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Ages and Stages Questionnaires
ASQ 2 Month (Download) 2019-11-04329.74 KB
ASQ 3 - Activities for Infants 1-16 months (Download) 2019-11-22125.4 KB
ASQ 3 - Overall Questions (Download) 2019-11-2260.94 KB
ASQ 4 Month (Download) 2019-11-04336.19 KB
ASQ 6 Month (Download) 2019-11-04389.36 KB
ASQ 8 Month (Download) 2019-11-04404.68 KB
ASQ 9 Month (Download) 2019-11-04352.69 KB
ASQ 10 Month (Download) 2019-11-04393.98 KB
ASQ 12 Month (Download) 2019-11-04373.71 KB
Eligibility Tools
Eligibility Checklist (Download) 2019-12-1947.56 KB
Enrollment Behavioral Eligibility Worksheet (Download) 2021-08-2735.08 KB
Screening and Enrollment Log (Download) 2020-04-0737.62 KB
Screening Behavioral Eligibility Worksheet (Download) 2021-08-2735.78 KB
Growth Charts
Boys Head Circumference for Age Birth to 2 years (Download) 2019-10-3022.36 KB
Boys Length for Age Birth to 2 Years (Download) 2019-10-30715.33 KB
Boys Weight for Age Birth to 2 Years (Download) 2019-10-30721.08 KB
Girls Head Circumference for Age Birth to 2 years (Download) 2019-10-3022.76 KB
Girls Length for Age Birth to 2 Years (Download) 2019-10-30714.64 KB
Girls Weight for Age Birth to 2 Years (Download) 2019-10-30717.43 KB
International Newborn Size Reference Charts for Very Preterm Infants (Boys) (Download) 2019-10-304.07 MB
International Newborn Size Reference Charts for Very Preterm Infants (Girls) (Download) 2019-10-304.06 MB
International Newborn Size Standards (Boys) (Download) 2019-10-304.06 MB
International Newborn Size Standards (Girls) (Download) 2019-10-304.05 MB
International Postnatal Growth Standards for Preterm Infants (Boys) (Download) 2019-10-303.68 MB
International Postnatal Growth Standards for Preterm Infants (Girls) (Download) 2019-10-303.68 MB
Informed Consent Support Materials
Sample Informed Consent (IC) Coversheet (Download) 2019-09-3035.09 KB
Sample Informed Consent Comprehension Assessment (ICCA) - Infants (Download) 2021-08-2739.5 KB
Sample Informed Consent Comprehension Assessment (ICCA) - Mothers (Download) 2021-08-2741.86 KB
Lab/Sample Collection
AVERY L7656 labels or equivalent (for A4 paper) (Download) 2019-11-19220.5 KB
MTN Laboratory Center HIV Testing Notification & Query Form (Download) 2016-04-1326.82 KB
Procedure Guide for HIV Confirmation and Seroconversion (Download) 2019-11-04936.77 KB
Self-Collected Vaginal Swab Instructions (Download) 2019-06-21327.65 KB
Small Slide Labels or equivalent (for 8.5”x11” paper) (Download) 2019-11-19329 KB
Specimen Label Template Implementation Requirements, Installation, and Use (Download) 2019-11-19468.17 KB
Swab Collection Order Guide (Download) 2020-09-17338.36 KB
Visit LDMS Specimen Tracking Sheet (Download) 2021-01-1873.72 KB
Other Tools/Templates
Visit Calendar Tool - Cohort 1 (Download) 2019-12-1845 KB
Visit Calendar Tool - Cohort 2 – V1.1 (Download) 2021-08-1968.57 KB
Visit Calendar Tool - Cohort 2 – V2.0 (Download) 2021-09-0368.25 KB
Qualitative Component
IDI Debrief Report Template (Download) 2021-07-1543.67 KB
In-Depth Interview Guide (Download) 2021-04-14228.14 KB
Qualitative Component Readiness Checklist (Download) 2019-08-2332.87 KB
Qualitative Interview (IDI) Checklist (Download) 2021-06-0232.55 KB
Qualitative Participation Log (Download) 2021-07-0725.92 KB
Qualitative Standard Operating Procedure (SOP) (Download) 2019-10-1536.38 KB
Regulatory/FD Documents
Financial Disclosure Form (Download) 2019-08-0255.12 KB
Financial Disclosure Form for Protocol Chair (Download) 2019-08-0255.15 KB
Meeting Report: Stakeholders Consultation on MTN-042 (Download) 2018-10-012.73 MB
SOP Templates
Data Management SOP (Download) 2019-11-13220.5 KB
MTN-042/MTN-043 Clinic Study Product Accountability and Destruction (non-pharmacy) (Download) 2019-10-2447.74 KB
Source Document SOP (Download) 2021-05-0563.67 KB
Safety/Clinical/Product Use Management
AE Text Guidance (Download) 2020-06-231.24 MB
Baseline Medical History Questions Guide (Download) 2019-10-18246.87 KB
Clinical Flow Sheets (Download) 2019-12-18476.03 KB
Gestational Age (GA) Dating Tool (Download) 2021-05-1441.95 KB
Infant Medical/Anthropometry/Feeding History Guide (Download) 2020-04-08205.07 KB
Infant Photo Guide (Download) 2020-02-06606.3 KB
MTN-042 Ultrasound Request Form (Download) 2020-03-3039.91 KB
MTN-042/043 PSRT Query Form (Download) 2021-04-2746.83 KB
Sample Visit Checklists
2 Week/4 Week Visit Checklist – COHORT 2 (Visits 4.0 & 6.0) (Download) 2021-05-0555 KB
6-Week PPO Visit/Mother SEV Checklist – COHORT 2 (Visit 103/203) (Download) 2021-05-0549.44 KB
Bi-weekly Post-36 Weeks Visit Checklist – COHORT 2 (Visits 8.0, 10.0, 12.0) (Download) 2021-05-0551.44 KB
Early Termination MOTHER Checklist – COHORT 2 (Download) 2021-05-0554.26 KB
Enrollment Visit Checklist – COHORT 2 (Download) 2021-05-0557.35 KB
Infant 6 & 12-Month PPO/ Early SEV Visit Checklist – COHORT 2 (Visit 204 & 205) (Download) 2021-05-0543.35 KB
Infant Phone Contact Checklist- 1 Week PPO Visit - Visit 202 - Cohort 2 (Download) 2021-05-0537.85 KB
Mother Phone Contacts Checklist- COHORT 2 Visits 3, 5, 7, 9, 11, 13 & 102 (Download) 2021-05-0540.8 KB
Mother Post-Seroconversion Quarterly Visit Checklist (Download) 2019-10-1753.31 KB
Pelvic Exam Checklist (Download) 2020-09-1741.94 KB
PPO Visit Checklist – COHORT 2 (Visit 101/201) (Download) 2021-05-0554.59 KB
Screening Visit Checklist (Mothers)– COHORT 2 (Download) 2021-05-0552.86 KB
Study Education/Prescreening Tools
MTN-042 and MTN-043 Study Education Slides (Download) 2021-08-279.97 MB
MTN-042 Male Partner Factsheet (Download) 2021-07-29828.63 KB
MTN-042 Study Overview Factsheet (Download) 2021-08-27429.38 KB
MTN-042 Study Product Factsheet (Download) 2021-08-271.07 MB
MTN-042/MTN-043 Study Enrollment Decision Tool Instructions (Download) 2019-10-30191.8 KB
MTN-042/MTN-043 Study Enrollment Decision Tool Worksheet (Download) 2019-10-30134.02 KB
Pros and Cons Exercise Demonstration Video (Download) 2019-10-3119.11 KB
Provider Guide Template (Download) 2021-08-27989.08 KB
Ring Removal Card (Download) 2021-06-17517.06 KB
Study Exit
Sample Infant Study Exit Worksheet (Download) 2020-04-0830.87 KB
Sample Maternal Study Exit Worksheet (Download) 2020-04-0832.92 KB
Sample Permission to Contact Log (Download) 2020-04-0826.23 KB
Study Product Logs
MTN-042/043 Off-Site Visit Log (Download) 2019-10-23166.29 KB
MTN-042/MTN-043 Clinic Vaginal Ring Destruction Log (Download) 2019-10-23167.64 KB
MTN-042/MTN-043 Participant-Specific Clinic Study Product Accountability Log (Download) 2019-10-23209.47 KB
Study Product/Counseling Materials
Contraceptive Counseling Worksheet (Download) 2019-10-1853 KB
HIV Pre/Post Test & STI Risk Reduction Counseling Worksheet (Download) 2019-10-1859.5 KB
MTN-042 and MTN-043 Counseling Manual (Download) 2021-07-20420.05 KB
MTN-042 and MTN-043 Pill Counseling Flip Chart (Download) 2019-09-261.8 MB
MTN-042 and MTN-043 Ring Counseling Flip Chart (Download) 2019-09-261.88 MB
Oral Truvada Use Instructions (Download) 2019-06-12779.57 KB
Protocol Counseling Guide (Download) 2020-04-01172.44 KB
Sample Product Use Adherence Counseling Worksheet (Download) 2019-10-0758 KB
Vaginal Ring Insertion Instructions (Download) 2019-12-18415.75 KB