Table 1. Behavioral Assessments in VOICE.
Assessment | When administered | Mode of administration | Used in analysis |
---|---|---|---|
Demographics | Screening | Interviewer | yes |
Baseline behavioral assessment | Enrollment | Interviewer | no |
Monthly product adherence and behavioral assessment (MBA) | Monthly (not administered at quarterly, semiannual, annual or PUEV visits) | Interviewer | yes |
Oral product adherence and behavioral assessment (OPA) | Quarterly, PUEV | Interviewer | yes |
Vaginal product adherence and behavioral assessment (VPA) | Quarterly, PUEV | Interviewer | yes |
Menstrual practices and study disclosure assessment | Annual, PUEV, scheduled study exit (excludes early termination) | Interviewer | no |
Audio computer assisted self-interviewing assessment (adherence, acceptability, sexual activity, intra-vaginal practices, product sharing) | Enrollment, quarterly, annual, PUEV, exit, (also administered when product held/discontinued for prior 4 weeks) | Self-administered via computer | no |
Study exit behavior assessment | Scheduled study exit (excludes early termination visits) | Interviewer | no |
Termination visit (TVB and TOB) | Exit | Interviewer | yes |
PUEV=product use end visit