1. IMPAACT 2010 Pharmacy, Study Drug, and Concomitant Medication Considerations at Entry
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2. 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 Medications

3. Process Flow SES generates SIDs for mother and infant,
START
Informed
Consent
Obtained ?
Initiate study drug and
follow
per SoE
Assign PIDs
Obtain screening number from SES
yes
yes
Enrolled
in SES ?
yes
Eligible? no
STOP
SES generates SIDs for mother and infant,
and generates prescribing information
for the maternal study drug regimen
that corresponds to the random assignment

4. 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?

5. 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.
Reminder that many/most enrolled women will be newly diagnosed with HIV infection.

6. What are the key messages?

7. What are the key messages?
ARVs ?
How do
ARVs
work?
What are
the benefits of taking ARVs?
What
side effects to expect or
look out for
What
to take
When
to take it
How to
take it
How to remember
to take it
What to do
if limited access to food or
clean water
What to do if
forget instructions
What to do if
have trouble taking
What to do if
feel sick

8. Important Interactions with Commonly Used Concomitant Medications

9. 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.

10. What are your questions?