Study Product Adherence Counseling At Follow-up Visits

MTN-003

Study-Specific Training

Continue Client Centered Approach Begun at Enrollment

Greet client and establish rapport Describe purpose of the session Emphasize confidentiality of the session Listen effectively, allow client to speak, avoid

interruptions Communicate effectively, verbally and non-verbally Communicate at client’s level of understanding Use open-ended questions Clarify misconceptions Provide positive reinforcement

Counselor’s role is to ask questions, actively listen to participant’s responses, and guide participant toward next steps

Outcome should be participant identifyingHer barriers to adherenceHer strategies and action plans to try to

address the barriersSupported and facilitated by the counselor

Continue Client Centered Approach Begun at Enrollment

Protocol Requirements

Monthly Visits: Provision of study product supplies Instructions for study product use Study product adherence counseling

Monthly Visit Checklist

Assess eligibility to continue product use:

IF ELIGIBLE: Review Unused Product Returns slip completed by

pharmacy staff. Provide product use instructions and adherence counseling

per Follow-Up Adherence Counseling Checklist; document per site SOPs.

Schedule next visit. Complete Study Product Request Slip marked RE-

SUPPLY; product also may be RE-ISSUED. Give completed white original Study Product Request Slip

to participant to bring to pharmacy; retain yellow copy in participant’s study notebook.

Follow-up Adherence Counseling Worksheet

Page 1 (items 1-6) Establish rapport, explain purpose of session Assess product use since last visit

Page 2 (items 7-10) Option 1: Used product all of the time Option 2: Used product most or some of the time Option 3: Used product not at all

• Items 7-8 differ by level of product use

• Items 9-10 are the same for all participants Page 3 (items 11-12, notes)

Documentation: barriers, plans, detailed notes

Now let’s discuss key details from each page …

Page 1: Product Use Since Last Visit

Items 3-4: Assess participant’s level of product use since her last visit based on her self-report All of the time Most of the time Some of the time Not at all

Qualitative assessment used to guide the adherence counseling that will be provided later in the session

Page 1: Product Use Since Last Visit

Checklist includes example open-ended questionsTo begin, can you tell me, what has been your experience with [inserting gel] / [taking tablets] since your last visit?

And example probes: How often have you been able to [insert gel] / [take both of your

tablets]? When do you usually [insert gel] / [take your tablets]? Do you have a

usual time during the day or evening/night? [If applicable] Do you usually take both of your tablets at the same time?

At your last visit, the plans/strategies that we wrote down for you to try included [specify]. Did you try these plans/strategies? Did they work for you?

Did you have any challenges with [inserting gel] / [taking both of your tablets] every day? If yes, how did you address these challenges?

[If she reports perfect adherence]: Was there even one day when you may have forgotten or were not able to [insert gel] / [take your tablets]?

Page 1: Product Use Since Last Visit

Items 5-6: Assess participant’s level of product use since her last visit based on her self-report AND her unused product count All of the time Most of the time Some of the time Not at all

Page 1: Product Use Since Last Visit

Counselor must compare the participant’s report with her unused product count from pharmacyIf discrepancy:

• Explain/summarize the discrepancy• Probe to clarify• Use neutral and non-judgmental

approach

Example probe

Today you returned 8 unused [applicators] / [tablets]. If we count up the number of days since your last visit, and how many [applicators] / [tablets] you were given at your last visit, this would seem to indicate that you did not [insert gel] / [take tablets] on about [X] days since your last visit. This seems to differ from what we just talked about. Can you explain or help me to understand this difference? Is it possible you have forgotten some times when you were not able to [insert gel] / [take tablets]?

Page 2: Adherence Counseling and Plan

Item 7: Provide adherence counseling Item 8: Develop adherence plan/strategies

for the coming monthBoth tailored to the participant’s current

experiences with product use

Product Use: All of the Time(page 2, option 1)

Adherence counseling should include: Positive reinforcement Discussion of effective adherence strategies Planning for the next month

Key Messages: Keep up the good work

I would like to know, what helps you to be able to [insert gel] / [take tablets] every day?

Do you have strategies that you would recommend for other women in the study?

Based on what we have talked about, you are doing very well with [inserting gel] / [taking tablets]. I would like to write down some strategies that you can use to help make sure you also do well between today and your next visit. Do you foresee any changes or challenges over the next month? What do you think your strategies should be?

Product Use: Most or Some of the Time(page 2, option 2)

Adherence counseling should include: Positive reinforcement Probing Follow-up on issues/problems that are

preventing higher levels of adherence Planning for the next month

Key Messages:Doing well, but let’s try to address issues/challenges

You have done well with [inserting gel] / [taking tablets] on [most OR some] days since your last visit. Can you tell me about the days when you did [insert gel] / [take tablets]? What helped you to be able to [insert gel] / [take tablets] on those days?

Now let us talk about the days when you were not able to [insert gel] / [take tablets]? What was different about those days? Was there one main reason why you were not able to [insert gel] / [take tablets] on those days?

Product Use: None of the Time(page 2, option 3)

Adherence counseling should include: Positive reinforcement (if applicable) Focus on barriers to product use Planning for the next month

Key Messages:Overcoming adherence challenges

It seems that you are having issues/problems/challenges with [inserting gel] / [taking tablets]. Can you tell me more about the reasons for this? What do you think is the main or most important reason?

Did you try the strategies discussed at your last visit? Were they useful? Which one?

Earlier in the study, it seems that you were able to [insert gel] / [take tablets] more consistently. What has changed since that time?

Can you tell me about any days when you did [insert gel] / [take tablets]? What made it possible for you to [insert gel] / [take tablets] on those days?

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

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

Page 2, Item 9: Reinforce Key Adherence Messages

Keep your [gel] / [tablets] in your possession. At home, keep them in a secure dry place, out of the sun and safe from children

Do not share your [gel] / [tablets] with anyone else and do not use other women’s gel or tablets

Bring all remaining [gel] / [tablets] to all clinic visits Contact study staff to tell us you have any questions or

problems or need more [gel] / [tablets] before your next visit. Likewise, if you will be away, tell study staff in advance and take [gel] / [tablets] with you.

Page 2, Item 9: Reinforce Key Adherence Messages

Item 11: Clearly document the adherence barriers/challenges the participant is facing in the box provided

Item 12: Clearly document the adherence plan/strategies the participant will attempt to carry out between today’s visit and her next visit in the box provided

Record details in notes (use additional pages if needed)

Page 3: Documentation

Final Tips and Reminders

Take your time and use visual aids Sample study products Product use instructions Table-top flip chart Resistance fact sheet

Reassure participant that she is doing well – positive reinforcement!

Identify strategies to best fit her needs Reassure her that study staff are available to help

and support her – she can ask questions and raise issues or problems at any time

What are your questions and comments?