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 Instructions 1. 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 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

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