MTN-026 Study Implementation Materials

Behavioral Assessments
Baseline Behavioral Survey (Download) 2016-09-261.06 MB
EXIT Behavioral Survey (Download) 2016-03-17429 KB
Follow-up Single-Dose Behavioral Survey (Download) 2016-03-17462.12 KB
In Depth Interview (IDI) EXIT Guide (Download) 2015-10-12220.84 KB
In-Depth Interview (IDI) SINGLE DOSE Guide (Download) 2015-10-12167.14 KB
Behavioral Assessments - THAI VERSION
Baseline Behavioral Survey (Download) 2016-06-01582.89 KB
EXIT Behavioral Survey (Download) 2016-06-01321 KB
Follow-up Single-Dose Behavioral Survey (Download) 2015-09-28150.86 KB
In-Depth Interview (IDI) EXIT Guide (Download) 2015-12-22356.72 KB
In-Depth Interview (IDI) SINGLE DOSE Guide (Download) 2015-12-22328.05 KB
Clinical/Safety Management
Baseline Medical History Questions Form (Download) 2017-08-2131.29 KB
MTN Rectal Terms MedDRA Preferred Term Cheat Sheet (Download) 2017-11-0827.59 KB
Protocol Safety Review Team Query Form (Download) 2017-07-1733.62 KB
Counseling Tools/Worksheets
Contraceptive Counseling Worksheet (Download) 2017-07-2626.64 KB
HIV Pre/Post Test and Risk Reduction Counseling Worksheet (Download) 2017-04-2429.06 KB
Informational Booklet (Download) 2017-07-17151.32 KB
Protocol Counseling Worksheet (Download) 2017-07-2731.45 KB
Counseling Tools/Worksheets - THAI VERSION
Informational Booklet (Download) 2017-08-01166.17 KB
Informed Consent Support Materials
ICCA True/False (Download) 2017-07-1729.07 KB
Informed Consent Coversheet (Download) 2017-07-1730.63 KB
Open Ended Comprehension Assessment (Download) 2017-07-1780 KB
Other Tools/Templates
Avery 5267 Specimen Labels (Download) 2017-08-10222 KB
Eligibility Checklist (Download) 2017-08-0739.9 KB
Enrollment Behavioral Eligibility Worksheet (Download) 2017-08-2534.83 KB
LDMS Specimen Tracking Sheet - Blood Samples (Download) 2017-09-06424.23 KB
LDMS Specimen Tracking Sheet - Female Specimens (Download) 2017-09-06580.59 KB
LDMS Specimen Tracking Sheet - Rectal Specimens (Download) 2018-01-02407.64 KB
Product Use Instructions (Download) 2017-07-17649.71 KB
Screening and Enrollment Log (Download) 2017-07-2636.01 KB
Screening Behavioral Eligibility Worksheet (Download) 2017-08-2534.13 KB
Study Staff Delegation of Duties (DoD) and Signature Key/Staff Roster (Download) 2017-07-2697 KB
Visit Calendar Tool (Download) 2017-08-1620.78 KB
Other Tools/Templates - THAI VERSION
Screening Behavioral Eligibility Worksheet (Download) 2017-08-01276.75 KB
Enrollment Behavioral Eligibility Worksheet (Download) 2017-08-01237.44 KB
Product Use Instructions (Download) 2017-07-17317.36 KB
Regulatory/FD Documents
Financial Disclosure Form (Download) 2016-05-0321.83 KB
Financial Disclosure Form for Protocol Chair (Download) 2016-05-0322.39 KB
Financial Disclosure Form Training Slides (Download) 2017-08-09924.23 KB
SOP Templates
Data Management (Download) 2017-08-08230.5 KB
Source Documentation (Download) 2017-08-08106.49 KB
Accrual and Retention (Download) 2017-11-20352.65 KB
Anorectal Examination and Sample Collection (Download) 2017-11-201.77 MB
CASI Survey Test Instructions for Sites (Download) 2017-11-20430.53 KB
Clinical Management and Laboratory-Related CRFs (Download) 2017-11-20520.25 KB
Clinical Management Overview (Download) 2017-11-20613.61 KB
Counseling Considerations (Download) 2017-11-20754.41 KB
Enrollment Considerations (Download) 2017-11-20407.67 KB
Follow-up Visit CRFs and Other Tools (Download) 2017-11-20574 KB
Follow-up Visit Requirements (Download) 2017-11-20460.33 KB
IDI Training - Silom (Download) 2017-11-20332.49 KB
IDI Training - UAB and PITT (Download) 2017-11-201.11 MB
Laboratory Training Enrollment Visit (Download) 2017-11-20466.11 KB
Laboratory Training Follow-Up Visits (Download) 2017-11-20518.55 KB
Laboratory Training Screening Visit (Download) 2017-11-20475.01 KB
Screening and Enrollment Visit CRFs, Tools, and Processes (Download) 2017-11-20259.19 KB
Screening Procedures (Download) 2017-11-20680.32 KB
Study Product Considerations (Bangkok) (Download) 2017-11-20723.95 KB
Study Product Considerations (UAB-Pitt) (Download) 2018-01-26834.89 KB
Visit Checklists
Enrollment Visit Checklist (Download) 2017-12-0140.69 KB
Genital Exam Checklist (Download) 2017-12-0143.78 KB
Screening Visit Checklist (Download) 2017-12-0140.44 KB
Visit 13 (Last Study Product Admin/Early Term) Checklist (Download) 2018-04-1341.33 KB
Visit 17 (Follow-Up Safety Contact/Term Visit) Checklist (Download) 2017-08-1431.57 KB
Visit 3 (Single Dose Administration Visit) Checklist (Download) 2018-04-1338.9 KB
Visits 14-16 (PK Visits) Checklist (Download) 2018-04-1340.31 KB
Visits 4-6 (PK Visits) Checklist (Download) 2017-12-0136.83 KB
Visits 7-12 (Study Product Administration Visits) Checklist (Download) 2017-12-0140.08 KB

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