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Operational Guidance
Operational Guidance #1: Individual Drug Level Results Visual Tool (Download) 2016-05-2084.76 KB
Operational Guidance #2: Recruitment Lists and Prioritization of Accrual Targets (Download) 2016-05-2645.87 KB
Operational Guidance #3: Debriefing Reports and Drug Detection Level for IDI Participants Pre-Selected for an FGD (Download) 2016-06-1586.04 KB
Operational Guidance #4: Male Partner Considerations, Phase 2 Accrual Reporting, and Recording Uploads (Download) 2018-04-04199.37 KB
i. Phase 2 Case Report Forms
Behavior Assessment (BA) Phase 2 (Download) 2017-10-0559.95 KB
Demographic Information Form (DEM) Phase 2 (Download) 2018-01-1161.06 KB
Participant Status Form (PSF) P2 (Download) 2018-01-1152.13 KB
Protocol Deviation Report V2.0 (Download) 2017-12-21102 KB
Social Harms Report V2.0 (Download) 2017-12-2199.5 KB
i. Phase 2 IC Support
Phase 2 Enrollment Informed Consent Comprehension Checklist - Female Participants (Download) 2017-10-1729.71 KB
Phase 2 Enrollment Informed Consent Comprehension Checklist - Male Partner (Download) 2017-10-1732.54 KB
Phase 2 Sample Informed Consent Coversheet (Download) 2017-10-1829.25 KB
i. Phase 2 Interview Guides and Checklists
Phase 2 Female In-depth Interview (IDI) Topic Guide (Download) 2017-10-1251.94 KB
Phase 2 FGD Group Checklist V1.1 (Download) 2018-01-3031.57 KB
Phase 2 FGD MP Individual Checklist V1.0 (Download) 2017-12-2132.42 KB
Phase 2 IDI Visit Checklist V1.1 (Download) 2018-01-3036.9 KB
Phase 2 Male Partner Focus Group Discussion (FGD) Topic Guide (Download) 2017-10-1233.59 KB
Phase 2 Male Partner In-Depth Interview (IDI) Topic Guide (Download) 2017-10-1233.72 KB
Phase 2 Screening & Recruitment Checklist V1.2 (Download) 2018-02-2039.98 KB
i. Phase 2 Other Materials
Phase 2 Opinion Tool – Female Participants (Download) 2018-02-0717.29 KB
Phase 2 Opinion Tool – Male Partner’s (Download) 2018-02-0717.15 KB
Phase 2 RD Feedback Over Time Supplement V1.0 (Download) 2017-12-21176.63 KB
Phase 2 Sample S&E Log: Female V1.0 (Download) 2017-10-1029 KB
Phase 2 Sample S&E Log: Male V1.0 (Download) 2017-10-1025.94 KB
i. Phase 2 SOP Templates
Participant Accrual and Eligibility Determination V1.0 (Download) 2017-12-2141.27 KB
Participant Confidentiality V2.0 (Download) 2017-12-2134.55 KB
Phase 2 Data Management Template SOP (Download) 2018-01-30143.5 KB
ii. Phase 1 Case Report Forms
Behavior Assessment (BA) (Download) 2016-02-0157.39 KB
Demographic Information Form (DEM) (Download) 2016-02-0145.57 KB
Participant Status Form Phase 1 (Download) 2016-08-05113.79 KB
ii. Phase 1 IC Support
Enrollment Informed Consent Comprehension Checklist (Download) 2015-09-2528.8 KB
Informed Consent Coversheet (Download) 2016-01-1228.75 KB
ii. Phase 1 Interview Guides and Checklists
FGD Group Visit Checklist (Download) 2016-03-2826.51 KB
FGD Individual Participant Visit Checklist (Download) 2016-03-2828.82 KB
Focus Group Discussion (FGD) Topic Guide (Download) 2016-02-28126 KB
IDI Visit Checklist (Download) 2016-03-2829.89 KB
In-depth Interview (IDI) Topic Guide (Download) 2016-02-28134.5 KB
Screening/Recruitment Checklist (Download) 2016-01-1238.68 KB
ii. Phase 1 Other Materials
Adherence Trajectory Tool (Download) 2016-02-1953.13 KB
Adherence Trajectory Tool (Breakout) (Download) 2016-03-0351.52 KB
FGD Debriefing Report (Download) 2016-03-3122.46 KB
IDI Debriefing Report (Download) 2016-03-3122.63 KB
Individual Drug Level Results Visual Tool (Download) 2016-03-31538.88 KB
Individual FGD Debriefing Report (Download) 2016-06-0820.84 KB
Male Circumcision and HIV Prevention (Download) 2011-11-14280.21 KB
Sample Screening and Enrollment Log (Download) 2016-02-1724.21 KB
Screening and Accrual Tracker (Download) 2016-07-0724.24 KB
ii. Phase 1 SOP Templates
Data Management SOP Template (Download) 2016-04-01120 KB
Participant Accrual and Eligibility Determination (Download) 2016-02-1739.47 KB
ii. Phase 1 Training
Study Specific Training Video (Download) 2016-03-2250.29 MB
Study-Specific Training (Download) 2016-03-221.8 MB