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(HA)ART Making
ART Possible
Nikole Gettings, 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:
 Katherine Leopard, CHOICES Community Partners Coordinator
www.memphischoices.org
Financial Disclosure: None
Learning Objectives
After this presentation, the learner will:
1.Competently address the reproductive life planning needs of of HIV
positive patients, without judgment and affording the patient every
respect.
2.Describe fertility options for individuals living with HIV and
increase competence to make knowledgeable recommendations for
serodiscordant women/couples wanting to conceive, including use of
assisted reproductive technology [ART] procedures available.
3.Identify resources in literature for clinical guidance in care and
expected outcomes of fertility programs offering services to
individuals living with HIV
Why Parallel Paths?
 Women have sexual and reproductive health needs
related to HIV testing and prevention
• Routine HIV Testing
• Prevention Counseling
• Linkages to HIV Care, if Infected
 Women Living with HIV have
sexual and reproductive
health needs
• Pregnancy Prevention
• Pregnancy Planning
• Basic GYN Care
• STI Testing and Treatment
• Prenatal Care
• Abortion
Horton, Gettings, and Marshall (2009).
Over 30 Years of HIV
HIV and Fertility
Bendikson, Anderson, & Hornstein, (2002).
Reproductive Desire
Chen, JL (2001): Fertility desires and intentions of HIV-positive men and women. (2001) Family Planning Perpectives; 33: 144-152
1440 HIV patients
29% of both women and men desired children
69% of women and 59% of men realistically expected
to have 1 or more children
Women Living Positive Survey, December 2006-
March 2007
Squires, 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: 1-7
700 Women
227 had been pregnant
39% had children
48% “never asked by provider if they were pregnant or
thinking about getting pregnant”
57% never discussed appropriate treatment before
becoming pregnant
61% personally believed they could have children with
appropriate medical care
59% felt society strongly urges them not to have children
First Steps: Memphis TGA HIV + Women
Reproductive Needs Survey
31 Question Survey
Publication
Results
Success:
 St. Jude Children’s Research Hospital, HIV Care Clinic
 Ryan White Community Needs Assessment: 3 Questions added
Goal 2014: 3+ 3 for total of 6 Questions
McGowan, Marshall, Gettings, Capece, Rinsdale. (2014)
[Procreation]
is central to
personal
identity, to
dignity and
to the
meaning of
one’s life.
~ Robertson
(1994)
Acrylic Small Square Painting "Little Lovers" 2012
by Gioia Albano
Augusto E. Semprini, Italy, 1992
85 couples, male HIV +,
female HIV –
29 women suitable for
timed insemination
 15 women, 17
pregnancies
Semprini, et al. (1992). Lancet, 340: 1317-19.
Semprini’s Theory
HIV Testing of Final Spermatozoa
0.9% Failure Rate
Semprini, et al. (1992). Lancet, 340: 1317-19
Semprini’s
Technique
Semprini, et al 1992 - Data as of October 14, 1992
Semprini, et al. (1992). Lancet, 340: 1317-19
Patient Treatment No of
insemination
Attempts
Pregnancy Outcome
A hCG 1 Singleton 39 weeks
B hCG 1 Singleton 39 weeks
C FSH, hMG, hCG 1 Twins 35 weeks
D FSH, hMG, hCG 1 Singleton 37 weeks
E* FSH, hCG/FSH, hMG, hCG 4/1 Preclinical miscarriage/triplets 37 weeks
F FSH, hMG, hCG 1 Singleton 40 weeks
G FSH, hMG, hCG 1 Singleton, 39 weeks
H FSH, hCG 2 Singleton, ongoing 35
I FSH, hMG, hCG 5 Ongoing, 32 weeks
J hCG 2 Ongoing, 21 weeks
K* FSH, hCG/FSH, hcG 1/1 Preclinical miscarriage/ongoing 21 weeks
L hMG, hCG 3 Twins ongoing 25 weeks
M hCG 3 Miscarriage 7 weeks
N hCG 4 Miscarriage 7 weeks
O hMG, hCG 1 Preclinical miscarriage
Semprini, et al 1992
PCR Testing of all final spermatazoa fraction showed
no HIV infected cells
50 + inseminations
No partner seroconversion
All 10 babies born HIV FREE
Semprini, et al. (1992). Lancet, 340: 1317-19
Mandelbrot et al 1997
Mandelbrot, L, Heard I, Henrion-Geant, E, Henrion, R (1997). Natural conception in HIV-negative women with HIV-infected partners. Lancet; 349: 850-851
92 HIV serodiscordant couples (male HIV +)
Unprotected intercourse only at ovulation
Protected intercourse at all other times
104 pregnancies
4 maternal seroconversions (4.3%)
CDC 1990
Center for Disease Control. (1990). HIV-1 infection and artificial insemination with processed semen. MMWR; 39:249-256
For any couple with one or both partners infected
with HIV abstain from engaging in sexual activities
or consistently use condoms
1999 International Perinatal HIV Group
The International Perinatal HIV Group. (1999) The mode of delivery and the risk of vertical transmission of human immunodeficiency virus type 1, a meta-
analysis of 15 prospective cohort studies. New England Journal of Medicine; 340: 977-987
1:500 to 1:1000 for each single act of intercourse
Bioethics
Ethical Concerns
 Creation of child infected with HIV
 Premature death of parents
 Transmission of virus: Medical staff, partner, other couples
Principals of Bioethics
 Autonomy
 Beneficence
 Justice
Lyerly, A., Anderson, J. (2001).
Risks Benefits
Potential transmission
to uninfected partner
Potential transmission
to couple’s child(ren)
Shortened life span of
one or both parents
Risk of transmission to
partner can be lowered
Risk of vertical
transmission with
appropriate medical
care is 0-2%
Couples experiencing
fertility difficulties can
achieve conception
Medical Ethical Concerns
Lyerly, A., Anderson, J. (2001).
1994 June 2010
All individuals seeking
fertility assistance
should be tested for
HIV
If individual is HIV +,
couple should be
counseled on donor
sperm, adoption, or not
having children.
• HIV is a chronic,
manageable disease and
expected life span can be
near normal
• If individual is HIV +,
couple should be counseled
on ways to plan a
pregnancy while
significantly decreasing
risk of HIV transmission to
HIV – partner and/or
child(ren).
The Ethics Committee of the American Society
for Reproductive Medicine
The Ethics Committee of the American Society for Reproductive Medicine (June
The Ethics Committee of the American Society for Reproductive
Medicine (1994)
1993 December 2010
Women seeking
pregnancy should weigh
her desire for
childbearing against the
potential harm to an
infected child
Physicians should weigh
the moral
appropriateness of any
medical treatment
Physicians should be
prepared to have detailed
discussions about how to
plan a pregnancy to
avoid HIV transmission
Artificial insemination,
although not guaranteed
to have no risk, is
endorsed as a way to
avoid transmission
American Congress of Obstetricians &
Gynecologists [ACOG]
The Committee on Ethics of the American College of Obstetricians
and Gynecologists (2010).
The Committee on Ethics of the American College of Obstetricians
and Gynecologists (1993).
1985 2001
Physicians encouraged
to advise HIV positive
women to defer
pregnancy because of
poor outcomes
associated with
pregnancy and
childbirth while
positive
Physicians are
instructed to inform
HIV positive clients
about all their
reproductive options
with counseling that is
non-directive and
supportive of client’s
decision
Centers for Disease Control [CDC]
Centers for Disease Control (1990). Centers for Disease Control, 2001
“…[U]NLESS HEALTH CARE WORKERS CAN SHOW THAT THEY
LACK THE SKILL AND FACILITIES TO TREAT HIV-POSITIVE
PATIENTS SAFELY OR THAT THE PATIENT REFUSED
REASONABLE TESTING AND TREATMENT, THEY MAY BE
LEGALLY AS WELL AS ETHICALLY OBLIGATED TO PROVIDE
REQUESTED REPRODUCTIVE ASSISTANCE.
AMERICAN SOCIETY FOR REPRODUCTIVE MEDICINE: ETHICS
COMMITTEE, 2004
Barriers to Pregnancy Planning
for Women Living with HIV
Daar & Daar, 2006
Access to Fertility Services for HIV
Low cost
options: Higher
risk
Effectiveness
rates of ART
Risks of
complications
Kalu, Wood, Vourliotis, and Gilling-Smith, 2010
Lack of Providers
American
clinicians remain
slow to embrace
the reproductive
needs of patients
living with HIV.
Myths
Lack of Policy
Training
Resources
Equipment
Facilities
< 5% of US
Reproductive
Facilities
Frodshom, et al., 2005; Sauer, M. 2006; Daar & Daar, 2006
Restrictive Regulatory Framework
Knowingly exposing
HIV negative individual
to potential infection
Crime for HIV + male
to provide sperm for
insemination
Liability Concerns for
negative partner or fetal
infection
UK: Regulatory body
[HFEA]
USA: Regulations vary
from state to state and
strong support for
individual provider
policy
TN: Reference?
Kalu, Wood, Vourliotis, and Gilling-Smith, 2010; Frodshom, et al., 2005; Sauer, M. 2006; Daar & Daar, 2006
Pregnancy Planning Options for
People Living with HIV
HAART Making ART Possible: II
“…[u]nless health
care workers can
show that they lack
the skill and
facilities to treat
HIV-positive
patients safely or
that the patient
refused reasonable
testing and
treatment, they may
be legally as well
as ethically
obligated to
provide requested
reproductive
assistance.
Ethics Committee of ASRM, (2004).
What are the Options?
Options: Adoption
Options: Child Free Living
Options: Donor Sperm
ART: Assisted Reproductive
Technologies
American Society for
Reproductive Medicine
American College of
Obstetricians and
Gynecologists
ASRM: 2008
Guidelines for
Reducing the Risk of
Viral transmission
during fertility
treatment
ACOG: 2010
Practice Bulletin No.
117, Dec. 2010
The care of HIV-
infected Woman
Guidelines
Preconception
Care
 No smoking
 Avoidance of
STD’s
 Avoid substance
abuse
 Increase folic
acid
 Vaccines for
hepatitis A & B
 Pneumococcal
and influenza
 Sustiva/efaviren
z: pregnancy
category D
 Prep for delivery
ACOG, Practice Bulletin Number 117, December 2010. Practice Committee of ASRM (2008).
Eligibility for ART Programs
Practice Committee ASRM (2008). ACOG Practice Bulletin, Number 117, December 2010.
Viral Load CD-4 Count
Undetectable
< 20,000
Stable x 6 months
> 250
Prefer > 400
Stable x 6 months
HIV Care Specifics Evaluation
ACOG Practice Bulletin, Number 117, December 2010. Practice Committee of ASRM (2008).
Cesarean delivery
Breastfeeding
Newborn prophylactic care
Male Work Up Female Work Up
STD Testing
 GC/CT
 RPR
 HSV I & II
 Trichomoniasis
 Hepatitis B & C
Sperm Analysis
General Physical
 STD Testing
 GC/CT
 RPR
 HSV I & II
 Trichomoniasis
 Hepatitis B & C
 FSH, LH, and Progesterone
 Day 3 & Day 21
 Lipid Panel
 Follicular Development Evaluation
 Hysterosalpingogram (HSG)
Fertility Work Up
ACOG Practice Bulletin, Number 117, December 2010. Practice Committee ASRM (2008)
Male Female
Asymptomatic HIV
infected No decreased
fertility
Hypogonadism
Advanced HIV
 Reduction in sperm
concentration
 Decreased total sperm count
 Increased abnormal forms
Zidovudine therapy
improves sperm analysis
regardless of CD4 counts
No clear evidence of
decreased fertility
No menstrual
irregularity
Possible increase in
tubal factor infertility
HIV and Infertility
ACOG Practice Bulletin, Number 117, December 2010. Practice Committee ASRM (2008)
ADD PICTURE
Pregnancy Planning for HIV
Pregnancy Planning Options: HIV+
Timed, unprotected intercourse
Timed insemination at home
Artificial Reproductive Technologies [ART]
 Sperm Donor with insemination
 Sperm Washing
 Intracytoplasmic sperm injection with attempted implantation
Role of PrEP
Guidelines
 American College of Obstetricians and Gynecologists [ACOG]: No.
117, Dec. 2010
 The Practice Committee of American Society for Reproductive Medicine
[ASRM]: Fertility and Sterility Vol 90, Supp 3, November 2008
World Health Organization, (July 2012). ACOG Practice Bulletin, 117, Dec. 2010. The Practice Committee of the
American Society for Reproductive Medicine. 2008
Serodiscordant: HIV+ Female/HIV- Male
Timed, unprotected intercourse at time of ovulation,
4.3% seroconversion rate, ACOG and ASRM
Insemination with partner’s sperm at ovulation
 Home Insemination (avoids potential exposure to HIV for male)
 Office Insemination
 Unwashed: Intra-cervical insemination
 Washed: intrauterine, only when indicated by male infertility , ASRM
Donor sperm, ACOG
In-vitro Fertilization, ACOG, ASRM
Intracytoplasmic sperm injection, ACOG, ASRM*
PrEP
Savasi, V., Ferrazzi, E., Fiore, S. (2008); World Health Organization, (July 2012). ACOG, Practice Bulletin 117,
December 2010. The Practice Committee of the American Society for Reproductive Medicine. 2008
Serodiscordant: HIV+ Male/HIV- Female
Timed, unprotected intercourse around ovulation:
4.3% seroconversion rate, ASRM, ACOG
Insemination: ACOG, ASRM
 Home insemination without wash (avoids intercourse)
 Sperm washing (ASRM: 3 step and AGOC) followed by
insemination via intrauterine insemination or intracytoplasmic
sperm injection
Donor Sperm, ACOG
PrEP
Van Leeuwen, E., Repping, S., Prins, J.M., Reiss, P., van der Veen, F. (unknown date). ; Savasi, V., Ferrazzi, E., Fiore, S. (2008);
World Health Organization (July 2012). ACOG Practice Bulletin 117, December 2010. The Practice Committee of the American
Society for Reproductive Medicine, November 2008.
Non-Discordant Couple: HIV+/HIV+: ASRM Only
Timed, unprotected intercourse around ovulation
Insemination
 Home insemination without wash (avoids intercourse)
 Sperm washing followed by insemination via intrauterine
insemination or intracytoplasmic sperm injection
Donor Sperm
PrEP: Not applicable
Teaching
Timed
Intercourse
and the
Menstrual
Cycle
Teaching: Home Insemination
Male ejaculates in clean, dry container (glass jar,
sterile urine cup)
Fresh sperm is drawn up into syringe (no needle)
Place syringe into vagina and depress plunger or
place sperm in cervical cap or diaphragm and place
in vagina
Recommendations regarding timing: Based on
ovulation (every other day starting at cycle day 5
until menses or + pregnancy test)
Syringe is re-useable but should be cleaned and
dried thoroughly
Teaching: Role of PrEP
Truvada Daily: 300 mg/200 mg
Hepatitis B Vaccine/evaluate immunity
HIV Negative confirmed
Routine access to healthcare provider and health
resources for ongoing evaluation
 Creatinine Clearance >60 ml per minute
 HIV evaluation q 3 months
 STI evaluation and treatment as indicated
 Pregnancy
 Safety to continue PrEP during pregnancy
World Health Organization, (July 2012); Centers for Disease Control (August 2012).
ADVANTAGES: TECHNOLOGY
DISADVANTAGES: ACCESS, COST, RISKS
ART: Assisted Reproductive
Technologies
3 Step Preparation
ART
Sperm Washing:
3 Step process
for either
intrauterine
insemination or
intracytoplasmic
sperm injection
+ PCR DNA
Testing of Final
Spermatazoa
Intrauterine Insemination
(IUI)
IVF: Intracytoplasmic Sperm
Injection (ICSI)
Sauer, et al. (2009).
Providing fertility care to
men seropositive for
human
immunodeficiency virus:
reviewing 10 years of
experience and 420
consecutive cycles of in
vitro fertilization and
intracytoplasmic sperm
injection. Fertility and
Sterility; 91(6): 2455-
2460
Sauer, et al. (2009).
HIV + Pregnancy Options: Programs
Columbia University, New York
Bedford Laboratory, Boston
Dr. Ringler
United Kingdom
Denver Colorado
Semprini
Valenciaona de Microbiologia, Valencia, Spain
University of Milan, Milan, Italy
CHOICES, Memphis Center for Reproductive Health
Resources
http://php.ucsf.edu/bapac
www.memphischoices.org
www.gardenoffertility.com
www.creathe.org
www.cyclebeads.com
www.thewellproject.org
www.hivcenternyc.org
www.studiosemprini.com
www.thebody.com
CASE STUDY # 1:
Adam and Brenda
Can we plan a pregnancy
• PMHxPMHx
• MedicationsMedications
• Family HxFamily Hx
• Social HxSocial Hx
• Sexual HxSexual Hx
CASE STUDY # 1:
Adam and Brenda
Can we plan a pregnancy
• 39 yo AA Male,39 yo AA Male,
HIV-infectedHIV-infected
• 43 yo AA female,43 yo AA female,
non-HIV infectednon-HIV infected
• MarriedMarried
• PreviouslyPreviously
treatedtreated
(unsuccessful) at(unsuccessful) at
fertility Clinicfertility Clinic
Austin TX, 2012Austin TX, 2012
• Would like toWould like to
discuss fertilitydiscuss fertility
planning optionsplanning options
CASE STUDY # 1:
Adam and Brenda
Can we plan a pregnancy
• Are there anyAre there any
significantsignificant
PmHX (otherPmHX (other
than HIV-than HIV-
infection) thatinfection) that
may havemay have
additionaladditional
impacts onimpacts on
fertilityfertility
planning?planning?
CASE STUDY # 1:
Adam and Brenda
Can we plan a pregnancy
• Which of theWhich of the
following pre-following pre-
fertilityfertility
evaluations areevaluations are
most critical formost critical for
fertilityfertility
evaluationtoevaluationto
order for him?order for him?
• A) STI ScreeningA) STI Screening
• B) SpermB) Sperm
analysisanalysis
• C) BothC) Both
CASE STUDY # 1:
Adam and Brenda
Can we plan a pregnancy
• Which of theWhich of the
following pre-following pre-
fertilityfertility
evaluations areevaluations are
most critical formost critical for
eligibility foreligibility for
PREP for her?PREP for her?
• A) STI ScreeningA) STI Screening
includingincluding
Hepatitis PanelHepatitis Panel
• B)FSH/LH/ProgeB)FSH/LH/Proge
sterone Levelssterone Levels
• C) HSGC) HSG
CASE STUDY # 1:
Adam and Brenda
Can we plan a pregnancy
• Which of theWhich of the
following optionsfollowing options
are the LEASTare the LEAST
likely to result inlikely to result in
her infection withher infection with
HIV?HIV?
• A) Timed,A) Timed,
unprotectedunprotected
intercourseintercourse
• B) PREP +B) PREP +
IntravaginalIntravaginal
timedtimed
inseminationinsemination
• C) Intra-UterineC) Intra-Uterine
InseminationInsemination
CASE STUDY # 1:
Adam and Brenda
Can we plan a pregnancy
• Which of theWhich of the
following optionsfollowing options
are the MOSTare the MOST
likely to result inlikely to result in
successfulsuccessful
conception?conception?
• A) Timed,A) Timed,
unprotectedunprotected
intercourseintercourse
• B) PREP +B) PREP +
Intravaginal timedIntravaginal timed
inseminationinsemination
• C) IVF withC) IVF with
IntracytoplasmicIntracytoplasmic
Sperm InjectionSperm Injection
(ICSI)(ICSI)
• D) Either A or BD) Either A or B
CASE STUDY # 1:
Adam and Brenda
Can we plan a pregnancy
• What is theWhat is the
next follow upnext follow up
steps forsteps for
Brenda andBrenda and
Adam?Adam?
References
 Aaron, E., Criniti, S., (2007). Preconception health care for HIV-infected women. Topics in HIV
Medicine; 15(4): 137-141.
 The Committee on Ethics of the American College of Obstetricians and Gynecologists (1993). Human
immunodeficiency virus infection: physician’s responsibilities, American College of Obstetricians and
Gynecologists. Committee Opinion No 130.
 The Committee on Ethics of the American College of Obstetricians and Gynecologists (2010). Practice
Bulletin Number 117: Gynecologic care for women with human immunodeficiency virus. Obstetrics &
Gynecology; 116 (6) : 1492-1509.
 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, The practice Committee (2008). Guidelines for reducing
the risk of viral transmission during fertility treatment. Fertility and Sterility; 90(Supplement 3): S156-62.
 Apoola, A, tenHof, J., Allan, P. (2001). Access to infertility investigations and treatment in couples
infected with HIV: questionaire survey. BMJ; 323: 1285.
 Baeten, J.M., et al. (July 2012).Antiretroviral Prophylaxis for HIV Prevention in heterosexual men and
women. New England Journal of Medicine, 367(5); 399-410. Downloaded April 15, 2013 from :
nejm.org
 Barreiro, P., Duerr, A., Beckerman, K., Soriano, V. (2006). Reproductive options for HIV-serodiscordant
couples. AIDS Reviews; 8: 158-170.
References, continued
 Bendikson, K., Anderson, D., Hornstein, M. (2002). Fertility options for HIV patients. Current Opinion in
Obstetrics and Gynecology; 14: 453-457.
 Centers for Disease Control (1990). HIV-1 infections and artificial insemination with processed semen.
Morbidity and Mortality Weekly Report; 39: 249-256.
 Centers for Disease Control (August 2012). Interim Guidance for Clinicians Considering the use of
preexposure prophylaxis for the prevention of HIV in heterosexually active adults. Morbidity and Mortality
Weekly Report; 61(31); 586-589. Accessed online at
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6131a2.htm
 Daar, E., Daar, J. (2006). Human immunodeficiency virus and fertility care: embarking on a path of
knowledge and access. Fertility and Sterility; 85(2): 298-300.
 Frodshom, LCG, Boag, F. Bbarton, S., Gilling-Smith, C. (2005). Human immuno-deficiency virus infection
and fertility care in the United Kingdom: demand and supply. Fertility & Sterility, 85: 285-289
 Garrido, N., et al. (2004). Report of the results of a 2 year programme of sperm wash and ICSI treatment
for human immunodeficiency virus and hepatitis C virus serodiscordant couples. Human Reproduction;
19 (11): 2581-2586.
 Gruskin, S., Firestone, R., MacCarthy, S., Ferguson, L. (2008). HIV and pregnancy intentions: Do
services adequately respond to women’s needs?. American Journal of Public Health; 98(10): 1-5.
Accessed at www.ajph.org/cgi/doi/10.2105/AJPH.2008.137232
 Horton, Marshall, Gettings (2009). Horton, Gettings, Marshall, (2009): Integration of HIV Prevention
Services, Reproductive Health and Abortion Care; United States Conference on AIDS, poster presentation
 Kalu, E., Wood, R., Vourliotis, M., Gilling-Smith, C. (2009). Fertility needs and funding in couples with
blood-borne viral infection. HIV Medicine (2010) ; 11: 90-93.
References, continued
 Lampe MA, Smith DK, Anderson GJE, Edwards AE, Nesheim SR. (2011). Achieving safe conception in
HIV-discordant couples: the potential role of oral preexposure prophylaxis (PrEP) in the United States. Am
J Obstet Gynecol 2011;204:488.
 Lyerly, A., Anderson, J. (2001). Human immunodeficiency virus and assisted reproduction: reconsidering
evidence, reframing ethics. Fertility and Sterility; 75(5): 843-858.
 Mandelbrot, L., Heard, I., Henrion, -Geant, E., Henrion, R. (1997). Natural conception in HIV-negative
women with HIV-infected partners. Lancet; 349: 850-851.
 McGowan, T., Pepper-Marshall, J., Gettings, N., et al. (2014). First Steps of (H)AART making ART
possible: Assessing Sexual and Reproductive Health Needs of HIV-Positive Women in the Memphis TGA.
Gay and Lesbian Medical Association, Nursing Summit. Poster Presentation.
 Melo, M., et a. (2008). Human immunodeficiency type-1 virus (HIV-1) infection in serodiscordant couples
(SDCs) does not have an impact on embryo quality or intracytoplasmic sperm injection (ICSI) outcome.
Fertility and Sterility; 89 (1): 141-150.
 Minkoff, H., Santoro, N. (2000). Ethical considerations in the treatment of infertility in women with human
immunodeficiency virus infection. New England Journal of Medicine; 342(23): 1748-1750.
 Robertson, J. (1994). Children of choice: Freedom and the new reproductive technologies. Princeton,
NJ: Princeton University Press.
 Saur, M. (2005). American physicians remain slow to embrace the reproductive needs of human
immunodeficiency virus-infected patients. (2006). Fertility and Sterility; 85(2): 295-297.
 Saur, et al. (2009). Providing fertility care to men seropositive for human immunodeficiency virus:
reviewing 10 years of experience and 420 consecutive cycles of in vitro fertilization and intracytoplasmic
sperm injection. Fertility and Sterility; 91(6): 2456-2460.
References, continued
 Savasi, V., Ferrazzi, E., Fiore, S. (2008). Reproductive assistance for infected couples with bloodborne
viruses. Placenta; 29: S160-165.
 Semprini, et al (1992). Insemination of HIV-negative women with processed semen of HIV-positive
partners. Lancet; 340: 1317-1319
 Semprini, A., Vucetich, A., Hollander, L. (2004). Sperm washing, use of HAART and role of elective
caesarean section. Current Opinion in Obstetrics and Gynecology; 16: 465-470.
 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.
 Thornton, A., Fomanelli, F., Collins, J. (2004). Reproduction decision making for couples affected by HIV:
A review of the literature. Topics in HIV Medicine. 12(2): 61-67.
 Van Leeuwen, E., Repping, S., Prins, J.M., Reiss, P., van der Veen, F. (unknown date). Assisted
reproductive technologies to establish pregnancies in couples with an HIV-I infected man. Van Zuiden
Communications.
 World Health Organization [WHO]. (July 2012). Guidance on oral pre-exposure prophylaxis (PrEP) for
serodiscordant couples, men and transgender women who have sex with men at high risk of HIV:
recommendations for use in the context of demonstration projects. Accessed online at:
http://www.who.int/hiv/pub/guidance_prep/en/
Questions?
Nikole Gettings, MSN
Director of Clinical Services
901-488-3417
ngettings@memphischoices.org

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HAART Making ART Possible 2015 Fall P2P

  • 1. (HA)ART Making ART Possible Nikole Gettings, RN, MSN, CNM, APN
  • 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:  Katherine Leopard, CHOICES Community Partners Coordinator
  • 5. Learning Objectives After this presentation, the learner will: 1.Competently address the reproductive life planning needs of of HIV positive patients, without judgment and affording the patient every respect. 2.Describe fertility options for individuals living with HIV and increase competence to make knowledgeable recommendations for serodiscordant women/couples wanting to conceive, including use of assisted reproductive technology [ART] procedures available. 3.Identify resources in literature for clinical guidance in care and expected outcomes of fertility programs offering services to individuals living with HIV
  • 6. Why Parallel Paths?  Women have sexual and reproductive health needs related to HIV testing and prevention • Routine HIV Testing • Prevention Counseling • Linkages to HIV Care, if Infected  Women Living with HIV have sexual and reproductive health needs • Pregnancy Prevention • Pregnancy Planning • Basic GYN Care • STI Testing and Treatment • Prenatal Care • Abortion Horton, Gettings, and Marshall (2009).
  • 7. Over 30 Years of HIV
  • 8. HIV and Fertility Bendikson, Anderson, & Hornstein, (2002).
  • 9. Reproductive Desire Chen, JL (2001): Fertility desires and intentions of HIV-positive men and women. (2001) Family Planning Perpectives; 33: 144-152 1440 HIV patients 29% of both women and men desired children 69% of women and 59% of men realistically expected to have 1 or more children
  • 10. Women Living Positive Survey, December 2006- March 2007 Squires, 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: 1-7 700 Women 227 had been pregnant 39% had children 48% “never asked by provider if they were pregnant or thinking about getting pregnant” 57% never discussed appropriate treatment before becoming pregnant 61% personally believed they could have children with appropriate medical care 59% felt society strongly urges them not to have children
  • 11. First Steps: Memphis TGA HIV + Women Reproductive Needs Survey 31 Question Survey Publication Results Success:  St. Jude Children’s Research Hospital, HIV Care Clinic  Ryan White Community Needs Assessment: 3 Questions added Goal 2014: 3+ 3 for total of 6 Questions McGowan, Marshall, Gettings, Capece, Rinsdale. (2014)
  • 12. [Procreation] is central to personal identity, to dignity and to the meaning of one’s life. ~ Robertson (1994) Acrylic Small Square Painting "Little Lovers" 2012 by Gioia Albano
  • 13. Augusto E. Semprini, Italy, 1992 85 couples, male HIV +, female HIV – 29 women suitable for timed insemination  15 women, 17 pregnancies Semprini, et al. (1992). Lancet, 340: 1317-19.
  • 15. HIV Testing of Final Spermatozoa 0.9% Failure Rate Semprini, et al. (1992). Lancet, 340: 1317-19 Semprini’s Technique
  • 16. Semprini, et al 1992 - Data as of October 14, 1992 Semprini, et al. (1992). Lancet, 340: 1317-19 Patient Treatment No of insemination Attempts Pregnancy Outcome A hCG 1 Singleton 39 weeks B hCG 1 Singleton 39 weeks C FSH, hMG, hCG 1 Twins 35 weeks D FSH, hMG, hCG 1 Singleton 37 weeks E* FSH, hCG/FSH, hMG, hCG 4/1 Preclinical miscarriage/triplets 37 weeks F FSH, hMG, hCG 1 Singleton 40 weeks G FSH, hMG, hCG 1 Singleton, 39 weeks H FSH, hCG 2 Singleton, ongoing 35 I FSH, hMG, hCG 5 Ongoing, 32 weeks J hCG 2 Ongoing, 21 weeks K* FSH, hCG/FSH, hcG 1/1 Preclinical miscarriage/ongoing 21 weeks L hMG, hCG 3 Twins ongoing 25 weeks M hCG 3 Miscarriage 7 weeks N hCG 4 Miscarriage 7 weeks O hMG, hCG 1 Preclinical miscarriage
  • 17. Semprini, et al 1992 PCR Testing of all final spermatazoa fraction showed no HIV infected cells 50 + inseminations No partner seroconversion All 10 babies born HIV FREE Semprini, et al. (1992). Lancet, 340: 1317-19
  • 18. Mandelbrot et al 1997 Mandelbrot, L, Heard I, Henrion-Geant, E, Henrion, R (1997). Natural conception in HIV-negative women with HIV-infected partners. Lancet; 349: 850-851 92 HIV serodiscordant couples (male HIV +) Unprotected intercourse only at ovulation Protected intercourse at all other times 104 pregnancies 4 maternal seroconversions (4.3%)
  • 19. CDC 1990 Center for Disease Control. (1990). HIV-1 infection and artificial insemination with processed semen. MMWR; 39:249-256 For any couple with one or both partners infected with HIV abstain from engaging in sexual activities or consistently use condoms
  • 20. 1999 International Perinatal HIV Group The International Perinatal HIV Group. (1999) The mode of delivery and the risk of vertical transmission of human immunodeficiency virus type 1, a meta- analysis of 15 prospective cohort studies. New England Journal of Medicine; 340: 977-987 1:500 to 1:1000 for each single act of intercourse
  • 21. Bioethics Ethical Concerns  Creation of child infected with HIV  Premature death of parents  Transmission of virus: Medical staff, partner, other couples Principals of Bioethics  Autonomy  Beneficence  Justice Lyerly, A., Anderson, J. (2001).
  • 22. Risks Benefits Potential transmission to uninfected partner Potential transmission to couple’s child(ren) Shortened life span of one or both parents Risk of transmission to partner can be lowered Risk of vertical transmission with appropriate medical care is 0-2% Couples experiencing fertility difficulties can achieve conception Medical Ethical Concerns Lyerly, A., Anderson, J. (2001).
  • 23. 1994 June 2010 All individuals seeking fertility assistance should be tested for HIV If individual is HIV +, couple should be counseled on donor sperm, adoption, or not having children. • HIV is a chronic, manageable disease and expected life span can be near normal • If individual is HIV +, couple should be counseled on ways to plan a pregnancy while significantly decreasing risk of HIV transmission to HIV – partner and/or child(ren). The Ethics Committee of the American Society for Reproductive Medicine The Ethics Committee of the American Society for Reproductive Medicine (June The Ethics Committee of the American Society for Reproductive Medicine (1994)
  • 24. 1993 December 2010 Women seeking pregnancy should weigh her desire for childbearing against the potential harm to an infected child Physicians should weigh the moral appropriateness of any medical treatment Physicians should be prepared to have detailed discussions about how to plan a pregnancy to avoid HIV transmission Artificial insemination, although not guaranteed to have no risk, is endorsed as a way to avoid transmission American Congress of Obstetricians & Gynecologists [ACOG] The Committee on Ethics of the American College of Obstetricians and Gynecologists (2010). The Committee on Ethics of the American College of Obstetricians and Gynecologists (1993).
  • 25. 1985 2001 Physicians encouraged to advise HIV positive women to defer pregnancy because of poor outcomes associated with pregnancy and childbirth while positive Physicians are instructed to inform HIV positive clients about all their reproductive options with counseling that is non-directive and supportive of client’s decision Centers for Disease Control [CDC] Centers for Disease Control (1990). Centers for Disease Control, 2001
  • 26. “…[U]NLESS HEALTH CARE WORKERS CAN SHOW THAT THEY LACK THE SKILL AND FACILITIES TO TREAT HIV-POSITIVE PATIENTS SAFELY OR THAT THE PATIENT REFUSED REASONABLE TESTING AND TREATMENT, THEY MAY BE LEGALLY AS WELL AS ETHICALLY OBLIGATED TO PROVIDE REQUESTED REPRODUCTIVE ASSISTANCE. AMERICAN SOCIETY FOR REPRODUCTIVE MEDICINE: ETHICS COMMITTEE, 2004 Barriers to Pregnancy Planning for Women Living with HIV Daar & Daar, 2006
  • 27. Access to Fertility Services for HIV Low cost options: Higher risk Effectiveness rates of ART Risks of complications Kalu, Wood, Vourliotis, and Gilling-Smith, 2010
  • 28. Lack of Providers American clinicians remain slow to embrace the reproductive needs of patients living with HIV. Myths Lack of Policy Training Resources Equipment Facilities < 5% of US Reproductive Facilities Frodshom, et al., 2005; Sauer, M. 2006; Daar & Daar, 2006
  • 29. Restrictive Regulatory Framework Knowingly exposing HIV negative individual to potential infection Crime for HIV + male to provide sperm for insemination Liability Concerns for negative partner or fetal infection UK: Regulatory body [HFEA] USA: Regulations vary from state to state and strong support for individual provider policy TN: Reference? Kalu, Wood, Vourliotis, and Gilling-Smith, 2010; Frodshom, et al., 2005; Sauer, M. 2006; Daar & Daar, 2006
  • 30. Pregnancy Planning Options for People Living with HIV HAART Making ART Possible: II “…[u]nless health care workers can show that they lack the skill and facilities to treat HIV-positive patients safely or that the patient refused reasonable testing and treatment, they may be legally as well as ethically obligated to provide requested reproductive assistance. Ethics Committee of ASRM, (2004).
  • 31. What are the Options?
  • 36. American Society for Reproductive Medicine American College of Obstetricians and Gynecologists ASRM: 2008 Guidelines for Reducing the Risk of Viral transmission during fertility treatment ACOG: 2010 Practice Bulletin No. 117, Dec. 2010 The care of HIV- infected Woman Guidelines
  • 37. Preconception Care  No smoking  Avoidance of STD’s  Avoid substance abuse  Increase folic acid  Vaccines for hepatitis A & B  Pneumococcal and influenza  Sustiva/efaviren z: pregnancy category D  Prep for delivery ACOG, Practice Bulletin Number 117, December 2010. Practice Committee of ASRM (2008).
  • 38. Eligibility for ART Programs Practice Committee ASRM (2008). ACOG Practice Bulletin, Number 117, December 2010.
  • 39. Viral Load CD-4 Count Undetectable < 20,000 Stable x 6 months > 250 Prefer > 400 Stable x 6 months HIV Care Specifics Evaluation ACOG Practice Bulletin, Number 117, December 2010. Practice Committee of ASRM (2008). Cesarean delivery Breastfeeding Newborn prophylactic care
  • 40. Male Work Up Female Work Up STD Testing  GC/CT  RPR  HSV I & II  Trichomoniasis  Hepatitis B & C Sperm Analysis General Physical  STD Testing  GC/CT  RPR  HSV I & II  Trichomoniasis  Hepatitis B & C  FSH, LH, and Progesterone  Day 3 & Day 21  Lipid Panel  Follicular Development Evaluation  Hysterosalpingogram (HSG) Fertility Work Up ACOG Practice Bulletin, Number 117, December 2010. Practice Committee ASRM (2008)
  • 41. Male Female Asymptomatic HIV infected No decreased fertility Hypogonadism Advanced HIV  Reduction in sperm concentration  Decreased total sperm count  Increased abnormal forms Zidovudine therapy improves sperm analysis regardless of CD4 counts No clear evidence of decreased fertility No menstrual irregularity Possible increase in tubal factor infertility HIV and Infertility ACOG Practice Bulletin, Number 117, December 2010. Practice Committee ASRM (2008)
  • 43. Pregnancy Planning Options: HIV+ Timed, unprotected intercourse Timed insemination at home Artificial Reproductive Technologies [ART]  Sperm Donor with insemination  Sperm Washing  Intracytoplasmic sperm injection with attempted implantation Role of PrEP Guidelines  American College of Obstetricians and Gynecologists [ACOG]: No. 117, Dec. 2010  The Practice Committee of American Society for Reproductive Medicine [ASRM]: Fertility and Sterility Vol 90, Supp 3, November 2008 World Health Organization, (July 2012). ACOG Practice Bulletin, 117, Dec. 2010. The Practice Committee of the American Society for Reproductive Medicine. 2008
  • 44. Serodiscordant: HIV+ Female/HIV- Male Timed, unprotected intercourse at time of ovulation, 4.3% seroconversion rate, ACOG and ASRM Insemination with partner’s sperm at ovulation  Home Insemination (avoids potential exposure to HIV for male)  Office Insemination  Unwashed: Intra-cervical insemination  Washed: intrauterine, only when indicated by male infertility , ASRM Donor sperm, ACOG In-vitro Fertilization, ACOG, ASRM Intracytoplasmic sperm injection, ACOG, ASRM* PrEP Savasi, V., Ferrazzi, E., Fiore, S. (2008); World Health Organization, (July 2012). ACOG, Practice Bulletin 117, December 2010. The Practice Committee of the American Society for Reproductive Medicine. 2008
  • 45. Serodiscordant: HIV+ Male/HIV- Female Timed, unprotected intercourse around ovulation: 4.3% seroconversion rate, ASRM, ACOG Insemination: ACOG, ASRM  Home insemination without wash (avoids intercourse)  Sperm washing (ASRM: 3 step and AGOC) followed by insemination via intrauterine insemination or intracytoplasmic sperm injection Donor Sperm, ACOG PrEP Van Leeuwen, E., Repping, S., Prins, J.M., Reiss, P., van der Veen, F. (unknown date). ; Savasi, V., Ferrazzi, E., Fiore, S. (2008); World Health Organization (July 2012). ACOG Practice Bulletin 117, December 2010. The Practice Committee of the American Society for Reproductive Medicine, November 2008.
  • 46. Non-Discordant Couple: HIV+/HIV+: ASRM Only Timed, unprotected intercourse around ovulation Insemination  Home insemination without wash (avoids intercourse)  Sperm washing followed by insemination via intrauterine insemination or intracytoplasmic sperm injection Donor Sperm PrEP: Not applicable
  • 48. Teaching: Home Insemination Male ejaculates in clean, dry container (glass jar, sterile urine cup) Fresh sperm is drawn up into syringe (no needle) Place syringe into vagina and depress plunger or place sperm in cervical cap or diaphragm and place in vagina Recommendations regarding timing: Based on ovulation (every other day starting at cycle day 5 until menses or + pregnancy test) Syringe is re-useable but should be cleaned and dried thoroughly
  • 49. Teaching: Role of PrEP Truvada Daily: 300 mg/200 mg Hepatitis B Vaccine/evaluate immunity HIV Negative confirmed Routine access to healthcare provider and health resources for ongoing evaluation  Creatinine Clearance >60 ml per minute  HIV evaluation q 3 months  STI evaluation and treatment as indicated  Pregnancy  Safety to continue PrEP during pregnancy World Health Organization, (July 2012); Centers for Disease Control (August 2012).
  • 50. ADVANTAGES: TECHNOLOGY DISADVANTAGES: ACCESS, COST, RISKS ART: Assisted Reproductive Technologies
  • 51. 3 Step Preparation ART Sperm Washing: 3 Step process for either intrauterine insemination or intracytoplasmic sperm injection + PCR DNA Testing of Final Spermatazoa
  • 53. IVF: Intracytoplasmic Sperm Injection (ICSI) Sauer, et al. (2009). Providing fertility care to men seropositive for human immunodeficiency virus: reviewing 10 years of experience and 420 consecutive cycles of in vitro fertilization and intracytoplasmic sperm injection. Fertility and Sterility; 91(6): 2455- 2460 Sauer, et al. (2009).
  • 54. HIV + Pregnancy Options: Programs Columbia University, New York Bedford Laboratory, Boston Dr. Ringler United Kingdom Denver Colorado Semprini Valenciaona de Microbiologia, Valencia, Spain University of Milan, Milan, Italy CHOICES, Memphis Center for Reproductive Health
  • 56. CASE STUDY # 1: Adam and Brenda Can we plan a pregnancy • PMHxPMHx • MedicationsMedications • Family HxFamily Hx • Social HxSocial Hx • Sexual HxSexual Hx
  • 57. CASE STUDY # 1: Adam and Brenda Can we plan a pregnancy • 39 yo AA Male,39 yo AA Male, HIV-infectedHIV-infected • 43 yo AA female,43 yo AA female, non-HIV infectednon-HIV infected • MarriedMarried • PreviouslyPreviously treatedtreated (unsuccessful) at(unsuccessful) at fertility Clinicfertility Clinic Austin TX, 2012Austin TX, 2012 • Would like toWould like to discuss fertilitydiscuss fertility planning optionsplanning options
  • 58. CASE STUDY # 1: Adam and Brenda Can we plan a pregnancy • Are there anyAre there any significantsignificant PmHX (otherPmHX (other than HIV-than HIV- infection) thatinfection) that may havemay have additionaladditional impacts onimpacts on fertilityfertility planning?planning?
  • 59. CASE STUDY # 1: Adam and Brenda Can we plan a pregnancy • Which of theWhich of the following pre-following pre- fertilityfertility evaluations areevaluations are most critical formost critical for fertilityfertility evaluationtoevaluationto order for him?order for him? • A) STI ScreeningA) STI Screening • B) SpermB) Sperm analysisanalysis • C) BothC) Both
  • 60. CASE STUDY # 1: Adam and Brenda Can we plan a pregnancy • Which of theWhich of the following pre-following pre- fertilityfertility evaluations areevaluations are most critical formost critical for eligibility foreligibility for PREP for her?PREP for her? • A) STI ScreeningA) STI Screening includingincluding Hepatitis PanelHepatitis Panel • B)FSH/LH/ProgeB)FSH/LH/Proge sterone Levelssterone Levels • C) HSGC) HSG
  • 61. CASE STUDY # 1: Adam and Brenda Can we plan a pregnancy • Which of theWhich of the following optionsfollowing options are the LEASTare the LEAST likely to result inlikely to result in her infection withher infection with HIV?HIV? • A) Timed,A) Timed, unprotectedunprotected intercourseintercourse • B) PREP +B) PREP + IntravaginalIntravaginal timedtimed inseminationinsemination • C) Intra-UterineC) Intra-Uterine InseminationInsemination
  • 62. CASE STUDY # 1: Adam and Brenda Can we plan a pregnancy • Which of theWhich of the following optionsfollowing options are the MOSTare the MOST likely to result inlikely to result in successfulsuccessful conception?conception? • A) Timed,A) Timed, unprotectedunprotected intercourseintercourse • B) PREP +B) PREP + Intravaginal timedIntravaginal timed inseminationinsemination • C) IVF withC) IVF with IntracytoplasmicIntracytoplasmic Sperm InjectionSperm Injection (ICSI)(ICSI) • D) Either A or BD) Either A or B
  • 63. CASE STUDY # 1: Adam and Brenda Can we plan a pregnancy • What is theWhat is the next follow upnext follow up steps forsteps for Brenda andBrenda and Adam?Adam?
  • 64. References  Aaron, E., Criniti, S., (2007). Preconception health care for HIV-infected women. Topics in HIV Medicine; 15(4): 137-141.  The Committee on Ethics of the American College of Obstetricians and Gynecologists (1993). Human immunodeficiency virus infection: physician’s responsibilities, American College of Obstetricians and Gynecologists. Committee Opinion No 130.  The Committee on Ethics of the American College of Obstetricians and Gynecologists (2010). Practice Bulletin Number 117: Gynecologic care for women with human immunodeficiency virus. Obstetrics & Gynecology; 116 (6) : 1492-1509.  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, The practice Committee (2008). Guidelines for reducing the risk of viral transmission during fertility treatment. Fertility and Sterility; 90(Supplement 3): S156-62.  Apoola, A, tenHof, J., Allan, P. (2001). Access to infertility investigations and treatment in couples infected with HIV: questionaire survey. BMJ; 323: 1285.  Baeten, J.M., et al. (July 2012).Antiretroviral Prophylaxis for HIV Prevention in heterosexual men and women. New England Journal of Medicine, 367(5); 399-410. Downloaded April 15, 2013 from : nejm.org  Barreiro, P., Duerr, A., Beckerman, K., Soriano, V. (2006). Reproductive options for HIV-serodiscordant couples. AIDS Reviews; 8: 158-170.
  • 65. References, continued  Bendikson, K., Anderson, D., Hornstein, M. (2002). Fertility options for HIV patients. Current Opinion in Obstetrics and Gynecology; 14: 453-457.  Centers for Disease Control (1990). HIV-1 infections and artificial insemination with processed semen. Morbidity and Mortality Weekly Report; 39: 249-256.  Centers for Disease Control (August 2012). Interim Guidance for Clinicians Considering the use of preexposure prophylaxis for the prevention of HIV in heterosexually active adults. Morbidity and Mortality Weekly Report; 61(31); 586-589. Accessed online at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6131a2.htm  Daar, E., Daar, J. (2006). Human immunodeficiency virus and fertility care: embarking on a path of knowledge and access. Fertility and Sterility; 85(2): 298-300.  Frodshom, LCG, Boag, F. Bbarton, S., Gilling-Smith, C. (2005). Human immuno-deficiency virus infection and fertility care in the United Kingdom: demand and supply. Fertility & Sterility, 85: 285-289  Garrido, N., et al. (2004). Report of the results of a 2 year programme of sperm wash and ICSI treatment for human immunodeficiency virus and hepatitis C virus serodiscordant couples. Human Reproduction; 19 (11): 2581-2586.  Gruskin, S., Firestone, R., MacCarthy, S., Ferguson, L. (2008). HIV and pregnancy intentions: Do services adequately respond to women’s needs?. American Journal of Public Health; 98(10): 1-5. Accessed at www.ajph.org/cgi/doi/10.2105/AJPH.2008.137232  Horton, Marshall, Gettings (2009). Horton, Gettings, Marshall, (2009): Integration of HIV Prevention Services, Reproductive Health and Abortion Care; United States Conference on AIDS, poster presentation  Kalu, E., Wood, R., Vourliotis, M., Gilling-Smith, C. (2009). Fertility needs and funding in couples with blood-borne viral infection. HIV Medicine (2010) ; 11: 90-93.
  • 66. References, continued  Lampe MA, Smith DK, Anderson GJE, Edwards AE, Nesheim SR. (2011). Achieving safe conception in HIV-discordant couples: the potential role of oral preexposure prophylaxis (PrEP) in the United States. Am J Obstet Gynecol 2011;204:488.  Lyerly, A., Anderson, J. (2001). Human immunodeficiency virus and assisted reproduction: reconsidering evidence, reframing ethics. Fertility and Sterility; 75(5): 843-858.  Mandelbrot, L., Heard, I., Henrion, -Geant, E., Henrion, R. (1997). Natural conception in HIV-negative women with HIV-infected partners. Lancet; 349: 850-851.  McGowan, T., Pepper-Marshall, J., Gettings, N., et al. (2014). First Steps of (H)AART making ART possible: Assessing Sexual and Reproductive Health Needs of HIV-Positive Women in the Memphis TGA. Gay and Lesbian Medical Association, Nursing Summit. Poster Presentation.  Melo, M., et a. (2008). Human immunodeficiency type-1 virus (HIV-1) infection in serodiscordant couples (SDCs) does not have an impact on embryo quality or intracytoplasmic sperm injection (ICSI) outcome. Fertility and Sterility; 89 (1): 141-150.  Minkoff, H., Santoro, N. (2000). Ethical considerations in the treatment of infertility in women with human immunodeficiency virus infection. New England Journal of Medicine; 342(23): 1748-1750.  Robertson, J. (1994). Children of choice: Freedom and the new reproductive technologies. Princeton, NJ: Princeton University Press.  Saur, M. (2005). American physicians remain slow to embrace the reproductive needs of human immunodeficiency virus-infected patients. (2006). Fertility and Sterility; 85(2): 295-297.  Saur, et al. (2009). Providing fertility care to men seropositive for human immunodeficiency virus: reviewing 10 years of experience and 420 consecutive cycles of in vitro fertilization and intracytoplasmic sperm injection. Fertility and Sterility; 91(6): 2456-2460.
  • 67. References, continued  Savasi, V., Ferrazzi, E., Fiore, S. (2008). Reproductive assistance for infected couples with bloodborne viruses. Placenta; 29: S160-165.  Semprini, et al (1992). Insemination of HIV-negative women with processed semen of HIV-positive partners. Lancet; 340: 1317-1319  Semprini, A., Vucetich, A., Hollander, L. (2004). Sperm washing, use of HAART and role of elective caesarean section. Current Opinion in Obstetrics and Gynecology; 16: 465-470.  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.  Thornton, A., Fomanelli, F., Collins, J. (2004). Reproduction decision making for couples affected by HIV: A review of the literature. Topics in HIV Medicine. 12(2): 61-67.  Van Leeuwen, E., Repping, S., Prins, J.M., Reiss, P., van der Veen, F. (unknown date). Assisted reproductive technologies to establish pregnancies in couples with an HIV-I infected man. Van Zuiden Communications.  World Health Organization [WHO]. (July 2012). Guidance on oral pre-exposure prophylaxis (PrEP) for serodiscordant couples, men and transgender women who have sex with men at high risk of HIV: recommendations for use in the context of demonstration projects. Accessed online at: http://www.who.int/hiv/pub/guidance_prep/en/
  • 68. Questions? Nikole Gettings, MSN Director of Clinical Services 901-488-3417 ngettings@memphischoices.org

Notes de l'éditeur

  1. Welcome to everyone and a special thanks to AR Cares and ASU for inviting me. My name is Nikole Gettings, I am a CNM practicing in Memphis TN. I specialize in reproductive healthcare. Today, I will be speaking about HAART and ART. In other words: Acronyms and their complications. (HA)ART: or Highly active Anti-Retroviral Therapy as many of you know, has changed the face of HIV and made ART: or Assisted Reproductive Technology a critical component of care for people living with HIV-infection.
  2. The content of today’s slide was reviewed for CME’s by the folks listed here who functioned as the Medical Review Committee in preparation for a webinar version conducted in 2013 in partnership with ARHP
  3. MAKE SHORT!!! CHOICES is a Reproductive Health Facility located in the Heart of Midtown in Memphis TN Primary Clinician for CHOICES: Memphis Center for Reproductive Health 7 Years Ambulatory Surgical Center Director of Clinical Services Medical Director Services: Wellness care, PAP’s, STD testing for Men and Women, Adolescents Fertility Counseling and assistance for Same sex couples and infertility work ups Colposcopy Terminations: Physician Only State, Elective aspiration and medical terminations Miscarriage Management HIV Specific Care: Reproductive Health Care Transgender care management
  4. None
  5. STOP: Audience Survey: Students? Clinicians? HIV? Who in this room believes individuals who are HIV infected may have sexual partner(s) who are not HIV infected? Who believes that HIV infected individuals may have a desire to have children? Who believes that it is both possible and safe for HIV-infected individuals to pursue having children? Who knows how to counsel HIV-infected individuals on resources and or ways to plan a healthy/safe pregnancy for the non-infected partner and potential future child? Please hold questions until the end If I do not finish: Contact information provided as well as link to the 2013 webinar version of this presentation. There have been recent updates, including clinical guidelines for today’s purposes.
  6. In 2008, when I started practicing as a clinician at CHOICES, then Memphis Center for Reproductive Health, I was brought on staff in the midst of a project that my colleague Jennifer Marshall- now Jennifer Marshall-Pepper- was spearheading regarding bridging the gap that had developed in provision of services around reproductive health care and HIV healthcare. That work led to the development of this presentation, as well as creation of a network of providers first in Memphis, then across the state of TN and today including reaching across to AR and down to Mississippi. The purpose of this network is to address the critical gap in in provision of clinical services addressing reproductive health care within the HIV-infected population as well as incorporating aspects of routine HIV screening and care into settings that provide reproductive care but may not provide screening or linkage to care for HIV-infected individuals. It was thru this networking both with other providers and with the community of HIV-infected individuals that as a clinician, I became aware of the very few resources for HIV-infected individuals addressing multiple components of care including pre-conception and fertility planning. It was also thru this work that CHOICES became committed to providing clinician training regarding multiple aspects of reproductive health specific concerns for the HIV-infected such as today’s presentation.
  7. Many of you are familiar with the timeline of HIV over the past 30 plus years. There are some Highlights worth noting in reference to today’s topic: 1994: Heterosexual contact became a greater risk than injection drug use; 1994 also became the year we started to see significant impact on vertical transmission with AZT 2 years later in 1996: Dr. John Bartlett the director of Johns Hopkins AIDS service right here in Baltimore, noted that strategies changed from preparing patients diagnosed with HIV to die to treatment regimens that allowed them to live The advent of HAART and use of cesarean section as well as other advances in research and clinical practices for prenatal care, antepartum and postpartum care in the HIV-infected population has led to decreasing the risk of vertical transmission to below 2% And of course even today, there are changes such as the 2012 release of guidelines for the use of PREP to prevent seroconversion in partners of HIV-infected in the intimate partner which were again updated as recently as 2014 a few months ago
  8. Interwoven in the timeline we just looked at, and a lesser known timeline is the work that also been going on for 20 years in fertility work with HIV. This one we are going to explore in more depth today, so lets start with almost 25 years ago. 1990:CDC report of single case of HIV infection from HIV + husband to his wife after insemination with washed sperm 1991 British Medical Journal : Published articles citing their concerns with welfare of child and health of medical staff 1993: American College of Obstetricians and Gynecologists: [ACOG]: Stated that HIV + women desiring pregnancy should be counseled to consider her interest in childbearing and the potential suffering of an infected infant, physicians should consider medical and moral appropriateness of delivering preconception care to an HIV + individual 1994 American Society for Reproductive Medicine Ethics Committee: HIV infection is a serious contraindication to Assisted Reproductive Technologies, couples should be counseled to adopt, consider donor insemination and/or child-free living; physicians have NO MORAL obligation to offer services if it is believed there is a risk to patient or offspring 1997: International Federation of Gynecology and Obstetrics Committee for the Study of Ethical Aspects of Human Reproduction: Only seronegative individuals should be allowed to participate in assisted reproduction
  9. I happen to be one of 5 siblings and not too long ago one of my sisters sent a message to the other 4 of us asking: “Are you a rule follower or a rule breaker?” As a middle child, I was the only one to respond appropriately: Neither. I am a rule maker. Despite the “official word” that HIV-infected individuals should not have or desire a family of biologically related children, many HIV-infected individuals in fact did and do dream the impossible. And although small in number, researchers and clinicians have been investigating ways to help make these dreams come true. In 2001, Chen published a study of nearly 1500 HIV infected patients- both men and women and “proved” this dream existed and that many HIV-infected women and men believed this dream to be realistic.
  10. Despite these dreams, there are definitely some road blocks along the way. Squires and associates in 2011 showed that despite many advances of the past 20 years, there is still a lot of stigma by both providers and fear of the individuals seeking our care Of the 700 women surveyed, 227 had or were pregnant at the time of this survey and of those 39% had children However, 48% never asked by provider if they were pregnant or thinking about getting pregnant 57% never discussed appropriate treatment before getting pregnant This study also identified many fears HIV-infected women had in regards to pregnancy plans Some of the fears identified: Women are afraid children will be taken away from them secondary to HIV positive status Women fear their children will be ostracized because of mother’s HIV positive status Lack of resources: poverty, language barriers, lack of medical insurance, lack of education
  11. This survey, conducted in 2011 by myself as part of a team supported by CHOICES and in conjunction with both the other authors listed here and a collaboration of providers in Memphis who serve the HIV-infected population in the Memphis community, reflected similar findings to those of Chen and later Squires. Results of this study specific to fertility were on display yesterday as a poster outside the exhibit hall as part of the Nursing Summit. Anyone interested can obtain a copy of the poster presentation I have here Additionally, there will be a full manuscript available upon request that I hope to hear will be accepted for publication. The survey was a 31 question survey designed to ask HIV-infected women of reproductive age in the Memphis Community both quantitative and qualitative questions regarding their reproductive life history, pregnancy desire, plans and their experience with educational, social support and medical services in working towards these goals. The results from the survey of 85 HIV-infected women were similar to the larger surveys previously published by Chen and Squires. However, what I am most proud of is the successful actions that were implemented after the results of the survey were shared with the collaborators. The HIV network Parallel Paths I mentioned previously, was integral in translating the results of the study into clinical outcomes. Most notably: ST. Jude Children’s Research Hospital incorporated routine counseling to their HIV –infected patients. Some of you may be aware, that in addition to the amazing work that St. Jude does regarding cancer care and research in children, they also have a clinic dedicated to caring for young people who are born with or contract HIV prior to age 21. In Memphis, anyone who is diagnosed HIV-infected, is referred to care which is provided regardless of ability to pay, until the young person reaches the age of 21. As a direct result of the results of this survey, HIV providers and social workers as well as peer mentors in the St. Jude HIV clinic incorporate complete reproductive health histories including asking about desires and plans for having or raising children into their clinical care. Based on personal communication with clinical and research staff, the potential for one day planning to have a child or children of their own is often a positive motivator for the young people. It is a positive motivator for remaining in care and remaining adherent to medications. A second direct result and in fact part of the motivation for conducting the study in Memphis was the Ryan White Community Needs Assessment and the resultant Community Plan. Previous to the release of these survey results, the annual Ryan White community needs assessment simply did not survey reproductive needs regarding fertility desire or pregnancy planning. The 2012 Needs assessment included 3 questions specific to reproductive desire and whether fertility planning was available or received from clinicians and the plans for the 2014 Needs assessment are to double this to 6 total questions specific to reproductive care. The 3 questions chosen in 2012 were taken directly from the questions my colleagues and myself included in our study. So what do we think of these desires and pregnancy within our HIV-infected population? Hopefully, after today’s presentation, you will feel more comfortable providing at least referrals and perhaps even counseling and for some of you even some of the services involved in providing care for HIV-infected individuals, their partners, and their families along the way in their journey to have their own family.
  12. John Robertson, in his book “Children of CHOICE: Freedom and the New Reproductive Technologies stated this: Read Slide He was not speaking directly about HIV-infected individuals, but he was addressing individuals facing chronic illness or with diagnosed genetic disorders who face the possibility of passing their diagnosis on to any children they choose to conceive.
  13. Dr. Semprini, an OB in Italy understood this. In fact, he understood it and published a shocking report based on his understanding in 1992. Yes…1992..2 years before we began to see significant evidence of decreased vertical transmission (transmission from infected mother to infant during pregnancy, childbirth or postpartum, and 4 years before Dr. Bartlett made is statement charging us to change our clinical guidance for HIV-infected individuals from preparations to die to encouragement to live a long life. Oh yeah- and yes- if you recall- 1992 was also when the policy and guideline boards were almost unanimously drafting policies and guidelines stating that individuals infected with HIV should be asked to never engage in sexual activity, much less procreation. Clinicians were given explicit instructions to ignore these desires and to cite rules of “moral appropriateness” to anyone admitting to such verboten desires or seeking clinical guidance. Are we surprised thus that even 2 decades later, HIV-infected individuals face fear and stigma around voicing a desire for this basic human identity? Well, Semprini was a clinician determined to listen to his patients more than the policy and guideline writers. He started with 85 sero-discordant couples. These 85 couples were male HIV+, and since this was before sexual transmission outstripped transmission from injection drug use. All of the males infected with HIV in this cohort had contracted HIV, often in their “wild” youth/early 20’s, they sought care with Semprini after they had matured, settled down, found long term partners. However, like many of us, these wild youth eventually “grew up” and all of these individuals had lived a drug free life and led otherwise normal lives working and making their way thru life. These individuals and their partners were overcome with the desire to pursue childbearing and to raise a family of their own. I am sure many in this room can identify with this desire. Yet, they were barred from this privilege because of this small piece of who they were- their HIV infected diagnosis. Of the 85 couples screened and selected for participation, 29 of the women were found to be good candidates for insemination. Of the 29 selected candidates, 15 women underwent insemination with their HIV-infected partners sperm. 17 pregnancies resulted.
  14. Now Semprini was not forging forward against all the published policies and guidelines without some legitimate theory as to why he might actually be doing more good than harm. Later research supported one reason for this may be that spermatazoa have not been illustrated to have CD4, CCR5 or CXCR4 Receptors which are thought to be a requirement for HIV He also understood a primary tenet of the Hippocratic Oath. Do no Harm. He understood that because procreation is such a central tenet to humanity, that many of these couples would privately pursue pregnancy in the way that most people pursue pregnancy even though they understood the risk. In couples who ultimately pursued this path, approximately 7.2% of the non-infected partner- often the woman- would seroconvert in the process of attempting to conceive over the course of the “standard” accepted 12 months/1 Year it takes for couples to conceive in the absence of infertility. This resulted in approximately 0.07% risk of infection per act of intercourse and a cumulative risk of 4% seroconversion per conception. But Semprini believed that it was possible that the semen itself was not the guilty party in the case of HIV. He believed, although there was limited data at the time to support this belief that it was possible that the HIV virus was carried in the seminal fluid but not attached to the sperm itself. Because seminal Fluid includes cellular and cell-free components in a complex fluid matrix that varies with each ejaculate. The cellular components include sperm, polymorphonuclear cells, immature germ cells, lymphocytes, macrophages and occasional genitourinary epithelial cells as well as White blood cells And of course the requisite Spermatozoa Semprini believed their were many other possible carriers of the HIV virus within the matrix of semen.
  15. Semprini used a series of sperm washing techniques still used today to effectively separate the spermatazoa from the other components of the seminal fluid. The steps involved in sperm washing were first a density centrifugation, second a standard swim up, followed by yet another centrifuge. Finally, and this is the point that Semprini emphasized in his 1992 publication, the resulting sperm “pellet” as it is called, was tested for HIV using PCR technology. And this was, and still is, the vital step. In his report out of of 516 sperm preparations a total of 5 samples showed a positive PCR in HIV DNA. These samples were discarded and not utilized for insemination.
  16. And here is the evidence of his work. The middle 2 columns demonstrate one of his primary goals which was to reduce the potential for transmission by reducing the number of “tries” it took to achieve conception, even though the spermatazoa samples used had tested negative for presence of HIV-DNA. This was, to Semprini and others, simply a matter of applying statistics. Although the majority of selected couples did NOT have a diagnosis of infertility, Semprini was determined to apply these statistics in every way possible and to utilize every assistance possible to support conception with as few inseminations as possible. Hence he did elect to provide hormone support to cause ovulation. The majority of couples conceived with only 1-2 inseminations, or in Semprini’s mind, 1-2 possible exposures. While a few required 3, 4 or 5. As is usually seen when utilizing fertility hormones to support conception, some multiple gestations resulted.
  17. And in 1992, he broadcasted his results in 10 short paragraphs in The Lancet. Some of the pregnancies as seen in the last slide were in the 2nd or 3rd trimester by the time of publication, so at that time, only 10 babies had been born- All HIV free. And, most importantly Semprini, despite the naysayers, proved that his work did in fact uphold the Hippocratic oath. There were no seroconversions of the partner and thus by helping these couples achieve their dreams, Semprini in fact not only did no harm, he reduced likely reduced harm that would have resulted if these individuals had risked pursuit of their dream without clinical guidance and assistance.
  18. A few years later, 5 to be exact, Mandelbrot and others, proved the importance of Semprini’s theory that he was reducing harm by assisting these couples. Mandelbrot documented the result of what happens when clinical guidance is used to teach basic tenets of using selective, timed intercourse in coordination with ovulation to couples anxious to conceive despite HIV-diagnosis His results supported Semprini’s theoretical risk of 4%. If you recall, this was the percentage Semprini theorized of HIV-negative partners who would seroconvert if he did not provide additional assistance. Mandelbrot’s 92 couples, similar to Semprini’s couples the male was the HIV-infected partner, practiced protected intercourse using condoms at all times except during ovulation. The clinical services were educational only with no sperm washing and no ovulation stimulation. The couples were given instructions on monitoring and tracking ovulation and had limited, time unprotected intercourse. A total of 104 pregnancies resulted, however, sadly, 4 of the couples experienced maternal seroconversion. Mandelbrot showed that denying HIV infected individuals clinical care and access to ART or selected Artificial Reproductive Technologies, even in the absence of documented infertility, did more good than harm.
  19. In a little while, I will be reviewing the key clinical components of providing care for HIV-infected individuals desiring pregnancy, but first, I want to take a look at the evidence based impact that Semprini and Mandelbrot’s as well as others had on the policy and guidelines. Although, as you will see the impact was slow. First let’s look at the history of the CDC policy that was created regarding HIV-infection and reproduction. You should know that this policy was based on a single case study that occurred here in the US around the same time that Semprini was listening to his patients in Italy. Hemophiliac husband, HIV+ since 1985 HIV – Wife, annual testing Intercourse 2-4 times a month, since 1986, always with a latex condom, denied oral, anal intercourse Denied any contact with blood or blood products, husband injected with Factor VII No other partners since 1986, no injection drug use August, October, December 1989: 3 inseminations September 1989: Viral illness 3 weeks after 1 insemination centrifuge only 2 inseminations centrifuge + Percoll density gradient No sperm fractions were tested for HIV No pregnancy Read slide This left no discussion open around desired or potential fertility
  20. The CDC decree of “no sex for HIV-infected individuals” was upheld for years despite evidence from individuals such ast the International Perinatal HIV group who showed that actual risk with female-to-male intercourse, although yes a risk, was somewhere between 1:500 and 1:1000 chance per act of intercourse. To put a little perspective on this, consider the risk some individuals who have genetic abnormalities of which we could name several, where the risk of passing on that genetic disease to a potential child is 25% or 1 in 4. The CDC does not tell these individuals or their partners to “not have sex”.
  21. And yet, to be fair, as is often the case, these guidelines and policies were created in an effort to do no harm. The ethical concerns cited by the CDC and other organizations at the time, were perfectly honorable concerns such as: Creation of a life infected with HIV from conception or soon after Premature death of one or both parents resulting in possible orphaning of the child And fear of spreading infection via offering clinical care to those infected. One only has to listen to the daily reports on the Ebola crisis right now to understand how this can be, in some viruses and illnesses, including HIV, a concern that cannot be discounted flippantly. In 2001, Lyerly and Anderson published a well outlined theoretical support for why the 3 principals of bioethics, Autonomy, beneficence and justice, perhaps are better served by providing access to fertility services and reproductive planning for couples affected by HIV-infection.
  22. Based on the clinical evidence accumulating, Lyerly and Anderson proposed that the benefits of providing guidance and clinical care to HIV affected couples was beginning to outweigh the benefits.
  23. And today, we can see the impact all of this work has had on successfully changing those thoughtful although ultimately unsupported guidelines. In 2010, the Ethics Committee of ASRM or Association of Reproductive Medicine updated their policy to state: Read Slide
  24. In December 2010, ACOG followed suite and not only instructed physicians to be prepared to have detailed discussions about planning a pregnancy with their HIV-infected clients but also cautiously endorsed artificial insemination, an ART typically reserved for cases of diagnosed male infertility, as a way to decrease the risk of transmission to the uninfected female partner.
  25. And the CDC? They were actually the front runners in this and in 2001, the same year Lyrtely and Anderson published their theoretical basis supporting clinical care for pregnancy planning in HIV-infected individuals, the CDC changed their policy. I will caution you that there are some publications in this work, even as recently as 2013, that incorrectly state the CDC has never changed their statement regarding HIV-infected pregnancy planning. However, the clinical guidelines for care have been updated.
  26. HIV positive patients also, as we know often lack resources to obtain basic care much less fertility services Even IUI is more expensive for HIV patients due to increased washing and testing ICSI: Much more expensive for example Sauer and colleagues illustrated in their results
  27. Despite these positive outcomes, there is still evidence especially in the United states that we continue to have a lack of providers and lack of access 2001: Survey of 324 Fertility Clinics, 57% responded, 18% offered some form of ART to HIV positive couples Sauer addressed this issue in his 2006 publication 10 Clinics registered with American Society for Reproductive Medicine who admitted to providing some aspect of HIV positive care Columbia University in NY -Lack of training in fertility and endocrinology regarding HIV and reproductive tract tissue/germ cells Criminal act to place material in a person potentially harboring HIV Liability Cost! Recommendation to house completely separate laboratory for HIV + eggs or sperm if stored this is due to theoretical, but never proven potential to possibly confer HIV unintentionally
  28. “…[u]nless health care workers can show that they lack the skill and facilities to treat HIV-positive patients safely or that the patient refused reasonable testing and treatment, they may be legally as well as ethically obligated to provide requested reproductive assistance. ASRM, Ethics Committee 2004 So let’s talk now about how in a variety of settings and within a multi-disciplanary team of providers you can provide components of care to individuals, couples and families affected by HIV-infection.
  29. Donor sperm can be ordered from many organizations either to the patient’s home or to the fertility specialist’s office Unwashed sperm can safely be used for home insemination Washed sperm can be used for in-office intra-uterine inseminations
  30. Before we move on a few words about Guidelines: The recommendations I will present today are supported, unless noted otherwise, by these guidelines. I am happy to email you PDF versions of these guidelines if you need access to them. ASRM is my preference simply because as the name indicates, the guidelines cover fertility planning and fertility treatment in regards to multiple viruses including: HIV, Hepatitis A, B, (co-infection with D) and C, Human Pappilloma Virus, Human T-Cell Viruses, herpes virus family including Epstein Barr virus, cytomegalovirus, herpes simplex virus and human herpes viruses type 6 &amp;8 As a
  31. Plan your Pregnancy! Applies to HIV-infected and affected individuals too. Goal is to improve health of women before conception and identify risk factors for maternal and fetal outcomes Specific goal in HIV Infected and affected couples is to avoid transmission to the uninfected partner using risk reduction techniques as appropriate and when indicated.
  32. As we are seeing in many arenas of healthy living when HIV-infected, keeping viral load low and CD-4 count high leads to optimal outcomes in a variety of ways.
  33. Seminal viral load does appear to correlate with plasma viral load but can be variable There have been findings where undetectable viral plasma levels have been found to have seminal HIV presence detected – keeping in mind, that seminal fluid is not the same as spermatazoa as we discussed earlier. *Has found to be increased likelihood when co-infection of other STI or genital tract inflamation is found ASRM: specifies &amp;lt;10,000 is optimal based on research
  34. Goals of Screening per American Society for Reproductive Medicine: Identify and treat pre-exisiting infections Document new transmissions resulting from intrauterine insemination or in vitro fertilization Ensure appropriate steps can be taken to minimize the risks of sexual and vertical transmission
  35. Both ACOG and ASRM address utilization of infertility assessments as well as treatment techniques when indicated in the HIV-infected population with two primary objectives: Using proven techniques for the purpose of reducing risk of transmission to the uninfected partner even in the absence of infertility. I will be covering these techniques and their indications in more detail in a few moments Avoiding restriction of HIV-affected couples from accessing infertility treatments when indicated
  36. In my own experience most of the steps we have gone thru so far, can be completed by clinicians practicing in many settings and in coordination with referral sites for additional evaluation, counseling and treatment. Now we will move on to discuss specific recommendations dependent on the specific configuration regarding which individual is HIV-infected
  37. These are the methods I will review today. A note about Guidelines: when applicable, I have indicated if a particular method is endorsed by either the American College of Obstetricians and Gynecologists. These clinical guidelines were released in 2010. These address multiple areas of reproductive health in HIV-infected women including a section addressing fertility. The American Society for Reproductive Medicine ASRM- guidelines were updated in 2013, initial development of this powerpoint was based on 2008. These clinical guidelines, I personally find more utilization in the clinical setting since the guidelines are written as “Guidelines for reducing the risk of viral transmission during fertility treatment”. Includes not only HIV, including differentiating between HIV-1 and HIV-2, as well as Hepatitis A, B and C, human T-cell lymphotropic viruses, HPV and several members of the herpes virus family including Ebstein Barr, cytomegalovirus, and HSV 2, 6 and 8. Major change was addition of a single paragraph addressing Cochrane Review showing significant difference in transmission rates when the infected partner was maintained on HAART.
  38. Reproductive assistance for the HIV + female Options for this couple are Insemination with partner’s sperm at ovulation Insemination with donor sperm In-vitro fertilization Intracytoplasmic sperm injection We are going to cover the last 2 options when in a few moments in more detail in regards to treatment options for HIV + male, so lets spend just a few minutes on insemination with either her partner’s sperm or donor sperm
  39. For couples who are HIV + male and HIV – female, sperm washing followed by IUI or ICSI is the primary method recommended However, there have been some studies around timed intercourse and using PEP
  40. ASRM does address, although briefly and without specific guidelines or endorsements. Primarily they state that that “risk reduction techniques have been used with the goal of reducing the risk of superinfection of the female partner with different strains of HIV or drug-resistant HIV”
  41. Major point of this slide is to remind you that in working with HIV-infected and affected clients, you need to plan to spend lots of education time. Consider your clinic and clinician resources regarding planned education sessions.
  42. In the publications by Semprini in 1992 he emphasized specific techniques that he believed led to the differences between his outcomes and the CDC reports from 1989/1990 Specifically he talked about the process of washing the sperm and testing the sperm with PCR testing
  43. Sperm is collected from HIV + male partner using masturbation or sperm retrieval methods Sperm is washed using a combination of swim up, gradient centrifugation and centrifugation Sperm preparation takes approximately 2-3 hours PCR testing for final sperm fraction Sperm can either be frozen or used immediately Sperm is drawn up into IUI catheter Speculum inserted vaginally IUI catheter inserted gently through cervical os Sperm placed in uterus Woman is advised to rest in office for 30 minutes Timed in accordance to natural fertility Use of fertility inducing medications such as clomid and HcG can stimulate ovarian follicle development and decrease the number of inseminations needed (thus theoretically reducing risk of HIV transmission and in reality reducing the total cost) 1-3 IUI per cycle generally recomended. To increase chances of conception
  44. 258 Serodiscordant couples 181 proceeded with treatment 128 couples 161 clinical pregnancies: 116 delivered from 103 couples 21 spontaneous abortions /1 elective abortion 2ndary to trisomy 21 5 ectopic pregnancies 170 neonates delivered 41% multiple pregnancies 39% pregnancy rate per embryo transfer NO female seroconversions and no neonate seroconversions
  45. Donor sperm can be ordered from many organizations either to the patient’s home or to the fertility specialist’s office Unwashed sperm can safely be used for home insemination Washed sperm can be used for in-office intra-uterine inseminations
  46. And of course, as many of us are aware, the newly released PREP guidelines in 2012 and already revised in 2014 are likely to have an impact on this work and the clinical care recommendations to come, however, the data will likely be some time before it is fully tabulated.