MTN-003 Study Implementation Materials

Description	Date	Size
ACASI Training Scripts
ACASI Audio Training Script Instructions (BEMBA) [1]	2009-Nov-11	34.5 KB
ACASI Audio Training Script Instructions (NYANJA) [2]	2009-Nov-11	33.54 KB
ACASI Audio Training Script Instructions (SHONA) [3]	2009-Sep-29	29.8 KB
ACASI Audio Training Script Instructions (ZULU) [4]	2009-Sep-21	35.81 KB
Informed Consent Support Materials
Circumcision Fact Sheet [5]	2009-Jun-30	316.18 KB
Community Fact Sheet [6]	2009-Jun-30	251.69 KB
Condoms Fact Sheet [7]	2009-Jun-30	277.05 KB
English Booklet South Africa and Uganda [8]	2009-Jan-08	4.52 MB
English Booklet Zambia [9]	2009-Feb-23	4.28 MB
English Booklet Zimbabwe [10]	2009-Jan-08	4.2 MB
Gel Use Instructions [11]	2009-Jun-30	466 KB
Male Partner Fact Sheet [12]	2009-Jun-30	370.98 KB
Participant Fact Sheet [13]	2009-Jun-30	269.13 KB
Resistance Fact Sheet [14]	2009-Jun-30	155.19 KB
Side Effects Pamphlet [15]	2010-Aug-22	57.8 KB
Table-Top Flip Chart [16]	2009-Jun-30	5.44 MB
Tablet Use Instructions [17]	2009-Jun-30	612.78 KB
Other Materials
10 Key Messages for Product Use [18]	2011-May-03	84.5 KB
ACASI Questionnaire Schedule [19]	2011-Mar-22	203.91 KB
Adverse Event Reporting and Pregnancy [20]	2010-Nov-24	52.69 KB
Concept Proposal Form [21]	2011-Oct-25	31.5 KB
Creatinine Clearance Worksheet Convert [22]	2010-Feb-16	44.5 KB
Creatinine Clearance Worksheet No Convert [23]	2010-Feb-16	35.5 KB
CRF Request Form [24]	2011-Nov-16	30.74 KB
DAIDS Site FDA Inspection Preparation Checklist [25]	2011-Mar-10	34 KB
Enrollment Adherence Counseling [26]	2009-Aug-06	73 KB
Enrollment Informed Consent Comprehension Checklist [27]	2009-May-05	50.5 KB
Follow-up Adherence Counseling Worksheet, Version 2.0 [28]	2011-Apr-09	41.5 KB
HIV Tests Performed During FOLLOW-UP in VOICE [29]	2010-May-26	47.16 KB
MTN-003 Financial Disclosure Form [30]	2009-Sep-15	71 KB
MTN-003 Visit Scheduling Tool [31]	2010-Nov-22	49.5 KB
PK Collection Scenarios Fingerstick Sites [32]	2011-Jul-14	91.68 KB
PK Collection Scenarios Non Fingerstick Sites [33]	2011-Jul-14	95.54 KB
Procedures for HIV seroconversion in MTN-003 [34]	2010-Aug-10	35.5 KB
Product Ordering Tool [35]	2010-Jan-29	21 KB
Product Returns Training Presentation [36]	2010-Nov-17	1.71 MB
Protocol Safety Team Review Query Form LOA2 [37]	2010-Sep-09	46 KB
Publication Guidelines [38]	2011-Oct-25	74 KB
Safety Line Call Record [39]	2009-Sep-08	31.5 KB
Sample Adverse Event Tracking Log [40]	2009-Aug-06	42.5 KB
Sample Certificate of Completion [41]	2011-Aug-18	29 KB
Sample Informed Consent Cover Sheet [42]	2009-May-05	71 KB
Sample Informed Consent PBMC [43]	2011-Jun-24	39 KB
Sample Pregnancy Management Worksheet [44]	2009-Aug-06	75 KB
Sample Product Use Instruction Checklist [45]	2011-May-03	45 KB
Sample Safety Monitoring Flow Sheets [46]	2010-Jun-23	238 KB
Seroconverter Specimen Collection Tool [47]	2011-Mar-21	46.5 KB
VOICE Oral Truvada/Placebo PUEV Scheduling Tool [48]	2011-Dec-20	45 KB
Visit Checklists
01: Screening, Part 1 [49]	2010-Apr-15	97.5 KB
02: Between Screening Part 1 and Screening Part 2 Worksheet [50]	2010-Apr-15	63 KB
03: Screening, Part 2 [51]	2010-Apr-15	89.5 KB
04: Screening, Pelvic Exam [52]	2010-Apr-15	70.5 KB
05: Between Screening Part 2 and Enrollment Worksheet [53]	2010-Apr-15	67.5 KB
06: Enrollment [54]	2010-Apr-15	129.5 KB
07: Month 1 Visit [55]	2010-Apr-15	114 KB
08: Monthly Visit [56]	2010-Apr-15	109.5 KB
09: Quarterly Visit [57]	2010-Apr-15	110.5 KB
10: Follow-up Pelvic Exam [58]	2010-Apr-15	67 KB
11: Semi Annual Visit [59]	2010-Apr-15	118.5 KB
12: Annual Visit [60]	2010-Apr-15	95 KB
13: Product Use End Visit (PUEV) [61]	2010-Apr-15	107 KB
14: Termination/Study Exit Visit [62]	2010-Apr-15	98 KB
15: Interim Vist Checklists [63]	2010-Aug-15	75.5 KB
16: HIV Sample 2 Visit Checklist [64]	2010-Aug-15	43.5 KB
17: Post-Seroconversion Checklist [65]	2011-Mar-21	57.21 KB