1. PRECONCEPTION AND REPRODUCTIVE HEALTH FOR WOMEN AND MEN LIVING WITH HIV 2012 FTCC Meeting Shannon Weber, MSW Judy Levison, MD, MPH Mary Jo Hoyt, MS, FNP

2. What is preconception care it and why should we care about it? Shannon Weber, MSW

3. Disclosures  We have no financial disclosures.

4. Goals of preconception care in the context of HIV infection  Prevent unintended pregnancy  Prevent HIV transmission to partner  Optimize maternal & paternal health  Improve maternal and fetal outcomes  Prevent perinatal HIV transmission ACOG Practice Bulletin No 117; December, 2010

5. Importance of preconception care  Women and men living with HIV want to have children.  Many pregnancies among HIV-infected women are unintended.  Contraception is under utilized, including men in the conversation.  Women and men face barriers related to stigma and conception with serodiscordant partners  Preconception counseling and care not addressed pro-actively  Reproductive health care often not a priority for patients or providers

7. Estimated number of births to women living with HIV infection, 2000-2006 Office of Inspector General (Fleming), 2002 Whitmore, et al. CROI, 2009

8. amfAR email survey of US adults, n=4831 (2008)

9. HIV+ women internalize stigma around conception  Women Living Positive Survey  n=700 HIV+ women on ARVs for 3+ yrs  59-61% believed could have children if appropriate care  59% believed society strongly urges not to have children  Squires et al. AIDS PATIENT CARE and STDs 2011

10. Reduce stigma, normalize desires

11. What are reproductive rights?  The basic right of all couples and individuals to decide freely and responsibly the number, spacing and timing of their children and to have the information and means to do so, and the right to attain the highest standard of sexual and reproductive health. World Health Organization

12. Hey, Mom………

13. Unintended pregnancy Finer/Henshaw Perspec Sex Repro Health 2006; Massad AIDS 2004; Koenig AJOG 2007; Floridia Antivir Ther 2006 US general population49% pregnancies unintended US, WIHS 232 HIV+ women77% pregnancies while using contraception (vs. 60% HIV-) US1090 HIV+ adolescents 83.3% unplanned 49-52% HIV status known Italy334 HIV+ on ARV57.6% unplanned

15. Men’s sexual and reproductive health  Provides guidance to programs that plan to develop or enhance clinical services for male clients  Defines the scope of male sexual and reproductive health services and set standards for their content and design  Provides a wide range of prevention, health education and treatment issues related to male health and sexual function http://www.cicatelli.org/titlex/downloadable/MaleGuidelines2009.pdf

16. HIV heterosexual serodiscordant couples  Estimated to be 140,000 US serodiscordant couples  About half desire children  Lampe, et al Am Journal Of Obst and Gyn, 204(6), 488e1-8, 2011  Increasing call volume to the National Perinatal HIV Hotline (888-448-8765) from clinicians and patients seeking safer conception options.

17. Every interaction is an opportunity  To discuss HIV status or testing  To discuss reproductive health desires  Preconception  Contraception  Safer conception The stories in our lives do not always coincide with the reminders in the medical health record. Start the conversation. Stay open. Repeat.

18. Primary HIV care includes reproductive health  If we succeed at integrating preconception and family planning into primary care model  Every HIV-exposed pregnancy will be planned and well-timed  There will be no HIV transmission to infants or to uninfected partners  The health of all HIV-affected parents and infants will be optimized

19. Preconception Care Case Studies Judy Levison, MD, MPH

20. Science: There is evidence that individual components of preconception care work:  Rubella vaccination  HIV/AIDS screening  Management and control of:  Diabetes  Hypothyroidism  PKU  Obesity  Folic acid supplements  Avoiding teratogens:  Smoking  Alcohol  Oral anticoagulants  Accutane

21. Role Play!

22. Case 1—Roberta  30 year-old woman tested HIV+ positive during her recent pregnancy and started HIV treatment  CD4 (T-cells) have improved on treatment and her viral load is undetectable  Infant is 4 months old and HIV-uninfected  Plan:  Renew medications today, check labs before she returns for a check up in 3 months.  Encourage adherence  Remind to use condoms

23. Case 1—Roberta…  You ask about contraception.  She previously used oral contraceptives and asks about restarting them.  How do you counsel her?

24. Focus on couples where a partner is HIV-positive  How do you know if your patient and his/her partner are considering pregnancy?  You have to ask!  If they do NOT desire pregnancy, then ask what they are doing for contraception  Let’s review contraception and preconception counseling for couples who are infected or affected by HIV

25. Condoms  The one method that protects against STDs and provides contraception  How do your clients feel about using male condoms? Female condoms?

26. Male condoms

27. Female condoms

28. Condoms  However, 15% failure rate in preventing pregnancy  Many couples (even serodiscordant couples=one partner HIV+ and one partner HIV-) use condoms off and on, rather than always  So, a second method is recommended

29. Oral contraceptives  Same criteria as for HIV- women if woman is NOT on antiretroviral therapy (ART)  Problematic for HIV+ women on ART  Ritonavir, lopinavir, nelfinavir, amprenavir, and darunavir (PIs) and nevirapine (NNRTI) increase metabolism of ethinyl estradiol and/or norethindrone, thus lowering efficacy of OCPs  Atazanavir (PI) and efavirenz (NNRTI) increase ethinyl estradiol levels (clinical impact unknown) ACOG (2010), Gynecologic care for women with human immunodeficiency virus. Practice Bulletin #117.

30. Contraception

31. Other hormonal options  Patch (Ortho Evra), vaginal ring (Nuva Ring), and transdermal implant (Implanon)  Warnings are similar to OCPs regarding drug-drug interactions  However, in theory, they avoid the “first pass” effect of liver metabolism that may occur with oral agents and should not be subject to the same limitations as OCPs  Depo-Provera: OK (concerns that DMPA might increase HIV viral shedding have not been supported) Conference on Retroviruses and Opportunistic Infections (March 2012), Seattle.

32. Intrauterine devices (IUDs)  No known drug interactions  No increase in shedding of HIV  2 types  Copper (Paragard) works for 10 years, may be associated with heavier menses, periods regular)  Levonorgestrel IUD (Mirena) works for 5 years, reduces menstrual blood loss (is FDA-approved as a treatment for menorrhagia), periods scant and not regular

33. IUDs (2)

34. Permanent sterilization  Laparoscopic tubal ligation  Essure (hysteroscopically placed coils in tubes)  Postpartum tubal ligation  Vasectomy

35. Laparoscopic tubal ligation

36. Essure

37. Postpartum tubal ligation

38. Vasectomy

39. Integrating preconception and HIV care Challenges:  Lack of comfort and/or knowledge  Actual or perceived lower level of priority compared to other issues  Time constraints  Role of the primary care provider not entirely clear

40. The Serodiscordant Couple

41. Role Play!

42. Case 2--Julia  Julia is 31, HIV+, diagnosed 2 years ago after ending a relationship with an HIV-infected partner  No history of HIV-related illness  Not on HIV medications  CD4 in the 600's  VL is 65, 000  New partner is HIV-uninfected  Seems anxious and upset  Plan:  Discuss pros and cons of starting HIV treatment  Recommend HIV testing for partner  Reinforce the importance of using condoms.  Refer to a support group  Re-check her VL and CD4 in 3 months.  Continue to evaluate for and discuss HIV treatment

43. Case 2—Julia …  You ask Julia if she wants to have another child.  She says, “Yes.”  You ask, “When?”  She says, “ Now.”  How do you counsel her?

44. How do YOU feel about her wanting to get pregnant?  That is ridiculous—who will take care of your children if you die and you would risk having an HIV+ child?  I, as your health care provider, will be angry if you get pregnant.  I need to think about this.  You have every right to do this. Let’s work together to do it right.

45.  The first two responses may have been appropriate before we saw the successes of the HAART era  But in 2011:  Perinatal transmission is <1-2%  Men and women with HIV can expect to live to see their children grow into adulthood

46. Preconception counseling  If a woman is not on ARVs, consider starting them prior to attempting conception  If a woman is on ARVs and is considering pregnancy  Substitute other ARVs for efavirenz (Sustiva) because of possible risk of neural tube defects (NTDs)  Recommend folate or prenatal vitamins preconceptionally to reduce chance of NTDs

47. Serodiscordant couples  If the woman is HIV+ and the man is HIV-, discuss the options of:  Ovulation predictor kits  Home insemination (“turkey baster method”)

48. Ovulation predictor kits These replace the old basal body temperature charts

49. When the time is right, the choices are:  Home insemination with partner’s semen The “turkey baster” method * A needle-less syringe works fine

50. Alternatives  Insemination in a doctor’s office with partner’s semen  Having penile/vaginal intercourse only during the 24 hours after the LH surge and using condoms the rest of the month—if this is the plan, then placing the woman on ARVs prior to attempted conception will further protect her partner  Post or pre-exposure prophylaxis for male? If yes, how many doses? Baeten, J. and Celum, C. 2011. Antiretroviral pre exposure prophylaxis for HIV prevention among heterosexual African men and women: The Partners PrEP Study. Int. AIDS Society, Rome.

51. And one more word about condoms…  If we do not broaden our discussions around reproductive health (leaving it at "use condoms“), many individuals will do what they will do at home in order to achieve pregnancy  It’s much better that they conceive with support and knowledge of safe options. We don’t want clients to feel they have to hide their desire to have children.

52. Role Play!

53. Case 3—Richard  32 year old HIV- positive male diagnosed with HIV 3 years ago,  On ARVs. CD4 600 and VL<48 (undetectable)  Excited about plans to get married next month to a woman he’s been dating for a year  Plan:  Refill medications  Counsel on use of condoms  Return in 6 months

54. Case 3—Richard  You ask Richard whether his fiancee has been tested for HIV  He says, “Yes, and she is HIV-negative.”  You ask whether they are thinking about having children  He tells you, “Yes, sooner rather than later.”  How do you counsel him?

55. Serodiscordance  If the man is HIV+ and the woman is HIV-, consider:  Maximal viral suppression of the male  Ovulation predictor kit/ timed insemination with washed sperm  Intracytoplasmic sperm injection (ICSI)  Ovulation predictor kit/timed intercourse  Post-exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP) for female  Donor insemination

56. Sperm washing  Cost is in the $1500 range  Not widely available http://aids.about.com/cs/womensresources/a/washing.htm http://www.thebody.com/content/art911.html

57. Has the time come for natural conception in the context of full viral suppression?  Barreiro  62 serodiscordant couples  HIV+ partner on ART and VL < 500  No transmission of HIV  HPTN 052  96% reduction in transmission of HIV among serodiscordant couples (ARVs started if CD4 350-500) Barreiro et al. (2007) Is natural conception a valid option for HIV serodiscordant couples? Human Reproduction, 22 (9), 2353 Cohen, M. et al. 2011. Prevention of HIV-1 with early antiretroviral therapy. NEJM 365: 493-505.

58. What if both partners are HIV-positive?  When a couple is not attempting conception, we recommend condoms to avoid superinfection and sharing of antiretroviral resistant virus  If pregnancy desired: Ovulation predictor kit, maintaining an undetectable viral load, and once monthly unprotected sex is a reasonable approach

59. How can contraceptive and preconception care be integrated into routine care? Mary Jo Hoyt, MSN

60. Integrating preconception and HIV care  Simplify:  Ask patients about reproductive plans  Discuss the importance of planning for pregnancy  Ensure contraceptive needs are met  Develop a preconception plan in consultation with experts

61. Integrating preconception and HIV care  Co-locate/integrate OB-GYN and HIV services  Develop collaborative relationships, bilateral communication, formal linkages, referral indications and practice guidelines  Consider development of a peer educator program  Provide training and support

63. General preconception care resources  CDC preconception care site: http://www.cdc.gov/ncbddd/preconception/ http://www.cdc.gov/ncbddd/preconception/  Preconception care advocacy group: http://www.beforeandbeyond.org. Includes http://www.beforeandbeyond.org  2011 preconception summit information  Professional education materials  Published articles

64. Number 117, December 2010 Gynecologic Care for Women With Human Immunodeficiency Virus Guidelines

65. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States  Preconception Counseling and Care for HIV-Infected Women of Childbearing Age  Reproductive Options for HIV-Concordant and Serodiscordant Couples http://www.aidsinfo.nih.gov

66. Training  This site will offer self-study modules (CEUs/CMEs available) covering ACOG guidelines on reproductive health care in the context of HIV. http://womenandhiv.org [Coming soon]

67. Training  FXB Center will host Preconception Care webinar. Self-study modules will also be available [Coming soon]  Preconception care in the context of HIV infection  Contraceptive care for women/couples living with HIV infection  Safer conception for HIV-discordant couples Webinar Self-study modules http://www.fxbcenter.org/ http://www.aids-etc.org

68. Support tools: Patient Brochure

70. Support Tools: EPIC Template  Are you interested in having a child?  When do you wish to conceive?  Currently 6 mos-1yr, 1-2 years; >2years  Are you currently using condoms?  Are you currently using contraceptive other than condoms:?  If Yes what method:  If no are you seeking pregnancy:  Would you like information on planning a safe pregnancy that may reduce the risk of HIV transmission to your partner and your baby?  Do you know and understand your CD4 count and viral load?

71. Support Tools: EPIC Template (2)  Do you understand the importance of being in optimal health before becoming pregnant?  Counseling elements when definitely considering pregnancy:  Antiretroviral medications that are not recommended in pregnancy (e.g. EFV)  Options for discordant couples:  Referral to Women’s Service: Preconception Counseling

72. Support tools: Client questionnaire

73. Support tools: Provider Checklist

74. Support tools: Counseling Guide A counseling guide for providers with suggested scripts for discussing fertility desires and preconception care with women of reproductive are living with HIV.

77. Support tools: Guidelines for Use of ARV Therapy in Pregnancy

78. Clinical tools: Guidelines for Use of ARV Therapy in Pregnancy

79. Expert consultation and information updates The ReproIDHIV listserv is a forum for discussing clinical cases, finding patient referrals, sharing protocols and upcoming events, and networking with colleagues.  Sponsored by:  UCSF/HRSA National HIV/AIDS Clinicians’ Consultation Center  Infectious Disease Society of Obstetricians and Gynecologists  UCSF Fellowship in Reproductive Infectious Disease  http://www.nccc.ucsf.edu/ http://www.nccc.ucsf.edu/ To be added to the listserv contact: Shannon Weber sweber@nccc.ucsf.edu

80. Expert Consultation(at no cost)  Perinatal HIV Hotline  National Perinatal HIV Consultation and Referral Service  1-888-448-8765  Warmline  National HIV/AIDS Telephone Consultation Service  1-800-933-3413

81. Speaker contact information Shannon Weber, MSW National HIV/AIDS Clinicians' Consultation Center sweber@nccc.ucsf.edu Judy Levison, MD, MPH Baylor College of Medicine jlevison@bcm.edu Mary Jo Hoyt MSN, FNP FXB Center, UMDNJ AETC National Resource Center hoyt@umdnj.edu