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REPRODUCTIVE CHOICE AND FAMILY PLANNING FOR PERSONS LIVING WITH HIV/AIDS Nikole D. Gettings, BS, RN, MSN, CNM, APN ACTIVITY PLANNING COMMITTEE Medical Review Committee Donna Randolph, MD, CHOICES Medical Director Bev Byrum, MSN, NP, Adjunct Faculty, Vanderbilt School of Nursing Nikole Gettings, MSN, CNM, CHOICES Clinic Services Director Patricia M. Flynn, MD, Member, St. Jude Faculty, Arthur Ashe Chair in Pediatric AIDS Research, Director, Clinical Research, Infectious Diseases, Director, Translational Trials Unit, Co-Leader, HIV Therapeutics & Vaccine Development, CIDC Victoria Harris, Ed.D. Director of Education, TN AIDS Education & Training Center, Vanderbilt Comprehensive Care Clinic Project Administrative Coordination: Lanita Williams, MPH, ARHP Program Manager Katherine Leopard, CHOICES Community Partners Coordinator Jennifer Pepper, CHOICES Assistant Director LEARNING OBJECTIVES: AFTER TODAY’S PRESENTATION THE LEARNER WILL: Discuss the reproductive life needs of persons living with HIV and demonstrate the ability to assist patients to develop an effective reproductive life plan. 2. Explain to patients the most effective contraception options and the specific drug interaction between HAART and hormonal birth control methods. 3. Provide counseling tips regarding pregnancy options for persons living with HIV in a non-directive way including healthy preconception practices. 4. Identify local and national resources for reproductive health care for persons living with HIV. 1. HIV STATISTICS (2007) MCGOWAN, PEPPER, GETTINGS, CAPECE AND RINSDALE, 2014 Has Your HIV Medical Provider talked to you about Pregnancy Planning Yes 41% No 59% Case Study # 2: When are you planning a pregnancy? Kayla • 37 yo AA female, presents for annual GYN and STI Screening • Sexually Active • Was on Depo with PCP; unsure of why depo was stopped about 9+ months prior • Does not want any additional pregnancies Case Study # 2: When are you planning a pregnancy? Kayla PMH Medications Family History Social History Sexual Health History DEVELOPING A REPRODUCTIVE LIFE PLAN: PREGNANCY PLANNING When do you want to plan a pregnancy? How many pregnancies or children would you like to plan? Are there health issues you should address before planning a pregnancy? Do you have special medical needs you will need care for during a pregnancy to protect the health of yourself or your baby? Ezeanolue, E., et al (2011); Squires, et al., (2011) ; MMWR June 2013; MMWR April 2014 DEVELOPING A REPRODUCTIVE LIFE PLAN: PREGNANCY PREVENTION How do you want to prevent a pregnancy? How long do you want to prevent a pregnancy? What would you do if a pregnancy occurred now? What has worked well for you in the past? What have you heard about? What did you like or not like about a previous method? Partner involvement in decision making? Special Medical or health issues? MMWR June 2013; MMWR April 2014 DEVELOPING A REPRODUCTIVE LIFE PLAN: PATIENT DECISION FACTORS Cost Side effects Delivery Method Control How long will it work Effectiveness MMWR June 2013; MMWR April 2014 DEVELOPING A REPRODUCTIVE LIFE PLAN: CLINICIAN DECISION FACTORS Fertility Desire Medical History and co-morbidities Age Smoking Status Access to healthcare Adherence to healthcare Decision making ability MMWR June 2013; MMWR April 2014 CATEGORIZING CONTRACEPTION Hormonal Non Hormonal Pill Withdrawal Patch Spermicide Ring Condom (Male and Female) Medroxyprogesterone Copper Intrauterine Device Levonogestral Sterilization Intrauterine Device Male Female CATEGORIZING CONTRACEPTION Short Acting Long Acting Withdrawal Medroxyprogesterone Spermicide Levonogestral Condoms (Male and Female) Pills Patch Ring Intrauterine Device Copper Intra Uterine Device Sterilization Male Female WHO ELIGIBILITY CRITERIA FOR STARTING CONTRACEPTION WHO 1: Can use the method. No restrictions to use WHO 2: Can use the method. Advantages generally outweigh the theoretical or proven risks. If method is chosen, more than usual follow up may be indicated. WHO 3: Should not use the method unless clinician makes clinical judgment that patient can safely use it. Method of last choices, for which regular monitoring may be indicated. WHO 4: Should not use method. Condition represents an unacceptable risk if method is used. QUALITY OF EVIDENCE I: Evidence obtained from at least one properly designed randomized controlled trial. II-1: Evidence obtained from well-designed controlled trials without randomization. II-2: Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group. II-3: Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments also could be regarded as this type of evidence. III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees. U.S. Preventative Services Task Force QUALITY OF RECOMMENDATIONS BASED ON RESEARCH Level A: Recommendations are based on good and consistent scientific evidence Level B: Recommendations are based on limited or inconsistent scientific evidence Level C: Recommendations are based primarily on consensus and expert opinion. American College of Obstetricians and Gynecologists, 2010 GUIDELINES CDC: MMWR U.S. Selected Practice Recommendations for Contraceptive Use, 2013 Vol. 62, No. 5; June 21, 2013 Providing Quality Family Planning Services: Recommendations of the CDC and the U.S. Office of Population Affairs,Vol. 63, No. 4; April 25 2014 American College of Obstetricians and Gynecologists ACOG: 2010 Practice Bulletin No. 117, Dec. 2010 The care of HIV-infected Woman CONTRACEPTION AND HIV: SPECIAL FACTORS Pregnancy Prevention Effectiveness Risk of HIV infection acquisition Risk of HIV progression Risk of increase viral load of HIV Risk of decrease CD-4 count Risk of infectious complications Additional risk of STI vulnerability Risk of overall complications Risk of increased transmission rate of HIV to partner(s) ACOG, 2010; Ezeanolue, et al., 2011 LARC: INTRAUTERINE DEVICES (IUDS) WHO Category 2 No difference in complications between HIV+, clinically well, and HIV- women Higher rate of efficacy than combined oral contraceptives No adverse effects on CD4 count No association between IUD and HIV transmission: No increased genital shedding of HIV RNA Women with advanced immunosuppression: WHO 3, monitor closely for signs of infection Kapiga 1998, Morrison 2001; Heikinheimo, et al. 2006; Richardson et al, 1999 LEVONOGESTRAL INTRAUTERINE SYSTEM Levonorgestrel-containing (Mirena and Skyla): Studies are limited, but growing body of evidence continues to support use with same WHO criteria as Copper IUD: 2/3 • Limited studies show no known drug interactions for women on HAART • No increase in HIV RNA genital shedding • No decrease in CD4 Lehtovirta, P, et al., 2007; Heikinheimo, et al., 2006 IUD PATIENT COUNSELING PEARLS: COPPER IUD (PARAGARD) Primary mechanism is copper ion effects on sperm 1-10 year Cost effective No Hormonal Side Effects Menstrual bleeding Ongoing Evaluation: Annual or symptom based Hatcher, et al., Contraceptive Technology, 2007. IUD PATIENT COUNSELING PEARLS: LEVONOGESTREL INTRA-UTERINE SYSTEM Primary mechanism: thickens cervical discharge to inhibit sperm mobility Secondary mechanism: ovulation inhibition and resultant endometrial thinning 1-5 years Cost effective Hormonal Side Effects Bleeding Pattern Evaluation: Annual or symptom based Hatcher, et al., Contraceptive Technology, 2007 LARC: LEVONORGESTREL – IMPLANT (NEXPLANON/IMPLANON) WHO Category: 1 Specific Studies are very limited Similarities to other hormonal methods Fakoya 2008 LEVONORGESTREL IMPLANT: PATIENT COUNSELING PEARLS Primary mechanism: thickens cervical discharge to inhibit sperm mobility Secondary mechanism: ovulation inhibition and resultant endometrial thinning May be used for 1-3 years Provider Training Implantation: Needle Removal: small incision Bleeding pattern Other hormonal side effects; scarring with insertion or removal Evaluation: Redness, persistent pain at site of insertion Hatcher, et al., (2007), Contraceptive Technology; LARC: MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) WHO Category: 1 No risk of HIV disease progression No adverse effects on CD4 count or viral load Inconsistent results regarding hormonal contraceptive and increased risk of HIV-1 DNA or RNA shedding from genital tract. Weight Gain/Loss Bone Mineral Density Fat Re-Distribution Minimal to no drug interactions Watts 2008, Yin 2005, Brown 2007 MEDROXYPROGESTERONE ACETATE: PATIENT COUNSELING PEARLS Primary Mechanism of Action: Primary mechanism: thickens cervical discharge to inhibit sperm mobility Secondary mechanism: ovulation inhibition and resultant endometrial thinning 3 month intervals (13 weeks) Delivery method: Shot, unable to remove once administered Cost Effective Hormonal Side Effects Bleeding Pattern Other Side Effects: Headaches, depression Weight Calcium Supplementation Hatcher et al., Contraceptive Technology, 2007; Watts, et al., 2008 SHORT ACTING HORMONAL METHODS: THE PILL, PATCH, AND RING WHO Category 1 Attention to drug interactions with HAART and ARV Risk of HIV progression, CD4 count, viral load and risk of transmission as well as HIV-1 genital shedding are similar to other hormonal methods Panel on Antiretroviral Guidelines for Adults and Adolescents 2008; World Health Organization, 2010; HORMONAL SHORT ACTING COUNSELING PEARLS Primary mechanism: thickens cervical discharge to inhibit sperm mobility Secondary mechanism: ovulation inhibition and resultant endometrial thinning Delivery Method: Patient controlled daily, weekly or monthly Effectiveness: Compared to other methods Bleeding Patterns Other Side Effects Drug Interactions Hatcher, et al., (2007), Contraceptive Technology EMERGENCY CONTRACEPTION Interactions with ART have not been studied • British recommendations: double-dose Copper IUD placement • Especially for women who present 4-5 days after intercourse Stewart 2007, Fakoya 2008 CONTRACEPTION AND HIV: DRUG INTERACTIONS Increased steroid dosage (contraception) P450 Metabolism Increased ART medication dosage Decrease steroid dosage (contraception) Decrease ART Medication dosage Complicated interactions Adverse side effects ACOG, 2010; WHO, 2010 DRUG INTERACTIONS TO CONSIDER Drug Interactions • Efavirenz® is not recommended for use by women with childbearing potential - UNLESS- Two effective methods of contraception are used together • Birth defects have been seen with use of Efavirenz® (Sustiva® and Atripla®) • Fosamprenavir (Lexiva®) is not recommended for use together with hormonal contraceptive ACOG, 2010; http:www.hiv-druginteractions.org; http://hivinsite.ucsf.edu/insite?page=ar-00-02; WHO, 2010 CONTRACEPTION AND HIV: GENERAL DRUG INTERACTIONS SUMMARY Contraception Hormonal Metabolism Ritonavir-Boosted Protease Inhibitors: Decrease hormonal contraceptive efficacy Non-Nucleoside Reverse Inhibitor: Contraceptive Efficacy may be affected: Nevirapine Atazanavir or indinavir Efavirenz Anti-Retro Viral Effects Ritonavir: Liver transaminases Tipranavir/Ritonavir: Increased skin and musculoskelatal adverse events; possible increased drug hypersensitivity DRUG INTERACTIONS TO CONSIDER • Studies are limited and type specific • Aptivus® (tipranavir) • Kaletra® (lopinavir/ritonavir) • Norvir® (ritonavir) • Prezista® (darunavir/ritonavir) • Lexiva® (Telzir/fosamprenavir) • Viracept® (nelfinavir) • Viramune® (nevirapine) • Rifabutin® • Rifampin® ACOG, 2010; http:www.hiv-druginteractions.org; http://hivinsite.ucsf.edu/insite?page=ar-00-02; WHO, 2010 Case Study # 2: When are you planning a pregnancy? Kayla • Does Kayla want a pregnancy? • Is Kayla at risk for pregnancy? • Does Kayla have any contraindications to pregnancy? Case Study # 2: When are you planning a pregnancy? Kayla • Which contraception(s) have the least contraindications for Kayla? • A) Paragard IUD • B) OCP • C) Depo • D) Either A or C Case Study # 2: When are you planning a pregnancy? Kayla • Which contraception(s) would be the MOST effective for Kayla? • A) Depo • B) IUD • C) Pills • D) Condoms Case Study # 2: When are you planning a pregnancy? Kayla • Which contraception(s) could you start Kayla on today? • A) Depo • B) IUD • C) Essure • D) Condoms Case Study # 2: When are you planning a pregnancy? Kayla • Kayla chooses Depo today. What exam(s) are necessary before you initiate depo? • A) STI Screening • B) PAP Smear • C) Pregnancy Test • D) None of the above Case Study # 2: When are you planning a pregnancy? Kayla • Do you have any other concerns for Kayla that you may want to address today? • Social Behavioral • Mental Health • Violence/Abuse Case Study # 2: When are you planning a pregnancy? Kayla • What are the key teaching points you want to emphasize to Kayla before she leaves today? • Given Kayla’s PmHx, are there any specific tools that may be more/less helpful in providing education? RESOURCES CHOICES www.memphischoices.org HIV Treatment Guidelines www.aidsinfo.nih.gov Birth Control Fact Sheets http://www.birth-controlcomparison.info/ The Well Project www.thewellproject.com Providing Quality Family Planning Services: Recommendations of CDC and the U.S. Office of Population Affairs (April 2014). MMWR Recommendations and Reports,Vol 63, No 4. CME: http://www.cdc.gov/mmwr/cme/conted.html ARHP: Birth Control CME emails ARHP:The Bedsider Reproductive Life Planning Tool Examples http://dhss.delaware.gov/dph/chca/files/adultlifeplan2011.pdf http://everywomannc.com/sites/default/files/documents/Are%20You%20Ready%20- %20Sex%20And%20Your%20Future.pdf http://famplan.org/Resources/Docs/adult_rhp_busy_woman.pdf http://famplan.org/Resources/Docs/teen_rlp.pdf REFERENCES Aaron, E., Criniti, S., (2007). Preconception health care for HIV-infected women. Topics in HIV Medicine; 15(4): 137-141. American College of Obstetricians and Gynecologists [ACOG]. Committee on Practice Guidelines- Gynecology. (December 2010). Practice Bulletin Number 117: Gynecologic care for women with human immunodeficiency virus. Obstetrics & Gynecology; 116 (6) : 14921509. American Society for Reproductive Medicine, The Ethics Committee (2010). Human immunodeficiency virus and infertility treatment. Fertility and Sterility; 94(1): 11-15. American Society for Reproductive Medicine [ASRM]. The practice Committee (2008). Guidelines for reducing the risk of viral transmission during fertility treatment. Fertility and Sterility; 90(Supplement 3): S156-62. Castano, P., (2007). Use of intrauterine devices and systems by HIV-infected women. Contraception, 75: S51-S54. Centers for Disease Control and Prevention. (June 2013)U.S. Selected Practice Recommendations for Contraceptive Use, 2013: Adapted from the World Health Organization Selected Practice Recommendations fro Contraceptive Use, 2nd Edition. MMWR 62:5. Centers for Disease Control and Prevention [CDC]. U.S. Medical eligibility criteria for contraceptive use, 2010. Morbidity and Mortality Weekly Report. 2010: 59. REFERENCES Ezeanolou, E., Stumpf, P., Soliman, E., Fernandez, G., Jack, I., (2011). Contraception choices in a cohort of HIV+ women in the era of highly active antiretroviral therapy. Contraception, 84:94-97. Fakoya, A, et al. (2008). BHIVA, BASHH & FSRH guidelines on sexual and reproductive health. British HIV Association. HIV Medicine, 9: 681-720. Gavin, L..; Moskosky, S. ; Carter, M., et al. (2014) Providing Quality Family Planning Services: Recommendations of CDC and the U.S. Office of Population Affairs. MMWR 63 (4): 1-54. Hatcher, R., Trussell, J., Nelson, A., Cates, W., Stewart, F., Kowal, D. Contraceptive Technology. 19th ed. 2007. Ardent Media, INC., New York, NY. Heikinheimo, O., Llehtovirta, P., Suni, J., Paavonen, J., (2006). The levonorgestrel-releasing intrauterine system (LNG-IUS) in HIV-infected wommen: effects on bleeding patterns, ovarian function and genital shedding of HIV. Human Reproduction, 21: 2857-2861. Horton, R., Gettings, N., Marshall, J., (2009). Abstract: Integration of HIV prevention and reproductive health services. Contraception, 80: 220, P80. Jain, A.K., (2012). Hormonal Contraception and HIV acquisition risk: implications for individual users and public policies. Contraception, 86:645-652. REFERENCES Lehtovirta, P., Paavonen, J., Heikinheimo, O., (2007). Experience with the levonorgestrel-releasing intrauterine system among HIV-infected women. Contraception, 75: 37-49. Leticee, N., Viard, J., Yamgnane, A., Karmochkine, M., Benachi, A., (2012). Case Report: Contraceptive failure of etonogestrel implant in patients treated with antiretrovirals including efavirenz. Contraception, 85: 425-427. MacGowan, T., and Marshall, J. (unpublished): Memphis Center for Reproductive Health, Documenting the Reproductive Health Care Needs of HIV-Infected Women in Memphis, TN: An Interview Survey, a convenience sample of 69 WLWHA, ages 17-44. Morrison, et al. (2001). Is the intrauterine device appropriate contraception for HIV-1-infected women?. British Journal of Obstetrics and Gyneaecology, 108 (8): 784-790. New York State Department of Health AIDS Institute, in Collaboration with the Johns Hopkins University Division of Infectious Disease, HIV Clinical Guidelines. Available at http://www.hivguidelines.org/clinical-guidelines/womens-health/preconception-care-for-hiv-infectedwomen/. Accessed (12/27/2012) [Preconception Care for HIV Infected Women: Principles of Preconception Care for HIV Infected Women of Childbearing Potential] Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. 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. Available at http://aidsinfo.nih.gov/contentfiles/lvguidelines/PerinatalGL.pdf. Accessed (12/27/2012) [Pg. C-1, Preconception Counseling and Care for HIV-Infected Women of Childbearing Age.] Richardson, BA, Morrison, CS, Sekadde-Kigondu, C, Simei, SK, Overbaugh, J, Panteleeff, DD, et al., (1999). Effect of intrauterine device use on cervical shedding of HIV-1 DNA. AIDS, 13:2091-2097 Roccio, M., et al., (2011). Low-dose combined oral contraceptive and cervicovaginal shedding of human immunodeficiency virus. Contraception, 83:564-570. REFERENCES Scholler-Gyure, M., Kakuda, T., et al. (2009). Effect of steady-state etravirine on the pharmacokinetics and parmacodynamics of ethinylestradiol and norethindrone. Contraception, 80: 44-52. Squires, K., et al. (2011). Health needs of HIV-infected women in the United States: Insights from the women living positive survey. AIDS patient care and STDs; 25(5): 1-7. Stringer, EM., Kaseba, C., et al. (August 2007). A randomized trial of the intrauterine contraceptive device vs hormonal contraception in women who are infected with the human immunodeficiency virus. American Journal of Obstetrics & Gynecology, 197(2): 144e1-8. Taneepanichskul, S., Tanprasertkul, C., (2001). Use of Norplant implants in the the immediate postpartum period among asymptomatic HIV-1 positive mothers. Contraception, 64: 39-41. Watts, D. H., Park, J., et al. (2008). Safety and tolerability of depot medroxyprogesterone acetate among HIV-infected women on antiretroviral therapy: ACTG A5093. Contraception, 77: 84-90. World Health Organization [WHO]. Medical Eligibility Criteria for Contraceptive Use. 4th ed. Geneva, Switzerland. Accessed at: http://whqlibdoc.who.int/publications/2010/9789241563888_eng.pdf Zieman, M., Hatcher, R., Cwiak, C., Darney, P., Creinin, M., Sstosur, H. 2007-2009 Managing Contraception: For your pocket. 2007. Bridging the Gap Foundation, Tiger, GA. THANK YOU! Nikole Gettings, MSN, CNM 901-488-3417 [email protected]