Study Product Return Re-Supply and Re-Issue MTN-003 Study-Specific Training

Overview of Presentation Some Definitions Some Definitions Review of Visit Flow Review of Visit Flow Study Product Return Study Product Return Study Product Hold/Discontinuation Study Product Hold/Discontinuation Study Product Re-Supply Study Product Re-Supply Study Product Re-Issue Study Product Re-Issue Some Examples for Discussion Some Examples for Discussion

Definitions Study Product Return Study Product Return Refers to participants bringing their unused study product to follow-up visits for counting at the site pharmacy Refers to participants bringing their unused study product to follow-up visits for counting at the site pharmacy Returned product may either be retained in the pharmacy or re-issued to the participant Returned product may either be retained in the pharmacy or re-issued to the participant

Definitions Study Product Re-Supply Study Product Re-Supply Refers to dispensing new supplies of study product Refers to dispensing new supplies of study product Tablets re-supplied in quantities of 30 Tablets re-supplied in quantities of 30 Gel usually re-supplied in quantities of 30 but may be re-supplied in quantities of 10 or 20 Gel usually re-supplied in quantities of 30 but may be re-supplied in quantities of 10 or 20

Definitions Study Product Re-Issue Study Product Re-Issue Refers to providing participants with their own previously returned study product Refers to providing participants with their own previously returned study product

Visit Flow

Study Product Return Participants instructed to bring all unused product to all visits Participants instructed to bring all unused product to all visits Pharmacy staff count returned product and determine quantity: Pharmacy staff count returned product and determine quantity: Expected to be returned Expected to be returned Actually returned Actually returned Available for re-issue Available for re-issue

Product Eligible for Re-Issue Pharmacy staff will determine based on factors such as: Pharmacy staff will determine based on factors such as: Physical condition Physical condition Expiry Dates Expiry Dates Oral: 30 days after bottle is opened Oral: 30 days after bottle is opened Gel: 60 days after dispensed Gel: 60 days after dispensed Indicated by “do not use after” date Indicated by “do not use after” date Key counseling message: Use re-issued product first

Comments: Comments: Only four of each tablet are available for re-issue before the “do not use after” date (2 APR 2010). Remind participant to take re-issued product first, then open new bottles.

Comments: Comments: All of the tablets returned are in good condition. However, an unequal number of TDF/placebo and FTC/TDF or placebo were returned, therefore the most available for re-issue is 2 of each tablet.

4 0 0 Comments: Comments: Four gels were expected to be returned, but none were actually returned. Participant stated she did not accidentally leave at home, but suspects that her sister may have used some of her gels.

1 4 2 Comments: Comments: Of 4 gels returned, 2 were damaged. Therefore only 2 applicators are available for re-issue

Study Product Return Clinic staff use information recorded on the Study Product Returns Form to Clinic staff use information recorded on the Study Product Returns Form to Guide adherence counseling Guide adherence counseling Guide the ordering of study product to be re-supplied and re-issued Guide the ordering of study product to be re-supplied and re-issued

Study Product Re-Supply At each follow-up visit, authorized clinic staff must assess participant eligibility to continue product use At each follow-up visit, authorized clinic staff must assess participant eligibility to continue product use For those NOT eligible, product use is temporarily held or permanently discontinued For those NOT eligible, product use is temporarily held or permanently discontinued Document fully in participant’s clinic records Document fully in participant’s clinic records Inform pharmacy Inform pharmacy

Study Product Retrieval For participants NOT eligible to continue product use, product retrieval may be required, if participant did not bring all unused product to her visit For participants NOT eligible to continue product use, product retrieval may be required, if participant did not bring all unused product to her visit Retrieval may be done by Retrieval may be done by Participant returning product Participant returning product Study staff conducting outreach to retrieve product from participant Study staff conducting outreach to retrieve product from participant

Study Product Retrieval See protocol Section 6.6 for retrieval requirements See protocol Section 6.6 for retrieval requirements 24 hours for HIV (oral & vaginal) 24 hours for HIV (oral & vaginal) 24 hours for Grade 3+ liver or renal toxicity (oral) 24 hours for Grade 3+ liver or renal toxicity (oral) otherwise 5-7 days working days (oral & vaginal) otherwise 5-7 days working days (oral & vaginal) Inform Protocol Safety Review Team if product not retrieved within timeframe Inform Protocol Safety Review Team if product not retrieved within timeframe

Study Product Re-Supply For participants eligible to continue product use, authorized clinic staff determine quantity of product needed until next visit For participants eligible to continue product use, authorized clinic staff determine quantity of product needed until next visit Usually 30-day supply Usually 30-day supply Up to 60-day supply permitted at IoR discretion Up to 60-day supply permitted at IoR discretion More than 60-day supply requires approval of DAIDS Medical Officer (see SSP Section 9) More than 60-day supply requires approval of DAIDS Medical Officer (see SSP Section 9)

Study Product Request Slip For signatures, follow local regulations on: For signatures, follow local regulations on: Staff authorized to “prescribe” vs “re-supply” Staff authorized to “prescribe” vs “re-supply” How often an authorized prescriber must sign How often an authorized prescriber must sign NB: Authorized prescriber must sign for all resumptions NB: Authorized prescriber must sign for all resumptions Document authorizations on staff roster and maintain current listings of staff in each category Document authorizations on staff roster and maintain current listings of staff in each category

Study Product Re-Issue For participants eligible to continue product use, authorized clinic staff determine quantity of product needed until next visit For participants eligible to continue product use, authorized clinic staff determine quantity of product needed until next visit Total amount = re-supply + re-issue Total amount = re-supply + re-issue To determine total amount, consider To determine total amount, consider Number of days until next visit Number of days until next visit Standard re-supply quantities (30 tablets/bottle; 10 gels/carton) Standard re-supply quantities (30 tablets/bottle; 10 gels/carton) Quantity available for re-issue Quantity available for re-issue

Ideal Quantity Unless specific concerns are identified by the IoR or designee, aim to provide the larger of these two quantities Unless specific concerns are identified by the IoR or designee, aim to provide the larger of these two quantities Quantity needed for daily use through the next scheduled visit date, plus 7 days Quantity needed for daily use through the next scheduled visit date, plus 7 days or or Quantity needed for daily use through the next target visit date, plus 7 days Quantity needed for daily use through the next target visit date, plus 7 days

Minimum Quantity At a minimum, participants must be provided with enough study product for daily use until their next scheduled study visit At a minimum, participants must be provided with enough study product for daily use until their next scheduled study visit Ideal is ideal, Ideal is ideal, minimum is required minimum is required

Study Product Re-Supply For example, if next visit is targeted to take place in 28 days, but is scheduled to take place in 29 days, aim to provide a 36-day supply (29+7=36) For example, if next visit is targeted to take place in 28 days, but is scheduled to take place in 29 days, aim to provide a 36-day supply (29+7=36) That is, ideally re-supply 30 and re-issue 6 if available from the participant’s returns That is, ideally re-supply 30 and re-issue 6 if available from the participant’s returns At a minimum, a 29-day supply is required At a minimum, a 29-day supply is required Remember Expiry: Instruct and counsel participant to use re-issued product first Remember Expiry: Instruct and counsel participant to use re-issued product first

Example #1 Today’s visit date = 1 SEP 09 Today’s visit date = 1 SEP 09 Unused Product Returns slip indicates 2 TDF and 2 TDF/FTC tablets available for re-issue Unused Product Returns slip indicates 2 TDF and 2 TDF/FTC tablets available for re-issue Target date for next visit is Sunday, 27 SEP 09 Target date for next visit is Sunday, 27 SEP 09 Scheduled date for next visit is Friday, 25 SEP 09 Scheduled date for next visit is Friday, 25 SEP 09 What is the ideal quantity of product to provide to the participant at today’s visit? What is the ideal quantity of product to provide to the participant at today’s visit? How much would you re-supply and how much would you re-issue? How much would you re-supply and how much would you re-issue?

Today’s visit date = 1 SEP 09 Today’s visit date = 1 SEP 09 The next visit’s Target Date is 27 SEP 09 The next visit’s Target Date is 27 SEP 09 What is the number of days from today to the target date? Example #1

SUNMONTUEWEDTHUFRISAT 12 Start Count Target Date Example #1

Today’s visit date = 1 SEP 09 Today’s visit date = 1 SEP 09 The next visit’s Scheduled Date is 25 SEP 09 The next visit’s Scheduled Date is 25 SEP 09 What is the number of days from today to the scheduled date?

SUNMONTUEWEDTHUFRISAT 12 Start Count Scheduled Date Example #1

Today’s visit date = 1 SEP 09 Today’s visit date = 1 SEP 09 The next visit’s Target Date is 27 SEP 09 (26 days from today) The next visit’s Target Date is 27 SEP 09 (26 days from today) The next visit’s Scheduled Date is 25 SEP 09 (24 days from today) The next visit’s Scheduled Date is 25 SEP 09 (24 days from today) What is the ideal quantity of product to provide to the participant at today’s visit?

SUNMONTUEWEDTHUFRISAT 12 Start Count Target Date Example #1 Correct answer 26+7=33

Example #1 Today’s visit date = 1 SEP 09 Today’s visit date = 1 SEP 09 Unused Product Returns Form indicates 2 TDF and 2 TDF/FTC tablets available for re-issue Unused Product Returns Form indicates 2 TDF and 2 TDF/FTC tablets available for re-issue The next visit’s Target Date is 27 SEP 09 The next visit’s Target Date is 27 SEP 09 The next visit’s Scheduled Date is 25 SEP 09 The next visit’s Scheduled Date is 25 SEP 09 The ideal quantity of product to provide is 33 The ideal quantity of product to provide is 33 How much would you re-supply and how much would you re-issue? 1. Re-supply 2, Re-issue Re-supply 3, Re-issue Re-supply 31, Re-issue 2 4. Re-supply 30, Re-issue 2

Example #2 Today’s visit date = 1 SEP 09 Today’s visit date = 1 SEP 09 Unused Product Returns Form indicates 8 applicators available for re-issue Unused Product Returns Form indicates 8 applicators available for re-issue The next visit’s Target Date is Saturday, 26 SEP 09 The next visit’s Target Date is Saturday, 26 SEP 09 The next visit’s Scheduled Date is Monday, 28 SEP 09 The next visit’s Scheduled Date is Monday, 28 SEP 09 What is the ideal quantity of product to provide to the participant at today’s visit? What is the ideal quantity of product to provide to the participant at today’s visit? How much would you re-supply and how much would you re-issue? How much would you re-supply and how much would you re-issue?

Today’s visit date = 1 SEP 09 Today’s visit date = 1 SEP 09 The next visit’s Target Date is 26 SEP 09 The next visit’s Target Date is 26 SEP 09 What is the number of days from today? Example #2

SUNMONTUEWEDTHUFRISAT 12 Start Count Target Date Example #2

Today’s visit date = 1 SEP 09 Today’s visit date = 1 SEP 09 The next visit’s Scheduled Date is 28 SEP 09 The next visit’s Scheduled Date is 28 SEP 09 What is the number of days from today?

SUNMONTUEWEDTHUFRISAT 12 Start Count Scheduled Date Example #2

Today’s visit date = 1 SEP 09 Today’s visit date = 1 SEP 09 The next visit’s Target Date is 26 SEP 09 The next visit’s Target Date is 26 SEP 09 The next visit’s Scheduled Date is 28 SEP 09 The next visit’s Scheduled Date is 28 SEP 09 What is the ideal quantity of product to provide to the participant at today’s visit?

SUNMONTUEWEDTHUFRISAT 12 Start Count Example #2 Correct answer 27+7=34 Scheduled Date

Example #2 Today’s visit date = 1 SEP 09 Today’s visit date = 1 SEP 09 Unused Product Returns Form indicates 8 applicators available for re-issue Unused Product Returns Form indicates 8 applicators available for re-issue The next visit’s Target Date is 26 SEP 09 The next visit’s Target Date is 26 SEP 09 The next visit’s Scheduled Date is 28 SEP 09 The next visit’s Scheduled Date is 28 SEP 09 How much would you re-supply and how much would you re-issue? 1. Re-supply 26, Re-issue 8 2. Re-supply 4, Re-issue Re-supply 30, Re-issue 4 4. Re-supply 30, Re-issue 8

Example #3 Today’s visit date = 1 SEP 09 Today’s visit date = 1 SEP 09 Participant does not return any unused applicators but reports that she has an unopened carton of gel at home that she forgot to bring with her to the visit Participant does not return any unused applicators but reports that she has an unopened carton of gel at home that she forgot to bring with her to the visit Target date for next visit is Saturday, 26 SEP 09 (number of days from today = ___ ) Target date for next visit is Saturday, 26 SEP 09 (number of days from today = ___ ) Scheduled date for next visit is Monday, 28 SEP 09 (number of days from today = ___ ) Scheduled date for next visit is Monday, 28 SEP 09 (number of days from today = ___ ) How will you handle this situation? How will you handle this situation? 25 27

Example #4 Unused Product Returns slip indicates 4 TDF and 4 TDF/FTC tablets available for re-issue Unused Product Returns slip indicates 4 TDF and 4 TDF/FTC tablets available for re-issue Target Date is in 28 days Target Date is in 28 days Scheduled Date is in 37 days Scheduled Date is in 37 days What is the ideal and minimum quantity to supply? 1. Ideal 35, Minimum Ideal 35, Minimum Ideal 44, Minimum Ideal 44, Minimum 30

Example #4 Ideal 44, Minimum 37 Ideal 44, Minimum 37 Four of each tablet available for re-issue Four of each tablet available for re-issue How might you handle this situation? How might you handle this situation? Consider re-scheduling participant Consider re-scheduling participant Up to 60-day supply permitted at IoR discretion Up to 60-day supply permitted at IoR discretion More than 60-day supply requires approval of DAIDS Medical Officer More than 60-day supply requires approval of DAIDS Medical Officer Can always consult the PSRT Can always consult the PSRT

Scheduled Minimum Ideal Print 2 copies: - File one in participant binder - Send one to pharmacy with study product request slip

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