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

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

3. Product Use Management: Grade 3 Adverse Events
START AE
addressed
in protocol sections
9.5?
Assess AE relationship to product no
not related
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 EventsAE
addressed
in protocol section 9.5?
HOLD
product.
CONSULT
PSRT. no
yes
Follow
relevant protocol
section
Protocol Reference: Section 9.4

5. Product Use Management for ORAL Study Product:
Decreased Creatinine Clearance
START
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. CONTINUE product, unless permanent discontinuation guidelines apply.
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. Re-evaluate by speculum exam in 3-5 days.
Product Use Management during VAGINAL RING use:
Superficial epithelial disruption (abrasion/peeling)
Re-evaluate by speculum exam in 3-5 days.
Is it worse?
CONTINUE product.
Perform naked eye exam.
HOLD
product and consult the PSRT.
Yes No
CONTINUE
product.
Protocol Reference: Section 9.5

8. Product Use Management during VAGINAL RING use :
Deep epithelial disruption (ulceration)
Re-evaluate by speculum exam in 3-5 days.
Has it resolved?
Re-evaluate by speculum exam in 2-3 days.
Has it resolved?
If confirmed by investigator, HOLD
Product
CONTINUEHOLD
consult the PSRT. No No
Yes
Yes
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. Re-evaluate by speculum exam in 3-5 days.
Product Use Management during VAGINAL RING use :
Localized erythema or edema (area less than 50%)
Re-evaluate by speculum exam in 3-5 days.
Is it worse?
CONTINUE product.
Perform naked eye exam.
HOLD
product and consult the PSRT.
Symptomatic?
Yes 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%)
Re-evaluate by speculum exam in 3-5 days.
Has it resolved?
Re-evaluate by speculum exam in 2-3 days.
Has it resolved?
HOLD
Product and perform naked eye examination
CONTINUEHOLD
consult the PSRT. No No
Yes
Yes
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. CONTINUE product and perform naked eye pelvic examination
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 no
Continue
Product use
Protocol Reference: Section 9.5

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