9 Collect 1 swab from lateral vaginal wall for pH assessment. Enrollment Swab fluid onto pH strip. Document findings on Pelvic Exam 4-Week; 8-Week; CRF. 12-Week 10 Collect vaginal fluid (2 swabs) from the lateral vaginal wall Enrollment for quantitative vaginal culture assessment. Document 4-Week; 8-Week; storage on the Specimen Storage CRF. 12-Week 11 Collect 1 swab from lateral vaginal wall for Gram stain (turn Enrollment; swab 3x). Roll swab across two labeled slides and air dry. 4-Week; 8-Week; Document storage on the Specimen Storage CRF. 12-Week 12 Collect vaginal fluid (1 swab) for biomarker analyses at MTN Enrollment, NL. Document storage on the Specimen Storage CRF. 4-Week; 12-Week 13 If clinically indicated and per local standard of care, swab All suspicious genital lesion for genital herpes testing. 14 Collect ecto- and endocervical or vaginal cells for Pap smear Only if indicated (if indicated at screening to confirm eligibility). 15 Collect 1 manufacturers recommended swab from the Screening; if vaginal canal (according to the specific manufacturer’s clinically indicated recommendations) away from any abnormalities for NAAT at Enrollment for GC/CT testing. 16 Collect CVL for biomarker analyses at the MTN NL. Enrollment; Document storage on the Specimen Storage CRF. 4-Week; 12-Week 17 Place for flow Enrollment; PITTSBURGH and CASE sites ONLY: cytobrush cytometry in the cervical os and collect sample. Document storage on the Specimen Storage CRF. 18 Intensive PK SUBSET ONLY: Collect two (2) cervical biopsies 12-Week for PK. Document storage on the Pharmacokinetics CRF. 19 Remove speculum and perform bimanual exam. All 20 Document all findings on Pelvic Exam Diagrams All and Pelvic Exam CRF. Document specimen collection on the LDMS Tracking Sheet. 202agesults CRF.on ndings on Pelvic Exam and Pelvic Exam Diagram CRFs
9 Collect 1 swab from lateral vaginal wall for pH assessment. Swab fluid onto pH strip. Document findings on Pelvic Exam CRF. Enrollment 4-Week; 8-Week; 12-Week 10 Collect vaginal fluid (2 swabs) from the lateral vaginal wall for quantitative vaginal culture assessment. Document storage on the Specimen Storage CRF. Enrollment 4-Week; 8-Week; 12-Week 11 Collect 1 swab from lateral vaginal wall for Gram stain (turn swab 3x). Roll swab across two labeled slides and air dry. Document storage on the Specimen Storage CRF. Enrollment; 4-Week; 8-Week; 12-Week 12 Collect vaginal fluid (1 swab) for biomarker analyses at MTN NL. Document storage on the Specimen Storage CRF. Enrollment, 4-Week; 12-Week 13 If clinically indicated and per local standard of care, swab suspicious genital lesion for genital herpes testing. All 14 Collect ecto- and endocervical or vaginal cells for Pap smear (if indicated at screening to confirm eligibility). Only if indicated 15 Collect 1 manufacturers recommended swab from the vaginal canal (according to the specific manufacturer’s recommendations) away from any abnormalities for NAAT for GC/CT testing. Screening; if clinically indicated at Enrollment 16 Collect CVL for biomarker analyses at the MTN NL. Document storage on the Specimen Storage CRF. Enrollment; 4-Week; 12-Week 17 PITTSBURGH and CASE sites ONLY: Place cytobrush for flow cytometry in the cervical os and collect sample. Document storage on the Specimen Storage CRF. Enrollment; 18 Intensive PK SUBSET ONLY: Collect two (2) cervical biopsies for PK. Document storage on the Pharmacokinetics CRF. 12-Week 19 Remove speculum and perform bimanual exam. All 20 Document all findings on Pelvic Exam Diagrams and Pelvic Exam CRF. Document specimen collection on the LDMS Tracking Sheet. All 202agesults CRF.on ndings on Pelvic Exam and Pelvic Exam Diagram CRFs
MTN024_Pelvic%20Exam%20CL_v1.1_20May2014.docx