Microbicide Trials Network

MTN-017 Study Implementation Materials

Baseline Behavioral Questionnaire2012-Sep-11145.5 KB
Follow-up Behavioral Questionnaire2012-Sep-11148.48 KB
IDI Guide Daily Gel2013-Feb-1581.94 KB
IDI Guide RAI Gel2013-Feb-1589.31 KB
IDI Guide Tablet2013-Feb-1565.46 KB
SMS 101 Sample Training Guide2012-Oct-30516.99 KB
SMS Diary Instructions2013-May-1320.2 KB
SMS Diary Instructions - SPANISH2013-May-0819.09 KB
SMS Diary Instructions - THAI2014-Feb-1471.03 KB
SMS Diary Instructions - THAI (Word Format)2014-Feb-1416.4 KB
SMS Readiness Assessment2012-Oct-1716.73 KB
SMS Readiness Assessment - SPANISH2012-Oct-1717.89 KB
SMS Readiness Assessment - THAI2014-Feb-14156.64 KB
SMS Readiness Assessment Staff Instructions2012-Oct-17109.95 KB
SMS Readiness Assessment Staff Instructions - SPANISH2012-Oct-1716.48 KB
SMS Readiness Assessment Staff Instructions - THAI2014-Feb-14149.55 KB
SMS System Frequently Asked Questions2013-Nov-07224.03 KB
SMS System Frequently Asked Questions - SPANISH2013-Nov-0719.65 KB
SMS System Frequently Asked Questions - THAI2014-Feb-1463.89 KB
SMS Training Script2012-Oct-2339 KB
SMS Training Script - SPANISH2012-Oct-2339.5 KB
SMS Training script - THAI2014-Feb-14109.97 KB
Clinical/Safety/Product Use Management
Baseline Medical History Questions Sheet2013-Mar-0427.14 KB
DAIDS Toxicity Table2012-Aug-31382.21 KB
MedDRA AE Preferred Terms2014-Apr-1887.26 KB
Non-DataFax MTN-017 Follow-up Medical History Log2012-Dec-1791.94 KB
PSRT Query Form2012-Oct-1962 KB
Rectal Grading Table2012-May-1197.52 KB
Counseling Tools/Worksheets
Before and After Sex Gel Use Instructions2012-Oct-24466.92 KB
Before and After Sex Product Use Instructions FAQs2014-Jun-1240.2 KB
Daily Gel Use Instructions2012-Oct-24461.87 KB
Daily Tablet Use Instructions2012-Oct-18445.88 KB
HIV and Risk Reduction Counseling Worksheet2012-Nov-0822.63 KB
Participant Centered Adherence Counseling Guide2014-Oct-152.12 MB
Participant Centered Adherence Counseling Guide - SPANISH2014-Oct-15522.49 KB
Participant Centered Adherence Counseling Guide - THAI2014-Oct-151.86 MB
Product Use Before and After Sex Gel (Spanish)2012-Oct-24482.6 KB
Product Use Daily Gel (Spanish)2012-Oct-24551.13 KB
Product Use Instructions Counseling Worksheet2013-Aug-0943.5 KB
Product Use Tablet (Spanish)2012-Oct-18456.55 KB
Protocol Adherence Counseling Worksheet2013-Aug-0944 KB
Informed Consent Support Materials
English Informed Consent Booklet2013-Apr-254.56 MB
IC Comprehension Assessment - Multiple Choice2013-Apr-0527.33 KB
IC Comprehension Assessment - Open Ended2013-Apr-0527.42 KB
IC Comprehension Assessment - True/False2013-Apr-0527.75 KB
Informed Consent Booklet (Spanish)2013-Apr-254.39 MB
Sample IC Coversheet2012-Oct-1623.29 KB
Other Tools/Templates
Calculated Creatinine Clearance Worksheet2014-Jan-1743 KB
Delegation of Duties/ Signature Log/ Staff Roster2012-Jul-1782 KB
LDMS Specimen Tracking Sheet2013-Oct-30365.82 KB
LDMS Specimen Tracking Sheet - Tissue Subset2013-Sep-30445.79 KB
MTN-017 Financial Disclosure Form2014-Aug-0722.01 KB
MTN-017 Product Count Tool (includes the PDR-applicators tool, PDR-tablets tool, and DCI tool)2013-May-0219.92 KB
MTN-017 Visit Scheduling Tool (includes the Follow-up Visit Calendar tool and the Last Day to Enroll tool)2013-May-0215.97 KB
Screening and Enrollment Log2012-Oct-1919.76 KB
Study Visits and Procedures2013-Mar-28183.9 KB
Suggested Filing Structure for MTN-017 Essential Documents2013-Apr-2966.44 KB
Site Activation Process2012-Jul-022.98 MB
Study Contacts
MTN-017 Study Communication Contact Sheet2013-Aug-05200.29 KB
Visit Checklists
Overview of Checklists and Identification of Current Versions2013-Aug-09127.95 KB
01: Screening Visit Checklist2013-Jul-2242.97 KB
02: Enrollment/Initiate Period 1 - Visit Checklist2013-Jul-2949.2 KB
03: Mid-Period Visits (Visits 3, 6, 9)2013-Jul-2247.02 KB
04: Initiate Period 2 & 32013-Jul-2244.59 KB
05: Period 1/2 End Visit (Visits 4 & 7)2013-Jul-2247.15 KB
06: Period 3 End/Final Clinic Visit/Early Termination (Visit 10)2013-Jul-2242 KB
07: Rectal Exam Checklist - (Enrollment and Follow Up)2013-Jul-2234.63 KB
08: Period 1 Follow Up Phone Calls Checklist2013-Jul-2225.49 KB
09: Period 1 Follow Up Phone Calls - Rectal Biopsy/Fluid Subset2013-Jul-2225.6 KB
10: Eligibility Criteria2013-Apr-2922.97 KB