Welcome! The Webinar will being in just a few minutes. Please remember to turn on your computer speakers and adjust speaker volume. REPRODUCTIVE HEALTH AND HIV: PRECONCEPTION CARE, FAMILY PLANNING & SAFER CONCEPTION This teleconference is made possible by the Cooperative Agreement #5U65PS000815-03 from the Centers for Disease Control and Prevention Special thanks to AETC, Title X and CDC EMCT partners The views expressed by the speakers and moderators do not necessarily reflect the official polices of the Dept. of Health and Human Services nor does mention of trade names or organizations imply endorsement by the U.S. Government. Webinar schedule Session 1: Preconception Care in the Setting of HIV Infection Session 2: Contraceptive care for women/couples living with HIV infection Session 3: Safer conception for HIV-discordant couples Navigating the Webinar Three short videos will be shown during the webinar Please close other applications on your computer At times during the webinar, we will ask poll questions A separate window will show the questions Choose your response Responses will be displayed after you vote Please type your questions or comments for the speakers in the chat box at the bottom right of your screen. Materials and Evaluation Participants will receive and e-mail with links to the webinar recording, slide set, support tools and evaluation survey The link for the evaluation survey is available in the chat box If you did not register for this event, please send your name and e-mail address to phillijm@umdnj.edu Preconception care in the setting of HIV infection William Short MD, MPH Assistant Professor of Medicine, Division of Infectious Diseases Jefferson Medical College of Thomas Jefferson University William.Short@jefferson.edu Module objectives Explain the goals and discuss the importance of preconception care in the context of HIV. Demonstrate preconception counseling for women and couples with HIV, including special considerations for preconception counseling for HIVinfected men. Describe preconception assessment and interventions for women living with HIV. Module objectives Explain the role of the HIV primary care provider in preconception counseling and care Discuss models of integration of preconception care Case study Gloria is a 32 year old HIV+ AA female HIV acquired from a previous boyfriend No significant medical history/on no medication CD4 380 and viral load is 24,000 She is returning for her 2nd visit to discuss ART Role Play Poll amfAR, n=4831 US adults email survey (2008) 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 Caucasian (67%) vs. Hispanic (53%), (p < 0.05) South (66%) vs. Northeast (52%) or Midwest (55%), (p < 0.05) ID (62%) vs. FP/GP (62%) vs. NP or PA care (48%) (p < 0.05) Squires et al. (2011) AIDS patient care and STDs Fertility desires and intentions Studies of fertility desires and intentions have consistently shown that many women living with HIV want to have children. Survey of >1400 HIV+ adults in care in 1998: 28% of bisex/heterosex men 29% of women want children in future Survey of 450 HIV+ women in the UK in 2011 75% stated they wanted more children Fertility desires and intentions Factors Associated with fertility desires Positive influence Negative influence • • • • • • • • • • Younger age No children Antiretroviral therapy Interventions for PMTCT Partner’s/family members’ wish for children • HIV-related stigma Already having one or more children Personal health concerns Concerns about infecting partner Concerns about infecting child Negative or judgmental attitudes of health workers, family • HIV-related stigma Contraceptive Use Among US Women with HIV Women's Interagency HIV Study (WIHS): In over 30% of these visits, HIVinfected women reported not using any form of contraception. Massad et al. (2007) J Women’s Health Estimated # of births to women with HIV 9000 8500 8000 7500 7000 6500 6000 5500 2000 2001 2002 2003 High Estimate 2004 2005 2006 Low Estimate Fleming (2002) Office of Inspector General Whitmore, et al. (2009) CROI Live birth rates among HIV+ women before and after HAART availability Comparison of live birth rates 1994-1995 (pre-HAART era) and 2001-2002 (HAART era) in HIV+ and HIVwomen 15-44 years Largest difference (306% increase) was seen in women >35 years old In HAART era, 150% increase in live birth rate among HIV+ women vs. 5% increase among HIV- women Sharma, et al. AJOG 2007 Preconception care “Interventions that aim to identify and modify biomedical, behavioral and socials risks to a women’s health or pregnancy outcomes through prevention and management” Early prenatal care is not enough CDC. MMWR 2006;55:1-23 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 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 Unintended pregnancy US general population US, 232 HIV+ women WIHS 49% pregnancies unintended 77% pregnancies while using contraception (vs. 60% HIV-) US 83.3% unplanned 49-52% HIV status known 57.6% unplanned Italy 1090 HIV+ adolescents 334 HIV+ on ARV Finer and Henshaw (2006) Perspec Sex Repro Health; Massad (2004) AIDS Koenig (2007) AJOG ; Floridia (2006) Antivir Ther Are HIV providers discussing reproductive desires? Women Living Positive Survey (n=700, ARVs for 3+ years) 48% previously pregnant or considering pregnancy were never asked about their pregnancy intentions (n=227) 57% currently or previously pregnant or considering pregnancy had not discussed treatment options (n=239) 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. 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 Squires et al (2011) AIDS pt care and STDs Establish reproductive desires WHO? Every reproductive-aged woman and man Even if they do not have a current sexual partner WHEN? At initial evaluation Intervals throughout the course of care Conduct preconception counseling Conduct preconception counseling when: There is an expressed interest in conceiving There is nonuse/inadequate use of effective contraception There is a change in relationship or personal circumstances Conduct preconception counseling Conduct preconception counseling when: She is taking medications with potential reproductive toxicity or interaction with hormonal contraception She is at risk for unintended pregnancy There is new information about pregnancy and HIV She plans enrollment in a clinical trial Conduct preconception counseling Impact of pregnancy on HIV and impact of HIV on pregnancy Risk factors for MTCT and strategies to reduce those risks ARV medications C-section Avoidance of BF Risks/benefits of HIVrelated medications Disclosure of HIV diagnosis Partner testing Safer conception options Conduct preconception counseling Address alcohol, drugs and/or tobacco use Recommend avoidance of OTCs Consider delaying pregnancy until health is optimized Optimize preconception health Screen for: Syphilis Provide: Refer for: Genetic screening, based on history Contraception, as needed, to delay pregnancy while health issues are addressed Folic acid 400 mcg daily Immunizations, as needed, for: hepatitis B rubella varicella Optimize preconception health Perform clinical staging, CD4 testing and viral load as indicated Assess and treat opportunistic infections Assess need for prophylaxis against OIs Optimize treatment/control of other chronic diseases Review all medications for safety in pregnancy Consider ARV treatment Initiate/modify ARV treatment for women who need it for their own health: Consider the regimen’s effectiveness for treatment of HIV, hepatitis B disease status, potential for teratogenicity and possible adverse outcomes . Adjust ARV regimens to exclude efavirenz or other drugs with teratogenic potential during the preconception period. How can preconception care be integrated into the HIV primary care setting? 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 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 Integrating preconception and HIV care Provide training and support Guidelines: Perinatal HIV guidelines and ACOG practice bulletin clearly describe components of preconception care Training curriculum and job aids: Links to materials will be sent to webinar participants Integrating preconception and HIV care Simplify approach by emphasizing core principles: Ask clients of reproductive age about their reproductive plans Discuss the importance of planning for pregnancy to ensuring preconception health/safer conception Ensure contraceptive needs are met Develop a preconception plan for women/couples who want to become pregnant or who are not using adequate contraception Integrating preconception and HIV care An informational brochure for clients on preconception health and the importance of preconception care Integrating preconception and HIV care Guide to preconception counseling for the HIV care provider Questions and Comments* *Type in the chat box and then click “Enter” Contraceptive Care for Women with HIV Infection and their Partners Kimberly McClellan, MSN, WHNP-BC, CRNP Director Women's Health AIDS Care Group, Chester PA ksv23@drexel.edu Objectives Describe considerations for selecting appropriate contraceptive and compare options for women living with HIV Explain specific consideration related to hormonal contraception and antiretroviral treatment Identify issue related to hormonal contraception and HIV progression, transmission or acquisition Case study One year later: Gloria initiated ATV/r + TDF/FTC combination therapy and has achieved viral suppression with CD4 count of 500 She is here for a routine visit and is doing well Role Play Poll Benefits of Contraception for HIV-Positive Women Prevents unintended pregnancy Half of all pregnancies in U.S. are unintended Allows women to plan a pregnancy that Is well timed Occurs in optimal health Minimizes risks for perinatal transmission Special Considerations Regarding HIV and Contraception Potential drug interaction with antiretrovirals (ARVs) Possible effects on HIV transmission Possible effects on HIV acquisition Possible effects on HIV progression Typical Effectiveness of Contraception HIV-positive women generally have the same options as uninfected women US Medical Eligibility Criteria for Contraceptive Use US Medical Eligibility Criteria: Categories Oral contraceptives Same medical criteria as for HIV-uninfected women if woman is NOT on ART Drug-drug interactions are possible between ARVs and hormonal contraceptives (HCs) HCs are metabolized by same pathways and cytochrome P450 enzymes as many PIs and NNRTIs These interactions can cause changes in the efficacy of the ARV or contraception ACOG (2010), Gynecologic care for women with human immunodeficiency virus. Practice Bulletin #117. Hormonal Contraception: Alternate Delivery Methods Combined Patch is a thin plastic square worn on body Releases estrogen and progestin through the skin Works by preventing ovulation Efficacy Limited research suggests may be more effective than COCs Decreased efficacy in women over 90 kg Hormonal Contraception: Alternate Delivery Methods Limited research suggests health risks and benefits are similar to COCs Side Effects Skin irritation or rash where patch is applied Changes in bleeding pattern Headaches Nausea Vomiting Breast tenderness Abdominal pain Hormonal Contraception: Alternate Delivery Methods Combined Vaginal Ring is placed into the vagina Releases estrogen and progestin Works by preventing ovulation Efficacy Limited research suggests may be more effective at preventing pregnancy than COCs Alternative Delivery Methods Limited research suggests risks and benefits similar to COCs Side effects Changes in bleeding pattern Headaches Nausea Breast tenderness Vaginitis Leukorrhea/increase in Lactobacillus Alternate Delivery Methods These delivery methods also vulnerable to drug interactions One small study found significant interaction between the estrogen and progestin hormones of the patch and lopinavir/ritonavir More research needed on these delivery methods DMPA Injectable (IM,SQ) progestin only contraception Given every 3 months Works by preventing ovulation Efficacy 97% effective as commonly used Over 99% effective when used as directed (3 pregnancies per 1000 women) Contraceptive Implants Thin rods or tubes containing a progestin hormone. Provide effective contraception for at least 3 yrs. Suppresses ovulation and changes cervical mucus. Menstrual irregularities in most users. 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 Medical Eligibility Criteria for IUD* LNG-IUD LNG-IUD Cu-IUD Cu-IUD Initiation Continuation Initiation Continuation High Risk for HIV 2 2 2 2 HIV Infection 2 2 2 2 AIDS 3 2 3 2 Clinically Well on ARV Therapy 2 2 2 2 *Adapted from: U.S. medical eligibility criteria for contraceptive use. Category 2: A condition for which the advantages of using the method generally outweigh the theoretical or proven risks. Category 3: A condition for which the theoretical or proven risks usually outweigh the advantages of using the method. IUD and HIV Considerations No higher risk in HIV-positive women over uninfected women for Complications Infections IUD use not associated with increased risk for transmission to sex partners Women with IUD in place who develop AIDS should be monitored for pelvic infection Hormonal Contraception and NNRTI Interaction Table No effect on oral ethinyl estradiol Decreased active metabolites of norgestimate (levonorgestrel AUC ↓ 83%; norelgestromin ↓64%) A reliable method of barrier contraception must be used in addition to HC due to decreases in progestin levels. Implant: ↓ etonogestrel A reliable method of barrier contraception must be used due to reports of contraceptive failure. Levonorgestrel AUC ↓58% Effectiveness of emergency contraception may be diminished Etravirine (ETR) Ethinyl estradiol AUC ↑22% Norethindrone: no significant effect No dosage adjustment necessary Nevirapine (NVP) Ethinyl estradiol AUC ↓20% Norethindrone AUC ↓19% Use alternative or additional methods Efavirenz (EFV) No dosage adjustment needed DMPA: no significant change Hormonal Contraception and Ritonavirboosted PI Table Atazanavir/ritonavir (ATV/r) ↓ Ethinyl estradiol ↑ Norgestimate Oral contraceptive should contain at least 35 mcg of ethinyl estradiol. OCs containing progestins other than norethindrone or norgestimate have not been studied. Darunavir/ritonavir (DRV/r) Ethinyl estradiol ↓44% Norethindrone AUC ↓14% Use alternative or additional method. Fosamprenavir/ritonavir (FPV/r) Ethinyl estradiol AUC ↓ 37% Norethindrone AUC ↓34% Use alternative or additional method. Lopinavir/ritonavir (LPV/r) Ethinyl estradiol AUC ↓42% Norethindrone AUC ↓17% Use alternative or additional method. Saquinavir/ritonavir (SQV/r) ↓Ethinyl estradiol Use alternative or additional method. Tipranavir/ritonavir (TPV/r) Ethinyl estradiol AUC ↓48% Norethindrone: no significant change Use alternative or additional method. Hormonal Contraception and PIs without Ritonavir Table Atazanavir (ATV) Ethinyl estradiol AUC ↑48% Norethindrone AUC ↑110% Oral contraceptive should contain no more than 30 mcg of ethinyl estradiol or use alternative method. OCs containing less than 25 mcg of ethinyl estradiol or progestins other than norethindrone or norgestimate have not been studied. Fosamprenavir (FPV) With APV: ↑Ethinyl estradiol and ↑norethindrone; ↓APV 20% Use alternative method. Indinavir (IDV) Ethinyl estradiol AUC ↑25% Norethindrone AUC ↑26% No dose adjustment. Nelfinavir Ethinyl estradiol AUC ↓47% Norethindrone ↓18% Use alternative or additional method. Adapted from: 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. http://aidsinfo.nih.gov/ContentFiles/PerinatalGL.pdf Hormonal Contraception and CCR5 antagonist/integrase inhibitor table CCR5 antagonist Maraviroc (MVC) No significant effect on ethinyl estradiol of levonorgestrel Safe to use in combination No significant drug effect No dose adjustment necessary Integrase inhibitor Raltegravir Adapted from: 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. http://aidsinfo.nih.gov/ContentFiles/PerinatalGL.pdf Condoms Efficacy Pregnancy prevention as commonly used Pregnancy prevention when used correctly and consistently Male condom 85% Female condom 79% Male condom 98% Female condom 95% Male condom is 80-95% effective at preventing HIV transmission when used correctly and consistently Dual Contraceptive Use Condom use should be encouraged for women To prevent HIV/STI acquisition Condom use should be encouraged in HIV-positive women To prevent HIV transmission Prevent STI acquisition As an adjuvant to contraceptives Condoms alone have a failure rate of 15%-21% at preventing pregnancy Spermicides: Not recommended Spermicides are not recommended by CDC Disrupt cervical mucosa Potentially increase viral shedding Increase transmission of HIV to uninfected partners Diaphragms and cervical caps are not encouraged by the CDC due to concerns about their use with spermicides Female and Male Sterilization Contraceptive sterilization is Male-vasectomy: the most widely used Cutting/occluding both vas method of family planning deferens Clients should be advised that sterilization should be considered permanent 1st yr failure rate-0%-0.5% Female-sterilization Transabdominal Transcervical Tubal sterilization Occlusion method Hormonal Contraception and HIV Acquisition: WHO Technical Statement Most studies found no statistically significant association between oral contraception and HIV acquisition Evidence on injectable HC varied with some studies showing increases between 48% to 100% and other studies reporting no association Due to inconsistent data and limitations of the studies performed WHO rated the current evidence as low HIV Transmission and Hormonal Contraception: WHO Technical Statement Recent observational study found a 2-3 increase in HIV transmission in women using injectables over oral contraception Findings from studies assessing HC and genital HIV shedding are not consistent Studies assessing HC and viral load generally showed no negative effect WHO rates the evidence for HIV transmission and injectable use as low and HIV transmission and oral contraception as very low HIV Disease Progression and Hormonal Contraception: WHO Technical Statement None of the 10 observational studies conducted found a significant association between hormonal contraception and HIV progression One randomized controlled trial found an increased risk of progression for HC users compared to copper IUD users Due to flaws in this study --- high rates of method switching and loss to follow-up --- the evidence for HC and HIV progression is rated as low WHO Recommendations No restriction on the use of any hormonal contraceptive method for HIV-positive women or women at high risk for HIV infection Critical importance must be placed on the consistent and correct use of condoms for the prevention of HIV acquisition or transmission Most concern is focused on the evidence of HIV acquisition and DMPA because a causal relationship is neither established nor ruled out Voluntary use of contraception by HIV positive women who wish to prevent pregnancy continues to be an important PMTCT strategy Questions and Comments* *Type in the chat box and then click “Enter” Safer Conception for Sero-Discordant Couples Judy Levison, MD, MPH Associate Professor, Departments of Obstetrics and Gynecology and Family and Community Medicine Baylor College of Medicine Houston, Texas jlevison@bcm.edu Objectives Describe two methods of conception for an HIV+ woman and an HIV- man List three methods of conception for an HIV+ man and an HIV- woman The Serodiscordant Couple HIV discordance in couples Population based sample of HIV infected persons in care 58% of men and 70% of women had a primary partner 50% of couples were in serodiscordant relationships 20% were in relationships with partners whose HIV status was unknown Family Planning Perspectives, 33 (4); 144-52, 2001 Estimated 140,000 serodiscordant heterosexual couples in the U.S., about half of whom want children Am Journal of Obst and Gyn, 204(6), 488e1-8, 2011 Case presentation Two years later: Gloria continues to do well on her combination regime and maintains an undetectable viral load. At this appointment she seems anxious to discuss some big news. Role Play Poll The first two responses may have been appropriate before we saw the successes of the HAART era But in 2012: Perinatal transmission is <1-2% Men and women with HIV can expect to live to see their children grow into adulthood 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 Serodiscordant couples If the woman is HIV+ and the man is HIV-, discuss the options of: Ovulation predictor kits Home insemination (“turkey baster method”) Ovulation predictor kits These test kits replace the old basal body temperature charts When the time is right, the choices are: Home insemination with partner’s semen The “turkey baster” method *A needle-less syringe works fine Home insemination During the 24 hours after the LH surge has occurred as documented by the ovulation predictor kit, ejaculate into a cup or into a condom without a spermicide Suction semen into a syringe Place syringe in vagina and deposit semen Remain lying down for 20 minutes Return to having protected sex with condoms Alternatives Insemination in a doctor’s office with partner’s semen Penile/vaginal intercourse only during the 24 hours after the LH surge and using condoms the rest of the month. Placing the woman on ARVs prior to attempted conception will further protect her partner Post or pre-exposure prophylaxis for male (PEP or PrEP)? If yes, how many doses? Baeten, J. and Celum, C. (2011) The Partners PrEP Study. Int. AIDS Society, Rome 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. 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 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 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) Human Reproduction, 22 (9), 2353 Cohen, M. et al. (2011). NEJM 365: 493-505. 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 Preconception counseling is not being addressed Data suggests that reproductive counseling does not often occur until after conception Recent study of 181 women: Only 31% reported a personalized discussion with their provider specific to their childbearing plans. Of those who had a personalized discussion, most were initiated by the client rather than the provider. S. Finocchario-Kessler, et al., AIDS Patient Care and STDS, 24(5), 317-23, 2010 Support Tools: EPIC Template Are you interested in having a child? When do you wish to conceive? Are you currently using condoms? Are you currently using contraceptive other than condoms? Currently 6 mos-1yr, 1-2 years; >2years 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? Support Tools: EPIC Template Do you know and understand your CD4 count and viral load? 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 Final notes on preconception counseling… Contraception and pregnancy desires change over time. Just because someone did not desire pregnancy in 2011 does not tell you what he or she wants in 2013. Don’t forget to ask the men if they and their partners are planning a pregnancy. Let them know that there are preconception counseling services available. Questions and Comments* *Type in the chat box and then click “Enter” Thank you! Participants will receive and e-mail with links to the webinar recording, slide set and support tools Please visit this link to submit your evaluation: https://www.surveymonkey.com/s/preconception2012 If you did not register for this event, please send your name and e-mail address to phillijm@umdnj.edu