| Description | Date | Size |
|---|
| Baseline Behavioral Survey (Download) | 2016-09-26 | 1.06 MB |
| EXIT Behavioral Survey (Download) | 2016-03-17 | 429 KB |
| Follow-up Single-Dose Behavioral Survey (Download) | 2016-03-17 | 462.12 KB |
| In Depth Interview (IDI) EXIT Guide (Download) | 2015-10-12 | 220.84 KB |
| In-Depth Interview (IDI) SINGLE DOSE Guide (Download) | 2015-10-12 | 167.14 KB |
| Baseline Behavioral Survey (Download) | 2016-06-01 | 582.89 KB |
| EXIT Behavioral Survey (Download) | 2016-06-01 | 321 KB |
| Follow-up Single-Dose Behavioral Survey (Download) | 2015-09-28 | 150.86 KB |
| In-Depth Interview (IDI) EXIT Guide (Download) | 2015-12-22 | 356.72 KB |
| In-Depth Interview (IDI) SINGLE DOSE Guide (Download) | 2015-12-22 | 328.05 KB |
| Baseline Medical History Questions Form (Download) | 2017-08-21 | 31.29 KB |
| MTN Rectal Terms MedDRA Preferred Term Cheat Sheet (Download) | 2017-11-08 | 27.59 KB |
| Protocol Safety Review Team Query Form (Download) | 2017-07-17 | 33.62 KB |
| Contraceptive Counseling Worksheet (Download) | 2017-07-26 | 26.64 KB |
| HIV Pre/Post Test and Risk Reduction Counseling Worksheet (Download) | 2017-04-24 | 29.06 KB |
| Informational Booklet (Download) | 2017-07-17 | 151.32 KB |
| Protocol Counseling Worksheet (Download) | 2017-07-27 | 31.45 KB |
| Informational Booklet (Download) | 2017-08-01 | 166.17 KB |
| ICCA True/False (Download) | 2017-07-17 | 29.07 KB |
| Informed Consent Coversheet (Download) | 2017-07-17 | 30.63 KB |
| Open Ended Comprehension Assessment (Download) | 2017-07-17 | 80 KB |
| Avery 5267 Specimen Labels (Download) | 2017-08-10 | 222 KB |
| Eligibility Checklist (Download) | 2017-08-07 | 39.9 KB |
| Enrollment Behavioral Eligibility Worksheet (Download) | 2017-08-25 | 34.83 KB |
| LDMS Specimen Tracking Sheet - Blood Samples (Download) | 2017-09-06 | 424.23 KB |
| LDMS Specimen Tracking Sheet - Female Specimens (Download) | 2017-09-06 | 580.59 KB |
| LDMS Specimen Tracking Sheet - Rectal Specimens (Download) | 2018-01-02 | 407.64 KB |
| Product Use Instructions (Download) | 2017-07-17 | 649.71 KB |
| Screening and Enrollment Log (Download) | 2017-07-26 | 36.01 KB |
| Screening Behavioral Eligibility Worksheet (Download) | 2017-08-25 | 34.13 KB |
| Study Staff Delegation of Duties (DoD) and Signature Key/Staff Roster (Download) | 2017-07-26 | 97 KB |
| Visit Calendar Tool (Download) | 2017-08-16 | 20.78 KB |
| Screening Behavioral Eligibility Worksheet (Download) | 2017-08-01 | 276.75 KB |
| Enrollment Behavioral Eligibility Worksheet (Download) | 2017-08-01 | 237.44 KB |
| Product Use Instructions (Download) | 2017-07-17 | 317.36 KB |
| Financial Disclosure Form (Download) | 2016-05-03 | 21.83 KB |
| Financial Disclosure Form for Protocol Chair (Download) | 2016-05-03 | 22.39 KB |
| Financial Disclosure Form Training Slides (Download) | 2017-08-09 | 924.23 KB |
| Data Management (Download) | 2017-08-08 | 230.5 KB |
| Source Documentation (Download) | 2017-08-08 | 106.49 KB |
| Accrual and Retention (Download) | 2017-11-20 | 352.65 KB |
| Anorectal Examination and Sample Collection (Download) | 2017-11-20 | 1.77 MB |
| CASI Survey Test Instructions for Sites (Download) | 2017-11-20 | 430.53 KB |
| Clinical Management and Laboratory-Related CRFs (Download) | 2017-11-20 | 520.25 KB |
| Clinical Management Overview (Download) | 2017-11-20 | 613.61 KB |
| Counseling Considerations (Download) | 2017-11-20 | 754.41 KB |
| Enrollment Considerations (Download) | 2017-11-20 | 407.67 KB |
| Follow-up Visit CRFs and Other Tools (Download) | 2017-11-20 | 574 KB |
| Follow-up Visit Requirements (Download) | 2017-11-20 | 460.33 KB |
| IDI Training - Silom (Download) | 2017-11-20 | 332.49 KB |
| IDI Training - UAB and PITT (Download) | 2017-11-20 | 1.11 MB |
| Laboratory Training Enrollment Visit (Download) | 2017-11-20 | 466.11 KB |
| Laboratory Training Follow-Up Visits (Download) | 2017-11-20 | 518.55 KB |
| Laboratory Training Screening Visit (Download) | 2017-11-20 | 475.01 KB |
| Screening and Enrollment Visit CRFs, Tools, and Processes (Download) | 2017-11-20 | 259.19 KB |
| Screening Procedures (Download) | 2017-11-20 | 680.32 KB |
| Study Product Considerations (Bangkok) (Download) | 2017-11-20 | 723.95 KB |
| Study Product Considerations (UAB-Pitt) (Download) | 2018-01-26 | 834.89 KB |
| Enrollment Visit Checklist (Download) | 2017-12-01 | 40.69 KB |
| Genital Exam Checklist (Download) | 2017-12-01 | 43.78 KB |
| Screening Visit Checklist (Download) | 2017-12-01 | 40.44 KB |
| Visit 13 (Last Study Product Admin/Early Term) Checklist (Download) | 2018-04-13 | 41.33 KB |
| Visit 17 (Follow-Up Safety Contact/Term Visit) Checklist (Download) | 2017-08-14 | 31.57 KB |
| Visit 3 (Single Dose Administration Visit) Checklist (Download) | 2018-04-13 | 38.9 KB |
| Visits 14-16 (PK Visits) Checklist (Download) | 2018-04-13 | 40.31 KB |
| Visits 4-6 (PK Visits) Checklist (Download) | 2017-12-01 | 36.83 KB |
| Visits 7-12 (Study Product Administration Visits) Checklist (Download) | 2017-12-01 | 40.08 KB |