Microbicide Trials Network

MTN-034/IPM 045 Study Implementation Materials

Adherence Counseling Session Manuals
01: Enrollment Visit Session - PrEP2017-Oct-1342.69 KB
02: Enrollment Visit Session - Ring2017-Oct-1338.32 KB
03: Follow-Up Visit Session - PrEP - no drug levels2017-Oct-1332.91 KB
04: Follow-Up Visit Session - Ring - no drug levels2017-Oct-1333.02 KB
05: Follow-Up Visit Session - PrEP - with drug levels2017-Oct-13155.54 KB
06: Follow-Up Visit Session - Ring - with drug levels2017-Oct-13142.44 KB
Adherence Counseling Session Support Materials
01: Adherence Counseling Worksheet2017-Oct-1371 KB
02: Expectations Handout2017-Oct-16262.17 KB
03: Adherence Goals Worksheet2017-Oct-1650.58 KB
04: Adherence Support Menu2018-Jan-30655.73 KB
05: Confidence Ruler2017-Oct-16157.76 KB
06: Daily Planner Worksheet2017-Oct-1672.81 KB
07: Wireless Drug Level Handout2017-Oct-16110.64 KB
CRFs/Data Collection
MTN-034 DRAFT Case Report Forms for IRB Submissions2017-Jul-181.1 MB
SCHARP Data Request Form2017-Jul-18100.21 KB
Eligibility Tools
Eligibility Checklist2017-Jul-0342.42 KB
Enrollment Behavioral Eligibility Worksheet – ENGLISH2017-Jul-1230.74 KB
Screening and Enrollment Log2017-Jul-1230.82 KB
Screening Behavioral Eligibility Worksheet - ENGLISH2017-Jul-1231.99 KB
IC Support/ Factsheets/ Education
Convo Cards2018-Jan-304.59 MB
Factsheet - One page2017-Oct-10413.5 KB
Factsheet Overview Booklet2017-Oct-10562.28 KB
IC Comprehension Assessment Template– ENGLISH2017-May-1634.19 KB
IC Coversheet Template2017-Jul-1229.74 KB
Informed Consent Flipchart2018-Jan-307.12 MB
Ring Poster2018-Jan-301019.03 KB
Tablet Poster2018-Jan-304.7 MB
Talking Points2018-Jan-30517.87 KB
Fun Images - High Resolution2017-Oct-1251.93 MB
Other (non-Adherence) Counseling Tools
Contraceptive Counseling Worksheet2017-Jul-1253.5 KB
HIV and STI Counseling Worksheet2017-Jul-1261 KB
Sample Pregnancy Management Worksheet2017-Jul-3192 KB
Regulatory/FD Documents
DoA Log Template2017-Jul-12104 KB
Financial Disclosure Form2015-Aug-1825.08 KB
Financial Disclosure Form for Protocol Chair2015-Aug-1824.79 KB
Financial Disclosure Form Training Slides2017-Feb-27924.23 KB
Meeting Report: Stakeholders consultation on REACH (MTN-034) 2016-Sep-293.34 MB
Safety/ Clinical/Product Use Management
Baseline Medical History Questions Sheet2017-Aug-1044.05 KB
Female Genital Grading Table2007-Nov-30130.87 KB
Product Use Management Flow Sheets2017-Jul-12104.99 KB
Protocol Safety Review Team (PSRT) Query Form2017-Aug-2241.46 KB
Ring Use Instructions2017-Oct-10482.24 KB
Safety Lab and Creatinine Clearance Calculator2017-Jul-1254.79 KB
Self-Collected Vaginal Swab Instructions2017-Jul-12428.96 KB
Tablet Use Instructions2017-Oct-10522.63 KB
Sample Visit Checklists
01: Screening Visit Checklist2018-Jan-1151.23 KB
02: Enrollment Visit Checklist2018-Jan-1155.38 KB
03: Monthly Visit Checklist2018-Jan-1162.42 KB
04: Visit 23/PUEV Checklist/Early Termination Checklist2018-Jan-1150.46 KB
05: Visits 3, 10, 17, and 24 - SEV/Phone Contact Checklist2018-Jan-1139.67 KB
06: Pelvic Exam Checklist2018-Jan-1141.02 KB
SOP Templates
Clinic Product Accountability SOP2017-Jun-2949.34 KB
Clinic Study Product Destruction Log2017-Jul-0321.02 KB
Participant-Specific Clinic Study Product Accountability Log2017-Jul-0323.41 KB
Source Documentation SOP2018-Feb-0955.53 KB