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Assisted reproduction for couples affected by human immunodeficiency virus in California
Assisted reproduction for couples affected by human immunodeficiency virus in California Survey results demonstrate that the majority of fertility clinics in California are willing to care for couples affected by human immunodeficiency virus (HIV) if legal restrictions are removed. In response to scientific advances and evolving clinical standards, California reversed the limitations placed on the provision of assisted reproduction for HIV-positive men in 2008. (Fertil Steril 2009;91:1540–3. 2009 by American Society for Reproductive Medicine.) Key Words: HIV, HIV discordant couples, assisted reproduction, sperm washing
Since the widespread implementation of highly active antiretroviral therapy (HAART), the lifespan of individuals affected by human immunodeficiency virus (HIV) has increased from an average age of 45 to an average age of 65 years (1). With the changing prognosis of the disease, HIV is now viewed as a chronic illness, and HIV-affected individuals desire traditional life goals, including families. Chen et al. (2) found that approximately 30% of HIV-infected adults desire children during their lives. In the United States, the risk of perinatal HIV transmission can be decreased from 25% with no treatment to <1% with standard therapy during pregnancy (3–5). Couples who are HIV discordant (couples in which only one partner is infected with HIV) face the risk of transmitting the virus to the uninfected partner when trying to conceive naturally. Risk of disease transmission has been estimated to be 4.3% in HIV discordant couples practicing timed intercourse, or 1 transmission out of 1000 episodes of unprotected intercourse (6, 7).
sperm from the potentially HIV-containing components of semen (8). Since 1987, numerous observational cohort studies have reported over 4500 ART procedures using processed sperm from an HIV-positive man to establish a pregnancy in his HIV-negative female partner (9–18). Although no randomized control studies have been performed examining the efficacy of these procedures compared with other methods of conception, there have been no reports of HIV transmission to mother or infant when using standardized sperm processing techniques, suggesting that these procedures are safe and effective at preventing disease transmission (15, 16, 19, 20). In 1990, the U.S. Centers for Disease Control and Prevention reported a single case of HIV transmission to the female partner of an infected man after intrauterine insemination of processed sperm; however, the initial sperm processing did not involve density gradient techniques and would be considered suboptimal by current standards of care (21).
Assisted reproductive techniques including intrauterine insemination, in vitro fertilization (IVF), and intracytoplasmic sperm injection (ICSI) have been used for HIV-discordant couples to limit an HIV-negative woman’s exposure to infectious semen when trying to conceive. Sperm washing techniques and, in some circumstances, polymerase chain reaction (PCR) testing are used in conjunction with assisted reproduction technology (ART) to separate uninfected
The American Society for Reproductive Medicine (ASRM) has stated that ‘‘unless health care workers can show that they lack the skill and facilities to treat HIVpositive 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’’ (22, p. 221). Patients should be counseled concerning disease transmission risks, informed of risk-reducing strategies, and encouraged to seek care to minimize HIV transmission (22). The American College of Obstetricians and Gynecologists (ACOG) further supported this opinion by stating, ‘‘Assisted reproductive technology should not be denied to HIV-infected couples solely on the basis of their positive serostatus’’ (23, p. 33). Notably, there is no federal requirement mandating HIV testing of men donating sperm to intimate partners for the purpose of assisted reproduction.
Received July 14, 2008; revised August 31, 2008; accepted September 4, 2008; published online October 29, 2008. N.B. has nothing to disclose. M.S. has nothing to disclose. S.W. has nothing to disclose. D.C. received a $25,000 grant from Pfizer (New York, NY) to conduct an investigator-initiated research project. Supported by University of California San Francisco Area of Concentration Student Funding 2006–2007, San Francisco, California. Presented as a poster at Infectious Diseases Society for Obstetrics and Gynecology Annual Scientific Meeting, Boston, Massachusetts, August 9–11, 2007. Presented as a poster at the 2007 National HIV Prevention Conference, Atlanta, Georgia, December 2–5, 2007. Reprint requests: Deborah Cohan, M.D., Department of Obstetrics, Gynecology and Reproductive Sciences, San Francisco General Hospital, 1001 Potrero Avenue, Ward 6D, 6D-22 (UCSF Box 0842), San Francisco, CA 94110 (FAX: 415-206-3112; E-mail: cohand@ obgyn.ucsf.edu).
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Although these ART procedures are available in the United States and supported by professional organizations, many fertility clinics do not serve HIV-affected couples. Sauer et al. (24) in 2006 estimated that 10 clinics (approximately 3% of fertility clinics nationwide) openly provided
Fertility and Sterility Vol. 91, No. 4, Supplement, April 2009 Copyright ª2009 American Society for Reproductive Medicine, Published by Elsevier Inc.
0015-0282/09/$36.00 doi:10.1016/j.fertnstert.2008.09.013
care to HIV-positive men (24). Furthermore, state laws in California and Delaware have explicitly limited the availability of services. From 1989 to 2008, the California Health and Safety Code prohibited the transfer of sperm from donors who test positive for HIV, thereby prohibiting the treatment of couples in which the male partner is HIV-positive, even in the setting of an HIV-infected female partner (25).
and 2.5% military based. Clinics were dispersed throughout California although primarily clustered around urban centers. Forty-five percent of responding clinics (18 out of 40) had had requests for care from HIV-affected couples within the year prior to the survey. A total of 73 couples were reported to have requested care at 18 clinics with a range of 1 to 25 couples and a median number of two couples requesting care per clinic per year.
We hypothesized that access to ART services is limited in California for HIV-affected couples desiring to conceive. The provision of services is limited due to both individual clinic policies affecting treatment of HIV-positive women and the California Health Code prohibiting use of semen from HIV-positive men. To obtain ART services, HIVdiscordant couples must travel outside of California (24). The limited provision of infertility treatment to HIV-discordant couples may lead to an increase in HIV transmission through attempts to conceive naturally (26). We examined the practices and attitudes surrounding provision of ART for HIV-positive patients by surveying all identified fertility clinics in California. Our objectives were to determine the status of ART service provision for HIV-positive women in California and examine fertility clinics’ willingness to provide ART for HIV-positive patients in California if legal restrictions were changed.
Sixty-three percent of clinics had an official policy on provision of care for HIV-affected couples. In compliance with California regulations, all clinics reported universal HIV testing of male partners before use of ART. Universal testing of female recipients was also performed by nearly all clinics (98%) as recommended by national professional organizations. Sixty-eight percent of clinics with policies allowed provision of care for HIV-infected women with uninfected male partners while prohibiting the use of sperm from an HIV-positive donor. Twenty-eight percent of clinic policies restricted care even more than state regulations at the time of the survey, providing no ART for HIV-affected couples.
We identified fertility clinics using public access internet health directories including the Centers for Disease Control and Prevention, the Society for Assisted Reproductive Technology, the National Fertility Directory, the National Infertility Association (Resolve), and Internet Health Resources. California-based reproductive endocrinologists were consulted regarding the completeness of this list. We administered a confidential, structured 16-item survey to all medical directors of identified fertility clinics in California through a Web-based survey tool (Survey Monkey, http://www.surveymonkey.com) and/or faxed paper surveys for those clinics without e-mail contacts. We followed-up with bi-weekly to monthly e-mail and telephone reminders to nonresponders for 6 months. The survey examined the presence of clinic policies regarding provision of services for HIV-infected patients, services provided at the time of the survey, and attitudes toward provision of services for HIV-infected men if the California law were to allow therapeutic use of donated sperm for a designated recipient. The survey was based upon instruments used in previous studies conducted in the United Kingdom and Australia (27, 28). We imported all data into a relational database and performed summary statistics using Microsoft Excel 2004 (Microsoft Corp., Redmond, WA). The Committee on Human Research at the University of California, San Francisco, approved the study before its initiation. Forty-one of the 68 clinics (60%) responded to the survey. Of those responding, 85% of clinics self-identified as private practice clinics, 10% academically affiliated, 2.5% health-maintenance organization (HMO) clinics, Fertility and Sterility
Although 29% of the clinics had provided ART for HIVpositive women with uninfected partners, 72% of respondents endorsed willingness to provide services for these patients. Regarding services for HIV-discordant couples with an HIV-positive male partner, clinics were more willing to provide IVF/ICSI (74%) than intrauterine insemination (55%). Additionally, if state law were to change, 73% (27 out of 37) and 65% (24 out of 37) of clinics reported their willingness to provide care for HIV-concordant and HIV-discordant couples, respectively. The HIV epidemic in the resource-rich setting has changed significantly in the past decade, and scientific advances can now be implemented in clinical settings. Despite this progress, access to ART for HIV-discordant couples is limited by the paucity of providers nationwide willing and/ or equipped to care for these couples (24). The situation is further complicated by state regulations that are more restrictive than federal law, including the California state prohibition of the use of semen from an HIV-positive man. For HIV-positive women with HIV-negative male partners, assisted reproduction has always been legal in California. Almost a third of the clinics had provided ART services for these couples, but the majority expressed willingness to do so. It is interesting that the majority of California fertility clinics surveyed were also willing to provide care for HIVdiscordant couples with an HIV-infected male partner, a trend not appreciated nationally (24). The number of HIV-affected couples requesting care within the previous year was small; however, this likely is an underestimate due to the number of couples desiring assisted reproduction who do not seek these services because of state restrictions. As with all surveys, our study had limitations. The response rate of 60% may limit the generalizability of our
1541
findings. Nonetheless, the geographic distribution appropriately represented both rural and urban settings throughout northern and southern California. Moreover, we assessed a clinic’s theoretical willingness to provide services if the law were to change, but this does not necessarily translate to actual provision of care. Despite these limitations, the findings of this survey were instrumental in helping reverse the California legal restrictions. During the implementation of this survey, we assisted in amending the California prohibition against the use of semen from HIV-infected donors for the use in ART. This was a collaborative effort with national experts on ART and HIV and received endorsement by local chapters of ACOG, ASRM, the American Academy for HIV Medicine, and the American Civil Liberties Union. The amendment was signed into law January 1, 2008, by Governor Arnold Schwarzenegger. California Health and Safety Code now allows the use of semen from an HIV-positive man for ART with a designated recipient after mutual informed consent has been obtained (25). By 2010, the state department of health services will adopt state specific guidelines regarding patient evaluation and treatment, specimen processing, laboratory management, and follow-up care. Although these state regulations are pending, facilities should follow practice guidelines as published by ASRM (29). Semen must be effectively processed using density gradient centrifugation with the swim-up method. Sperm may be tested for HIV before use, though this is not mandated. In addition, the HIV-infected donor should be managed with antiretroviral therapy. If conception does occur, access to appropriate prenatal care for the woman and follow-up HIV testing of the mother and baby should occur. Although addressing legal restrictions against ART for HIV-affected couples is a crucial first step, ultimately these couples will only be able to access care if clinics establish protocols and begin offering services. The National Perinatal HIV Consultation and Referral Service (1-888-4488765) has begun assembling a network of fertility clinics in the United States willing to provide services for HIV-affected couples. This new era in the HIV epidemic should prompt reproductive infertility and endocrinology specialists to embrace the opportunity to provide HIV-affected couples seeking conception with potentially life-saving ART.
Acknowledgments: The authors thank Jeff Sheehy from the AIDS Research Institute and Carol Stuart for assistance in organizing our survey and legislative advocacy, the clinic directors who participated in the survey, and the couples and community-based and advocacy organizations who assisted in the legislative effort.
Nena Barnhart, M.D.a Maureen Shannon, C.N.M., F.N.P., Ph.D.a,b Shannon Weber, M.S.W.c Deborah Cohan, M.D., M.P.H.a 1542
Barnhart et al.
Correspondence
a
Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California San Francisco, San Francisco, California; b School of Nursing and Dental Hygiene, University of Hawai’i at Ma˜noa, Honolulu, Hawaii; and c National HIV/AIDS Clinicians’ Consultation Center, San Francisco, California
REFERENCES 1. Lohse N, Hansen AB, Pedersen G, Kronberg G, Gerstoft J, Sorensen HT, et al. Survival of persons with and without HIV infection in Denmark, 1995–2005. Ann Intern Med 2007;146:87–95. 2. Chen JL, Phillips KA, Kanouse DE, Collins RL, Miu A. Fertility desires and intentions of HIV-positive men and women. Fam Plann Perspect 2001;33:144–52. 65. 3. Shapiro D, Tuomala R, Samelson R, Burchett S, Ciupak G, McNamara J, et al. Mother-to-child HIV transmission rates according to antiretroviral therapy, mode of delivery, and viral load in 2895 U.S. Women (PACTG 367). Presented at the 11th Conference on Retroviruses and Opportunistic Infections, February 8–11, 2004; San Francisco, CA. 4. Warszawski J, Tubiana R, Le Chenadec J, Blanche S, Teglas JP, Dollfus S, et al. Mother-to-child HIV transmission despite antiretroviral therapy in the ANRS French Perinatal Cohort. AIDS 2008;22: 289–99. 5. Townsend CL, Cortina-Borja M, Peckham CS, de Ruiter A, Lyall H, Tookey PA. Low rates of mother-to-child transmission of HIV following effective pregnancy interventions in the United Kingdom and Ireland, 2000–2006. AIDS 2008;22:973–81. 6. Gray RH, Wawer MJ, Brookmeyer R, Sewankambo NK, Serwadda D, Wabwire-Mangen F, et al. Probability of HIV-1 transmission per coital act in monogamous, heterosexual, HIV-1-discordant couples in Rakai, Uganda. Lancet 2001;357:1149–53. 7. Mandelbrot L, Heard I, Henrion-Geant E, Henrion R. Natural conception in HIV-negative women with HIV-infected partners. Lancet 1997;349:850–1. 8. Thornton AC, Romanelli F, Collins J. Reproduction decision making for couples affected by HIV: a review of the literature. Top HIV Med 2004;12:61–7. 9. Semprini AE, Levi-Setti P, Bozzo M, Ravizza M, Taglioretti A, Supizio P, et al. Insemination of HIV-negative with processed semen of HIV-positive partners. Lancet 1992;340:1317–9. 10. Semprini AE, Fiore S, Pardi G. Reproductive counselling for HIV-discordant couples. Lancet 1997;349:1401–2. 11. Marina S, Marina F, Alcolea R, Exposito R, Huguet J, Nadal J, et al. Human immunodeficiency virus type 1-serodiscordant couples can bear healthy children after undergoing intrauterine insemination. Fertil Steril 1998;70:35–9. 12. Sauer MV, Chang PL. Establishing a clinical program for human immunodeficiency virus 1-seropositive men to father seronegative children by means of in vitro fertilization with intracytoplasmic sperm injection. Am J Obstet Gynecol 2002;186:627–33. 13. Pe~na JE, Thornton MH, Sauer MV. Assessing the clinical utility of in vitro fertilization with intracytoplasmic sperm injection in human immunodeficiency virus type 1 serodiscordant couples: report of 113 consecutive cycles. Fertil Steril 2003;80:356–62. 14. Ohl J, Partisani M, Wittemer C, Schmitt M-P, Cranz C, Stoll-Keller F, et al. Assisted reproduction techniques for HIV serodiscordant couples: 18 months of experience. Hum Reprod 2003;18:1244–9. 15. Sauer MV. Sperm washing techniques address the fertility needs of HIV-seropositive men: a clinical review. Reprod Biomed Online 2005;10:135–40. 16. Gilling-Smith C, Nicopoullos JDM, Semprini AE, Frodsham LCG. HIV and reproductive care—a review of current practice. BJOG 2006;113:869–78.
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17. Savasi V, Ferrazzi E, Lanzani C, Oneta M, Parrilla B, Persico T. Safety of sperm washing and ART outcome in 741 HIV-1-serodiscordant couples. Hum Reprod 2006;22:772–7. 18. Bujan L, Hollander L, Coudert M, Gilling-Smith C, Vucetich A, Guibert J, et al. Safety and efficacy of sperm washing in HIV-1-serodiscordant couples where the male is infected: results from the European CREAThE network. AIDS 2007;21:1909–14. 19. Politch JA, Xu C, Tucker L, Anderson DJ. Separation of human immunodeficiency virus type 1 from motile sperm by the double tube gradient method versus other methods. Fertil Steril 2004;81:440–7. 20. Kato S, Hanabusa H, Kaneko S, Takakuwa K, Suzuki M, Kuji N, et al. Complete removal of HIV-1 RNA and proviral DNA from semen by the swim-up method: assisted reproduction technique using spermatozoa free from HIV-1. AIDS 2006;20:967–73. 21. Centers for Disease Control and Prevention (CDC). HIV-1 infection and artificial insemination with processed semen. MMWR Morb Mortal Wkly Rep 1990;39(249):55–6. 22. Ethics Committee of the American Society for Reproductive Medicine. Human immunodeficiency virus and infertility treatment. Fertil Steril 2002;77:218–22. 23. American College of Obstetricians and Gynecologists Committee on Ethics. Human immunodeficiency virus: ethical guidelines for obstetri-
Fertility and Sterility
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cians and gynecologists. Committee Opinion 255. Obstet Gynecol 2001;97(Suppl):1–6. Sauer MV. American physicians remain slow to embrace the reproductive needs of human immunodeficiency virus-infected patients. Fertil Steril 2006;85:295–7. California Codes: Health and Safety Code. Section 1644–1644.5. Available at: http://www.leginfo.ca.gov/cgi-bin/waisgate?WAISdocID ¼06351319110þ1þ0þ0&WAISaction¼retrieve. Last revised January 1, 2008. Accessed on: May 17, 2008. Klein J, Pe~na JE, Thornton MH, Sauer MV. Understanding the motivations, concerns, and desires of human immunodeficiency virus 1-serodiscordant couples wishing to have children through assisted reproduction. Obstet Gynecol 2003;101:987–94. Apoola A, tenHof J, Allan PS. Access to infertility investigations and treatment in couples infected with HIV: questionnaire survey. BMJ 2001;323:1285. Pitts M, Shields P. Access to infertility investigations and treatment for HIV positive people: a survey of Australian infertility clinics. Aust NZ J Public Health 2004;289:360–2. Practice Committee of the American Society for Reproductive Medicine. Guidelines for reducing the risk of viral transmission during fertility treatment. Fertil Steril 2006;86(Suppl):11–7.
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Since the widespread implementation of highly active antiretroviral therapy (HAART), the lifespan of individuals affected by human immunodeficiency virus (HIV) has increased from an average age of 45 to an average age of 65 years (1). With the changing prognosis of the disease, HIV is now viewed as a chronic illness, and HIV-affected individuals desire traditional life goals, including families. Chen et al. (2) found that approximately 30% of HIV-infected adults desire children during their lives. In the United States, the risk of perinatal HIV transmission can be decreased from 25% with no treatment to <1% with standard therapy during pregnancy (3–5). Couples who are HIV discordant (couples in which only one partner is infected with HIV) face the risk of transmitting the virus to the uninfected partner when trying to conceive naturally. Risk of disease transmission has been estimated to be 4.3% in HIV discordant couples practicing timed intercourse, or 1 transmission out of 1000 episodes of unprotected intercourse (6, 7).
sperm from the potentially HIV-containing components of semen (8). Since 1987, numerous observational cohort studies have reported over 4500 ART procedures using processed sperm from an HIV-positive man to establish a pregnancy in his HIV-negative female partner (9–18). Although no randomized control studies have been performed examining the efficacy of these procedures compared with other methods of conception, there have been no reports of HIV transmission to mother or infant when using standardized sperm processing techniques, suggesting that these procedures are safe and effective at preventing disease transmission (15, 16, 19, 20). In 1990, the U.S. Centers for Disease Control and Prevention reported a single case of HIV transmission to the female partner of an infected man after intrauterine insemination of processed sperm; however, the initial sperm processing did not involve density gradient techniques and would be considered suboptimal by current standards of care (21).
Assisted reproductive techniques including intrauterine insemination, in vitro fertilization (IVF), and intracytoplasmic sperm injection (ICSI) have been used for HIV-discordant couples to limit an HIV-negative woman’s exposure to infectious semen when trying to conceive. Sperm washing techniques and, in some circumstances, polymerase chain reaction (PCR) testing are used in conjunction with assisted reproduction technology (ART) to separate uninfected
The American Society for Reproductive Medicine (ASRM) has stated that ‘‘unless health care workers can show that they lack the skill and facilities to treat HIVpositive 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’’ (22, p. 221). Patients should be counseled concerning disease transmission risks, informed of risk-reducing strategies, and encouraged to seek care to minimize HIV transmission (22). The American College of Obstetricians and Gynecologists (ACOG) further supported this opinion by stating, ‘‘Assisted reproductive technology should not be denied to HIV-infected couples solely on the basis of their positive serostatus’’ (23, p. 33). Notably, there is no federal requirement mandating HIV testing of men donating sperm to intimate partners for the purpose of assisted reproduction.
Received July 14, 2008; revised August 31, 2008; accepted September 4, 2008; published online October 29, 2008. N.B. has nothing to disclose. M.S. has nothing to disclose. S.W. has nothing to disclose. D.C. received a $25,000 grant from Pfizer (New York, NY) to conduct an investigator-initiated research project. Supported by University of California San Francisco Area of Concentration Student Funding 2006–2007, San Francisco, California. Presented as a poster at Infectious Diseases Society for Obstetrics and Gynecology Annual Scientific Meeting, Boston, Massachusetts, August 9–11, 2007. Presented as a poster at the 2007 National HIV Prevention Conference, Atlanta, Georgia, December 2–5, 2007. Reprint requests: Deborah Cohan, M.D., Department of Obstetrics, Gynecology and Reproductive Sciences, San Francisco General Hospital, 1001 Potrero Avenue, Ward 6D, 6D-22 (UCSF Box 0842), San Francisco, CA 94110 (FAX: 415-206-3112; E-mail: cohand@ obgyn.ucsf.edu).
1540
Although these ART procedures are available in the United States and supported by professional organizations, many fertility clinics do not serve HIV-affected couples. Sauer et al. (24) in 2006 estimated that 10 clinics (approximately 3% of fertility clinics nationwide) openly provided
Fertility and Sterility Vol. 91, No. 4, Supplement, April 2009 Copyright ª2009 American Society for Reproductive Medicine, Published by Elsevier Inc.
0015-0282/09/$36.00 doi:10.1016/j.fertnstert.2008.09.013
care to HIV-positive men (24). Furthermore, state laws in California and Delaware have explicitly limited the availability of services. From 1989 to 2008, the California Health and Safety Code prohibited the transfer of sperm from donors who test positive for HIV, thereby prohibiting the treatment of couples in which the male partner is HIV-positive, even in the setting of an HIV-infected female partner (25).
and 2.5% military based. Clinics were dispersed throughout California although primarily clustered around urban centers. Forty-five percent of responding clinics (18 out of 40) had had requests for care from HIV-affected couples within the year prior to the survey. A total of 73 couples were reported to have requested care at 18 clinics with a range of 1 to 25 couples and a median number of two couples requesting care per clinic per year.
We hypothesized that access to ART services is limited in California for HIV-affected couples desiring to conceive. The provision of services is limited due to both individual clinic policies affecting treatment of HIV-positive women and the California Health Code prohibiting use of semen from HIV-positive men. To obtain ART services, HIVdiscordant couples must travel outside of California (24). The limited provision of infertility treatment to HIV-discordant couples may lead to an increase in HIV transmission through attempts to conceive naturally (26). We examined the practices and attitudes surrounding provision of ART for HIV-positive patients by surveying all identified fertility clinics in California. Our objectives were to determine the status of ART service provision for HIV-positive women in California and examine fertility clinics’ willingness to provide ART for HIV-positive patients in California if legal restrictions were changed.
Sixty-three percent of clinics had an official policy on provision of care for HIV-affected couples. In compliance with California regulations, all clinics reported universal HIV testing of male partners before use of ART. Universal testing of female recipients was also performed by nearly all clinics (98%) as recommended by national professional organizations. Sixty-eight percent of clinics with policies allowed provision of care for HIV-infected women with uninfected male partners while prohibiting the use of sperm from an HIV-positive donor. Twenty-eight percent of clinic policies restricted care even more than state regulations at the time of the survey, providing no ART for HIV-affected couples.
We identified fertility clinics using public access internet health directories including the Centers for Disease Control and Prevention, the Society for Assisted Reproductive Technology, the National Fertility Directory, the National Infertility Association (Resolve), and Internet Health Resources. California-based reproductive endocrinologists were consulted regarding the completeness of this list. We administered a confidential, structured 16-item survey to all medical directors of identified fertility clinics in California through a Web-based survey tool (Survey Monkey, http://www.surveymonkey.com) and/or faxed paper surveys for those clinics without e-mail contacts. We followed-up with bi-weekly to monthly e-mail and telephone reminders to nonresponders for 6 months. The survey examined the presence of clinic policies regarding provision of services for HIV-infected patients, services provided at the time of the survey, and attitudes toward provision of services for HIV-infected men if the California law were to allow therapeutic use of donated sperm for a designated recipient. The survey was based upon instruments used in previous studies conducted in the United Kingdom and Australia (27, 28). We imported all data into a relational database and performed summary statistics using Microsoft Excel 2004 (Microsoft Corp., Redmond, WA). The Committee on Human Research at the University of California, San Francisco, approved the study before its initiation. Forty-one of the 68 clinics (60%) responded to the survey. Of those responding, 85% of clinics self-identified as private practice clinics, 10% academically affiliated, 2.5% health-maintenance organization (HMO) clinics, Fertility and Sterility
Although 29% of the clinics had provided ART for HIVpositive women with uninfected partners, 72% of respondents endorsed willingness to provide services for these patients. Regarding services for HIV-discordant couples with an HIV-positive male partner, clinics were more willing to provide IVF/ICSI (74%) than intrauterine insemination (55%). Additionally, if state law were to change, 73% (27 out of 37) and 65% (24 out of 37) of clinics reported their willingness to provide care for HIV-concordant and HIV-discordant couples, respectively. The HIV epidemic in the resource-rich setting has changed significantly in the past decade, and scientific advances can now be implemented in clinical settings. Despite this progress, access to ART for HIV-discordant couples is limited by the paucity of providers nationwide willing and/ or equipped to care for these couples (24). The situation is further complicated by state regulations that are more restrictive than federal law, including the California state prohibition of the use of semen from an HIV-positive man. For HIV-positive women with HIV-negative male partners, assisted reproduction has always been legal in California. Almost a third of the clinics had provided ART services for these couples, but the majority expressed willingness to do so. It is interesting that the majority of California fertility clinics surveyed were also willing to provide care for HIVdiscordant couples with an HIV-infected male partner, a trend not appreciated nationally (24). The number of HIV-affected couples requesting care within the previous year was small; however, this likely is an underestimate due to the number of couples desiring assisted reproduction who do not seek these services because of state restrictions. As with all surveys, our study had limitations. The response rate of 60% may limit the generalizability of our
1541
findings. Nonetheless, the geographic distribution appropriately represented both rural and urban settings throughout northern and southern California. Moreover, we assessed a clinic’s theoretical willingness to provide services if the law were to change, but this does not necessarily translate to actual provision of care. Despite these limitations, the findings of this survey were instrumental in helping reverse the California legal restrictions. During the implementation of this survey, we assisted in amending the California prohibition against the use of semen from HIV-infected donors for the use in ART. This was a collaborative effort with national experts on ART and HIV and received endorsement by local chapters of ACOG, ASRM, the American Academy for HIV Medicine, and the American Civil Liberties Union. The amendment was signed into law January 1, 2008, by Governor Arnold Schwarzenegger. California Health and Safety Code now allows the use of semen from an HIV-positive man for ART with a designated recipient after mutual informed consent has been obtained (25). By 2010, the state department of health services will adopt state specific guidelines regarding patient evaluation and treatment, specimen processing, laboratory management, and follow-up care. Although these state regulations are pending, facilities should follow practice guidelines as published by ASRM (29). Semen must be effectively processed using density gradient centrifugation with the swim-up method. Sperm may be tested for HIV before use, though this is not mandated. In addition, the HIV-infected donor should be managed with antiretroviral therapy. If conception does occur, access to appropriate prenatal care for the woman and follow-up HIV testing of the mother and baby should occur. Although addressing legal restrictions against ART for HIV-affected couples is a crucial first step, ultimately these couples will only be able to access care if clinics establish protocols and begin offering services. The National Perinatal HIV Consultation and Referral Service (1-888-4488765) has begun assembling a network of fertility clinics in the United States willing to provide services for HIV-affected couples. This new era in the HIV epidemic should prompt reproductive infertility and endocrinology specialists to embrace the opportunity to provide HIV-affected couples seeking conception with potentially life-saving ART.
Acknowledgments: The authors thank Jeff Sheehy from the AIDS Research Institute and Carol Stuart for assistance in organizing our survey and legislative advocacy, the clinic directors who participated in the survey, and the couples and community-based and advocacy organizations who assisted in the legislative effort.
Nena Barnhart, M.D.a Maureen Shannon, C.N.M., F.N.P., Ph.D.a,b Shannon Weber, M.S.W.c Deborah Cohan, M.D., M.P.H.a 1542
Barnhart et al.
Correspondence
a
Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California San Francisco, San Francisco, California; b School of Nursing and Dental Hygiene, University of Hawai’i at Ma˜noa, Honolulu, Hawaii; and c National HIV/AIDS Clinicians’ Consultation Center, San Francisco, California
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