1. Management of Pregnancies

2. Remember… Pregnant women are excluded from enrollment in HOPE
Women who enroll in HOPE must be on an effective method of contraception
Pregnancy testing will be performed at every scheduled visit and at interim visits, if indicated
Even considering all of this, we still expect some women in HOPE to get pregnant!
Sites should encourage participants to report all signs or symptoms of pregnancy to study staff. If a participant is between study visits and suspects she may be pregnant, she may come to the clinic for an interim visit (this may be especially relevant during the quarterly visit follow-up portion of study participation)

3. Modified Procedures for Pregnant Participants
ALL study procedures including pregnancy testing continue except:
Offering a vaginal ring and giving product use instructions
Pelvic exams and self-administered vaginal fluid swabs after 24 weeks, unless participant willingness to continue these procedures is documented in her chart

4. Modified Procedures for Pregnant Participants
HIV prevention options counseling will continue, but adherence counseling portion of this will be discontinued. Tailor the session to focus on HIV risk reduction plans during pregnancy not including the ring
Contraceptive counseling may be abbreviated and tailored throughout pregnancy:
Early: Pregnancy by choice or contraceptive failure?
Late: Method selection post-delivery
Refer participant to antenatal care

5. Product Management: Hold
If during product use period:
Vaginal Ring Request Slip to pharmacy (only if prescription previously completed)
Clinical Product Hold/Discontinuation Log Form to SCHARP (regardless of acceptor/non-acceptor)

6. Product Management: Resume
Ring use may resume following pregnancy outcome and breastfeeding cessation, if applicable.
No earlier than 2 weeks after 1st trimester loss
No earlier than 4 weeks after 2nd trimester loss or delivery
Negative pregnancy test and pelvic exam required prior to product resumption
If date of pregnancy loss is unknown, restart timeline should be based off a negative pregnancy test.

7. Counseling for Pregnant Participants
IoR/designee should counsel follow site SOPs. Counseling to include:
Pregnant participants can continue follow-up in HOPE, but study product will be held because dapivirine has not been formally studied in pregnant women
Pregnant participants and their infants may join MTN-016.
The IoR/designee will counsel any participant who becomes pregnant regarding possible risks to the fetus according to site SOPs. This counseling may include messages such as:
• Like for any new medication, Dapivirine has not been formally evaluated in women who are pregnant – medications are usually studied in women who are not pregnant first.
• For that reason, women who become pregnant in HOPE are withdrawn from the study medication.
• Studies in animals, and studies in women of medications similar to Dapivirine, do not suggest harm to women who become pregnant or their babies.
• It is important to gather additional information in women for Dapivirine, and that is the reason that the study sites will follow women who become pregnant in HOPE and their infants.
• Participants who became pregnant in ASPIRE were/are also being followed in MTN-016, however the results from this study are not available yet. We will provide participants results of this study when known.

8. Counseling for Breastfeeding Participants
If live birth:
Counsel participant to continue breastfeeding in accordance with WHO as well as local/national guidelines
We do not know if dapivirine passes into breast milk or what effect it might have on babies
Current studies are ongoing to evaluate safety of dapivirine rings in breastfeeding women. Results will be shared if/when available.

9. Documentation
In addition to Vaginal Ring Request Slip and Clinical Product Hold/Discontinuation Log Form, complete:
Pregnancy Report and History CRF
Pregnancy Outcome CRF
Note: Continue to follow participants after Study Exit/Termination Visit until pregnancy outcome ascertained or PSRT agrees this is not possible
Whenever possible, collect medial records/other written documentation of pregnancy outocome

10. Pregnancy Management Tool
Pregnancy management worksheet available on HOPE website

11. MTN-016
All potentially eligible participants should be referred to MTN-016
Written referral not required, but must document referral in chart notes
Consider strategies to encourage/facilitate high uptake of MTN-016 from the start of HOPE!

12. Questions?