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Adherence Counseling Session Manuals
01: Enrollment Visit Session - PrEP (Download) 2017-10-1342.69 KB
02: Enrollment Visit Session - Ring (Download) 2017-10-1338.32 KB
03: Follow-Up Visit Session - PrEP - no drug levels (Download) 2017-10-1332.91 KB
04: Follow-Up Visit Session - Ring - no drug levels (Download) 2017-10-1333.02 KB
05: Follow-Up Visit Session - PrEP - with drug levels (Download) 2017-10-13155.54 KB
06: Follow-Up Visit Session - Ring - with drug levels (Download) 2017-10-13142.44 KB
Adherence Counseling Session Support Materials
01: Adherence Counseling Worksheet (Download) 2017-10-1371 KB
02: Expectations Handout (Download) 2017-10-16262.17 KB
03: Adherence Goals Worksheet (Download) 2017-10-1650.58 KB
04: Adherence Support Menu (Download) 2018-01-30655.73 KB
05: Confidence Ruler (Download) 2017-10-16157.76 KB
06: Daily Planner Worksheet (Download) 2017-10-1672.81 KB
07: Wireless Drug Level Handout (Download) 2017-10-16110.64 KB
CRFs/Data Collection
MTN-034 DRAFT Case Report Forms for IRB Submissions (Download) 2017-07-181.1 MB
SCHARP Data Request Form (Download) 2017-07-18100.21 KB
Eligibility Tools
Eligibility Checklist (Download) 2018-08-1442.99 KB
Enrollment Behavioral Eligibility Worksheet – ENGLISH (Download) 2017-07-1230.74 KB
Screening and Enrollment Log (Download) 2018-08-1331.19 KB
Screening Behavioral Eligibility Worksheet - ENGLISH (Download) 2017-07-1231.99 KB
IC Support/ Factsheets/ Education
Anatomy Presentation (Download) 2018-02-2112 MB
Convo Cards (Download) 2018-01-304.59 MB
Factsheet - One page (Download) 2017-10-10413.5 KB
Factsheet Overview Booklet (Download) 2017-10-10562.28 KB
IC Comprehension Assessment Template– ENGLISH (Download) 2017-05-1634.19 KB
IC Coversheet Template (Download) 2017-07-1229.74 KB
Informed Consent Flipchart (Download) 2018-01-307.12 MB
Ring Poster (Download) 2018-01-301019.03 KB
Tablet Poster (Download) 2018-01-304.7 MB
Talking Points (Download) 2018-01-30517.87 KB
Fun Images - High Resolution (Download) 2017-10-1251.93 MB
Other (non-Adherence) Counseling Tools
Contraceptive Counseling Worksheet (Download) 2018-02-2054 KB
HIV and STI Counseling Worksheet (Download) 2018-02-2061.5 KB
Pregnancy Case Worksheet (Download) 2018-02-1328.69 KB
Other Tools/Templates
Avery 5267 Specimen Labels (Download) 2018-10-02275 KB
HIV Confirmation Procedures Guide (Download) 2018-08-1045.37 KB
Pregnancy Participant Follow-up Visit Checklist (Download) 2018-08-1044.05 KB
Pregnant Participant Procedures Guide (Download) 2018-08-1041.84 KB
Seroconverter Follow-up Visit Checklist (Download) 2018-08-1045.41 KB
Small Slides Specimen Labels (Download) 2018-10-02275.5 KB
Specimen Label Template Implementation (Download) 2018-10-02468.17 KB
Visit Scheduling Tool (Includes Last Day to Enroll Tool, Follow-up Visit Calendar, Seroconverter Specimen Scheduling Tool) (Download) 2018-06-1122.36 KB
Qualitative Guides
FGD M18 Guide (Download) 2018-07-06163.2 KB
FGD M2 Guide (Download) 2018-07-06161.62 KB
Non-Acceptor IDI Guide (Download) 2018-07-06156.03 KB
Serial IDI 1 Guide (Download) 2018-07-06166.56 KB
Serial IDI 2 Guide (Download) 2018-07-06164.09 KB
Serial IDI 3 Guide (Download) 2018-07-06159.04 KB
Special Case IDI Guide (Download) 2018-07-06180.75 KB
Visual Tools (Download) 2018-07-06442.52 KB
Regulatory/FD Documents
DoA Log Template (Download) 2018-09-19102.5 KB
Financial Disclosure Form (Download) 2018-06-2822.71 KB
Financial Disclosure Form for Protocol Chair (Download) 2018-06-2822.31 KB
Financial Disclosure Form Training Slides (Download) 2017-08-09924.23 KB
Meeting Report: Stakeholders consultation on REACH (MTN-034) (Download) 2016-09-293.34 MB
SOP Templates
Clinic Product Accountability SOP (Download) 2017-06-2949.34 KB
Clinic Study Product Destruction Log (Download) 2018-09-1924.21 KB
Data Management SOP (Download) 2018-09-26219 KB
Participant-Specific Clinic Study Product Accountability Log (Download) 2018-09-1927.08 KB
Qualitative SOP (Download) 2018-08-1572 KB
Source Documentation SOP (Download) 2018-10-0556.72 KB
Safety/ Clinical/Product Use Management
Baseline Medical History Questions Guide (Download) 2018-09-1931.04 KB
Female Genital Grading Table (Download) 2007-11-30130.87 KB
Product Use Management Flow Sheets (Download) 2017-07-12105.48 KB
Protocol Safety Review Team (PSRT) Query Form (Download) 2017-08-2241.28 KB
Ring Use Instructions (Download) 2017-10-10482.24 KB
Safety Lab and Creatinine Clearance Calculator (Download) 2018-09-1274.54 KB
Self-Collected Vaginal Swab Instructions (Download) 2017-07-12428.96 KB
Tablet Use Instructions (Download) 2017-10-10522.63 KB
Sample Visit Checklists
01: Screening Visit Checklist (Download) 2018-08-1054.98 KB
02: Enrollment Visit Checklist (Download) 2018-08-1056.8 KB
03: Monthly Visit Checklist (Download) 2018-08-1064.36 KB
04: Visit 23/PUEV Checklist/Early Termination Checklist (Download) 2018-08-1053.93 KB
05: Visits 3, 10, 17, and 24 - SEV/Phone Contact Checklist (Download) 2018-08-1039.21 KB
06: Pelvic Exam Checklist (Download) 2018-08-1042 KB