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MTN-034 Clinical Flow Sheets

MTN-034 Clinical Flow Sheets. Version 1.0 12 July 2017. Product Use Management: Grade 1 and Grade 2 Adverse Events. AE addressed in protocol section 9.5?. no. CONTINUE product. yes. Follow relevant protocol section. Protocol Reference: Section 9.4. START.

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MTN-034 Clinical Flow Sheets

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  1. MTN-034 Clinical Flow Sheets Version 1.0 12 July 2017

  2. Product Use Management: Grade 1 and Grade 2 Adverse Events AE addressed in protocol section 9.5? no CONTINUE product. yes Follow relevant protocol section Protocol Reference: Section 9.4

  3. START Product Use Management: Grade 3 Adverse Events AE addressed in protocol sections 9.5? Assess AE relationship to product not related no CONTINUE product. yes related Follow relevant protocol section HOLD product. Re-evaluate at least weekly for up to 2 weeks. RESUME product. If same grade 3 AE recurs, regardless of relationship to product, HOLD product and CONSULT PSRT. grade ≤2 within 2 weeks after initiating hold grade >2 through 2 weeks after initiating hold Consult PSRT Protocol Reference: Section 9.4

  4. Product Use Management: Grade 4 Adverse Events AE addressed in protocol section 9.5? HOLD product. CONSULT PSRT. no yes Follow relevant protocol section Protocol Reference: Section 9.4

  5. START Product Use Management for ORAL Study Product: Decreased Creatinine Clearance Assess creatinine clearance rate  60 mL/min CONTINUE product. < 60 mL/min HOLD product and consult the PSRT. Re-test within 1 week of receipt of result. Continue HOLD and CONSULT PSRT. • 60 mL/min on re-test No re-test within 1 week < 60 mL/min on re-test Continue HOLD and CONSULT PSRT. PERMANENTLY DISCONTINUE product. Protocol Reference: Section 9.5

  6. Product Use Management: Sexually Transmitted Infections and Reproductive Tract Infections CONTINUE product, unless permanent discontinuation guidelines apply. Consult the PSRT if a permanent discontinuation is deemed necessary and instituted by the IoR/designee. Vaginally applied medications should not be used. Whenever possible, oral or parenteral medications should be used instead. *Treat per WHO guidelines, using observed single dose regimens whenever possible. Protocol Reference: Section 9.5

  7. Product Use Management during VAGINAL RING use: Superficial epithelial disruption (abrasion/peeling) HOLD product and consult the PSRT. CONTINUE product. Perform naked eye exam. Yes Re-evaluate by speculum exam in 3-5 days. Is it worse? No CONTINUE product. Protocol Reference: Section 9.5

  8. Product Use Management during VAGINAL RING use : Deep epithelial disruption (ulceration) If confirmed by investigator, HOLD Product CONTINUEHOLD consult the PSRT. No No Yes Yes Re-evaluate by speculum exam in 2-3 days. Has it resolved? Re-evaluate by speculum exam in 3-5 days. Has it resolved? CONTINUE product. CONTINUE product. If reoccurrence with no identified etiology, hold product and consult the PSRT regarding permanent discontinuation Protocol Reference: Section 9.5

  9. Product Use Management during VAGINAL RING use : Localized erythema or edema (area less than 50%) CONTINUE product. Perform naked eye exam. HOLD product and consult the PSRT. Symptomatic? Yes Re-evaluate by speculum exam in 3-5 days. Is it worse? No Asymptomatic? CONTINUE product. Re-evaluate at next scheduled visit Protocol Reference: Section 9.5

  10. Product Use Management during VAGINAL RING use : Generalized Erythema or Severe Edema (area more than 50%) HOLD Product and perform naked eye examination CONTINUEHOLD consult the PSRT. No No Yes Yes Re-evaluate by speculum exam in 2-3 days. Has it resolved? Re-evaluate by speculum exam in 3-5 days. Has it resolved? CONTINUE product. CONTINUE product. If reoccurrence with no identified etiology, hold product and consult the PSRT regarding permanent discontinuation Protocol Reference: Section 9.5

  11. Product Use Management during VAGINAL RING use : Unexpected genital bleeding Follow guidance for deep epithelial disruption CONTINUE product and perform naked eye pelvic examination Due to deep epithelial disruption? yes Continue Product use no Protocol Reference: Section 9.5

  12. Product Use Management during VAGINAL RING use : Cervicitis (including inflammation and/or friability) HOLD Product and evaluate for GC/CT; provide treatment as indicated CONTINUEHOLD consult the PSRT. No Yes Re-evaluate by speculum exam in 3-5 days. Has it resolved? CONTINUE product. Protocol Reference: Section 9.5

  13. Product Use Management during VAGINAL RING use : Genital petechia(e)/ genital ecchymosis CONTINUE product and perform naked eye exam; treat per clinician discretion Protocol Reference: Section 9.5

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