study product adherence counseling at enrollment mtn-003 study-specific training

Study Product Study Product Adherence Counseling Adherence Counseling

At EnrollmentAt Enrollment

MTN-003 MTN-003

Study-Specific TrainingStudy-Specific Training

Review of Review of Enrollment Visit Procedures Enrollment Visit Procedures Eligibility confirmationEligibility confirmation Informed consentInformed consent Behavioral interviews, blood for plasma Behavioral interviews, blood for plasma

archive, Hepatitis B vaccination if indicatedarchive, Hepatitis B vaccination if indicated Randomization Randomization prescription prescription obtain product obtain product Provide product use instructionsProvide product use instructions First product use at clinicFirst product use at clinic De-brief about first use, additional De-brief about first use, additional

information and instructions as neededinformation and instructions as needed Adherence counselingAdherence counseling

First Product UseFirst Product Use

After a participant receives her first After a participant receives her first dispensing of study product, she will dispensing of study product, she will complete her first product use at the complete her first product use at the clinicclinic


Rationale = ensure understanding, Rationale = ensure understanding, comfort and confidence with proper comfort and confidence with proper product use from the very beginning of product use from the very beginning of study participation study participation

– If further instruction or technical If further instruction or technical assistance is needed, can be provided assistance is needed, can be provided before participant is home on her ownbefore participant is home on her own

– Helps avoid the possibility of much time Helps avoid the possibility of much time going by in which participant may be going by in which participant may be unclear or uncomfortable with product unclear or uncomfortable with product useuse


It is important that the participant perform It is important that the participant perform each step of the product use instruction each step of the product use instruction herselfherself

Now that we have talked about the Now that we have talked about the instructions, let’s have you try to follow instructions, let’s have you try to follow the instructions yourself …the instructions yourself …

Do not perform any steps for herDo not perform any steps for her If she needs prompting or reminders, that If she needs prompting or reminders, that

is fine, but ensure she is able to perform is fine, but ensure she is able to perform each step herself before she leaves the each step herself before she leaves the clinic that dayclinic that day

First Product Use – TabletsFirst Product Use – Tablets Inability to swallow tablets is expected to be rare Inability to swallow tablets is expected to be rare For participants who have difficulty, advise to:For participants who have difficulty, advise to:

– Take a sip of water and relaxTake a sip of water and relax– Place the tablet at the back of the tongue and Place the tablet at the back of the tongue and

swallow it with water or juiceswallow it with water or juice– Try drinking water or juice with a strawTry drinking water or juice with a straw

After further guidance is provided, participant After further guidance is provided, participant should try again to take tablets at the enrollment should try again to take tablets at the enrollment visitvisit

NB: Avoid handling dispensed tablet suppliesNB: Avoid handling dispensed tablet supplies NB: Document in chart notes and inform NB: Document in chart notes and inform

pharmacy if more than one of either tablet is pharmacy if more than one of either tablet is used during an enrollment visitused during an enrollment visit

First Product Use – GelFirst Product Use – Gel Inability to insert gel is expected to be rareInability to insert gel is expected to be rare

For participants who have difficulty: For participants who have difficulty:

– Provide guidance to address the difficulty Provide guidance to address the difficulty encounteredencountered

– Provide empty applicator[s] for hands-on Provide empty applicator[s] for hands-on practice practice

After guidance is provided, and further practice After guidance is provided, and further practice takes place, participant should insert [another] takes place, participant should insert [another] applicator of gel at the enrollment visitapplicator of gel at the enrollment visit

NB: Avoid handling dispensed gel suppliesNB: Avoid handling dispensed gel supplies NB: Document in chart notes and inform NB: Document in chart notes and inform

pharmacy if more than one gel applicator is used pharmacy if more than one gel applicator is used during an enrollment visitduring an enrollment visit

First Product Use – GelFirst Product Use – Gel

Some logistics to keep in mindSome logistics to keep in mind

– Need to plan for private space for Need to plan for private space for participants to insert gelparticipants to insert gel

– Need to ensure biohazard receptacle Need to ensure biohazard receptacle available in all such spacesavailable in all such spaces

– Have panty liners available and be Have panty liners available and be prepared to tell women what to prepared to tell women what to expect vis-à-vis possible gel leakageexpect vis-à-vis possible gel leakage

Adherence Adherence Counseling:Counseling:

Key MessagesKey Messages

Insert one applicator or take one lighter tablet and one darker tablet every day.• As close as possible to the same time every day• Even on days when you do not have sex• Even on days during menses

How might you plan to do this? At what time do you think you will insert gel or take tablets each day? Is there an activity you do every day that might help you to remember to insert gel or take tablets every day?

If assigned to gel: You might find that some gel leaks out after insertion. This is normal. Because of this, you may want to use panty liners which we can give you. You also may want to consider inserting gel at bedtime. You should also consider when you and your partner usually have sex, as this could help determine when you would like to insert gel (explore advantages and disadvantages)._________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________


If you miss a dose, insert gel or take tablets as soon as you remember, but skip the missed dose if your next dose is due within 6 hours.

Example: Let’s say you usually take your dose at about 6:00 pm (around dinner time). If you forget to take a dose, and realize this when you wake up at about 6:00 am the next day, you should take the missed dose immediately, because there are about 12 hours left before the time of your next dose. On the other hand, if you did not realize that you missed a dose until your children come home from school, at about 3:00 pm, you should skip the missed dose, because there are only about 3 hours left before the time of your next dose.


Keep your product supplies in your possession.

• Do not remove labels from your cartons or bottles

• Avoid mix-ups with others at the clinic and at home

• Carry your supplies yourself

• Discuss with study staff if you cannot carry all supplies dispensed at once

• Discuss with study staff if you usually travel to and from the clinic with other women or if more than one woman in your household is in the study


At home, keep your product supplies in a secure dry place, out of the sun and safe from children.

How might you plan to do this? Where do you think you will keep your supplies?

______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________


Contact study staff if you have any questions or need more product between visits.


If you will be away, tell study staff in advance and take product with you.

Do not share your product and do not use other women’s product.• This will make it difficult to learn whether the products are safe and effective for preventing HIV• This could be harmful [refer to resistance fact sheet as needed]

If assigned to tablets:• It is very important to remember that the tablets given to you for this study are being tested to see if they prevent getting HIV. The tablets should not be used as treatment for people with HIV. As we have discussed, we do not know which tablets you are receiving (tenofovir, Truvada or placebo) and also, 3 ARV medicines are needed to properly treat HIV. If someone who has HIV takes your study tablets, this could be harmful for them. Therefore, please do not share tablets with anyone.


Bring all remaining product to all clinic visits.

• Supplies will be counted at pharmacy

• To help account for all supplies used in the study

• To help understand how participants are doing with using their product

• To help clinic and pharmacy staff provide the best possible counseling to address any difficulties


The study staff are here to help and support you. Please contact us if you have:

• Problems inserting gel or taking tablets

• Problems keeping your gel or tablets for your use only

• Any other problems (such as partner or family issues)



Remember, to properly test if the gel or tablets prevent getting HIV, it is very important that women in the study use the gel or tablets they are given every day.

Final Tips and RemindersFinal Tips and Reminders There is a lot of information to cover!There is a lot of information to cover! Take your time, use visual aids, and assess Take your time, use visual aids, and assess

participant understanding along the wayparticipant understanding along the way Reassure participant that although the Reassure participant that although the

information provided may seem like a lot information provided may seem like a lot to remember, she is capable of doing what to remember, she is capable of doing what she is being asked to doshe is being asked to do

Also reassure her that study staff are Also reassure her that study staff are available to help and support her – she can available to help and support her – she can ask questions and raise issues or problems ask questions and raise issues or problems at any timeat any time

What are What are your questions your questions and comments?and comments?

study product adherence counseling at enrollment mtn-003 study-specific training

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