MTN-003 Training

1. MTN-003 Training Administering Behavioral CRFs Things to Consider SSP Section 14

2. MTN-003 Behavioral CRFs

3. Before the interview … • Familiarize yourself with the assessments • Read through each question • Read through form instructions • Learn wording, definitions, skip patterns • Read through the Question-by-Question (QxQ) Guide (End of SSP Section 14) • Pay attention to CRF-specific instructions • Review interviewing probes (SSP Section 14.5) • Prior to study start, complete enough role-play interviews (at least 2) among site staff until interviewers feel comfortable administering forms

4. Form instructions vs.QxQ • Form instructions • Provide guidance on form completion • QxQ • Provides guidance on conducting the interview • defines terms • describes techniques for minimizing bias • describes item-specific techniques to help participant respond • instructs interviewer on how to address participant feedback • provides general guidance on interviewer-participant interactions

5. Basic Interviewing Skills • Same basic interviewing skills apply when administering the enrollment, and follow-up interviewer-administered CRFs. • Remember to: • Conduct interviews with a non-biased, non-judgmental approach. • - Includes conducting risk-reduction and product adherence counseling after completing the interview • Help participant feel comfortable sharing personal information and opinions while asking the study questions consistently.

6. During the interview … Remember to: • Read introductory statements as they appear on the form • Prepares participant for sensitive questions • Read interviewer-administereditemsword-for-word to allparticipants in all interviews. • When clarification is needed, repeat the item and/or response categories. • Use probes as needed – see SSP Section 14.5

7. During the interview … • Make sure participant understands the time frame referenced in a given question

8. During the interview … • Make sure participant understands topic transitions (e.g., vaginal sex  product use)

9. During the interview … • Present participant with appropriate show card when indicated • Present participant with appropriate visual aid when indicated

10. During the interview … • Define specific terms as needed (QxQ Glossary)

11. During the interview … QxQ Glossary

12. During the interview … • Watch for skip patterns • It isextremelyimportant for each interviewer to be very familiar with these forms before conducting his/her first interview.

13. During the interview … • When possible, clarify inconsistent responses duringthe interview

14. Do not read response categories unless form instructions state otherwise If categories not read aloud, select category that best fits participant’s response. Ask her to clarify her response or provide more specific information if needed to choose appropriate category. If response does not match existing category, choose “other, specify”, if available Record English translation after interview During the interview …

15. At the end of the interview … • Review completed questionnaires while participant is still with the interviewer. This way, errors and inconsistencies can be addressed with the participant. • Each questionnaire is a source document – responses cannotbe added or clarified once the participant has left the interview

16. Remember to … • Complete header on each form page (PTID, visit code) • Mark the “no data recorded on this page” for all pages left blank • Fax all form pages to SCHARP

17. It is important that all interviews be standardized within and across study visits and study sites!

18. Questions?