Enrollment

Enrollment Education, Product Use Instructions, and First

Product Use

Counseling Approach In ASPIRE

Participant-centered Focus on participant experience with ring

use Support and encourage product use by

decreasing barriers and increasing facilitative factors

Enrollment Education May occur before or after randomization.

Goals of the education session include: Facilitate high levels of ring knowledge and use. Solicit questions and assess understanding

about the study product. Increase participant familiarity with the ring. Discuss anticipated challenges. Build rapport with the participant.

Tools for Enrollment Education

Who will conduct the enrollment education session with participants at your site?

Page 379

Product Use Instructions After randomization, review ring insertion instructions with

participant in detail, using visual aids as needed.

Who will review product use instructions with participants at your site?

Documentation

No counselor worksheet. Document enrollment education and

product use instruction in chart notes. What aspects of enrollment education are

important to document? Mark as completed on Enrollment Visit

Checklist.

In a private space, allow the participant to practice inserting the vaginal ring.

Staff should stand by in case the participant has questions, requests guidance, or needs assistance.

If participant is unable to insert the ring even with staff guidance, a clinician may do it for her.

First Product Use: Insertion

After insertion, proper ring placement should be confirmed by digital examination.

If correct placement is confirmed, ask participant to feel ring position.

First Product Use: Digital Exam

First Product Use: Removal and Reinsertion Following examination, allow participant to practice

removing the ring and reinserting it.

Removal Instructions1. Before removing the ring, wash and dry your hands.

2. Choose a comfortable position (can reference ring insertion instructions for illustrations of different positions).

3. Put a finger into your vagina and hook it through the ring.

4. Gently pull down and forward to remove the ring.

5. If you will be reinserting the ring, follow the ring insertion instructions, and wash your hands when you are done. If you will not be reinserting the ring, continue to steps 6-9.

6. Place the used ring in the bag provided by clinic staff or other suitable container if the bag is not available.

7. Wash your hands.

8. Place used ring and container in a safe and private area out of reach of children or other occupants of the home.

9. Bring any used ring (in its container) with you to the clinic during your next study visit.

Page 383

First Product Use: Removal and Reinsertion

If the ring was not inserted correctly, provide additional information and guidance before reinsertion attempt.

Debrief with the participant about her first ring use experience.

What questions might you ask a participant about her first product use experience?

Documentation

Document participant experience with ring insertion and removal as well as digital exam checking placement in chart notes. What aspects of this are important to document in

chart notes? Flag any participant difficulties with ring

insertion and/or removal within chart notes or alert logs in participant binder for follow-up at next visit.

How do you feel about this product? If you were a participant, what kinds of

questions would you have? Would you have any concerns about using

the ring? Based on knowledge of your clinic,

community, and study population, what adherence challenges do you anticipate ASPIRE participants having?

Group Discussion

Activity