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1 MTN-003 Study Specific Training Randomization Overview.

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1 1 MTN-003 Study Specific Training Randomization Overview

2 2 Why Randomize? Ensures that all study groups in a clinical trial are comparable with regard to factors that could affect study outcomes (e.g., risk of HIV infection) –Age and other demographics –Past medical history and pre-existing conditions –Sexual behaviors and condom use Ensures that the study team will be able to clearly interpret the final study results –E.g. If the study drug has an effect in reducing HIV, the effect of the drug is due to the drug itself and not some other factor

3 3 What Randomization Achieves Active DrugPlacebo Mean Age (yrs) 2122 Mean Education (yrs) 11 Ever Pregnant 85%84% Married 5% Vaginal sex acts in last 7 days 55 Condom use in last 7 days 89%

4 4 MTN-003 Randomization Scheme All Participants (4200) Oral Tablet (2520) Truvada Tablet (840) Tenofovir Tablet (840) Placebo Tablet (840) Vaginal Gel (1680) Tenofovir Gel (840) Placebo Gel (840) Not Blinded Blinded

5 5 How Will the Randomization Process Work? Envelope randomization will be used SCHARP will provide two sets of envelopes to each site 1)Clinic Randomization Envelopes 2)Pharmacy Randomization Envelopes Each set of envelopes will be numbered sequentially Each clinic envelope will have a matching pharmacy envelope (matched by envelope number)

6 6 Each participant will be assigned a clinic randomization envelope and the matching pharmacy randomization envelope (e.g., a participant assigned clinic envelope 0100 will be assigned pharmacy envelope 0100, etc.) Assignment of the clinic envelope is the effective act of enrollment in MTN-003 Once a clinic envelope is assigned, the participant is considered officially enrolled in the study How Will the Randomization Process Work?

7 7 Importance of Sequential Clinic Envelope Assignment It is critical to the integrity of the study that clinic randomization envelopes are assigned in sequential order –If not assigned in proper order (even just one), this could have a serious impact on validity of study results. SCHARP will provide clinic and pharmacy envelope tracking records to document envelope assignments –This will help ensure that envelopes are assigned sequentially

8 8 Clinic Envelope Tracking Record

9 9 Randomization Envelopes Clinic envelopes sent to site clinics Pharmacy envelopes sent to site pharmacies Envelope specifications: –Large enough to contain A4 size paper –Opaque: manila folder inside each envelope –Tamper evident: sealed with blue tape –Labeled as Clinic or Pharmacy with site information, study number, envelope number All envelopes assembled and reviewed for at SCHARP before shipment to sites

10 10 Clinic Randomization Envelopes Maintained by clinic staff CLINIC MTN 003-Randomization Envelope DAIDS Site ID: CRS Name: R.K. Khan Hospital CRS Location: Durban, South Africa Envelope Number: 0001

11 11 Pharmacy Randomization Envelopes Maintained by pharmacy staff Look exactly like clinic envelopes, except labeled as PHARMACY PHARMACY MTN-003 Randomization Envelope DAIDS Site ID: CRS Name: R.K. Khan Hospital CRS Location: Durban, South Africa Envelope Number: 0001

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14 14 Clinic Randomization Envelopes Contain one MTN-003 prescription: –Two-part, no carbon required (NCR) form original (top part) is white copy (bottom part) is yellow –Assignment to Oral Tablets or Vaginal Gel Authorized prescriber or other designated clinic staff should complete information on prescription (e.g., PTID, Date Assigned) Signature of authorized prescriber is required Dispensing instructions for pharmacy staff Once completed, white (original) goes to pharmacy, yellow (copy) is filed, along with opened envelope, in the participant study notebook

15 15 Gel Prescription

16 16 Tablet Prescription

17 17 Pharmacy Randomization Envelopes Contain study product dispensing records that will be completed by pharmacy staff Dispensing records are linked to prescriptions by envelope number –The prescription from the clinic envelope will have the clinic envelope number pre-printed on it –The pharmacy will receive the prescription and assign the pharmacy envelope with this same number to the participant –Pharmacy staff will then dispense the assigned study product to the participant and record this information on the dispensing record.

18 18 Confirm participants eligibility for the study Complete the enrollment informed consent process Administer the Baseline Behavior Assessment CRF and Baseline ACASI questionnaire Obtain blood for plasma archive If applicable, administer Hepatitis B vaccine Before You Randomize…..

19 19 SCHARP Monitoring of Randomization Both clinic and pharmacy staff will record randomization information on CRFs and fax these CRFs to SCHARP Based on these CRFs, SCHARP will verify sequential assignment of clinic envelopes and proper random assignment to either oral tablets or vaginal gel SCHARP will also verify that the correct product was dispensed at the Enrollment Visit –SCHARP will monitor on-study dispensing as well

20 20 SCHARP Monitoring of Randomization If CRF data indicate a randomization error, SCHARP will contact the site clinic and/or pharmacy immediately to verify the information recorded on the CRF If it is determined that a randomization error has occurred, the Protocol Team will be notified and the site will be provided guidance on how to address the error

21 21 Operational Considerations Each site must establish an MTN-003 SOP for randomization (clinic procedures only) to specify: –Who will receive clinic randomization envelopes from SCHARP –Where clinic randomization envelopes and tracking record will be kept (secure location) –How clinic envelopes will be assigned and who will assign them –Who will complete prescriptions –Where opened envelopes and yellow (clinic) copies of prescriptions will be filed –Who will QA/QC randomization documentation and how often this will occur

22 22 If the site identifies a randomization error… Immediately contact the MTN-003 SCHARP Project Managers and FHI Clinical Research Managers and explain the situation Follow guidance provided by SCHARP and the Protocol Team –randomizations may need to be halted during this time

23 23 Questions???


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