Pre-Exposure Prophylaxis and Timed Intercourse for HIV-Discordant Couples

Summary

Human immunodeficiency virus (HIV) infection has now become a treatable disease and many infected individuals are interested in having a family. Couples in which the man is infected but the woman is HIV-negative (hereafter referred to as HIV-discordant) require medical intervention during procreation to prevent HIV transmission to the female and her child. The current view is that reducing the number of infections involving unprotected intercourse in HIV-discordant couples is a public health issue in the U.S. The safest methods for HIV-discordant couples are insemination using a sperm donor, adoption and remaining childless. However, some couples strongly desire a biologically related child. Fertility clinics in the United States have been resistant to treating HIV-discordant couples, offering only expensive, invasive techniques. This reduces access to care, leading to couples choosing unprotected intercourse to conceive a child. Pre-exposure prophylaxis (PrEP) is a treatment taken by the woman before having unprotected intercourse with an infected man. Truvada has been approved by the Food and Drug Administration (FDA) to reduce the risk of HIV-discordant couples and the Centers for Disease Control and prevention (CDC) has recommended that serodiscordant patients who wish to have a child be counseled on the availability of PrEP. When risks of transmission are minimized, including undetectable HIV in blood and use of PrEP, unprotected intercourse during the fertile period is likely to be a safe option for conceiving a child. The investigators propose to enroll HIV-discordant couples who have been counseled on the safer alternatives of donor insemination, adoption and remaining childless; have been offered referral to a clinic offering sperm washing with insemination or in vitro fertilization (IVF); have been apprised of the risks of using PrEP and one timed intercourse per cycle; and decide to proceed with this method. Couples will be from the population of HIV-discordant patients with a minimal risk of disease transmission as described above. After evaluation for normal fertility and low potential for disease transmission, the couple will receive instruction on timing of the most fertile day of the cycle, and the woman will be given a prescription for the PrEP medication. The woman and any offspring will be followed for 6 months using blood tests to check for evidence of HIV infection.

Timeline

Start

2015-11

Primary completion

2017-09-20

Completion

2017-09-20

Publications

• Background ACOG Committee Opinion no 595: Committee on Gynecologic Practice: Preexposure prophylaxis for the prevention of human immunodeficiency virus. Obstet Gynecol. 2014 May;123(5):1133-1136. doi: 10.1097/01.AOG.0000446855.78026.21.
• Background Practice Committee of American Society for Reproductive Medicine. Recommendations for reducing the risk of viral transmission during fertility treatment with the use of autologous gametes: a committee opinion. Fertil Steril. 2013 Feb;99(2):340-6. doi: 10.1016/j.fertnstert.2012.08.028. Epub 2012 Sep 10.
• Background Barreiro P, Castilla JA, Labarga P, Soriano V. Is natural conception a valid option for HIV-serodiscordant couples? Hum Reprod. 2007 Sep;22(9):2353-8. doi: 10.1093/humrep/dem226. Epub 2007 Jul 19.
• Background Daar ES, Daar JF. Human immunodeficiency virus and fertility care: embarking on a path of knowledge and access. Fertil Steril. 2006 Feb;85(2):298-300; discussion 301. doi: 10.1016/j.fertnstert.2005.08.018.
• Background De Carli G, Palummieri A, Liuzzi G, Puro V. Safe conception for human immunodeficiency virus-discordant couples: the preexposure prophylaxis for conception alternative. Am J Obstet Gynecol. 2014 Jan;210(1):90. doi: 10.1016/j.ajog.2013.08.011. Epub 2013 Aug 14. No abstract available.
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• Background Del Romero J, Castilla J, Hernando V, Rodriguez C, Garcia S. Combined antiretroviral treatment and heterosexual transmission of HIV-1: cross sectional and prospective cohort study. BMJ. 2010 May 14;340:c2205. doi: 10.1136/bmj.c2205.
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• Background Gilling-Smith C, Nicopoullos JD, Semprini AE, Frodsham LC. HIV and reproductive care--a review of current practice. BJOG. 2006 Aug;113(8):869-78. doi: 10.1111/j.1471-0528.2006.00960.x. Epub 2006 Jun 2.
• Background Gray RH, Wawer MJ, Brookmeyer R, Sewankambo NK, Serwadda D, Wabwire-Mangen F, Lutalo T, Li X, vanCott T, Quinn TC; Rakai Project Team. Probability of HIV-1 transmission per coital act in monogamous, heterosexual, HIV-1-discordant couples in Rakai, Uganda. Lancet. 2001 Apr 14;357(9263):1149-53. doi: 10.1016/S0140-6736(00)04331-2.
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• Background Lampe MA, Smith DK, Anderson GJ, Edwards AE, Nesheim SR. Achieving safe conception in HIV-discordant couples: the potential role of oral preexposure prophylaxis (PrEP) in the United States. Am J Obstet Gynecol. 2011 Jun;204(6):488.e1-8. doi: 10.1016/j.ajog.2011.02.026. Epub 2011 Mar 31.
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• Background Quinn TC, Wawer MJ, Sewankambo N, Serwadda D, Li C, Wabwire-Mangen F, Meehan MO, Lutalo T, Gray RH. Viral load and heterosexual transmission of human immunodeficiency virus type 1. Rakai Project Study Group. N Engl J Med. 2000 Mar 30;342(13):921-9. doi: 10.1056/NEJM200003303421303.
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• Background Saracco A, Veglia F, Lazzarin A. Risk of HIV-1 transmission in heterosexual stable and random couples. The Italian Partner Study. J Biol Regul Homeost Agents. 1997 Jan-Jun;11(1-2):3-6. No abstract available.
• Background Sauer MV. Sperm washing techniques address the fertility needs of HIV-seropositive men: a clinical review. Reprod Biomed Online. 2005 Jan;10(1):135-40. doi: 10.1016/s1472-6483(10)60815-2.
• Background Vernazza PL, Hollander L, Semprini AE, Anderson DJ, Duerr A. HIV-discordant couples and parenthood: how are we dealing with the risk of transmission? AIDS. 2006 Feb 28;20(4):635-6. doi: 10.1097/01.aids.0000210625.06202.c2. No abstract available.
• Background Vernazza PL, Graf I, Sonnenberg-Schwan U, Geit M, Meurer A. Preexposure prophylaxis and timed intercourse for HIV-discordant couples willing to conceive a child. AIDS. 2011 Oct 23;25(16):2005-8. doi: 10.1097/QAD.0b013e32834a36d0.
• Background Wawer MJ, Gray RH, Sewankambo NK, Serwadda D, Li X, Laeyendecker O, Kiwanuka N, Kigozi G, Kiddugavu M, Lutalo T, Nalugoda F, Wabwire-Mangen F, Meehan MP, Quinn TC. Rates of HIV-1 transmission per coital act, by stage of HIV-1 infection, in Rakai, Uganda. J Infect Dis. 2005 May 1;191(9):1403-9. doi: 10.1086/429411. Epub 2005 Mar 30.
• Background Whetham J, Taylor S, Charlwood L, Keith T, Howell R, McInnes C, Payne E, Home J, White D, Gilleece Y. Pre-exposure prophylaxis for conception (PrEP-C) as a risk reduction strategy in HIV-positive men and HIV-negative women in the UK. AIDS Care. 2014;26(3):332-6. doi: 10.1080/09540121.2013.819406. Epub 2013 Jul 22.

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