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Management of Pregnancies

Management of Pregnancies. 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

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Management of Pregnancies

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  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!

  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

  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.

  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

  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?

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