WOMEN'S INTERAGENCY HIV STUDY QUESTION BY QUESTION SPECIFICATIONS FORM 22: MEDICAL AND HEALTH HISTORY

Transcription

1 WOMEN'S INTERAGENCY HIV STUDY QUESTION BY QUESTION SPECIFICATIONS FORM 22: MEDICAL AND HEALTH HISTORY Guidelines for completing Form 22, Medical and Health 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 10/01/01b. 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: 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. Page 1 of 15

2 SECTION B: SYMPTOMS B1 B7: We want to know if the participant has experienced non-specific symptoms associated with HIV infection since her (MONTH) study visit. B1. Indicate if the participant experienced a fever for more than one month straight. If the symptom did not last more than one month, circle "2" (NO). PROBE: "Did you have (CONDITION) for more than one month?" B2. Question deleted. B3 B4: Indicate if the participant experienced these symptoms for more than two weeks. If the symptom did not last more than two weeks, circle "2" (NO). PROBE: "Did you have (CONDITION) for more than two weeks?" B5. Indicate if the participant had an unintended weight loss of 10 pounds or more that lasted for more than a month, since her (MONTH) study visit. Dieting and/or fasting are methods of intended weight loss and are not considered "unexpected," circle "2" (NO). If the participant specifies an unintentional weight loss of 10 pounds or more because of HIV infection or AIDS, circle "1" (YES). B6. Indicate if the participant has experienced any confusion, such as getting lost in a familiar place or the inability to perform routine mental tasks, since her (MONTH) study visit. B7. Indicate if the participant has experienced drenching night sweats since her (MONTH) study visit. NOTE: Remember to refer the participant (at the end of the interview) for any "YES" responses (as indicated by shaded boxes). PROMPT: ASK PARTICIPANT B8 ONLY IF ALL B1 B7 = NO; OTHERWISE, SKIP TO B9. B8. This question is asked only of participants who report they have NOT experienced any of the specific symptoms listed in Questions B1 B7. We want to know if the participant has experienced any symptoms or complaints about her health that are not on the above list. If the participant answers "YES," go to question B9. If the participant answers "NO," skip to question B10. PROMPT: ASK PARTICIPANT B9 IF ANY OF B1 B8 = YES; OTHERWISE, SKIP TO B10. B9. Indicate if the symptoms the participant has experienced have adversely affected her ability to carry out normal or daily activities. READ THE INTRODUCTION TO THE PARTICIPANT. THE QUESTIONS IN B10 ASK ABOUT CHANGES A PARTICIPANT MAY HAVE NOTICED IN THE SHAPE OF HER BODY. THEY REFER TO THE PERIOD OF TIME BETWEEN NOW AND HER LAST STUDY VISIT. DO NOT INCLUDE ANY CHANGES THAT ARE DUE TO PREGNANCY. USE BODY DIAGRAM CARD AS NEEDED. B10. Ask the participant if she has experienced any changes in the shape of her body or in the amount of her body fat. Use the body diagram card to point out the location of the supraclavicular and dorsocervical fat pads and, as needed, to clarify any other body area. If the participant answers NO, skip to question B11. If she answers YES, read questions B10a B10k to the participant. B11. These questions are intended to qualify the body measures recorded during the physical exam (Form 07). Indicate if the participant has taken any of the actions listed in questions B11a Page 2 of 15

3 B11g. For this question, we want to know if the participant has taken any actions to change or maintain the shape of their body. f. This question is intended to capture information concerning cosmetic surgeries that may affect the body measures recorded during the physical exam. We are only trying to capture cosmetic surgeries that may influence these body measures. B12. Record the bra size as chest size (e.g., 36 or 46) and cup size (e.g., A, CC, I). Three boxes are provided for recording cup size use as many as are needed, leaving unneeded boxes blank. If the participant does not wear a bra or if she reports wearing a sports bra, record 99 in the blanks provided for chest size and write -1 in the blanks provided for cup size. SECTION C: MEDICAL CONDITIONS AND CONCOMITANT ILLNESSES/SYMPTOMS NOTE: The questions asked in Sections C, D, and E are asked of both seropositive and seronegative women. Many of these questions refer to "HIV infection/aids" related conditions. Some women may become worried or upset while being administered these sections. You may want to say something such as: I need to ask these questions of everyone who is enrolled in this study. READ THE INTRODUCTION TO SECTION C. NOTE: In questions C1 through C14, if the participant self reports a diagnosis of cancer, but later reports that she had no biopsy, the interviewer should ask for clarification from the participant. For example, after the participant indicates that she has not had a biopsy, the interviewer could say, Did your doctor tell you that you definitely had cancer, or just that s/he suspected you might have cancer and should return for more tests? Since cancer can t be diagnosed without a biopsy, if the participant reports that she had no biopsy, the interviewer should ensure that the form does not indicate a cancer diagnosis. C1. a. Indicate if the participant remembers being told by a health care provider (doctor, nurse, physician's assistant or nurse practitioner) since her (MONTH) study visit that she had cervical cancer. Skip to question C2 if the participant answers NO. b. Record whether the participant has had surgery to treat cervical cancer since her (MONTH) study visit. PROBE: Been admitted to the hospital and had surgery in an operating room. c. Record whether the participant has had a CAT or MRI scan of her abdomen since her (MONTH) study visit. PROBE: A big donut-shaped machine that takes special pictures. d. Record whether the participant has been told that she needs either surgery or radiation therapy since her (MONTH) study visit. C2. Indicate if the participant remembers being told by a health care provider since her (MONTH) study visit that she had any other type of cancer besides cervical cancer. This includes any other kind of cancer (such as skin cancer, breast cancer, ovarian cancer, etc.). Skip to question C12 if the participant answers NO. C3. Ask the participant if she was told she has breast cancer since her (MONTH) study visit. If she answers NO, skip to question C4. If YES, ask question C3a. a. Ask the participant if she has had a lump removed from her breast by a surgeon. PROBE: Not a needle biopsy, but an incision resulting in stitches. b. Ask the participant if she has had a mastectomy. PROBE: Removal of entire breast. Page 3 of 15

4 C4 C11: Ask the participant whether or not she has been told she has each kind of cancer as listed in C4 C11. C12. At question C12, the interviewer should record the total number of cancers self-reported by the participant at this visit. Make sure to include cervical cancer if reported in question C1a, as well as all cancers reported in questions C3 C11. This question should not be read aloud to the participant. PROMPT: IF QUESTION C12 = 00, SKIP TO QUESTION C27. PROMPT: FOR EACH CANCER INDICATED IN QUESTION C12, COMPLETE QUESTIONS C13 C14. THE NUMBER OF BOXES COMPLETED MUST EQUAL THE VALUE RECORDED AT C12. INDICATE THE LOCATION OF EACH REPORTED CANCER IN a, THEN COMPLETE b f AS INDICATED FOR EACH. IF THE TOTAL NUMBER OF REPORTED CANCERS IS GREATER THAN TWO, PLEASE XEROX THIS PAGE AND INSERT THE COPY AFTER PAGE 7. C13 C14: These questions are to be completed if the participant reports any cancer diagnoses in question C1a or in any of questions C3 through C11. They are asked to determine whether or not she has been diagnosed with metastatic cancer, and, if so, to obtain details about its spread. a. Record the location of each reported cancer on this line. Do not ask the participant this question, just transfer the cancer diagnosis location from each of questions C1a and C3 C11 that she answered affirmatively. In questions C13 and C14, whenever you see (LOCATION) in a question, replace it with the location of the cancer diagnosis recorded in subquestion a. PROMPT: REPLACE (LOCATION) WITH THE LOCATION WRITTEN IN C13a/C14a. b. If this is the participant s first diagnosis of cancer, proceed to subquestion c; if not, skip to subquestion e. c. If the participant was told that this cancer had metastasized to another part of her body, proceed to subquestion d; if not, skip to question C14 if she reported another cancer diagnosis in questions C1a and C3 C11, or to question C15 if she reported no other cancer diagnoses. d. Record to where the participant s cancer has spread, then skip to question C14 if she reported another cancer diagnosis in questions C1a and C3 C11, or to question C15 if she reported no other cancer diagnoses. e. This question will only be asked if the participant indicates that she had received a prior cancer diagnosis. Indicate if the new cancer that the participant is now reporting had metastasized from her original cancer. Proceed to subquestion f regardless of whether she responds yes or no. f. Record the location of the original cancer. Proceed to question C14 if she reported another cancer diagnosis in questions C1a and C3 C11, or skip to question C15 if she reported no other cancer diagnoses. PROMPT: IF ANY OF C1 C11 = YES, THEN COMPLETE ASCERTAINMENT TRACKING CHECKLIST (ATC) FOR EACH ILLNESS AND OBTAIN MEDICAL RECORD RELEASE. ALSO, IF EITHER C13c/C14c OR C13e/C14e = YES, THEN COMPLETE ATC FOR METASTATIC CANCER. C15. Indicate if the participant has received cancer chemotherapies since her (MONTH) study visit. Do not explain further. C16. Indicate if the participant has received radiation treatments since her (MONTH) study visit. Do not explain further. C27. Indicate if the participant has been told she has asthma since her (MONTH) study visit. If the participant already has asthma, we want to know whether her asthma has worsened since her Page 4 of 15

5 (MONTH) study visit. For WIHS purposes, reports of this condition DO NOT require diagnosis by a health care provider (doctor, nurse, nurse practitioner or physician's assistant). C28 C30: These questions are about tuberculosis. Tell the participant we are referring to tuberculosis as TB for short. C28. Indicate if anyone in the participant's family or anyone she has lived with has had TB since her (MONTH) study visit. DO NOT DEFINE tuberculosis, family or lived with. C29. Indicate if the participant has had TB since her (MONTH) study visit. For WIHS purposes, reports of this condition DO NOT require diagnosis by a health care provider. Skip to question C30, if participant answers NO. a b: Indicate where the participant had TB in her body. These questions ask about the location of TB, whether it was in her lungs or another part of her body. If the participant answers other, record her answer verbatim in the space provided. The definition of these conditions is up to the participant. DO NOT explain further. c. Indicate if the participant received a chest x-ray for tuberculosis since her (MONTH) study visit. d. If the participant remembers being treated for TB, we want to know if she took medications for three months or longer. PROMPT: IF ANY OF C29a d = YES, THEN COMPLETE THE ASCERTAINMENT TRACKING CHECKLIST FOR EACH ILLNESS AND OBTAIN MEDICAL RECORD RELEASE. C30. Indicate if the participant has had a skin test for TB since her (MONTH) study visit. (Do not include the TB skin test administered to the participant at the last WIHS visit.) Skip to question C31, if participant answers NO, DON'T KNOW or declines to answer this question. a. Indicate when the last time (most recent time) the participant had a skin test for TB was. Interviewers should have a calendar available to aid the participant in determining the date of her last skin test. PROBE: I need the month and the year. Please estimate as best you can. b. Indicate if the participant remembers being specifically told that her TB test was positive (that her skin test showed exposure to TB). PROMPT: IF C30b = YES, THEN COMPLETE THE ASCERTAINMENT TRACKING CHECKLIST AND OBTAIN MEDICAL RECORD RELEASE. C31a g: This study is about the progression of HIV disease in women and we want to know if the women who participate in this study have any other illnesses or conditions that require medical care. In evaluating the progression of HIV in women, it is important to take into consideration the effect other illnesses may have in relation to HIV disease. These questions ask about conditions that REQUIRED OR REQUIRE medical care. We want to know if the participant has had any of these conditions since her (MONTH) study visit. If the participant does not recognize the medical terminology, circle "2" (NO). DO NOT LEAVE ANY BLANK. a. Indicate if the participant remembers having a sinus infection that required treatment with antibiotics. b. Indicate if the participant remembers having a urinary tract infection (bladder/ UTI/kidneys/pyelonephritis/urethritis) that required treatment with antibiotics. Page 5 of 15

6 C32a d: C33a b: c. Indicate if the participant remembers having high blood pressure or hypertension (blood pressure that is above the normal range) since her (MONTH) study visit. 1. Indicate whether or not the participant is taking any medication to lower her blood pressure. If yes, ensure that this medication is recorded in question F15 later in the interview. d. Indicate if the participant remembers having high blood sugar or diabetes. Do not define further. 1. Indicate whether or not the participant is taking insulin to treat her diabetes. If yes, ensure that this medication is recorded in question F15 later in the interview. 2. Indicate whether or not the participant is taking any medication other than insulin to lower her blood sugar or treat diabetes. If yes, ensure that this medication is recorded in question F15 later in the interview. e. Indicate if the participant remembers having high blood cholesterol, high triglyceride or blood lipid levels. 1. Indicate whether or not the participant is taking any medications to treat high cholesterol, high triglycerides or blood lipids. If yes, ensure that this medication is recorded in question F15 later in the interview. f. Indicate if the participant remembers having any rheumatologic disease including rheumatoid arthritis or lupus. g. Indicate if the participant remembers having a depression that required medical care. These questions ask about different liver conditions the participant may have had diagnosed since her (MONTH) study visit. If the participant does not recognize the medical terminology, circle "2" (NO). DO NOT LEAVE ANY BLANK. a. Indicate if the participant remembers having received a new diagnosis of hepatitis C since her (MONTH) study visit. Only record YES if it was a new diagnosis. b. Indicate if the participant remembers having been diagnosed with any liver disease, such as liver inflammation, cirrhosis or yellow jaundice. c. Indicate if the participant remembers having been diagnosed with ascites (abnormal fluid in the belly). d. Indicate if the participant remembers having been diagnosed with bleeding from enlarged veins in her esophagus or stomach. Indicate whether or not a health care provider has recommended that the participant receive a liver biopsy or medicine to treat hepatitis B and/or C since her (MONTH) study visit. a. If the participant s health care provider has recommended that the participant receive a liver biopsy, circle 1 (YES), regardless of whether she actually had it taken. Question E22e will ask the participant whether or not she has actually had a liver biopsy. PROMPT: IF ANY OF C32a C32d OR C33a C33b = YES, THEN COMPLETE ASCERTAINMENT TRACKING CHECKLIST AND OBTAIN MEDICAL RECORD RELEASE. C34a d: These questions ask about different heart conditions the participant may have had diagnosed since her (MONTH) study visit. If the participant does not recognize the medical terminology, circle 2 (NO). DO NOT LEAVE ANY BLANK. a. Indicate whether or not the participant has received a new diagnosis of angina or chest pain related to heart disease. Page 6 of 15

7 b. Indicate whether or not the participant has received a new diagnosis of congestive heart failure or CHF. c. Indicate whether or not the participant has had a heart attack (myocardial infarction or MI). d. Indicate whether or not the participant has had a stroke (CVA). C35. Indicate whether the participant takes aspirin three days or more of every week. PROMPT: IF ANY OF C34b C34d = YES, THEN COMPLETE ASCERTAINMENT TRACKING CHECKLIST AND OBTAIN MEDICAL RECORD RELEASE. SECTION D: SKIN AND ORAL CONDITIONS NOTE: The definition of health care provider changes in this section and now includes a dentist. D1 & D3: We want to know if the participant remembers being told by a health care provider (doctor, dentist, nurse, nurse practitioner or physician's assistant) that she had the conditions listed in D1 and D3 since her (MONTH) study visit. The words listed in parentheses in the form may be read to the participant to clarify the condition. To avoid biasing the interview, do not define further. Circle 1 (YES) only if the condition named was diagnosed in those words by a health care provider (doctor, dentist, nurse, nurse practitioner or physician's assistant). Skip to the next condition if the participant answers NO, DON'T KNOW or declines to answer. D1. Circle 1 (YES) if the participant has been specifically told by a health care provider that she had shingles or herpes zoster. b. Ask the participant if she has had two or more separate areas with shingles at the same time. D2. Deleted on form version 10/01/98. D3. Circle 1 (YES) if the participant has been specifically told by a health care provider that she had Candida or thrush, a Candida/yeast infection inside her mouth (oral candidiasis). D1a & D3a: Ask a only for responses of YES to D1 and D3. Enter the number of different times in the past six months that the participant had the specific condition reported in D1 and D3. PROBE: Please estimate as best you can. If the participant has difficulty totaling the number of times she had each condition, but can provide the number of times she had it each month, the interviewer should calculate the six-month total based on the participant s response. D4. Deleted on form version 10/01/98. E1 E23: SECTION E: AIDS DEFINING ILLNESSES These questions are asked of both seropositive and seronegative women. Although these illnesses are associated with HIV/AIDS, some of these illnesses can occur in women who do not have HIV/AIDS and we are interested in knowing what percentage of seronegative women experience the same illnesses as seropositive women. We are interested in knowing whether the participant has been told by a health care provider (doctor, dentist, nurse, nurse practitioner or physician assistants) that she had any of these AIDS-defining illnesses since her (MONTH) study visit. NOTE: We are interested only if Page 7 of 15

8 NOTE: the diagnosis was made by a health care provider and not in the participant's personal belief that she had any of these conditions. If the participant is unable to recognize the medical terminology, do not offer any definitions other than those in parentheses; circle 2 for NEVER HEARD OF IT. DO NOT LEAVE ANY BLANK. We believe if a participant was told by a health care provider that she had one of these illnesses, she would then recognize it. Circle 1 (YES) for each illness in questions E1 E23 that the participant reports was diagnosed by a doctor, dentist, nurse, nurse practitioner or physician's assistant. If the participant answers NO, skip to the next question and do not ask any subquestions. The questions in this section refer to illnesses and/or conditions that a health care provider told the participant she had since her (MONTH) study visit. For this reason, each question begins with the phrase, "Since your (MONTH) study visit..." However, after the first five questions, the phrase begins to appear in parentheses. This is done to minimize the number of times the interviewer has to read the phrase. When the phrase appears in parentheses, it is meant only as a clarification; the interviewer should read it only if it is necessary in order to make the question more clear to the participant. PROMPT: IF THE PARTICIPANT RESPONDS "YES" TO ANY OF THE AIDS-DEFINING ILLNESSES IN E4 E20, THE INTERVIEWER MUST COMPLETE THE ASCERTAINMENT TRACKING CHECKLIST AND OBTAIN A SIGNED MEDICAL RELEASE FORM. E1. Ask if the participant was told by a health care provider since her (MONTH) study visit that her CD4 count was less than 200 or less than 14%. Circle the appropriate response. E2. Circle 1 (YES) if the participant has had ulcers or sores lasting longer than one month that a health care provider told her was herpes simplex. E3. Circle 1 (YES) if the participant has had diarrhea (three or more soft or liquid stools per day) that has lasted for more than one month since her last (MONTH) study visit. If she answers NO, skip to question E5. E4i v: Circle 1 (YES) if the participant was told by a health care provider that her diarrhea was caused by any of the conditions listed. E5. Circle 1 (YES) if the participant has been told by a health care provider that she had a herpes simplex infection of the lungs or esophagus. PROBE: The tube between your mouth and stomach. E6. Ask if the participant was told by a health care provider since her (MONTH) study visit that she had PCP, pneumocystis carinii pneumonia. We specifically want to know about PCP and not other types of pneumonia other types are about asked separately. E7. Ask if the participant was told by a health care provider since her (MONTH) study visit that she had another type of pneumonia or a lung infection. If the participant is certain that she received a diagnosis of bronchitis only, record NO for the question. If she is not sure whether the diagnosis was for pneumonia, bronchitis or some other lung infection, record YES for the question. The definition of this condition is up to the participant. DO NOT explain further. If the participant responds "YES," ask questions E7a c. If the participant responds NO, skip to question E8. For example: If the participant said, I had bronchitis, the interviewer should not include that as a pneumonia. Bronchitis is not a pneumonia. a. Record the number of times the participant has had pneumonia, not PCP, in the past 12 months that required treatment with antibiotics. PROBE: Please estimate as best as you can. If the participant has difficulty totaling the number of times she had non-pcp pneumonia in the last year, but can Page 8 of 15

9 provide the number of times she had it each month, the interviewer should calculate the total based on the participant s response. b. Record the number of times the participant has had pneumonia, not PCP, since her (MONTH) study visit that required treatment with antibiotics. PROBE: Please estimate as best as you can. If the participant has difficulty totaling the number of times she had non-pcp pneumonia since her (MONTH) study visit, but can provide the number of times she had it each month, the interviewer should calculate the total based on the participant s response. If the participant remarks that she just answered this question, remind her that question E7a asks for the number of times in the past 12 months while E7b asks for the number of times since her (MONTH) study visit. c. Enter the month and year given by the participant as the last time she had non-pcp pneumonia. PROBE: I need the month and year (the last time) you had pneumonia. Interviewers should have a calendar available to aid the participant in determining the date she last had non-pcp pneumonia. E8. Circle 1 (YES) if the participant has been specifically told by a health care provider that she had Candida or thrush, a yeast infection of her esophagus. PROBE: The tube between your mouth and stomach. E9. Circle 1 (YES) if the participant has been specifically told by a health care provider that she had Candida or thrush, a yeast infection of the lungs or airway, inside her trachea or bronchi. E10. Circle 1 (YES) if the participant has been specifically told by a health care provider that she had an M-A-I infection which is sometimes called M-A-C or MAC. Definitions are provided in the question. The hyphens mean each letter needs to be pronounced separately and MAC without the hyphens is read as one word. E11. Circle 1 (YES) if the participant has been told specifically by a health care provider that she had a Toxo infection or toxoplasmosis of the brain. Do not explain further. E12a e: Circle 1 (YES) if the participant has been told specifically by a health care provider that she has C-M-V in any of the listed locations. E13. Circle 1 (YES) if participant has been told specifically by a health care provider that she had meningitis related to HIV. If participant answers NO, skip to question E14. a. Circle 1 (YES) if the participant was told by a health care provider that this was Crypto or Cryptococcal meningitis. E14. Circle 1 (YES) if the participant has been told specifically by a health care provider that she had a Cryptococcal infection in her blood or elsewhere in her body. If the participant answers NO, skip to question E15. E15. Circle 1 (YES) if the participant has been told specifically by a health care provider that she had Histo or a Histoplasmosis infection. If the participant answers NO or declines to answer, skip to question E16. a. We want to know specifically where the participant had the infection. Record the participant's response verbatim in the space provided. E16. Circle 1 (YES) if the participant has been told specifically by a health care provider that she had Cocci, coccidioidomycosis infection or valley fever. E17. Circle 1 (YES) if the participant has been told specifically by a health care provider that she had wasting syndrome, or severe weight loss. If the participant answers NO, skip to question E18. Page 9 of 15

10 a b: We are interested in knowing whether the participant had either of these conditions for at least one month while experiencing severe weight loss (i.e., wasting syndrome ). Read the stem question and insert the conditions listed at a and b where it says (CONDITION). Note that each condition is a separate question and should be read as such, in the order listed, in order to obtain two separate/distinct answers. c. Indicate if the participant was told by a health care provider that this/these symptom(s) was/were due to AIDS. E18. Circle 1 (YES) if the participant has been told by a health care provider that she had dementia or encephalopathy, or that she had a memory problem or confusion caused by HIV. E19. Circle 1 (YES) if the participant has been told by a health care provider that she had an infection in the blood with a bacteria called salmonella. If the participant answers NO, skip to question E20. a. Indicate if the participant has been told she had an infection in her blood more than once since her (MONTH) study visit. E20. Circle 1 (YES) if the participant has been told by health care provider that she had PML or progressive multifocal leukoencephalopathy, a disease of the brain. PROMPT: IF THE PARTICIPANT RESPONDED YES TO ANY OF QUESTIONS E4 E20, COMPLETE ASCERTAINMENT TRACKING CHECKLIST AND OBTAIN MEDICAL RECORD RELEASE. E21. Indicate if the participant was told by a health care provider since her (MONTH) study visit that she had AIDS. If the participant says, Yes, I was told I have HIV, ask, Were you told that you had AIDS? E22. We want to know if the participant has had a biopsy since her (MONTH) study visit. If the participant responds NO, skip to question E23. NOTE: If the participant self reported a diagnosis of cancer in questions C1 through C14, but then in question E22 reports that she had no biopsy, the interviewer should ask for clarification from the participant. For example, after the participant indicates that she has not had a biopsy, the interviewer could say, Did your doctor tell you that you definitely had cancer, or just that s/he suspected you might have cancer and should return for more tests? Since cancer can t be diagnosed without a biopsy, if the participant reports that she had no biopsy, the interviewer should ensure that the form does not indicate a cancer diagnosis. a g: These questions ask the participant exactly where in her body she had a biopsy. PROMPT: IF THE PARTICIPANT RESPONDED YES TO ANY OF QUESTIONS E22a g, COMPLETE AN AIDS AND CANCER SPECIMEN BANK ASCERTAINMENT TRACKING CHECKLIST (ACSB ATC) FOR EACH REPORTED BIOPSY AND OBTAIN MEDICAL RECORD RELEASE. E23. Indicate if the participant has been hospitalized since her (MONTH) study visit. a. Record the number of times the participant reports she has been hospitalized since her (MONTH) study visit. PROBE: Please try and remember as best you can. If the participant has difficulty totaling the number of times she has been hospitalized since her (MONTH) study visit, but can provide the number of times she was hospitalized each week or each month, the interviewer should calculate the total based on the participant s response. Page 10 of 15

11 SECTION F: 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. F1. A vaccine against HIV-1 can include vaccines which prevent infection with HIV or therapeutic vaccines (those which prevent progression of the infection). F2A. 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 F2B. 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 F2A 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 F2A, 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 F9A F9C TO SEE IF IT IS ON ONE OF THESE LISTS. If the drug is listed in questions F9A F9C, record its use there. If the drug is a complementary/alternative therapy, record its use in question F11. 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 participant indicates that she is taking Trizivir, mark the Trizivir box (code 240). The boxes for abacavir, AZT and 3TC should not be checked. For EACH medication reported, complete a Drug Form 1. If the participant is taking multiple antiretrovirals, mark each drug and complete a separate Drug Form 1 for each medication. EXAMPLES for Participant X : X is taking AZT, 3TC and Ritonavir. Mark the three boxes corresponding to AZT, 3TC, and Ritonavir and complete a separate Drug Form 1 for each drug. Page 11 of 15

12 F2B. X was taking AZT and ddi. She recently changed her regimen to AZT, ddc and Saquinavir. Mark the boxes corresponding to AZT, ddi, ddc and Saquinavir and complete a separate Drug Form 1 for each drug. X is in an AZT/ddI/Nelfinavir trial, and knows that she is taking AZT and ddi, but is not sure whether she is receiving Nelfinavir or a placebo (i.e., she is blinded to the treatment). Complete a separate Drug Form 1 for each drug. When filling out the drug form related to Nelfinavir, be sure to follow the specific directions on Drug Form 1 for blinded treatments. X reports taking Lobucavir in a research trial. Mark Other antiviral, print lobucavir in the specify box. Go to Drug List 1 and get the 3-digit code for Lobucavir (222). Write code 222 in the boxes for 3-digit drug code. Fill out a Drug Form 1 for Lobucavir. If the participant reports that she has not taken any antiviral medications since her (MONTH) study visit, check the box in this question and skip to question F8. F3. Questions F3a F3f are designed to capture information on structured treatment interruptions. These treatment interruptions do not have to be physician prescribed, but can be planned in advance by the participant on her own. It is also important to note and stress the timeframe change here this question is referring to the past three months rather than the past six months. a. If the participant responds that there was never a planned or prescribed period of time of two or more days during which she stopped all of her antiretroviral medications, skip to question F4. b. If the participant does not know the exact number of breaks, ask her to give her best estimate. c. If the participant responds that the breaks were not prescribed by a health care provider, skip to question F3e. d. Circle only one answer to this question. If the participant does not know the main reason that her health care provider prescribed the breaks, write in -8 as per WIHS interviewing convention. e. Since the time frame for this question is in the past three months, the interviewer should fill in the year rather than asking the participant to state the year. f. This question asks for the length of time (in days or weeks) that the participant skipped taking her antiretroviral medications the last time she had a planned or prescribed treatment interruption that lasted at least two days or longer. By the nature of this question, F3f must be at least two days or greater. Circle the corresponding days/weeks indicator based on the participant s response. If the participant answers in both days and weeks (e.g., My last interruption in therapy lasted three weeks and four days ), convert this response to days (e.g., convert three weeks, four days to 25 days). F4. Questions F4a F4d are designed to capture breaks in therapy caused by non-adherence. These breaks are very different than the structured therapy breaks that are captured in F3, and you should be sure that the participant understands the distinction while administering these questions. a. If the participant responds that she never took any unplanned breaks of at least one full day in her prescribed antiretroviral therapy, skip to question F5. b. If the participant does not know the exact number of breaks, ask her to give her best estimate. c. Since the time frame for this question is in the past three months, the interviewer should fill in the year rather than asking the participant to state the year. d. This question asks for the length of time (in days or weeks) that the participant skipped taking her antiretroviral meds the last time she had an unplanned or non-adherent break in treatment. Circle the corresponding days/weeks indicator based on the participant s response. Page 12 of 15

13 If the participant responds in hours greater than 24 hours, convert this to the closest number of days (e.g., convert a response of 45 hours to two days). If the participant answers in both days and weeks (e.g., My last interruption in therapy lasted three weeks and four days ), convert this response to days (e.g., convert three weeks, four days to 25 days). The remaining questions focus on how the participant has taken her medications in the past six months. F5. a. This question is designed to assess the patient s general level of adherence to all of her prescribed antiretroviral medications. If the participant responds that she took her antiretroviral meds 100% of the time, skip to question F6. b. Hand the participant Response Card D1. This question asks a series of reasons for missing medications and how often each reason applies. Read each reason to the participant and mark how frequently this reason causes her to miss her medications. At the end, ask the participant if there is any other reason that causes her to miss her medications. Print her response in the specify box and indicate how often this reason causes her to miss taking her medications. Since questions on structured treatment interruptions are now asked in a different section of the form, Prescribed by physician is no longer a valid response for this question. F6. a. Hand the participant Response Card D2 before asking her question F6. All participants reporting use of antivirals in question F2 should answer this question related to general adherence to their medication schedules. b. If the participant was never given special instructions for any of her antiretroviral medications, skip to question F7. c. Hand the participant Response Card D2 before asking her question F6c. F7. If the participant is currently taking at least two antiretroviral medications, circle YES to indicate that she is on combination therapy and proceed to ask her questions F7a d. If she is on mono therapy (currently taking only one antiretroviral medication), or she has taken more than one antiretroviral medication since her (MONTH) study visit but is not currently taking at least two antiretroviral medications, circle NO and skip to question F9. a d: NOTE: You may need to refer to the Drug Form 1 s completed after question F2a in order to determine whether the participant is currently taking at least two antiretroviral medications. Hand the participant Response Card 12 before asking her questions F7a F7d. These questions ask about the participant s attitudes towards transmission of HIV while on combination therapy. For each question, record whether she strongly agrees, agrees, is uncertain, disagrees or strongly disagrees. If the participant is hesitant to answer, PROBE for a response by saying, We are interested how you feel on this question, or, Which choice do you think is closest to how you feel? If the participant has difficulty choosing a category, the interviewer should re-focus the participant by re-asking the question. If the participant has questions about the question you are asking, respond with, Whatever you think the question means, or, However you understand it. If the participant remains hesitant, PROBE further by saying, Remember, there are no right or wrong answers. We are interested in your feelings on this. These questions will only be asked of women on antiretroviral therapy. Skip to question F9 after asking questions F7a F7d regardless of the participant's response. Page 13 of 15

14 F8. Hand the participant Response Card D3 before asking her question F8. F9A. F9B. F9C. This question asks for the MAIN reason a participant is not taking any antiviral medications. Read the responses to the participant and then circle the one answer that matches her response. If the participant s main reason for not taking any antiviral medications is not listed as one of the responses, circle any other reason and print her response in the specify box. Hand the participant Response Card D4. Ask the participant if she has taken the inhaled medication listed in question F9A since her (MONTH) study visit. If yes, mark an X in the appropriate box; if no, check the box indicating that the participant has not taken the medication listed in question F9A since her (MONTH) study visit and skip to question F9B. Ask the participant if she has taken any of the injected or infused medications listed in question F9B since her (MONTH) study visit. If yes, mark an X in the appropriate box(es); if no, check the box indicating that the participant has not taken ANY of the medications listed in question F9B since her (MONTH) study visit and skip to question F9C. Ask the participant if she has used any of the pills, liquids or creams listed in question F9C since her (MONTH) study visit. If yes, mark an X in the appropriate box(es); if no, check the box indicating that the participant has not taken ANY of the medications listed in question F9C since her (MONTH) study visit and skip to question F10. PROMPT: COMPLETE A DRUG FORM 2 FOR EACH MEDICATION MARKED IN QUESTIONS F9A THROUGH F9C. F10. Hand the participant Response Card D4a before asking her question F10. F10A. F10B. If the participant reports no use of hormone replacement therapy, skip to question F11. This question should be recorded as YES if the participant took the therapy for more than one month. This question should not be read aloud to the participant. For question F10A, the interviewer should record the type of hormone replacement therapy taken by the participant since her (MONTH) study visit. Be sure to specify the therapy taken if Other HRT was indicated in F10. If the participant reports use of both Estrogen and Progesterone hormone replacement therapy, record this as Combination in F10A. For question F10B, read the participant each reason listed and circle YES for each reason she reports that she is taking hormone replacement therapy. If she answers Other, specify the reason where listed on the form. F11A. F11B. Hand the participant Response Card D5. Ensure that the participant is aware that all enzyme therapies, flower remedies, herbs, homeopathic remedies and nutritional supplements such as vitamins or minerals should be reported in this question. If the participant has not taken any complementary or alternative medications since her last study visit, go to question F14. THIS LIST IN F11B IS NOT MEANT TO BE READ TO THE PARTICIPANT. Rather, the participant should read Response Card D5. If the participant cannot read or has problems with her vision, read the list of therapies and treatments. For each therapy the participant indicates that she has taken (since last visit), place an X in the corresponding box. Once you have placed an X in the corresponding box, ask the participant about her frequency of use, if she is currently taking the therapy, and her main reason for taking the therapy. For the participant s main reason, hand the participant Response Card D6 and record the number the participant indicates in the box corresponding to the drug under question. If the participant knows that she is taking a particular class of alternative therapies but does not know the exact therapies, this data can be captured using the other, unspecified boxes listed at the end of the Nutritional Supplements list and at the end of the Herbs list. Page 14 of 15

15 If the participant names a therapy that is not listed in question F11B, record her response in one of the specify fields at the end of the table. If the therapy is listed on Drug List 3, record the three-digit drug code in the corresponding boxes. If the therapy is not listed on Drug List 3, contact WDMAC to have a code assigned. F12. Mark only one response. If the participant s primary care provider is guiding the alternative therapy, go to question F15. If the participant responds that both herself and her primary care provider are guiding treatment, mark this response as primary care provider guiding treatment (response 1). F13. If the participant has discussed her alternative medication usage with the primary care provider or if she does not have a primary care provider, go to question F15. F14. Hand the participant Response Card D7. Mark only one response. F15. Ask the participant if she has taken any other PRESCRIBED medications not previously mentioned since her (MONTH) study visit. If yes, list those medications named in the specify fields provided. If possible, enter the exact name of the medication the participant is taking. However, if the participant knows that she is taking, for example, an anti-depressant or blood pressure medication, but can t remember the medications specific name(s), record anti-depressant or blood pressure medication. F16. Hand the participant Response Card D8. These questions should be asked of ALL participants, regardless of their HIV status and regardless of whether or not they are taking any prescribed medications or alternative therapies. Read the symptoms listed in F16a F16n one at a time to the participant. If the participant indicates that she has not experienced that symptom since her last visit, mark not at all and move on to the next symptom on the list. If she indicates that she has experienced that symptom since her last visit, ask her the severity of that symptom and record in appropriate place. Once you have recorded the severity, move on to parts (i) and (ii) asking if she felt that the particular symptom was a side effect of either her prescribed medications (i) or her alternative therapies (ii). If the participant has reported that she is on no prescribed medications at all, do not ask (i), but rather record N/A for (i). Similarly, if the participant has reported that she is taking no alternative therapies, do no ask question (ii), but record N/A for part (ii). F17a i: Hand the participant Response Card 12 before asking her questions F17a F17i. These questions ask about the participant s attitudes towards transmission of HIV in general. For each question, record whether she strongly agrees, agrees, is uncertain, disagrees or strongly disagrees. If the participant is hesitant to answer, PROBE for a response by saying, We are interested how you feel on this question, or, Which choice do you think is closest to how you feel? If the participant has difficulty choosing a category, the interviewer should re-focus the participant by re-asking the question. If the participant has questions about the question you are asking, respond with, Whatever you think the question means, or, However you understand it. If the participant remains hesitant, PROBE further by saying, Remember, there are no right or wrong answers. We are interested in your feelings on this. These questions will be asked of all women in the WIHS. F18. Record the time module ended. Circle the code for AM (code 1) or PM (code 2). Page 15 of 15