MTN-039 Study Implementation Materials

Description	Date	Size

Behavioral Assessments

Baseline CASI (Download)	2019-08-26	492.11 KB
Follow-Up Visit 4 CASI (Download)	2019-08-19	128.6 KB
Follow-Up Visit 8 CASI (Download)	2019-08-26	212.66 KB
IDI Exit Interview (Download)	2019-08-26	255.73 KB

Clinical/Safety Management

Baseline Medical History Guide (Download)	2019-09-04	29.86 KB
Protocol Safety Review Team Query Form (Download)	2019-09-30	37.16 KB

Counseling Tools

HIV/STI Counseling Worksheet (Download)	2019-08-02	210.2 KB
Protocol Counseling Worksheet (Download)	2020-04-23	35.29 KB

Informed Consent Support Materials

Informed Consent Comprehension Assessment (open ended) (Download)	2019-08-02	29.46 KB
Informed Consent Comprehension Assessment (T/F) (Download)	2019-08-02	32.47 KB
Informed Consent Coversheet (Download)	2019-08-02	26.49 KB

Other Tools/Templates

AVERY L7656 labels or equivalent (for A4 paper) (Download)	2019-10-10	281.5 KB
Draft CRFs (Download)	2019-08-08	514.32 KB
Eligibility Checklist (Download)	2019-10-01	41.26 KB
Enrollment Behavioral Eligibility Worksheet (Download)	2019-10-01	31.47 KB
LDMS Specimen Tracking Sheet - Blood Samples (Download)	2019-12-17	171.72 KB
LDMS Specimen Tracking Sheet - Cervicovaginal Fluid (Download)	2020-08-24	226.57 KB
LDMS Specimen Tracking Sheet - Rectal Biopsies (Download)	2019-12-17	255.57 KB
LDMS Specimen Tracking Sheet - Rectal Fluid (Download)	2020-08-24	220.29 KB
Rectal Insert Guide (Download)	2019-08-02	116.62 KB
Saline Enema for Home Use Instructions (Download)	2019-06-05	109.28 KB
Screening and Enrollment Log (Download)	2019-10-01	28.62 KB
Screening Behavioral Eligibility Worksheet (Download)	2019-10-01	32.31 KB
Small Slide Labels or equivalent (for 8.5”x11” paper) (Download)	2019-10-10	369.5 KB
Specimen Label Template Implementation Requirements, Installation, and Use (Download)	2019-10-10	468.17 KB
Visit Calendar Tool (Download)	2019-11-04	23.62 KB

Regulatory/FD Documents

Financial Disclosure Form (Download)	2019-08-02	54.5 KB
Financial Disclosure Form for Protocol Chair (Download)	2019-08-02	54.9 KB

SOP Templates

Source Documentation SOP Template (Download)

2019-10-03

50.64 KB

Visit Checklists

24-hour Post-Dosing Visit (Visits 4 and 8) (Download)	2019-10-01	38.62 KB
48-hour Post-Dosing Visit (Visits 5 and 9) (Download)	2019-10-01	37.77 KB
72-hour Post-Dosing Visit (Visits 6 and 10) (Download)	2019-10-01	42.13 KB
Dosing Visit (Visits 3 and 7) Checklist (Download)	2020-08-17	40.41 KB
Enrollment Visit Checklist (Download)	2019-10-01	43.16 KB
Final Contact (Visit 11)/Early Termination Checklist (Download)	2019-10-01	35.93 KB
Genital Exam Checklist (Group 1) (Download)	2020-08-17	36.29 KB
Genital Exam Checklist (Group 2) (Download)	2020-08-17	35.64 KB
Interim Visit Checklist (Download)	2020-08-17	33.8 KB
Screening Visit Checklist (Download)	2019-10-01	42.46 KB

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