1. Behavioral Assessment Training: Baseline Behavior Assessment, Demographics, Baseline Vaginal Practices Ariana Katz WGHI/RTI International San Francisco, CA

2. Agenda  Guidance for administration of behavioral CRFs  Review of Baseline Forms, highlighting guidance for new or unique questions

3. REMINDER: Using the ring in HOPE is a CHOICE CHOICE! – Participant’s choose the best HIV prevention method for them – Not every woman wants or is able to use the Ring now. E.g. Needs more time to decide Prefers another HIV prevention method Is at risk of IPV/ in an abusive relationship Lacks partner’s or other social support to choose the ring

4. Administering Behavioral Guides Remain neutral – Keep tone of voice and body language neutral – Express interest but avoid making reactions to participant’s responses Remain non-judgmental – Every choice is important & informative in HOPE – OK if they chose not to accept the ring at all. They can still participate! – OK if they accepted the ring but decided not to use. They can still participate! – OK if they used the ring some of the time but not all the time. (Yes, you guessed it….they can still participate!)

5. Administering Behavioral Guides (cont.) Language: CRFs should be administered in preferred language Different staff: Study staff administering behavioral CRFs should be a different person than staff providing counseling CRFs then counseling: At visits where both counseling and behavioral CRFs are administered, it is recommended that CRFs are administered prior to counseling sessions

6. Counseling & Behavioral CRFs: Acknowledging Redundancies Some topics on behavioral CRFs and within qualitative interviews (for qualitative sites) may also be discussed as part of the counseling sessions Acknowledge redundancies when appropriate to ease feeling fatigue from redundant study procedures. For example: – “I’m going to ask you some questions now and record your responses on these forms. As with all information you provide to the study, we will keep your responses confidential. Only others on the study team will have access to them. Some of the topics may come up in your counseling session, if your counselor thinks that discussing your answers might help him/her better understand your study experience or support your chosen HIV prevention plan.”

7. Demographic CRF DOMAINS COVERED – Birth date – Marriage – Education – Ethnic group or tribe – Alcohol & cigarette usage – Time spent traveling to clinic – Income & Employment – Pregnancy & children – Religion and religiosity – Food insecurity – Socio-economic status (SES) measures

8. NEW Demographic Questions Religion and religiosity – May influence acceptance of the ring – Will help characterize participants (if those who choose the ring or not differ) Food insecurity – Indicator of SES – May influence motivation join HOPE – Will help characterize participants Socio-economic status (SES) measures – May influence motivation to join – Will help characterize participants 11 What is the participant’s religion? (mark one) 1 Christian 2 Muslim 3 Other specify:______________________ 4 None  If none, go to item 12. 11a How many times a week does the participant attend religious services? (mark one) 1 More than once a week 2 Once a week 3 Less than once a week 4 Never 12 In the past four weeks, how often was the participant worried that she will not have enough food? (Read responses.) 1 Never 2 Rarely (once or twice) 3 Sometimes (3-10 times) 4 Often (more than 10 times) 13 Does the participant’s household have: …? [read options and indicate ‘yes’ or ‘no’ for all items] a Electricity or solar panels b. A radio c. A cassette player d. A television e. A mobile telephone f. A non-mobile telephone g. A refrigerator h. A table i. A sofa j. A bed k. A CD or digital music. player m. A VCR/DVD player n. A car o. A motorcycle p. A bicycle 1 Yes 2 No 1 Yes 2 No

9. Baseline Behavior Assessment CRF DOMAINS COVERED – Information about primary sex partner ( Change in sex partner since ASPIRE, age, living situation, financial support to participant, disclosure of study and ring, circumcision and HIV status, involvement in clinic ) – Other sex partners – Intimate partner violence – Participant sexual behavior – HIV risk perception (4 Q) – Vaginal ring worries – Understanding of partial efficacy – Decliners: Reasons declined participation – Enrollers: Reasons enrolled in HOPE

10. NEW Baseline Behavior Questions Change in sex partner since ASPIRE – May influence decision to choose/not choose ring Age of primary sex partner – Help characterize sexual partner Financial material/support from primary partner – May influence motivation to join Intimate partner violence** – May influence decision to choose/not choose ring – Will help characterize participants 2 Is your primary sex partner the same partner you had when you exited ASPIRE? 1 Yes 2 No 3How old is your primary sex partner? # years OR don’t know 4Are you currently living with your primary sex partner? 1 Yes 2 No 5Does your primary sex partner provide you with financial and/or material support? 1 Yes 2 No 14 The next questions are about your relationship with your primary sex partner or any other partners. In the past 12 months, has your primary sex partner or ANY other current or previous partner ever: 14aSlapped you, hit you with a fist or something else, or beaten you? 1 Yes 2 No 14bKicked, dragged, pushed, pulled your hair, choked or burnt you? 1 Yes 2 No 15In the past 12 months, has your primary sex partner or ANY other current or previous partner ever forced you to have sex by holding you down or hurting you? 1 Yes 2 No

11. NEW Baseline Behavior Questions Change in sex partner since ASPIRE – May influence decision to choose/not choose ring Age of primary sex partner – Help characterize sexual partner Financial material/support from primary partner – May influence motivation to join Intimate partner violence** – May influence decision to choose/not choose ring – Will help characterize participants 14 The next questions are about your relationship with your primary sex partner or any other partners. In the past 12 months, has your primary sex partner or ANY other current or previous partner ever: 14aSlapped you, hit you with a fist or something else, or beaten you? 1 Yes 2 No 14bKicked, dragged, pushed, pulled your hair, choked or burnt you? 1 Yes 2 No 15In the past 12 months, has your primary sex partner or ANY other current or previous partner ever forced you to have sex by holding you down or hurting you? 1 Yes 2 No **Capture only harm caused by sex partners (not a stranger or other non-partner)

12. NEW Baseline Behavior Questions HIV risk perception – Captures perceived vulnerability & perceived risk – Captures worries & likelihood of acquiring HIV Understanding of efficacy of dapivirine ring – Captures their understanding or belief about the level of protection – Not capturing what they heard from ASPIRE study results 22 In the past 12 months, was getting HIV something you have… 1 never thought about 2 rarely thought about 3 thought about often 23 How worried are you that you might get HIV in the next 12 months? 1 very worried 2 somewhat worried 3 not at all worried 24 How likely is it that you will become infected with HIV in the next 12 months? 1 very unlikely 2 somewhat likely 3 very likely 25How certain do you feel that you can protect yourself from getting infected with HIV? 1 very uncertain 2 somewhat certain 3 very certain 27How much protection do you feel that the Dapivirine ring can provide against HIV? 1 the ring can provide a little protection 2 the ring can provide some protection 3 the ring can provide a lot of protection

13. NEW Baseline Behavior Questions Reasons declined participation – Yellow highlighted text changes from responses asked in ASPIRE SEV – Want to compare if reasons for disinterest changed between ASPIRE and HOPE MAIN reason declined 28 [HOPE DECLINER GROUP ONLY] [IF PARTICIPANT IS ENROLLED IN HOPE, GO TO ITEM 30] I am going to read aloud a list of reasons why women may choose not to participate in HOPE. Please tell me all of the reason(s) that apply to you. Read each response aloud. a. You are not at risk for HIV b. It does not matter to you if you get HIV c. You are worried that the ring will harm your health d. The ring is not as good at preventing HIV as you thought e. You are worried people will think you are HIV positive f. You want to avoid side effects you experienced in ASPIRE g. You want to avoid side effects that you heard about in ASPIRE h. Waiting time at the clinic i. Having to return to the clinic frequently j. Having to keep the ring inserted all the time k. Having to keep the ring in during menses l. Having to keep the ring in during sex m. You or your partner want to get pregnant n. Having blood draws or other clinical procedures o. Having to answer questions about your behavior during the study p. Partner not supportive of study participation q. Family not supportive of study participation r. Other, specify:______________ If only one reason is marked, end of form. 29 What is the main reason that you are not willing to participate in HOPE? Mark the applicable sub-item number from item 28. IF PARTICIPANT IS PART OF THE DECLINER GROUP, END OF FORM. a b c d e f g h I j k l m n o p q r

14. NEW Baseline Behavior Questions Reasons joined HOPE – Yellow highlighted text changes from responses asked in ASPIRE SEV – Want to compare if reasons for interest changed between ASPIRE and HOPE MAIN reason joined 30 I am going to read aloud a list of reasons why women may choose to participate in HOPE. Please tell me all of the reason(s) that apply to you. Read each response aloud. a. To get tested for HIV b. To get counseling on reducing risk of HIV and STIs c. To help the community/to help fight the HIV epidemic d. Because the ring can protect you against HIV e. To make it safer for you to have sex without condoms f. Because this is the only or best way for you to get health care g. Because you have friends who will probably participate in HOPE h. Because you feel taken care of by the study staff i. Because being in the study allows you to join social events at the clinic j. Because being in the study helps you feel better about yourself k. Because your study visits give you someone to talk to l. Because the study visit reimbursement money is helpful m. Other, specify:__________________ If only one reason is marked, end of form 31What is the main reason that you are willing to participate in HOPE? Mark the applicable sub-item number from item 30. a b c d e f g h I j k l m

15. Baseline Behavioral Assessment: Notes Item 26: How worried are you about having a vaginal ring inside of you every day for a year? – If participant reports she is somewhat or very worried, interviewer, counselor or clinician may want to follow up with her after completion of the questionnaire – This question is asked of everyone (whether they accept the ring or not) If they do not accept ring, we want to know how worried they would be IF they were to wear a ring for a year

16. Baseline Vaginal Practices CRF Questions DOMAINS COVERED – Menstrual bleeding/spotting – Methods to control bleeding/spotting – What insert in vagina

17. NEW Baseline Vaginal Practices Questions What insert in vagina – Added traditional medicines – Added anything to make vagina dry or tight NOTE: If participant reports potentially harmful vaginal practices, clinician should follow up on these items when reviewing the ring use instructions with the participant. 3b.Traditional medicines 1 Yes 2 No 3c.Anything to make the vagina dry or tight 1 Yes 2 No

18. Discrepancies Discrepancies may arise between what a participant reports on CRFs, what she says in counseling sessions and what she says in her qualitative interview (for qualitative sites) Discrepancies are NOT expected to be reconciled