IMPAACT 2010 Pharmacy, Study Drug, and Concomitant Medication Considerations at Entry - PowerPoint Presentation

Slide1

IMPAACT 2010

Pharmacy, Study Drug, and Concomitant Medication Considerations at EntrySlide2

Protocol References

Section

Title

6.2

Entry Visit

5.1

Study Drug Regimens

5.2

Study Drug Administration

5.7

Study Drug Adherence Assessment and Counseling

5.8.1

Maternal Concomitant

MedicationsSlide3

Process Flow

3

Informed

Consent

Obtained

?

Assign PIDs

Obtain screening number from SES

Eligible?

Enrolled

in SES ?

STOP

Initiate study drug and

follow

per SoE

START

yes

yes

yes

no

SES generates SIDs for mother and infant,

and generates prescribing information

for the maternal study drug regimen

that corresponds to the random assignmentSlide4

Process Flow at Each Site

Who determines/confirms eligibility?

Who completes enrollment in SES?

How is SID and random assignment communicated to:

Prescribing clinician?

Pharmacist?

Who prepares study drug for the mother? How much?

Who dispenses study drug to the mother?Who provides study drug use and adherence information and counseling to the mother?

How is the first dose handled?Slide5

All sites must establish SOPs for prescribing and dispensing ARVs in this study.

Clinic and pharmacy staff should work together on these SOPs to specify the most appropriate site-specific procedures to be followed.

We understand that enrolled mothers should be provided with sufficient study drug at each visit to last through the next visit, taking the target date and allowable windows into account. Is there a recommended quantity of study drug to be provided at the study Entry Visit?

5Slide6

For the study Entry Visit,

site SOPs may specify dispensing of

either a 30-day supply or a 60-day supply

of study drug, taking into consideration that the first maternal follow-up visit, which is the Antepartum Week 4 Visit, is scheduled four weeks (28 days) after the Entry Visit, ± 2 weeks.

We understand that enrolled mothers should be provided with sufficient study drug at each visit to last through the next visit, taking the target date and allowable windows into account. Is there a recommended quantity of study drug to be provided at the study Entry Visit?

6Slide7

For sites that dispense a 30-day supply, special attention will be needed to ensure that mothers return for their Antepartum Week 4 Visits before running out of study drug.

For sites that dispense a 60-day supply, mothers are expected to have at least a two-week supply remaining at their Antepartum Week 4 Visits, which can be returned to the mothers (if in good condition) and “topped up” at the visit.

Please refer to the study-specific MOP for further consensus guidance on dispensing study drug at the Entry Visit as well as at antepartum and postpartum follow-up visits.

We understand that enrolled mothers should be provided with sufficient study drug at each visit to last through the next visit, taking the target date and allowable windows into account. Is there a recommended quantity of study drug to be provided at the study Entry Visit?

7Slide8

We expect that some but not all mothers will take their first dose at the study clinic on the day of enrollment. For mothers who do not take their first dose of study drug at the clinic, are we required to document the date and time of first dose? If so, when should this be done?

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Enrolled mothers are generally expected to take their first dose of study drug on the day of enrollment.

If for some reason this is not possible, the first dose should be taken on the day after enrollment.

The actual date of the first dose should be recorded; it is not necessary to record the time of the first dose.Slide9

We expect that some but not all mothers will take their first dose at the study clinic on the day of enrollment. For mothers who do not take their first dose of study drug at the clinic, are we required to document the date and time of first dose? If so, when should this be done?

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The protocol team strongly recommends that study staff proactively contact mothers who do not take their first dose at the clinic to confirm that the first dose was taken (e.g., by telephone or home visit), ideally on the day after enrollment.

In addition to confirming the date of first dose, per protocol Section 6.3, “

Between scheduled visits, particularly in the first month of study participation, study site staff are encouraged to contact mothers to address any issues or questions about their study participation, clarify instructions for use of study drugs, and/or provide adherence counseling as needed

.”

All study sites should establish SOPs describing how they will do this. Slide10

We expect that some but not all mothers will take their first dose at the study clinic on the day of enrollment. For mothers who do not take their first dose of study drug at the clinic, are we required to document the date and time of first dose? If so, when should this be done?

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The date of first dose of study drug will be entered into the

Study Treatment Initiation eCRF (ADM10009)

which is first required at the Entry Visit.

If the first dose of study drug does not occur at the Entry Visit, this will need to be indicated on the ADM10009 entered for the Entry Visit, with the expectation that another copy of the ADM10009 will be entered at the Antepartum Week 4 Visit, to record the first dose. In this scenario, site staff must contact the Protocol Data Managers to request that a copy of the ADM10009 be added the Antepartum Week 4 Visit folder in Rave.Slide11

Adherence Counseling

Study staff will provide adherence counseling to enrolled mothers throughout the period of study participation.

Counseling may be provided by clinic and/or pharmacy staff consistent with local standards of care and site SOPs

;

site SOPs must also meet for minimum requirements specified in the study-specific MOP with respect to initial and ongoing counseling and support. Counseling should be provided in a client-centered manner, tailored as needed to the information, skills building, and support needs of each mother.

Information on correct use of study drugs will be provided, particularly at the time of enrollment and in the early stages of follow-up, as well as at the time of any regimens changes.

Counseling will also address challenges

to consistent use of study drug over time, with the aim of supporting mothers in identifying strategies to address any such challenges.Slide12

What are the key messages?Slide13

What are the key messages?

When

to take it

How to

take it

How to remember

to take it

What

to take

What to do

if

forget instructions

What to do

if limited access to food or clean water

What to do

if feel sickWhat

are

ARVs ?

How do

ARVs

work?

What are

the benefits of taking ARVs?

What

side effects to expect or

look out for

What to do

if have trouble takingSlide14

Important Interactions with

Commonly Used Concomitant MedicationsSlide15

Important Interactions with

Commonly Used Concomitant Medications

Mothers who have not initiated

cotrimoxazole or isoniazid prophylaxis

prior to study entry should preferably defer initiation of these medications until at least two weeks after initiation of their study drug regimen, if eligible to initiate such prophylaxis per local standards of care.

Mothers in Arms 1 and 2 (i.e., the DTG-containing arms) who require cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications will be counseled to take these medications at least

six

hours before or at least two hours after taking DTG. Alternatively, DTG and supplements containing calcium or iron can be taken together with food. Slide16

DTG and Cation-Containing Concomitant Medications

Package insert for DTG

“Administer DTG 2 hours before or 6 hours after taking medications containing polyvalent cations.”

Take DTG

 wait 2 hours  Take medications containing polyvalent cationsORTake medications containing polyvalent cations  wait 6 hours  Take DTGSlide17

What are your questions?

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