WIHS QxQ Drug Form 1: Antiviral Medication - 10/01/02 Page 1 of 4 WOMEN'S INTERAGENCY HIV STUDY QUESTION BY QUESTION SPECIFICATIONS DRUG FORM 1: ANTIRETROVIRAL MEDICATIONS Guidelines for completing Drug Form 1, “Antiretroviral Medications.” General Instructions: 1. A Drug Form 1 should be completed for each medication a participant lists in question B2A on Form 22MED, Section B. Therefore, if a participant is or has been (since last visit) on three antiviral medications, the interviewer should fill out three Drug Form 1’s for that participant. To indicate to which specific drug a particular Drug Form 1 refers, the interviewer should check off ONE of the boxes listed at the top of the form. The listing of antiviral medications on Drug Form 1 is not complete. However, it does contain currently used medications to the best of our knowledge and each drug retains a unique code assigned by WDMAC. For any other antiviral medication used by the participant against HIV-1 that is not listed on Drug Form 1, mark the box denoted “Other antiviral” and print the name of the drug in the specify box. Refer to the current Drug List 1 to obtain codes for drugs not listed on Drug Form 1 and enter the code from Drug List 1. If the drug is not on Drug List 1, record code “998” for “other antiviral.” Bring this to the attention of the clinic coordinator/director. Notify WDMAC of any frequently used medications that do not have unique codes. 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. Interviewers should ignore the numbers in italics listed next to the check boxes at the beginning of the form. These numbers are for data entry purposes only. 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. When reading the questions, insert the actual drug name as stated by the participant where it says (DRUG). For both WIHS core visits and 3-month VRS visits, insert the date of the participant’s last completed core visit where it says (MONTH), regardless of whether she has attended an interim VRS visit.WIHS QxQ Drug Form 1: Antiviral Medication - 10/01/02 Page 2 of 4 5. If a participant had been (since last visit) taking a medication as part of a research study but then continued that medication after the trial ended during the same visit period, complete two drug forms. One form will correspond to the portion of the visit when the participant was enrolled in the trial. The second drug form will correspond to the portion of the visit continuing the medication usage but not as part of the trial. 6. If a participant is taking a medication as part of a research study but is not blinded to the treatment, complete the entire Drug Form 1, do not stop after Q.2.B. 7. All questions refer to the period since the participant’s last core study visit. 8. Questions 5–11 refer to antiviral medication adherence. They should only be answered for participants that are currently taking the specific anti-HIV medication referred to on the form. These questions should also be answered for medications taken as part of a research trial as long as the participant is not blinded to the treatment. Follow the skip patterns as they appear on the form. Question 1: This question refers to whether or not the participant started the medication since her last study visit. We want to know if this is a new medication OR a previous medication that the participant has started re-using since their last visit. If participants have been on a medication break and then start using the same drug again, they should respond “YES” to this question. If the medication is not a new medication that the participant has begun taking since her last visit, skip Q.1.B. and Q.1.C. If the medication is a previous one that the participant is re-using since their last visit, be sure to record the most recent date that they began re-taking that medication. If the participant cannot remember the exact month she began taking the medication, probe for the season and assign month as follows: Summer = July = 07 Fall = October = 10 Winter = January = 01 Spring = April = 04 If the participant cannot recall the exact date of the month, record the date as “15” per the Manual of Operations. Interviewers should have available an appropriate calendar to aid the participant in determining dates. Question 2: This question asks about how the participants have access to their antiretroviral medications. One of the responses for this question is a “Compassionate Use Program.” This type of program, also commonly referred to as an Expanded Access Program, is a program which makes investigational drugs available to patients prior to FDA approval. These types of programs are primarily used for very sick patients whose well being may depend upon early access to a particular drug. If the medication is/was not being taken as part of a research study, skip Q.2.B. If the medication is/was part of a blinded research study, stop after Q.2.B. Do not answer Q.3–Q.7 if the participant is/was taking this drug as part of a blinded reasearch study in which the participant does not/did not know whether she is/was taking the actual drug.WIHS QxQ Drug Form 1: Antiviral Medication - 10/01/02 Page 3 of 4 Question 3: Hand participant RESPONSE CARD E1. Mark only one response. Question 4: If the participant is currently taking the medication, skip Q.4.B–Q.4.C and go to