MTN-017 Study Implementation Materials

DescriptionDateSize
Behavioral
Baseline Behavioral Questionnaire (Download) 2012-09-11145.5 KB
Follow-up Behavioral Questionnaire (Download) 2012-09-11148.48 KB
IDI Guide Daily Gel (Download) 2013-02-1581.94 KB
IDI Guide RAI Gel (Download) 2013-02-1589.31 KB
IDI Guide Tablet (Download) 2013-02-1565.46 KB
SMS 101 Sample Training Guide (Download) 2012-10-30516.99 KB
SMS Diary Instructions (Download) 2013-05-1320.2 KB
SMS Diary Instructions - SPANISH (Download) 2013-05-0819.09 KB
SMS Diary Instructions - THAI (Download) 2014-02-1471.03 KB
SMS Diary Instructions - THAI (Word Format) (Download) 2014-02-1416.4 KB
SMS Readiness Assessment (Download) 2012-10-1716.73 KB
SMS Readiness Assessment - SPANISH (Download) 2012-10-1717.89 KB
SMS Readiness Assessment - THAI (Download) 2014-02-14156.64 KB
SMS Readiness Assessment Staff Instructions (Download) 2012-10-17109.95 KB
SMS Readiness Assessment Staff Instructions - SPANISH (Download) 2012-10-1716.48 KB
SMS Readiness Assessment Staff Instructions - THAI (Download) 2014-02-14149.55 KB
SMS System Frequently Asked Questions (Download) 2013-11-07224.03 KB
SMS System Frequently Asked Questions - SPANISH (Download) 2013-11-0719.65 KB
SMS System Frequently Asked Questions - THAI (Download) 2014-02-1463.89 KB
SMS Training Script (Download) 2012-10-2339 KB
SMS Training Script - SPANISH (Download) 2012-10-2339.5 KB
SMS Training script - THAI (Download) 2014-02-14109.97 KB
Clinical/Safety/Product Use Management
Baseline Medical History Questions Sheet (Download) 2013-03-0427.14 KB
DAIDS Toxicity Table (Download) 2012-08-31382.21 KB
MedDRA AE Preferred Terms (Download) 2014-04-1887.26 KB
Non-DataFax MTN-017 Follow-up Medical History Log (Download) 2012-12-1791.94 KB
PSRT Query Form (Download) 2012-10-1962 KB
Rectal Grading Table (Download) 2012-05-1197.52 KB
Counseling Tools/Worksheets
Before and After Sex Gel Use Instructions (Download) 2012-10-24466.92 KB
Before and After Sex Product Use Instructions FAQs (Download) 2014-06-1240.2 KB
Daily Gel Use Instructions (Download) 2012-10-24461.87 KB
Daily Tablet Use Instructions (Download) 2012-10-18445.88 KB
HIV and Risk Reduction Counseling Worksheet (Download) 2012-11-0822.63 KB
Participant Centered Adherence Counseling Guide (Download) 2014-10-152.12 MB
Participant Centered Adherence Counseling Guide - SPANISH (Download) 2014-10-15522.49 KB
Participant Centered Adherence Counseling Guide - THAI (Download) 2014-10-151.86 MB
Product Use Before and After Sex Gel (Spanish) (Download) 2012-10-24482.6 KB
Product Use Daily Gel (Spanish) (Download) 2012-10-24551.13 KB
Product Use Instructions Counseling Worksheet (Download) 2013-08-0943.5 KB
Product Use Tablet (Spanish) (Download) 2012-10-18456.55 KB
Protocol Adherence Counseling Worksheet (Download) 2013-08-0944 KB
Informed Consent Support Materials
English Informed Consent Booklet (Download) 2013-04-254.56 MB
IC Comprehension Assessment - Multiple Choice (Download) 2013-04-0527.33 KB
IC Comprehension Assessment - Open Ended (Download) 2013-04-0527.42 KB
IC Comprehension Assessment - True/False (Download) 2013-04-0527.75 KB
Informed Consent Booklet (Spanish) (Download) 2013-04-254.39 MB
Sample IC Coversheet (Download) 2012-10-1623.29 KB
Other Tools/Templates
Calculated Creatinine Clearance Worksheet (Download) 2014-01-1743 KB
Delegation of Duties/ Signature Log/ Staff Roster (Download) 2012-07-1782 KB
LDMS Specimen Tracking Sheet (Download) 2013-10-30365.82 KB
LDMS Specimen Tracking Sheet - Tissue Subset (Download) 2013-09-30445.79 KB
MTN-017 Financial Disclosure Form (Download) 2014-08-0722.01 KB
MTN-017 Product Count Tool (includes the PDR-applicators tool, PDR-tablets tool, and DCI tool) (Download) 2013-05-0219.92 KB
MTN-017 Visit Scheduling Tool (includes the Follow-up Visit Calendar tool and the Last Day to Enroll tool) (Download) 2013-05-0215.97 KB
Screening and Enrollment Log (Download) 2012-10-1919.76 KB
Study Visits and Procedures (Download) 2013-03-28183.9 KB
Suggested Filing Structure for MTN-017 Essential Documents (Download) 2013-04-2966.44 KB
Presentations
Site Activation Process (Download) 2012-07-022.98 MB
Study Contacts
MTN-017 Study Communication Contact Sheet (Download) 2013-08-05200.29 KB
Visit Checklists
Overview of Checklists and Identification of Current Versions (Download) 2013-08-09127.95 KB
01: Screening Visit Checklist (Download) 2013-07-2242.97 KB
02: Enrollment/Initiate Period 1 - Visit Checklist (Download) 2013-07-2949.2 KB
03: Mid-Period Visits (Visits 3, 6, 9) (Download) 2013-07-2247.02 KB
04: Initiate Period 2 & 3 (Download) 2013-07-2244.59 KB
05: Period 1/2 End Visit (Visits 4 & 7) (Download) 2013-07-2247.15 KB
06: Period 3 End/Final Clinic Visit/Early Termination (Visit 10) (Download) 2013-07-2242 KB
07: Rectal Exam Checklist - (Enrollment and Follow Up) (Download) 2013-07-2234.63 KB
08: Period 1 Follow Up Phone Calls Checklist (Download) 2013-07-2225.49 KB
09: Period 1 Follow Up Phone Calls - Rectal Biopsy/Fluid Subset (Download) 2013-07-2225.6 KB
10: Eligibility Criteria (Download) 2013-04-2922.97 KB

Source URL: https://mtnstopshiv.org/research/studies/mtn-017/mtn-017-study-implementation-materials