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

2. 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

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
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-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

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 is extremely important for each interviewer to be very familiar with these forms before conducting his/her first interview.

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

14. 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

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 cannot be 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?