Microbicide Trials Network

MTN-026 Study Implementation Materials

DescriptionDateSize
Behavioral Assessments
Baseline Behavioral Survey2016-Sep-261.06 MB
EXIT Behavioral Survey2016-Mar-17429 KB
Follow-up Single-Dose Behavioral Survey2016-Mar-17462.12 KB
In Depth Interview (IDI) EXIT Guide2015-Oct-12220.84 KB
In-Depth Interview (IDI) SINGLE DOSE Guide2015-Oct-12167.14 KB
Behavioral Assessments - THAI VERSION
Baseline Behavioral Survey2016-Jun-01582.89 KB
EXIT Behavioral Survey2016-Jun-01321 KB
Follow-up Single-Dose Behavioral Survey2015-Sep-28150.86 KB
In-Depth Interview (IDI) EXIT Guide2015-Dec-22356.72 KB
In-Depth Interview (IDI) SINGLE DOSE Guide2015-Dec-22328.05 KB
Clinical/Safety Management
Baseline Medical History Questions Form2017-Aug-2131.29 KB
MTN Rectal Terms MedDRA Preferred Term Cheat Sheet2017-Nov-0827.59 KB
Protocol Safety Review Team Query Form2017-Jul-1733.62 KB
Counseling Tools/Worksheets
Contraceptive Counseling Worksheet2017-Jul-2626.64 KB
HIV Pre/Post Test and Risk Reduction Counseling Worksheet2017-Apr-2429.06 KB
Informational Booklet2017-Jul-17151.32 KB
Protocol Counseling Worksheet2017-Jul-2731.45 KB
Counseling Tools/Worksheets - THAI VERSION
Informational Booklet2017-Aug-01166.17 KB
Informed Consent Support Materials
ICCA True/False2017-Jul-1729.07 KB
Informed Consent Coversheet2017-Jul-1730.63 KB
Open Ended Comprehension Assessment2017-Jul-1780 KB
Other Tools/Templates
Avery 5267 Specimen Labels2017-Aug-10222 KB
Eligibility Checklist2017-Aug-0739.9 KB
Enrollment Behavioral Eligibility Worksheet2017-Aug-2534.83 KB
LDMS Specimen Tracking Sheet - Blood Samples 2017-Sep-06424.23 KB
LDMS Specimen Tracking Sheet - Female Specimens2017-Sep-06580.59 KB
LDMS Specimen Tracking Sheet - Rectal Specimens2017-Sep-06549.29 KB
Product Use Instructions2017-Jul-17649.71 KB
Screening and Enrollment Log2017-Jul-2636.01 KB
Screening Behavioral Eligibility Worksheet2017-Aug-2534.13 KB
Study Staff Delegation of Duties (DoD) and Signature Key/Staff Roster2017-Jul-2697 KB
Visit Calendar Tool2017-Aug-1620.78 KB
Other Tools/Templates - THAI VERSION
Screening Behavioral Eligibility Worksheet2017-Aug-01276.75 KB
Enrollment Behavioral Eligibility Worksheet2017-Aug-01237.44 KB
Product Use Instructions2017-Jul-17317.36 KB
Regulatory/FD Documents
Financial Disclosure Form2016-May-0321.85 KB
Financial Disclosure Form for Protocol Chair2016-May-0321.26 KB
Financial Disclosure Form Training Slides2017-Aug-09924.23 KB
SOP Templates
Data Management2017-Aug-08230.5 KB
Source Documentation2017-Aug-08106.49 KB
Training
Accrual and Retention2017-Nov-20352.65 KB
Anorectal Examination and Sample Collection2017-Nov-201.77 MB
CASI Survey Test Instructions for Sites2017-Nov-20430.53 KB
Clinical Management and Laboratory-Related CRFs2017-Nov-20520.25 KB
Clinical Management Overview2017-Nov-20613.61 KB
Counseling Considerations2017-Nov-20754.41 KB
Enrollment Considerations2017-Nov-20407.67 KB
Follow-up Visit CRFs and Other Tools2017-Nov-20574 KB
Follow-up Visit Requirements2017-Nov-20460.33 KB
IDI Training - Silom2017-Nov-20332.49 KB
IDI Training - UAB and PITT2017-Nov-201.11 MB
Laboratory Training Enrollment Visit2017-Nov-20466.11 KB
Laboratory Training Follow-Up Visits2017-Nov-20518.55 KB
Laboratory Training Screening Visit2017-Nov-20475.01 KB
Screening and Enrollment Visit CRFs, Tools, and Processes2017-Nov-20259.19 KB
Screening Procedures2017-Nov-20680.32 KB
Study Product Considerations2017-Nov-20723.95 KB
Visit Checklists
Enrollment Visit Checklist2017-Dec-0140.69 KB
Genital Exam Checklist2017-Dec-0143.78 KB
Screening Visit Checklist2017-Dec-0140.44 KB
Visit 13 (Last Study Product Admin/Early Term) Checklist2017-Dec-0140.31 KB
Visit 17 (Follow-Up Safety Contact/Term Visit) Checklist2017-Aug-1431.57 KB
Visit 3 (Single Dose Administration Visit) Checklist2017-Dec-0137.99 KB
Visits 14-16 (PK Visits) Checklist2017-Dec-0139.59 KB
Visits 4-6 (PK Visits) Checklist2017-Dec-0136.83 KB
Visits 7-12 (Study Product Administration Visits) Checklist2017-Dec-0140.08 KB