1. Study Product Adherence Counseling At Follow-up Visits
MTN-003
Study-Specific Training

2. 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

3. Continue Client Centered Approach Begun at Enrollment
Counselor’s role is to ask questions, actively listen to participant’s responses, and guide participant toward next steps
Outcome should be participant identifying
Her barriers to adherence
Her strategies and action plans to try to address the barriers
Supported and facilitated by the counselor

4. Protocol Requirements
Monthly Visits:
Provision of study product supplies
Instructions for study product use
Study product adherence counseling

5. 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.
This slides shows the details of the product use instructions/adherence counseling item on the sample visit checklist. Site-specific checklists may be formatted somewhat differently but should guide the staff to cover the points shown here.

6. 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
This is a general overview of the follow-up adherence counseling worksheet. Spend time reviewing the worksheet and explaining the different page 2 options. Refer training participants to the handouts in the training binders so they are looking at the different pages as you are explaining the structure of the worksheet.

7. Now let’s discuss key details from each page …

8. 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

9. Page 1: Product Use Since Last Visit
Checklist includes example open-ended questions
To 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]?
This slide and the ones to follow show the adherence counseling items from the Follow-up Adherence Counseling Checklist. At each site, this checklist will be translated into local languages for ease of use. If applicable, can reinforce at this time that italicized text in the checklist provides sample wording that can and should be tailored for use at each site.

10. 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
Note that staff should use all available information (participant report AND product counts) to answer question 6 on the Follow-up Adherence Counseling Worksheet. This question captures the counselor’s assessment of how often the participant is using her product. For example, if the participant reports “All of the time” for question 4, but her product count indicates she missed 10 doses, the counselor might answer “Some of the time” for question 6.
Page 2 selection should be based on the answer to this question (counselor's assessment) NOT question 4 (participant’s assessment).

11. Page 1: Product Use Since Last Visit
Counselor must compare the participant’s report with her unused product count from pharmacy
If discrepancy:
Explain/summarize the discrepancy
Probe to clarify
Use neutral and non-judgmental approach

12. 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]?

13. Page 2: Adherence Counseling and Plan
Item 7: Provide adherence counseling
Item 8: Develop adherence plan/strategies for the coming month
Both tailored to the participant’s current experiences with product use

14. 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

15. 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?
In relation to the second bubble on this slide, emphasize that a possible challenges and an adherence plan should be discussed and documented each month, even for participants who are reporting very high levels of adherence.

16. 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

17. 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?

18. 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

19. 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?

20. Page 2, Item 9: Reinforce Key Adherence 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
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.

21. 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.

22. Page 3: Documentation
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)

23. 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

24. What are your questions and comments?