensure that, in addition to her prescribed antiretrovirals, she includes all antiretroviral medications that may have been taken as part of a research study, including those in which she may have been blinded (PROBE: unaware of whether you were taking the actual medication or a placebo) to the treatment. However, if the participant is HIV-negative, you do not need to read through the entire list of antiretroviral medications and can skip to question B2B. Mark each drug to which the participant responds with a “Yes” by placing an “X” in the corresponding box. Do not concern yourself with the three-digit numbers listed next to each box. These numbers are necessary for data entry purposes only. The antiviral drug listing in question B2A is not complete. However, it does contain currently used medications to the best of our knowledge. This list is updated every six months. For any other antiviral medication used by the participant against HIV-1 that is not on the list in question B2A, mark the box denoted “Other antiviral(s)” and print the name of the drug in the specify box. Check Drug List 1 to see if it is on this list. If so, record the three-digit code in the space allotted next to the “Specify” box. If the drug is not on Drug List 1, CHECK THE DRUGS LISTED IN QUESTIONS B9A–B9C TO SEE IF IT IS ON ONE OF THESE LISTS. If the drug is listed in questions B9A–B9C, record its use there. If the drug is a complementary/alternative therapy, record its use in question B11. Otherwise, bring this to the attention of the clinic coordinator/director. If the drug is not on the coding list, the center’s director should contact the coordinator at WDMAC to inquire about the applicability of getting a new drug code assigned. Use the drug code obtained from WDMAC. Complete a Drug Form 1. If a participant indicates that she is taking an antiviral medication, but does not know or cannot remember the name of the medication, mark the box denoted “Other antiviral(s)” and print “unknown” in the specify box. Enter “999” in the space provided for the three-digit drug code. If the participant reports more than one unknown antiretroviral medication, please list them as unknown1, unknown2, etc., for tracking purposes. If the participant indicates that she is taking “Combivir,” mark the “Combivir” box (code 227). The boxes for AZT and 3TC should not be checked. If the