For Visits 3, 10, and 17 ONLY, provide protocol adherence counseling by instructing participant of the following: For 72 hrs (3 days) prior to study visits: Abstain from non-study vaginal products and/or practices including but are not limited to spermicides, diaphragms, vaginally applied medication, menstrual cups, cervical caps, douches, lubricants, sex toys, etc. Stay sexually abstinent (i.e., no receptive intercourse - vaginal, anal, oral and finger stimulation). For entire study: Refrain from using on PEP and non-study PrEP Document any questions or issues on this checklist or in chart notes. For Visits 3, 10, and 17 ONLY, ask if the participant has any questions or concerns about the following: product (ring/tablet) she is currently taking Study adherence menu options and if she wants to make any changes. Document participant responses on this checklist or in chart notes. Complete the Follow-up Visit Summary CRF. Perform QC1: while participant is still present (on the phone or at the clinic), review the following for completion and clear documentation: Follow-Up Visit Summary to ensure all items are complete. AE Log(s) and Concomitant Medications Log CRFs to ensure all conditions, medications, AEs are captured consistently and updated. Chart notes to ensure complete and accurate Schedule next visit.* Provide contact information and instructions to report symptoms and/or request information, counseling, a new ring/tablets, or condoms before next visit. *If indicated after Visit 24/SEV. Provide reimbursement.
For Visits 3, 10, and 17 ONLY, provide protocol adherence counseling by instructing participant of the following: For 72 hrs (3 days) prior to study visits: Abstain from non-study vaginal products and/or practices including but are not limited to spermicides, diaphragms, vaginally applied medication, menstrual cups, cervical caps, douches, lubricants, sex toys, etc. Stay sexually abstinent (i.e., no receptive intercourse - vaginal, anal, oral and finger stimulation). For entire study: Refrain from using on PEP and non-study PrEP Document any questions or issues on this checklist or in chart notes. For Visits 3, 10, and 17 ONLY, ask if the participant has any questions or concerns about the following: product (ring/tablet) she is currently taking Study adherence menu options and if she wants to make any changes. Document participant responses on this checklist or in chart notes. Complete the Follow-up Visit Summary CRF. Perform QC1: while participant is still present (on the phone or at the clinic), review the following for completion and clear documentation: Follow-Up Visit Summary to ensure all items are complete. AE Log(s) and Concomitant Medications Log CRFs to ensure all conditions, medications, AEs are captured consistently and updated. Chart notes to ensure complete and accurate Schedule next visit.* Provide contact information and instructions to report symptoms and/or request information, counseling, a new ring/tablets, or condoms before next visit. *If indicated after Visit 24/SEV. Provide reimbursement.
mtn034_visit-phonecontacts-sevchecklists_v1.docx