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Additional Guidance
ACASI Communiqué #1 – Initial release of Version 2.0 of ACASI Tablet Software (Download) 2019-01-14118.99 KB
ACASI Communiqué #2 – RELEASE OF VERSION 2.0a of Software (Download) 2019-01-28101.4 KB
ACASI Communiqué #3 – RELEASE OF VERSION 2.0b of Software (Download) 2019-04-10137.89 KB
ACASI Communiqué #4 – RELEASE OF VERSION 3.0 of Software (Download) 2021-02-09100.28 KB
Adherence Counseling Session Manuals
01: Enrollment Visit Session - PrEP (Download) 2019-05-29310.68 KB
02: Enrollment Visit Session - Ring (Download) 2019-05-29294.67 KB
03: Follow-Up Visit Session - PrEP - no drug levels (Download) 2019-05-29211.65 KB
04: Follow-Up Visit Session - Ring - no drug levels (Download) 2019-05-29211.89 KB
05: Follow-Up Visit Session - PrEP - with drug levels (Download) 2019-05-29268.16 KB
06: Follow-Up Visit Session - Ring - with drug levels (Download) 2019-05-29255.64 KB
07: Choice Visit Session – PrEP (Download) 2019-07-03269.08 KB
08: Choice Visit Session – Ring (Download) 2019-07-03253.11 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) 2019-04-2673.57 KB
07: Wireless Drug Level Handout (Download) 2017-10-16110.64 KB
08: Adherence Support Counseling Feedback Form: Enrollment Visit (Download) 2019-04-0233.55 KB
09: Adherence Support Counseling Feedback Form: Follow-Up Visits (Download) 2019-04-0233.41 KB
Behavioral Assessment Tools
ACASI Enrollment (Visit 2) (Download) 2018-07-12222.52 KB
ACASI for Participants using No Product at Visits 20, 23, and Early PUEV/Discontinuation (Download) 2018-07-12224.2 KB
ACASI for Ring and Tablet Users at Visits 9, 16, and 23 (Download) 2018-07-12258.24 KB
ACASI for Ring Users at Visits 6, 13, 20, and Early PUEV/Discontinuation (Download) 2018-07-12232.98 KB
ACASI for Tablet Users at Visits 6, 13, 20, and Early PUEV/Discontinuation (Download) 2018-07-12227.63 KB
ACASI User Manual (Download) 2019-02-053.38 MB
COVID-19 Behavioral Assessment (Download) 2020-05-21284.15 KB
Early FGD Debriefing Report Template (Download) 2019-12-1351.54 KB
FGD Group Visit Checklist (Download) 2021-03-1833.09 KB
FGD Individual Participant Visit Checklist (Download) 2021-03-1829.06 KB
FGD M2 Guide (Download) 2018-07-06161.62 KB
FGD Transcript Template (Download) 2019-12-1327.75 KB
IDI Transcript Template (Download) 2019-12-1328.59 KB
Late FGD Debriefing Report Template (Download) 2021-01-1938.07 KB
Late FGD M18 Guide (Download) 2020-08-131.62 MB
Non-Acceptor IDI Debriefing Report Template (Download) 2019-12-1334.55 KB
Non-Acceptor IDI Guide (Download) 2020-07-15169.41 KB
Qualitative Interview (IDI) Checklist (Download) 2019-03-1540.77 KB
Qualitative Participation Log Template (Download) 2019-03-15277.27 KB
Serial IDI 1 (SIDI1) Debriefing Report Template (Download) 2019-12-1339.28 KB
Serial IDI 1 Guide (Download) 2020-07-15174.67 KB
Serial IDI 2 (SIDI2) Debriefing Report Template (Download) 2019-12-1335.63 KB
Serial IDI 2 Guide (Download) 2020-07-15173.86 KB
Serial IDI 3 (SIDI3) Debriefing Report Template (Download) 2019-12-1334.62 KB
Serial IDI 3 Guide (Download) 2020-07-15174.58 KB
Special Case (CIDI) Debriefing Report Template (Download) 2019-12-1334.85 KB
Special Case IDI Guide (Download) 2020-07-15190.23 KB
Visual Tools (Download) 2018-07-06442.52 KB
CRFs/Data Collection
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) 2019-05-2131.43 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 (PDF) (Download) 2020-03-046.11 MB
Informed Consent Flipchart (PowerPoint) (Download) 2020-03-0418.77 KB
REACH Video (Download) 2018-05-0918.36 KB
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
Operational Guidance
Operational Guidance #02: Laboratory Updates: Microbiota Swab Update (Download) 2020-10-09945.82 KB
Operational Guidance #1: Eligibility Criteria for HIV-Related Screen-outs (Download) 2019-05-21546.42 KB
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) 2019-02-28283.5 KB
Drug Feedback Tool (Download) 2019-07-1122.94 KB
LDMS Specimen Tracking Sheet (Download) 2019-02-22338.07 KB
LDMS Specimen Tracking Sheet (with flow for Zimbabwe) (Download) 2019-02-22343.43 KB
MTN Laboratory Center HIV Testing Notification & Query Form (Download) 2016-04-1328.03 KB
Participant Transfer Checklist for IDI participants: Receiving Site (Download) 2020-04-2730 KB
Participant Transfer Checklist for IDI participants: Transferring Site (Download) 2020-04-2731.63 KB
Residual Drug Feedback Process (Download) 2020-02-04432.88 KB
Risk Mitigation Plan (Download) 2021-06-29936.03 KB
Sample Permission to Contact Log (Download) 2020-06-0328.75 KB
Small Slides Specimen Labels (Download) 2019-02-28365 KB
Specimen Label Template Implementation (Download) 2018-10-02468.17 KB
Study Exit Worksheet (Download) 2020-06-0330.78 KB
Transfer Checklist - Receiving Site (Download) 2020-03-1229.2 KB
Transfer Checklist - Transferring Site (Download) 2020-03-1233.69 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 Data Communique #1: Additional Choice Non-Acceptor IDI (NIDI) and Serial IDI 3 (SIDI3) probes (Download) 2020-05-01182.89 KB
Qualitative Data Communique #3: LFGD Staff Interaction Probes (Download) 2021-02-23181.41 KB
Qualitative Operational Guidance #01: Administration of Late Focus Group Discussions (LFGDs) (Download) 2020-10-02147.37 KB
Regulatory/FD Documents
DoA Log Template (Download) 2018-09-19102.5 KB
Financial Disclosure Form (Download) 2019-03-2555.21 KB
Financial Disclosure Form for Protocol Chair (Download) 2019-03-2554.3 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) 2020-03-0427.35 KB
Qualitative SOP (Download) 2018-08-1572 KB
Source Documentation SOP (Download) 2020-07-2159.18 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) 2019-01-0257.76 KB
03: Monthly Visit Checklist (Download) 2020-07-2466.38 KB
04: Visit 23/PUEV Checklist/Early Termination Checklist (Download) 2019-01-0255.27 KB
05: Visits 3, 10, 17, and 24 - SEV/Phone Contact Checklist (Download) 2019-01-0237.16 KB
06: Pelvic Exam Checklist (Download) 2018-08-1042 KB
07: Pregnant/Breastfeeding Participant Visit Checklist (Download) 2020-08-3146.12 KB
08: Pregnant/Breastfeeding Participant Procedure Guide (Download) 2020-08-3140.4 KB
09: Seroconverter Follow-up Visit Checklist (Download) 2021-05-1447.57 KB
10: HIV Confirmation Seroconversion Procedure Guide (Download) 2020-07-2245.72 KB