DescriptionDateSize
Annual Meeting 2012
01. BAETEN- ASPIRE Start Up (Download) 2012-02-22486.71 KB
02. PALANEE- Retention (Download) 2012-02-22554.95 KB
03. CIANCIOLA- Participant Tracking Database (Download) 2012-02-22321.47 KB
04. SINGH- Contraception (Download) 2012-02-22211.46 KB
05. BUNGE- Genital Bleeding (Download) 2012-02-22193.43 KB
06. LIVANT- Lab (Download) 2012-02-22247.04 KB
07. BAETEN- 020 and 027 (Download) 2012-02-221.04 MB
08. SCHWARTZ- PSRT (Download) 2012-02-22179.94 KB
Annual Meeting 2013
01. BAETEN - ASPIRE Overview (Download) 2013-02-10732.8 KB
02. NEL - The Ring Study (Download) 2013-02-109.4 MB
03. NDASE - Site Practices for Participant Selection (Download) 2013-02-10611.99 KB
04. LUCAS - CWG Update (Download) 2013-02-10100.25 KB
05. GATI - Uganda Staffing Best Practice (Download) 2013-02-1088.43 KB
06. MUREWANHEMA - Zimbabwe Male Involvement Best Practice (Download) 2013-02-1060.4 KB
07. SCHWARTZ - Retention Overview (Download) 2013-02-10407.32 KB
08. REDDY - WRHI Retention Best Practice (Download) 2013-02-101.48 MB
09. CIANCIOLA - SCHARP Update (Download) 2013-02-1047.04 KB
10. FOSTER - Protocol Deviations to Date (Download) 2013-02-10603.18 KB
11. NDASE - Network Evaluation Process for ASPIRE (Download) 2013-02-10207.53 KB
12. MAYO - Intersection Between Accrual and Adherence (Download) 2013-02-10772.95 KB
13. SINGH - PSRT Queries and Product Relatedness (Download) 2013-02-10885.13 KB
14. LIVANT - Lab Reminders (Download) 2013-02-1020.86 KB
15. ANDERSON - MedDRA Refresher (Download) 2013-02-1054.85 KB
16. SINGH - Contraceptive Overview (Download) 2013-02-1068.67 KB
Annual Meeting 2014
01. Agenda (Download) 2014-02-2327.17 KB
02. BAETEN/PALANEE: Implementation Update (Download) 2014-02-23572.48 KB
03. BUNGE/SINGH: Contraceptive Action Team Update (Download) 2014-02-23343.33 KB
04. CHASAKARA: CWG Update (Download) 2014-02-23365.28 KB
05. CLELAND: DAIDS Laboratory Oversight Activities (Download) 2014-02-23604.56 KB
06. PARIKH: Updating the HIV Testing Algorithm (Download) 2014-02-23305.01 KB
07. LIVANT: HIV Testing Key Issues, Lessons Learned (Download) 2014-02-23927.05 KB
08. MONTGOMERY/HARTMANN: Qualitative Update (Download) 2014-02-23358.65 KB
09. NKHALAMBA: Qualitative Component Implementation Experience (Download) 2014-02-231.88 MB
10. DESMOND TUTU HIV FOUNDATION: Preliminary Feedback from Cape Town's Qualitative Team (Download) 2014-02-23264.39 KB
11. NOLAND: Preparing for Regulatory Inspections (Download) 2014-02-231.23 MB
Annual Meeting 2015
01: Agenda (Download) 2015-03-15223.22 KB
02: BAETEN/PALANEE: ASPIRE Implementation Update (Download) 2015-03-152.47 MB
03: NAIDOO: Update on PUEV Process and Participant Response (eThekwini CRS) (Download) 2015-03-15986.42 KB
04: BERTHIAUME: ASPIRE Study Closeout: Data Expectations (Download) 2015-03-15348.84 KB
05: ROSSI: Closeout/Results Communications (Download) 2015-03-15731.54 KB
06: NAKYANZI: June- December 2015: Maintaining Participant Contact and Plans for Results Dissemination(Kampala CRS) (Download) 2015-03-15207.51 KB
07: REDDY: June- December 2015: Maintaining Participant Contact and Plans for Results Dissemination (Wits RHI CRS) (Download) 2015-03-15893.26 KB
08: LIVANT: Laboratory Center Update (Download) 2015-03-15250.19 KB
09: MONTGOMERY: Qualitative Update (Download) 2015-03-151007.17 KB
10: MORAR: ASPIRE CWG Update (Download) 2015-03-15322.26 KB
11: SINGH: Understanding NNRTI Resistance and Linking to Care after ASPIRE (Download) 2015-03-15364.43 KB
12: BAETEN: ASPIRE Publications (Download) 2015-03-15103.77 KB
General ASPIRE
ASPIRE Study Overview (Download) 2012-08-156.56 MB
Regional Meeting 2012
01. BAETEN: ASPIRE activation: Where we are and where we are headed (Download) 2012-10-01589.08 KB
02. NEL: The Ring Study: The road we travelled (Download) 2012-10-013.29 MB
03. SIVA: ASPIRE ACCRUAL AT MRC HPRU (Download) 2012-10-01991.74 KB
04. MABUDE: “The Ring Study”: What have we learned? (Download) 2012-10-01559.05 KB
05. NDASE: Aspiring Toward Efficiency- Streamlining without Sacrifices (Download) 2012-10-01323.93 KB
06. REYNOLDS: The Recruitment Process at Emavundleni Research Centre (Download) 2012-10-01620.88 KB
07. CIANCIOLA: ASPIRE Study Reports - What You Should Know (Download) 2012-10-012.57 MB
08. SCHWARTZ: Activating for Off-site Visits (Download) 2012-10-01235.69 KB
09. BAETEN: Lessons learned from FDA audits (Download) 2012-10-01646.15 KB
10. PALANEE: The Big 5 (Download) 2012-10-01551.02 KB
11. LUTHULI: RETENTION LESSONS LEARNT AND STRATEGIES (Download) 2012-10-01280.59 KB
12. LIVANT: MTN-020 Algorithm (Download) 2012-10-01291.76 KB
13. BUNGE: The Management of HIV-Positive Pregnant Women (Download) 2012-10-01656.59 KB
14. RABE: Monitoring Adherence with Biofilms (Download) 2012-10-013.07 MB
15. RUSHWAYA: Participant Report of Ring Use in ASPIRE - ZIM Site Strategy (Download) 2012-10-01339.18 KB
Regional Meeting 2013
01. PALANEE/BAETEN: Meeting Overview and ASPIRE Implementation Update (Download) 2013-10-28737.04 KB
02. NEL: The Ring Study implementation Update and Lessons Learned so Far (Download) 2013-10-282.05 MB
03. ZULU: Adherence and Community Messaging (Blantyre CRS) (Download) 2013-10-282.27 MB
04. MUSARA: Adherence and Community Messaging (Zimbabwe CTU) (Download) 2013-10-28465.4 KB
05. MASILO: Adherence and Community Messaging (Madibeng Centre for Research- IPM) (Download) 2013-10-281.24 MB
06. MNQONYWA: Promoting Product Adherence at MRC HPRU: Recent Innovations (MRC CTU) (Download) 2013-10-28431.2 KB
07. MAYISELA/DLADLA/DIAS: Promoting Product Adherence: Recent Innovations (eThekwini CRS) (Download) 2013-10-281.44 MB
08. FRIEND: Adherence in the Ring Study (Qhakaza Mbokodo Research Clinic- IPM) (Download) 2013-10-282.38 MB
09. VAN DER STRATEN: MTN 020 Qualitative Component: Update (Download) 2013-10-28256.95 KB
10. From Interviews to Action (WRHI, Isipingo, Spilhaus, MU-JHU CRSs) (Download) 2013-10-28943.16 KB
11. SINGH/RIDDLER: MORE on Relatedness (Download) 2013-10-28169.32 KB
12. BUNGE: Genital Bleeding (Download) 2013-10-28141.96 KB
13. BUNGE: Genital Syndromes (Download) 2013-10-28175.97 KB
14. NYAKUDYA/MAKONI: Holistic Approach to Participant Care (Zengeza CRS) (Download) 2013-10-281.14 MB
15. MGODI: Case Study: Progressive Neutropenia (Zimbabwe CTU) (Download) 2013-10-28553.14 KB
16. MGODI: Case Study: Transaminitis (Zimbabwe CTU) (Download) 2013-10-28418.25 KB
17. NKHALAMBA: Ensuring Retention from Day 1: Pre-screening and Ensuring Motivation for MTN-020 (Lilongwe CRS) (Download) 2013-10-28423.46 KB
18. NYABADZA: Effective and Efficient QC Systems (Spilhaus CRS) (Download) 2013-10-281.73 MB
19. NDASE: Participant Adherence Discussions (Download) 2013-10-28228.98 KB
20. SSEGUYA/KIWEEWA: Participant Adherence Workshops: Kampala Site Experience (Download) 2013-10-281.84 MB
21. SIVA: Experiences with Participant Group Discussions from the Botha’s Hill CRS (Download) 2013-10-28366.69 KB
Regional Meeting 2014
01: PALANEE/BAETEN- ASPIRE Implementation Update (Download) 2014-10-251.14 MB
02: NEL- IPM 027 Current Status (Download) 2014-10-251.48 MB
03: PARIKH- MTN-020 LC: Resistance Results (Download) 2014-10-25155.81 KB
04: LIVANT- MTN-020 LC: HIV Testing Case Study and Study Closeout (Download) 2014-10-2577.77 KB
05: MONTGOMERY- MTN-020 Qualitative Update (Download) 2014-10-25269.58 KB
06: MATHEBULA- Wits RHI ASPIRE Qualitative Component: Updates and Emerging Themes (Download) 2014-10-25365.62 KB
07: MATOVU KIWEEWA- Recent Adherence Strategies Kampala Site (Download) 2014-10-252.03 MB
08: GOVENDER- Strategies to Improve Retention: Sharing Best Practices from the Isipingo CRS (Download) 2014-10-25638.67 KB
09: SCHWARTZ/BERTHIAUME/JACOBSON- Preparing for Study Closeout (Download) 2014-10-25267.03 KB
10: NAIDOO- ASPIRE CWG Considerations for Study Closeout (Download) 2014-10-25631.85 KB
11: HUNIDZARIRA- Contraceptive Counselling Considerations at Study Closeout (Download) 2014-10-25254.81 KB
Regional Meeting 2015
01: Baeten/Palanee- Meeting Overview (Download) 2015-10-052.35 MB
02: Nel- IPM 027 Current Status (Download) 2015-10-051016.02 KB
03: Baeten- Looking Forward to Results (Download) 2015-10-051.05 MB
04: Zulu- Preparing Participants and the Community for ASPIRE Results (Download) 2015-10-05121.91 KB
05: Mgodi/Mayo- Looking forward to HOPE (Download) 2015-10-05504.59 KB
06: Nakyanzi- HOPE: Considerations for Community Engagement in Open Label Extensions (Download) 2015-10-052.35 MB
07: Naidoo- HOPE: Adherence and Accountability (Download) 2015-10-05430.88 KB
08: Baeten- Introduction to EMA/FDA Inspections (Download) 2015-10-05360.18 KB
09: Hubby- Site Responsibilities- Preparing for Regulatory Inspections: FDA, EMA and the MCC (Download) 2015-10-05336.27 KB
10: Luzar- Inspections in the Network Structure and Responsible Parties (Download) 2015-10-053.01 MB
11: Nel- Regulatory Inspections: Sponsor Statement and Perspective (Download) 2015-10-05682.7 KB
12: Govender- Regulatory Inspections: Site Perspective (Download) 2015-10-05557.74 KB
13: Payton- Where Do We Go From Here? Regulatory Inspection Preparedness for ASPIRE Sites (Download) 2015-10-05309.53 KB
14: Baeten/Schwartz- ASPIRE Publications: Approach and Overview (Download) 2015-10-05120.71 KB
15: Aridor- MTN Publications- MTN-020 General Information (Download) 2015-10-05764.98 KB
Regional Meeting 2016 - ASPIRE Audit Prep
01: Interview with IoR Script #1 (Download) 2016-09-2750.15 KB
02: Informed Consent Process (IC) Script #2 (Download) 2016-09-2735.33 KB
03: IP Management Script # 3 (Download) 2016-09-2735.61 KB
04: Training/Hand over process Script # 4 (Download) 2016-09-2736.37 KB
05: Safety Assessment AE/SAE reporting Script # 5 (Download) 2016-09-2738.87 KB
06: Inspection Preparation: Dapivirine Ring Dossier Submission (Download) 2016-09-27160.32 KB
07: EMA Inspection Site perspective (Download) 2016-09-27360.72 KB
08: Inspection Interview (Download) 2016-09-27164.35 KB
09: Where do we go from here? (Download) 2016-09-27451.73 KB
Study-Specific Training
01: MTN-020 Training Protocol Overview (Download) 2013-01-023.17 MB
02: Dapivirine Overview (Download) 2013-01-021.57 MB
03: MTN 020 Accrual (Download) 2013-01-02301.5 KB
04: Screening Overview (Download) 2013-01-022.7 MB
05: Enrollment Overview (Download) 2013-01-022.05 MB
06: Randomizaion Initial Product Dispensation (Download) 2013-01-021.01 MB
07: Enrollment Education Product Use Instructions (Download) 2013-01-021.11 MB
08: PRE CRF Completion Overview (Download) 2013-01-02277 KB
09: Baseline Medical History Overview (Download) 2013-01-021.23 MB
10: MTN 020 Retention (Download) 2013-01-02389.5 KB
11: Retention Feedback and Ppt Tracking Database Overview (Download) 2013-01-02241.71 KB
12: Visit Types Follow-up Procedures (Download) 2013-01-021.66 MB
13: Adherence Counseling Overview (Download) 2013-01-02873.73 KB
14: HIV Counseling and Testing Overview (Download) 2013-01-02949.42 KB
15: Contraception Counseling (Download) 2013-01-02809.86 KB
16: Clinical Considerations (Download) 2013-01-02872.59 KB
17: Genital Bleeding Overview (Download) 2013-01-02129.8 KB
18: AE Overview Safety (Download) 2013-01-02227.12 KB
19: AE and GAE CRF Completion (Download) 2013-01-02423.5 KB
20: Study Product Considerstaions for Non-Pharmacy Staff (Download) 2013-01-021.09 MB
21: Product Use Management (Download) 2013-01-02978.7 KB
22: ASPIRE Lab Training (Download) 2013-01-022.57 MB
23: Off-Site Visits (Download) 2013-01-02187.59 KB
24: Counselor Training Module-Overview (Download) 2013-01-02747.5 KB
25: Informed Consent for Counselors (Download) 2013-01-022.57 MB
26: Adherence Counseling for Counselors (Download) 2013-01-021.64 MB
27: HIV Counseling Module for Counselors (Download) 2013-01-021.47 MB
28: Social Harms (Download) 2013-01-02796.25 KB
29: Protocol Deviations (Download) 2013-01-02153.78 KB
30: Resources and Communications (Download) 2013-01-02994.25 KB