2. 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
3. LEARNING OBJECTIVES:
AFTER TODAY’S PRESENTATION THE LEARNER
WILL:
1. 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.
5. MCGOWAN, PEPPER, GETTINGS,
CAPECE AND RINSDALE, 2014
No
59%
Yes
41%
Has Your HIV Medical Provider talked to you
about Pregnancy Planning
6. 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
7. Case Study # 2:
When are you planning
a pregnancy?
Kayla
PMH
Medications
Family History
Social History
Sexual Health History
8. 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
9. 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
10. 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
11. 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
13. HORMONAL MECHANISM OF ACTION
Primary: Thickening of
cervical/vaginal discharge:
Inhibits Sperm Mobility
Secondary: Inhibition of
Ovulation
No endometrial thickening
14. CATEGORIZING CONTRACEPTION
Short Acting Long Acting
Withdrawal
Spermicide
Condoms (Male and
Female)
Pills
Patch
Ring
Medroxyprogesterone
Levonogestral
Intrauterine Device
Copper Intra Uterine
Device
Sterilization
Male
Female
15. 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.
16. 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
17. 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
18. GUIDELINES
CDC: MMWR
American College of Obstetricians
and Gynecologists
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
ACOG: 2010
Practice Bulletin No. 117,
Dec. 2010
The care of HIV-infected
Woman
19. 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
20. 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
21.
22. 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
23. 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.
24. IUD PATIENT COUNSELING PEARLS:
LEVONOGESTREL INTRA-UTERINE
SYSTEMPrimary 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
25. LARC: LEVONORGESTREL – IMPLANT
(NEXPLANON/IMPLANON)
WHO Category: 1
Specific Studies are very
limited
Similarities to other
hormonal methods
Fakoya 2008
26. 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;
27. 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
28. 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
29. 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;
30. 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
31. 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
32. 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
33. 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
34. CONTRACEPTION AND HIV:
GENERAL DRUG INTERACTIONS
SUMMARYContraception 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
35. 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
36. 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?
37. 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
38. 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
39. 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
40. 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
41. 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
42. 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?
43. 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
44. 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
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American Society for Reproductive Medicine, The Ethics Committee (2010). Human
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American Society for Reproductive Medicine [ASRM]. The practice Committee
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Centers for Disease Control and Prevention [CDC]. U.S. Medical eligibility criteria
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