Microbicide Trials Network

MTN-025 Study Implementation Materials

DescriptionDateSize
ACASI/CRFs/Data Collection
MTN-025 ACASI Questionnaire (English)2016-Apr-2692.53 KB
MTN-025 Draft Case Report Forms for IRB submissions2016-Jun-211.87 MB
SCHARP Data Request Form2016-Sep-16100.21 KB
Counseling Tools/Worksheets
Choice, Adherence, and Open Reporting Messages Reference Sheet 2016-Aug-11369.28 KB
Contraceptive Worksheet2016-Jun-3049 KB
Counseling Messages following Rapid HIV Test Results2016-Jul-25381.2 KB
Counseling Q&A2017-Mar-2241.8 KB
Hair Collection Counseling Images2017-Jan-31622.49 KB
Hair Collection Counseling Messages2017-Jan-3150.9 KB
HIV Counseling Worksheet2016-Jul-0158 KB
HIV Prevention Options Counseling Demonstration Videos, v2.02017-Mar-0227.11 KB
HIV Prevention Options Counseling Flipchart2017-Jan-315.32 MB
HIV Prevention Options Counseling Manual v2.02017-Feb-15463.75 KB
HIV Prevention Options Counseling Worksheet2016-Jul-1858 KB
Pregnancy Case Worksheet2017-Feb-0230.23 KB
Residual Drug Feedback Over Time, v1.12017-Jan-26276.94 KB
Residual Drug Feedback Timeline v1.12017-Jan-26364.75 KB
Ring Use Instructions/Important Information2016-Jan-19396.12 KB
Sample Pregnancy Management Worksheet2016-Jul-0687 KB
Eligibility Tools
Decliner Behavioral Eligibility Worksheet - ENGLISH2016-Apr-13353.49 KB
Eligibility Checklist, HOPE2016-Jun-2779.13 KB
Eligibility Checklist, HOPE Decliner Population2016-Jun-2744.73 KB
Enrollment Behavioral Eligibility Worksheet - ENGLISH2016-Apr-13360.12 KB
Screening and Enrollment Log, HOPE2016-Jun-1328.41 KB
Screening and Enrollment Log, HOPE Decliner Population2016-Jun-0731.23 KB
Screening Behavioral Eligibility Worksheet - ENGLISH2016-Apr-13364.89 KB
HOPE Study Exit Materials
HOPE End of Study Messages Slides2017-Jul-265.3 MB
HOPE Internal QA for Sites2017-Jul-21315 KB
HOPE Operational Guidance #32017-Jul-26358.12 KB
HOPE Sample Study Exit Materials2017-Jul-2631.51 KB
MTN-025 PUEVSEV Training2017-Jul-261.36 MB
MTN025_PUEVTerm_Checklist_v1.1 (Tracked) Sample Study Exit Materials2017-Jul-2649.34 KB
IC Support/Factsheets/Education
Adherence & HIV Protection in HOPE2016-Aug-29293 KB
Anal Sex Factsheet2016-Mar-24340.01 KB
Choice in HOPE2016-Aug-25420.19 KB
Choice, Adherence and Open Reporting in HOPE2016-Oct-14708.71 KB
Circumcision Factsheet2011-Nov-14290.25 KB
HIV Prevention Methods Factsheet2016-Mar-29671.98 KB
HIV Resistance Factsheet2016-Jan-19432.01 KB
HOPE General Factsheet2016-Apr-19344.97 KB
HOPE Overview2016-Nov-032.11 MB
Information about Anal Sex2016-Nov-031.59 MB
Information about HIV Prevention Options2016-Nov-031.9 MB
Male Circumcision & HIV Prevention2016-Nov-031.09 MB
MTN-025 DECLINER IC Comprehension Assessment, English2016-Apr-25203.08 KB
MTN-025 IC Comprehension Assessment, English2016-Apr-25175.18 KB
Open Reporting & HOPE2016-Aug-29282.3 KB
Resistance Facts2016-Nov-031.56 MB
Ring FAQ Factsheet2016-Jan-19289.38 KB
Ring Frequently Asked Questions2016-Nov-032.02 MB
Sample Informed Consent Coversheet2016-Jun-0476 KB
Other Tools/Templates
Hair Collection2016-Jun-284.58 MB
IC/EC Reviewed Note2016-Aug-2681.5 KB
MTN Laboratory Center HIV Testing Notification & Query Form2016-Apr-1326.82 KB
Off Site Visit Log2016-Aug-1624.05 KB
Participant Tracking Database2016-Aug-085.38 MB
Participant Tracking Database User Manual2016-Jul-20321.67 KB
Participant-Specific Study Product Accountability Log2016-Sep-1427.18 KB
Record Receipt of Participant Specific Study Product2016-Jun-2826.44 KB
Self-collected Vaginal Swab Instructions (8 Steps)2016-Jun-211.4 MB
Serial In-depth Interview (SIDI) 2 Topic Guide2016-Jul-1330.06 KB
Serial In-depth Interview (SIDI) 2 Topic Guide (with Tracked Changes)2016-Jul-1336 KB
Specimen Label Macros (Avery) v2.02016-Aug-15284.5 KB
Transfer Inventory Log2017-Mar-0333.97 KB
Used Ring Destruction Log2016-Jun-2464 KB
Vaginal Self-Collected Vaginal Swab2016-Jun-232.48 MB
Visit Scheduling Tool (Includes Last Day to Enroll Tool, Follow-up Calendar Tool, and Study Exit Visit Scheduling Tool)2016-Sep-1630.7 KB
Regulatory/FD Documents
Financial Disclosure Form2016-May-0324.39 KB
Financial Disclosure Form for MRC and Zimbabwe Sites2016-May-0326.38 KB
Financial Disclosure Form for Protocol Chair2016-May-0324.51 KB
Financial Disclosure Form Training Slides2016-Apr-29495.58 KB
Template DoA Log2016-Jun-2696.5 KB
Safety/Clinical/Product Use Management
AE Text Guidance2016-Aug-10168.2 KB
Baseline Medical History Questionnaire2016-Jun-2336.8 KB
CONRAD: Colposcopy Manual2016-Oct-311.62 MB
CONRAD: Reference Poster for Colposcopy 2016-Oct-31459.2 KB
DAIDS Toxicity Table Version 2.02014-Nov-30323.54 KB
Emergency Phone Contact Form2016-Jun-2343.5 KB
Female Genital Grading Table2007-Nov-30130.87 KB
Genital Finding Terms2016-Jul-14477.05 KB
HOPE Safety Lab Results Calculator2016-Sep-0226.46 KB
Product Use Management Flow Sheets2016-Jun-23278.5 KB
Protocol Safety Review Team Query Form2016-Jul-1424.89 KB
SOP Templates
Accrual SOP Template2016-Jun-1588 KB
Data Management SOP2016-Oct-28232.5 KB
Eligibility SOP Template2016-Jun-27119 KB
PrEP SOP Template2016-Jul-0594.5 KB
Source Documentation Template2016-Oct-28104.11 KB
Study Visit Checklists
Decliner Visit Checklist2016-Jun-2735.37 KB
Enrollment Visit Checklist2016-Jun-2738.15 KB
General Interim Visit Checklist2016-Aug-2534.72 KB
Month 1 or 2 or Quarterly Visit Checklist2016-Sep-2038.61 KB
Pelvic Exam Checklist2016-Jun-2730.86 KB
PUEV, Early Termination, and Termination Visit Procedure2017-Jul-2646.78 KB
Ring Pick-Up Visit Checklist2016-Nov-3031.45 KB
Screening Visit Checklist2016-Jun-2735.11 KB
Seroconverter Visit Procedure2016-Aug-2542.43 KB
Transfer Checklist - RECEIVING SITE2017-Mar-0340 KB
Transfer Checklist - TRANSFERING SITE2017-Mar-0338.7 KB
Translated Documents – CHICHEWA
Adherence and HIV Protection in HOPE- CHICHEWA2016-Nov-16273.53 KB
Anal Sex Factsheet - CHICHEWA (Blantyre)2016-May-06339.05 KB
Anal Sex Factsheet - CHICHEWA (Lilongwe)2016-May-05338.23 KB
Choice in HOPE Study - CHICHEWA2016-Nov-16333.36 KB
Circumcision Factsheet – CHICHEWA (Blantyre)2012-Jan-26283.16 KB
Circumcision Factsheet – CHICHEWA (Lilongwe)2016-Apr-06354.2 KB
DECLINER IC Comprehension Assessment, Chichewa2016-Apr-29196.94 KB
Decliner Population Behavioral Eligibility Worksheet - CHICHEWA2016-Apr-13355.59 KB
Enrollment Behavioral Eligibility Worksheet - CHICHEWA2016-Apr-13413.75 KB
HIV Prevention Options Counseling Flipchart (Chichewa, Blantyre)2017-Jan-315.71 MB
HIV Prevention Options Counseling Flipchart (Chichewa, Lilongwe)2017-Jan-315.7 MB
HOPE General Factsheet - CHICHEWA (Blantyre)2016-May-06269.57 KB
HOPE General Factsheet - CHICHEWA (Lilongwe)2016-May-05340.69 KB
HOPE Open Reporting Factsheet (CHICHEWA)2016-Nov-16288.92 KB
IC Comprehension Assessment, Chichewa2016-Apr-29168.15 KB
MTN-025 ACASI Questionnaire (CHICHEWA)2016-Apr-26138.73 KB
Prevention Methods Factsheet - CHICHEWA (Blantyre)2016-May-06644.26 KB
Prevention Methods Factsheet - CHICHEWA (Lilongwe)2016-May-06644.44 KB
Resistance Factsheet - CHICHEWA (Blantyre)2016-May-06351.52 KB
Resistance Factsheet - CHICHEWA (Lilongwe)2016-May-03351.71 KB
Ring FAQ - CHICHEWA (Blantyre)2016-May-03291.71 KB
Ring FAQ - CHICHEWA (Lilongwe)2016-May-05279.42 KB
Screening Behavioral Eligibility Worksheet - CHICHEWA2016-Apr-13416.79 KB
Translated Documents – LUGANDA
Adherence HIV Protection in HOPE (Luganda)2016-Nov-17301.64 KB
Anal Sex Factsheet, English (Uganda)2016-Mar-24343.01 KB
Anal Sex Factsheet, Luganda (Uganda)2016-Apr-12345.66 KB
Choice in HOPE Study (Luganda)2016-Nov-17335.02 KB
Choice, Adherance and Open Reporting Multipage Booklet (Luganda)2016-Nov-17559.04 KB
Circumcision Factsheet, English (Uganda)2016-Apr-28293.93 KB
Circumcision Factsheet, Luganda (Uganda)2016-Apr-28313.33 KB
Decliner IC Comprehension Checklist, Lugunda (Uganda)2016-Apr-25207.07 KB
HIV Prevention Options Counseling Flipchart (Luganda)2017-Jan-315.65 MB
HOPE Anal Sex Powerpoint, Luganda2017-Apr-104.96 MB
HOPE Circumcision Powerpoint, Luganda2017-Apr-102.74 MB
HOPE General Factsheet, English (Uganda)2016-Apr-19346.93 KB
HOPE General Factsheet, Luganda (Uganda)2016-May-03328.77 KB
HOPE Open Reporting (Luganda)2016-Nov-17293.29 KB
HOPE Overview Powerpoint, Luganda2017-Apr-106.37 MB
HOPE Prevention Methods Powerpoint, Luganda2017-Apr-103.52 MB
HOPE Resistance Powerpoint, Luganda2017-Apr-103.48 MB
HOPE Ring FAQ, Powerpoint, Luganda2017-Apr-106.23 MB
IC Comprehension Checklist, Lugunda (Uganda)2016-Apr-25178.65 KB
MTN-025 ACASI Questionnaire (LUGANDA)2016-Apr-26142.3 KB
Prevention Methods Factsheet, English (Uganda)2016-Mar-29674.84 KB
Prevention Methods Factsheet, Lugunda (Uganda)2016-May-04556.09 KB
Resistance Factsheet, English (Uganda)2016-Jan-19434.25 KB
Resistance Factsheet, Luganda (Uganda)2016-Apr-13435.06 KB
Ring Factsheet, English (Uganda)2016-Jan-19291.92 KB
Ring Factsheet, Luganda (Uganda)2016-Apr-13292.99 KB
Ring Use/Important Information, Lugunda (Uganda)2016-Apr-27394.26 KB
Translated Documents – SHONA
Adherence HIV Protection in HOPE (Shona)2016-Nov-18296.53 KB
Anal Sex Factsheet, Shona2016-Apr-26297.07 KB
Choice in HOPE (Shona)2016-Aug-25441.92 KB
Choice, Adherance and Open Reporting Multipage Booklet (Shona)2016-Nov-18617.18 KB
Circumcision Factsheet – SHONA2016-Apr-05365.43 KB
Decliner Population Behavioral Eligibility Worksheet2016-May-06353.14 KB
DECLINER Population Screening and Enrollment Informed Consent, Shona2016-May-19204.65 KB
Enrollment Behavioral Eligibility Worksheet2016-May-06436.23 KB
Enrollment Informed Consent Comprehension Assessment, Shona2016-May-19176.58 KB
HIV Prevention Methods Factsheet, Shona2016-May-18641.37 KB
HIV Prevention Options Counseling Flipchart (Shona)2017-Jan-315.54 MB
HOPE Anal Sex Powerpoint, Shona2017-Apr-105.13 MB
HOPE Circumcision Powerpoint, Shona2017-Apr-102.72 MB
HOPE General Factsheet, Shona2016-May-13333.33 KB
HOPE Overview Powerpoint, Shona2017-Apr-107.15 MB
HOPE Prevention Methods, Shona2017-Apr-107.22 MB
HOPE Resistance Factsheet Powerpoint, Shona2017-Apr-103.41 MB
HOPE Ring FAQ Powerpoint, Shona2017-Apr-105.61 MB
MTN-025 ACASI Questionnaire (SHONA)2016-Apr-26185.18 KB
Open Reporting HOPE (Shona)2016-Nov-18360.68 KB
Resistance Factsheet, Shona2016-Apr-26551.92 KB
Ring FAQ Fact Sheet, Shona2016-Apr-26283.38 KB
Ring Use Instructions, Shona2016-Apr-27378.29 KB
Screening Behavioral Eligibility Worksheet2016-May-06440.51 KB
Translated Documents – XHOSA
Adherence & HIV Protection in HOPE (Xhosa)2016-Nov-18329.21 KB
Anal Sex (Cape Town)2016-May-10300.31 KB
Choice in HOPE Study (Xhosa)2016-Nov-18323.79 KB
Choice, Adherance and Open Reporting Multipage Booklet (Xhosa)2016-Nov-21613.93 KB
Circumcision Factsheet, XHOSA (Cape Town)2012-Mar-12283.46 KB
Decliner Population Behavioral Eligibility Worksheet2016-Jul-25352.99 KB
DECLINER Population Screening and Enrollment Informed Consent2016-Apr-25203.84 KB
Enrollment Behavioral Eligibility Worksheet2016-Jul-25359.42 KB
Enrollment Informed Consent Comprehension Assessment2016-Apr-25175.79 KB
General Factsheet (Xhosa)2016-Aug-11344.46 KB
HIV Prevention Options Counseling Flipchart (Xhosa)2017-Apr-191.39 MB
HOPE Anal Sex Powerpoint, Xhosa2017-Apr-106.39 MB
HOPE Circumcision Powerpoint, Xhosa2017-Apr-102.3 MB
HOPE Overview Powerpoint, Xhosa2017-Apr-102.16 MB
HOPE Prevention Methods Poweproint, Xhosa2017-Apr-105.97 MB
HOPE Resistance Factsheet Powerpoint, Xhosa2017-Apr-103.16 MB
HOPE Ring FAQ Powerpoint, Xhosa2017-Apr-105.66 MB
Open Reporting & HOPE (Xhosa)2016-Nov-18282.9 KB
Prevention Methods Fact Sheet2016-Jun-15675.34 KB
Resistance Factsheet2016-May-10419.99 KB
Ring FAQ (Xhosa)2016-Aug-11282.94 KB
Ring Use Instructions and Counseling2016-Jul-25407.66 KB
Screening Behavioral Eligibility Worksheet2016-Jul-25363.39 KB
Translated Documents – ZULU
Adherence and HIV Protection in HOPE (Zulu)2016-Nov-03299.31 KB
Anal Sex Factsheet - Zulu2016-May-24339.94 KB
Choice in HOPE Study (Zulu)2016-Nov-03332.98 KB
Choice, Adherance and Open Reporting Multipage Booklet (Zulu)2016-Nov-03584.89 KB
Circumcision Factsheet – ZULU (MRC/eTh)2012-Jan-27280.02 KB
Circumcision Factsheet – ZULU (WRHI)2012-Apr-10305.17 KB
Decliner Behavioral Eligibility Worksheet - ZULU2016-Apr-13355.43 KB
Enrollment Behavioral Eligibility Worksheet - ZULU2016-Apr-13362.13 KB
HIV Prevention Methods Factsheet - Zulu2016-May-24653.22 KB
HIV Prevention Options Counseling Flipchart, V2.0 (Zulu, MRC)2017-Jan-311.98 MB
HIV Resistance Factsheet - Zulu2016-May-24433.65 KB
HOPE Anal Sex Powerpoint, Zulu (eThekweni)2017-Apr-101.76 MB
HOPE Anal Sex Powerpoint, Zulu (MRC)2017-Apr-101.69 MB
HOPE Anal Sex Powerpoint, Zulu (WRHI)2017-Apr-101.71 MB
HOPE Circumcision Powerpoint, Zulu (WRHI)2017-Apr-101.15 MB
HOPE Circumcision Powerpoint, Zulu (eThekweni)2017-Apr-101.15 MB
HOPE Circumcision Powerpoint, Zulu (MRC)2017-Apr-101.15 MB
HOPE Overview Factsheet – ZULU2016-Jun-08336.8 KB
HOPE Overview Powerpoint, Zulu (eThekweni)2017-Apr-106.34 MB
HOPE Overview Powerpoint, Zulu (MRC)2017-Apr-103.02 MB
HOPE Overview Powerpoint, Zulu (WRHI)2017-Apr-106.34 MB
HOPE Prevention Methods Powerpoint, Zulu (eThekweni)2017-Apr-101.67 MB
HOPE Prevention Methods Powerpoint, Zulu (MRC)2017-Apr-102.43 MB
HOPE Prevention Methods Powerpoint, Zulu (WHRI)2017-Apr-102.45 MB
HOPE Resistance Factsheet Powerpoint, Zulu (eThekweni)2017-Apr-101.47 MB
HOPE Resistance Factsheet Powerpoint, Zulu (MRC)2017-Apr-101.94 MB
HOPE Resistance Factsheet Powerpoint, Zulu (WHRI)2017-Apr-101.45 MB
HOPE Ring FAQ Powerpoint, Zulu (eThekweni)2017-Apr-103.9 MB
HOPE Ring FAQ Powerpoint, Zulu (MRC)2017-Apr-103.9 MB
HOPE Ring FAQ Powerpoint, Zulu (WRHI)2017-Apr-103.9 MB
MTN-025 ACASI Questionnaire (ZULU)2016-Apr-26131.74 KB
MTN-025 DECLINER IC Comprehension Assessment, ZULU2016-Apr-25204.1 KB
MTN-025 IC Comprehension Assessment, ZULU2016-Apr-25176.24 KB
Open Reporting and HOPE (Zulu)2016-Nov-03283.26 KB
Power point: HIV Prevention Methods2017-Apr-101.67 MB
Power point: HOPE Overview2017-Apr-106.34 MB
Power point: Information about Anal Sex2017-Apr-101.76 MB
Power point: Information about Circumcision2017-Apr-101.15 MB
Power point: Information about HIV Resistance2017-Apr-101.47 MB
Power point: Ring FAQ2017-Apr-103.9 MB
Ring FAQ Factsheet - Zulu2016-May-24283.6 KB
Ring Use Instructions/Important Information (ZULU)2016-Apr-27386.05 KB
Screening Behavioral Eligibility Worksheet - ZULU2016-Apr-13366.63 KB