Microbicide Trials Network

MTN-020 Study Implementation Materials

ACASI/Data Collection
ACASI_Practice2011-Dec-079.9 KB
ACASI_Baseline2012-Feb-249.38 KB
ACASI_3 Month2016-Feb-2412.81 KB
ACASI_PUEV2012-Feb-2416.67 KB
SCHARP Data Request Form2013-Jul-0336.38 KB
Eligibility Checklist (Word Document)2013-Jan-03285.5 KB
Enrollment Visit Checklist2013-Jan-3136.51 KB
Follow-up Visit Checklist2013-Jul-31579.61 KB
Interim Visit Checklist2012-May-0120.47 KB
MTN-020 and MTN-015 Combined Visit Checklist, v1.22013-Aug-1238.42 KB
MTN-020 and MTN-015 Combined Visit Checklist, v2.02013-Aug-1536.24 KB
MTN-020 and MTN-015 Combined Visit Pelvic Exam Checklist, v2.02013-Aug-1532.43 KB
Pelvic Visit Checklist2013-Jan-3127.98 KB
PUEV/Early Term/Term Visit Checklist2014-Jul-3132.61 KB
Screening Visit Checklist2013-Jan-3132.92 KB
Seroconverter Visit Checklist2014-Jul-3128.53 KB
Transfer Checklist – Transferring Site2014-Mar-2630.13 KB
Transfer Inventory Log2014-Mar-2630.26 KB
Counseling Tools/Worksheets
Adherence Counseling Flow Sheet2012-May-0298.29 KB
Counseling and Education Manual2013-Jan-31251.26 KB
Counselor Reference for Anal Sex Counseling2014-Jun-11323.48 KB
Enrollment Education Flow Sheet2012-Nov-12104.6 KB
HIV Counseling Messages Reference2013-Jan-3126.36 KB
Ring Insertion Instructions/Important Information Sheet2012-Jan-04393.55 KB
Sample Contraceptive Counseling Worksheet2012-Mar-0534 KB
Sample HIV Counseling Worksheet2012-Mar-0539 KB
IC Support/Factsheets/Community Flipchart
Community Education Flipchart2011-Dec-162.17 MB
English IC Booklet2011-Dec-144.91 MB
Factsheet_Anal Sex 2014-Jun-11331.25 KB
Factsheet_ASPIRE2011-Nov-14409.37 KB
Factsheet_Circumcision2011-Nov-14280.21 KB
Factsheet_Condoms2011-Nov-14300.43 KB
Factsheet_Resistance2011-Nov-14369.56 KB
Factsheet_Ring2011-Nov-14279.13 KB
IC Compehension Checklist2011-Nov-08105.5 KB
Sample IC Coversheet, v1.22012-Mar-2059.5 KB
Other Tools/Templates
Avery Label Macro2012-Jun-04151.5 KB
Clinic Study Product Accountability Log2012-Jul-0934.11 KB
Clinic Study Product Accountability Log Cover Page2012-Jul-0948 KB
Delegation of Authority Template2012-Dec-2182.5 KB
MTN Network Lab HIV Testing Query Form2012-Nov-0221.69 KB
MTN-020 Financial Disclosure Form2014-Aug-0722.1 KB
MTN-020 Financial Disclosure Form - MRC and ZIM2014-Aug-0723.56 KB
MTN-020 Financial Disclosure Form - Protocol Chair2014-Aug-0722.4 KB
MTN-020 Label Template Instructions2012-Jun-04162.37 KB
Off Site Visit Log2013-Jan-31249 KB
Participant Tracking Database User Manual v1.02012-Jul-26437.94 KB
Ring Cutting Template2012-Jun-28137.15 KB
Sample Study Exit Materials2015-Feb-0818.35 KB
Screening and Enrollment Log2013-May-1324.93 KB
Self-Swab Collection Instructions (1 sided)2012-Oct-30310.82 KB
Self-Swab Collection Instructions (2 sided)2012-Oct-30403.89 KB
Small Gram Stain Label Macro2012-Aug-01170 KB
Visit Scheduling Tool (Includes Follow-up Visit Calendar tool, Last Day to Enroll tool, and Seroconverter Scheduling tool.)2014-Jul-0722.46 KB
Safety/Clinical/Product Use Management
AE/PRE Text Guidance Sheet2012-Aug-01122.46 KB
Baseline Medical History Questions2012-Jul-2422.04 KB
DAIDs Toxicity Table2004-Dec-28382.21 KB
Emergency Phone Contact Sheet2013-Jan-3127.5 KB
FGGT2007-Nov-30130.87 KB
Guide to Genital Finding Terms2012-Jun-28477.05 KB
Pre-existing Conditions Tracker2012-Jul-2412.89 KB
Pregnancy Management Worksheet2013-Jan-3169 KB
Product Use Management Flowsheets2012-Jul-17125.5 KB
PSRT Query Form2012-Jun-2889.86 KB
Safety Lab Results Calculator2012-Nov-2618.6 KB
SOP Templates
Accrual2012-Feb-0763 KB
Data Management SOP template 2012-May-10110 KB
Eligibility2012-Feb-0777.5 KB
Informed Consent2012-Feb-0773.5 KB
Off-Site2012-Feb-0765.5 KB
Participant Retention Procedures2012-May-1642.07 KB
Randomization2012-Apr-18103.36 KB
Safety Monitoring and Reporting Procedures2012-Jun-0484 KB
Source Documentation2012-May-23362 KB
Study Product Accountability SOP2013-Jan-2335.55 KB
Translation SOP2013-Jan-3159.5 KB