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

MTN-003 Behavioral CRFs Form: Administered at: Baseline Behavior Assessment Enrollment Visit Monthly Product Adherence & Behavior Assessment Monthly Visits (Months 1,2,4,5,7,8, etc.) Oral/Vaginal Product Adherence & Behavior Assessments Quarterly, Semiannual, Annual, and PUEV Visits (Months 3,6,9,12, etc.) Menstrual Practices and Study Disclosure Assessment Annual, PUEV, and Study Exit/Termination Visits Study Exit Behavior Assessment Study Exit/Termination Visit Perceived Product Assessment PUEV

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

Form instructions vs. QxQ 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

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.

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

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

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

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

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

During the interview … QxQ Glossary

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

When possible, clarify inconsistent responses during the interview Each interviewer should be familiar with responses requiring consistency before conducting his/her first interview.

During the interview … 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 Avoid rephrasing 14

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 cannot be added or clarified once the participant has left the interview

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

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

Questions?