AIDS NEWS SERVICE Michael Howe, MSLS, Editor AIDS Information Center VA Medical Center, San Francisco (415) 221-4810 ext 3305 September 2, 1994 Safer Sex: Information for Counselors (Part VI) REFERENCES - CONDOM EFFECTIVENESS AU - Thompson JL. et al. TI - Estimated condom failure and frequency of condom use among gay men. AB - OBJECTIVES. Condoms are designed to bar transmission of the human immunodeficiency virus (HIV), but they sometimes fail. This paper explores the effect of experience with condoms on condom failure among gay men. METHODS. Risk of condom failure (breakage or slippage) on a single occasion is estimated for four sexual acts reported over 12 months by a sample of gay New York City men (n = 741). The estimation procedure assumes that each episode in which a condom is used is an independent event. Evidence is offered to support this assumption. RESULTS. Risk of condom failure in a single episode was fairly high, particularly in anal intercourse, for men who had engaged in each act only a few times in the previous year. It declined rapidly with experience (e.g., to below 1% for receptive anal intercourse after about 10 episodes in the previous year). Condoms failed less often in oral than anal sex, but estimated risk of failure also decreased with experience. CONCLUSIONS. Gay men should be especially cautious the first few times they use a condom; after moderate experience, however, they may expect a low risk of condom failure. SO - Am J Public Health 1993 Oct;83(10):1409-13 AU - Weller SC TI - A meta-analysis of condom effectiveness in reducing sexually transmitted HIV. AB - Before condoms can be considered as a prophylaxis for sexually transmitted human immunodeficiency virus (HIV), their efficacy must be considered. This paper reviews evidence on condom effectiveness in reducing the risk of heterosexually transmitted human HIV. A meta-analysis conducted on data from in vivo studies of HIV discordant sexual partners is used to estimate the protective effect of condoms. Although contraceptive research indicates that condoms are 87% effective in preventing pregnancy, results of HIV transmission studies indicate that condoms may reduce risk of HIV infection by approximately 69%. Thus, efficacy may be much lower than commonly assumed, although results should be viewed tentatively due to design limitations in the original studies. SO - Soc Sci Med 1993 Jun;36(12):1635-44 AU - Richters J. et. al TI - How often do condoms break or slip off in use? AB - Men attending 3 sexually transmissible disease clinics and a university health service in Sydney were given a questionnaire asking how many condoms they had used in the past year and how many broke during application or use or slipped off. Respondents were 544 men aged 18 to 54 years. Of these, 402 men reported using 13,691 condoms for vaginal or anal intercourse; 7.3% reportedly broke during application or use and 4.4% slipped off. Men having sex with men reported slightly higher slippage rates than those having sex with women. Breakage and slippage were unevenly distributed among the sample: a few men experienced very high failure rates. A volunteer subsample reported 3 months later on condoms supplied to them: 36 men used 529 condoms, of which 2.8 broke during application or use and 3.4% slipped off. Many of these failures pose no risk to the user, especially those occurring during application, as long as they are noticed at the time, but failure may discourage future use. Research is needed to identify user behaviours related to breakage. SO - Int J STD AIDS 1993 Mar-Apr;4(2):90-4 AU - Boldsen JL. et al. TI - Aspects of comfort and safety of condom. A study of two thousand intercourses among volunteer couples. AB - In nearly 2,000 intercourses 14 different types of condoms were tested by 80 heterosexual and seven homosexual volunteer couples. The test couples were generally quite experienced in the use of condoms. It appears that the condoms rarely (1.3%) ruptured or slipped off during the actual intercourse. This means that emphasis must be put on consistency and skill in the use of condoms rather on technical improvements in the promotion of condoms as a means of preventing the spread of sexually transmitted infections like HIV. Lubricated condoms and condoms that were not too small were preferred by both users and their partners. Other condom properties were significant but of minor concern for the participants of the study. SO - Scand J Soc Med 1992 Dec;20(4):247-52 AU - Carey RF. et al. TI - Effectiveness of latex condoms as a barrier to human immunodeficiency virus-sized particles under conditions of simulated use [see comments] AB - Condoms were tested in an in vitro system simulating key physical conditions that can influence viral particle leakage through condoms during actual coitus. The system quantitatively addresses pressure, pH, temperature, surfactant properties, and anatomical geometry. A suspension of fluorescence-labeled, 110-nm polystyrene microspheres models free human immunodeficiency virus (HIV) in semen, and condom leakage is detected spectrofluoro- metrically. Leakage of HIV-sized particles through latex condoms was detectable (P less than 0.03) for as many as 29 of the condoms tested. Worst-case condom barrier effectiveness (fluid transfer prevention), however, is shown to be at least 10(4) times better than not using a condom at all, suggesting that condom use substantially reduces but does not eliminate the risk of HIV transmission. SO - Sex Transm Dis 1992 Jul-Aug;19(4):230-4 AU - Russell-Brown P. et al. TI - Comparison of condom breakage during human use with performance in laboratory testing. AB - This paper combines results from a study of the determinants of condom quality and use conducted by The Population Council in two countries in the Caribbean with results from a condom breakage study conducted by Family Health International (FHI) in the United States. The studies, conducted two years apart, compared the breakage rates of condoms from the same lot during human use to their performance in laboratory test results. Breakage rates of 12.9% for Barbados, 10.1% for St. Lucia and 6.7% for the United States compared to passing ASTM laboratory tests suggest that existing laboratory tests as used with the current pass/fail standards are either not sufficiently sensitive or not well-defined to reliably predict condom performance during human use. The study also suggests that user behaviors and practices may be a factor in condom breakage. If the condom is to be an effective method against unplanned pregnancy and STD/HIV infection, and if consumer confidence is to be retained, condom breakage during sexual intercourse must be reduced. SO - Contraception 1992 May;45(5):429-37 AU - Gerofi J. et al. TI - A study of the relationship between tensile testing of condoms and breakage in use. AB - The ability of the condom wall to maintain its integrity throughout sexual intercourse is critical to its role in halting the spread of major sexually transmissible pathogens including the human immunodeficiency virus. There are three principal in vitro performance tests applied to condoms: a test for freedom from holes, an inflation test, and tensile testing. In this study we subjected condoms that had broken in use to tensile tests in order to determine any correlation between their in vivo and in vitro performance. Condoms which had broken in use showed similar tensile properties to those which had not. All passed all tensile test criteria. Thus, the inclusion of tensile testing in National Standards for condoms is not sufficient to insure strong products. SO - Contraception 1991 Feb;43(2):177-85 AU - Albert AE. et al. TI - Condom use and breakage among women in a municipal hospital family planning clinic. AB - For those who choose to be sexually active, condoms are the best available means of protection against sexually transmitted diseases including the human immunodeficiency virus (HIV), which causes acquired immunodeficiency syndrome (AIDS). Condoms are also an effective method for preventing pregnancy. Unfortunately, condoms are not 100% effective at preventing pregnancy or the spread of infection, in part because condoms do break. In order to gain insight into condom breakage, a questionnaire was administered to women attending a municipal hospital family planning clinic. Thirty-six percent of the 106 subjects had experienced at least one condom breakage. Condom breakage occurred in approximately 1 out of 100 acts of intercourse using condoms, with a lifetime breakage rate of 10 per 1000 condom uses and a past year breakage rate of 8 per 1000 condom uses. Breakage rates did not differ substantially by age. Five percent of the women's unplanned pregnancies were attributed to broken condoms. The results of this study corroborate previously reported rates. Factors associated with these women's most recent breakage experiences included: vaginal intercourse, minimal foreplay, and breakage prior to ejaculation. Controlled studies will be needed to determine how the condom can be used to reduce the likelihood of breakage. SO - Contraception 1991 Feb;43(2):167-76 USE OF CONDOMS AND SPERMICIDES This is a statement and answers to questions from the Centers for Disease Control and Prevention (CDC) concerning the use of condoms and spermicides for HIV transmission prevention. The most effective barrier method to reduce the risk of passing HIV and other sexually transmitted diseases is a latex condom. Both lubricated (wet) and non-lubricated (dry) varieties are effective. Lubricated condoms may also reduce the risk of breakage and help minimize abrasion of the vagina. Clinical studies have shown that spermicides used in the vagina decrease the risk of cervical gonorrhea and chlamydia infections. Laboratory studies have shown that spermicides can destroy HIV when it is outside of cells, but these studies are incomplete. There have been NO studies that demonstrate spermicides' effectiveness against HIV during sexual intercourse in humans. Spermicides' effectiveness against other STDs may be influenced by the amount used, where it is put, and how much of the vagina it covers. Spermicides are not a replacement for condoms, but they could be considered an additional aid for reducing STD and HIV risk. To be most helpful, spermicide should thoroughly cover the inside of the vagina. Spermicide applied directly inside the vagina is the only way to achieve adequate coverage. The amount of spermicide that is on a spermicidally pre-lubricated condom is probably too little to stop sexually transmitted diseases. Use of spermicides in the rectum has not been shown to be safe or effective in preventing the transmission of STDs and HIV. 1. What is a spermicide? A spermicide is a contraceptive; a birth control method that works by killing sperm. It also has an effect against some types of sexually transmitted bacteria and viruses. 2. How is it used? Spermicide is available in creams, gels, foams, tablets, sponges, vaginal contraceptive films (VCF), and suppositories which a woman puts into her vagina before she has sex. Some lubricated condoms also contain a spermicide. The amount of spermicide that is on a prelubricated condom is probably too low to have much effect against sexually transmitted diseases. 3. What Kind (brand) should I use? Latex condoms are the recommended method of protection against sexually transmitted infections, including HIV. If you choose to use a spermicide in addition to a latex condom, the best kind to use is a form where the spermicide can completely cover the inside of the vagina, such as foams and creams. It does not matter what brand you use as long as it is used according to the package directions. 4. Can I use a spermicide without a condom? No! We are more certain about the protection offered by latex condoms. Spermicides' effectiveness against sexually transmitted infections depends on a vagina and cervix being thoroughly covered with spermicide. It is not always possible to guarantee complete coverage, so putting spermicide in the vagina serves only as a back-up to reduce, but not eliminate, the risk of infection in case the condom leaks or breaks. 5. Can I use a condom without a spermicide? Yes. Latex condoms, by themselves, provide an effective barrier to reduce the risk of passing sexually transmitted infections. Spermicides used with a condom may serve as a back-up to reduce the risk of infection in the event the condom leaks or breaks. 6. Where do I put the spermicide? Inside or outside the condom? How much? If you decide to use a spermicide, put the spermicide IN THE VAGINA, not on the condom. Spermicide should cover the inside of the vagina thoroughly. Use as much as the package directs. 7. Are pre-lubricated condoms with nonoxymol-9 okay to use? Latex condoms lubricated with nonoxynol-9 are as good as other and lubricated, latex condom. Lubrication may reduce the risk of condom breakage. 8. What is nonoxynol-9? Either nonoxynol-9 or octoxynol is the active ingredient in most spermicides. If you are using a spermicide as added protection against sexually transmitted diseases and HIV, the amount of spermicide that is on a condom is probably too little to help. It is better to put spermicidal foam or cream directly into the vagina. 9. Should a condom be used for oral sex? A latex condom should be used during mouth-to-penis contact. There are a variety of sexually transmitted diseases that can be passed through this type of contact, including HIV. 10. Should you use a spermicide when engaging in oral sex? A latex condom should be used during mouth-to-penis contact. Spermicidal lubrication on the condom is not likely to increase the protection provided by the condom. Do not use a spermicidally lubricated condom for oral sex, and NEVER use a separate application of spermicide in the mouth. (Centers for Disease Control and Prevention, HIV/AIDS Prevention Training Bulletin, April 23, 1991.) REFERENCES - NONOXYNOL (Arranged Chronologically) Elias CJ. Heise LL. Challenges for the development of female- controlled vaginal microbicides. AIDS. 1994;8:1-9. Fisher AA. Allergic contact dermatitis to nonoxynol-9 in a condom [news]. Cutis 1994 Mar;53(3):110-1. Bourinbaiar AS. et al. Comparative in vitro study of contraceptive agents with anti-HIV activity: gramicidin, nonoxynol-9, and gossypol. Contraception 1994 Feb;49(2):131-7. Stein ZA. Vaginal microbicides and prevention of HIV infection [letter]. Lancet 1994 Feb 5;343(8893):362-3. Jennings R. et al. The inhibitory effect of spermicidal agents on replication of HSV-2 and HIV-1 in-vitro. J Antimicrob Chemother 1993 Jul;32(1):71-82. Whaley KJ. et al. Nonoxynol-9 protects mice against vaginal transmission of genital herpes infections. J Infect Dis 1993 Oct;168(4):1009-11. Moench TR. et al. The cat/feline immunodeficiency virus model for transmucosal transmission of AIDS: nonoxynol-9 contraceptive jelly blocks transmission by an infected cell inoculum. AIDS 1993 Jun;7(6):797-802. Resnick L. et al. Comparative evaluation of spermicidal agents with virucidal activity against HIV. Int Conf AIDS. 1993 Jun 6-11;9(2):743 (abstract no. PO-C22-3154).]. Roddy RE. et al. A dosing study of nonoxynol-9 and genital irritation. Int J STD AIDS 1993 May-Jun;4(3):165-70. Zekeng L. et al. Barrier contraceptive use and HIV infection among high-risk women in Cameroon. AIDS 1993 May;7(5):725-31. Hochmeister MN. et al. Effects of nonoxinol-9 on the ability to obtain DNA profiles from postcoital vaginal swabs. J Forensic Sci 1993 Mar;38(2):442-7. Jones BM. et al. The in vivo effects of nonoxynol-9 contraception on vaginal microbial flora and colonization with Escherichia coli [letter; comment]. J Infect Dis 1993 Mar;167(3):777-8. Chantler E. et al. Quantification of the in vitro activity of some compounds with spermicidal activity. Contraception 1992 Dec;46(6):527-36. Lesher JL Jr. What's in a name when efficacy isn't efficacious? [letter; comment]. JAMA 1992 Dec 23-30;268(24):3434. Chantler E. et al. Compatibility between the spermicide nonoxynol 9 and mid-cycle human cervical mucus. Contraception 1992 Sep;46(3):289-95. Hermonat PL. et al. The spermicide nonoxynol-9 does not inactivate papillomavirus. Sex Transm Dis 1992 Jul-Aug;19(4):203-5. Gollub EL. et al. Nonoxynol-9 and the reduction of HIV transmission in women [letter;comment]. AIDS 1992 Jun;6(6):599-601. HOLES IN LATEX CONDOMS These are answers from the Centers for Disease Control and Prevention (CDC) to questions concerning reports of holes in latex condoms. 1. There have been recent reports of naturally occurring holes in latex that are big enough for HIV to pass through. Why does CDC still recommend condoms to prevent HIV infection? The reports of holes in latex appear to have originated from an article in Science Magazine about latex gloves, not condoms. Holes as large as 5 microns in diameter were evidently identified in latex used in gloves. However, gloves are only dipped in latex once when they are made, condoms are dipped twice in latex. Gloves are allowed to fail the water leak test at a rate of 40 per thousand, while condoms are only allowed 4 failures of the water leak test per thousand condoms before the entire batch is rejected. While holes large enough for HIV to pass through have been found in natural membrane condoms, latex condoms do not allow the HIV to pass through the condom unless the condom has been damaged or torn. Used properly, latex condoms are effective in reducing the risk of HIV infection. (Centers for Disease Control and Prevention, HIV/AIDS Prevention Training Bulletin, July 1, 1992.) LEAKING THROUGH LATEX CONDOMS These are answers from the Centers for Disease Control and Prevention (CDC) to questions concerning the possibility of HIV "leaking" through latex condoms. 1. Can HIV leak through microscopic holes in latex condoms? The Food and Drug Administration (FDA) published a study in the July-August 1992 issue of "STD" which examined whether HIV-sized glass beads could be forced through latex condoms under stressful laboratory conditions. These conditions included higher concentrations of the "virus" (glass beads) than in semen, a fluid that doesn't stick together as much as semen, and forces that simulated 10 minutes of thrusting AFTER ejaculation. Most latex condoms leaked absolutely nothing. The worst condom found would still reduce exposure risk by 10,000-fold, i.e., only 1 HIV virus might "leak" through only 1 of every 90 condoms. Other tests have shown that under "normal" conditions, HIV does not pass through a latex condom that is not torn or broken. 2. How often do condoms break? The studies do not agree on an exact rate of breakage. Many studies of condom effectiveness have counted how often women whose partners used condoms for birth control have gotten pregnant. This "failure rate" includes cases where the couple did not use a condom every time they had sex or used the condoms incorrectly. Some studies have included the times the condom was torn accidently by the people using it. Studies in other countries of breakage caused by defects in the condom itself show a breakage rate ranging from 0% to 7%. In the United States, most studies show the breakage rate is less than 2 out of every 100 condoms, probably less than 1 out of every 100. (Centers for Disease Control and Prevention, HIV/AIDS Prevention Training Bulletin, January 28, 1993.) Latex Condom Study Flawed [FDA has received] inquiries about a Mariposa Foundation study that ranks the quality of various brands of condoms. Media reports of the studies suggest that some brands leak and therefore may not provide protection against AIDS and other sexually transmitted diseases. FDA believes that the study is flawed and therefore cannot be relied upon to judge the relative quality of various brands of condoms. The agency is concerned that some people may stop using condoms as a result of this study. FDA's position continues to be that latex condoms, if used consistently and correctly, provide highly effective protection against sexually transmitted diseases, including AIDS. In 1988, the Mariposa Foundation, a private research group in Topanga, Calif., conducted a laboratory study of 31 condom brands to select condoms to be used in a clinical trial that would have evaluated their protection against HIV, the virus that causes AIDS. The clinical trial was never conducted. One part of Mariposa's laboratory study measured the ability of condoms to serve as a physical barrier to HIV. Test results indicated that at least eight brands offered excellent protection against the virus while at least five allowed some leakage. FDA does not believe these test results should be relied on, however, because the study was flawed for several reasons: 1. Too few batches were sampled to generalize about any brand as a whole. Mariposa sampled three batches for most brands. A sample of a few hundred condoms from a batch of a million might provide adequate information about that particular batch if the sample is taken in a scientifically random fashion, but it cannot establish the performance of the entire brand. Environmental and manufacturing conditions vary too much from one batch to another to allow conclusions about the effiacy of a particular brand on the basis of a small study sample. FDA regularly inspects condom manufacturers and tests samples of their products. When a faulty batch is found, the agency prevents the sale of that batch. This applies both to domestic and imported condoms. 2. Some brands include condoms made by different manufacturers. Some batches from a single brand in the Mariposa study could have come from a different manufacturer than the majority of condoms sold under that brand name. 3. The Mariposa Foundation did not consider possible deterioration due to improper storage conditions or age. Condoms deteriorate rapidly when subjected to extremes of temperature, and latex also deteriorates as it ages. FDA is establishing expiration dating for all latex condoms. Most domestic condoms already display an expiration date on the packaging. New regulations will require expiration dates for both domestic and imported latex condoms. (FDA TALK PAPER. U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, T93-45, October 12, 1993.) [Editor's Note: For information about this study, contact the Mariposa Education and Research Foundation, 3123 Schweitzer Drive, Topanga, CA 90290. Telephone: 818-704-4812. See also: Voeller B. Nelson J. Day C. Viral leakage risk differences in latex condoms. AIDS Research and Human Retroviruses. 1994;10(6):701-10.] The following is a question with an answer from the Centers for Disease Control and Prevention concerning FDA regulations regarding condoms. "Is it true that FDA does not have specific regulations regarding condoms? Do manufacturers set their own standards (thickness, strength, size, etc.), and if they change standards, they only have to register again with FDA?" Since 1976, condoms have been regulated under the Medical Device Amendments to the Food, Drug, and Cosmetic Act. Within the FDA, the Center for Devices and Radiological Health is responsible for assuring the safety and effectiveness of condoms as medical devices. While FDA performance standards have not been established for condoms, FDA does recognize the American Society for Testing and Materials (ASTM) Standard Specifications for Rubber Contraceptives (condoms) D3492-83 as a basis for the condom definition. However, if manufacturers choose to deviate from any of the ASTM specifica- tions, they are required to submit a premarket notification to the FDA at least 90 days before proposing to initiate commercial distribution in the United States. The FDA has also adapted its inspection sampling criteria to conform with the ASTM Standard D3492-83 for latex condoms. Beginning in the spring of 1987, FDA undertook an expanded program to inspect latex condom manufacturers, repackagers, and importers to evaluate their quality control and testing procedures. In testing condoms, FDA uses a waterleak test in which a condom is filled with 300 ml of water and checked for leaks. FDA criteria and the industry-acceptable quality level for condoms specify that in any given batch, the failure rate must not exceed four leaking condoms per 1000 condoms. (Centers for Disease Control and Prevention. Training Bulletin #37. March 25, 1993.) New Labeling to Provide Information About Contraceptives and STDs FDA has notified the manufacturers of certain contraceptives that labeling accompanying their products must state that they do not provide protection from sexually transmitted diseases (STDs), including AIDS. The labeling changes are expected by the fall [1993]. These products include oral contraceptives, intrauterine devices, implantable and injectable contraceptives, and natural membrane ("lambskin") condoms. FDA has instructed the manufacturers of these products to change the labeling so that information about the lack of protection against STDs is displayed prominently in clear language for the consumer. FDA is taking this action as part of ongoing education efforts to reduce the risk of HIV infection and other sexually transmitted diseases in sexually active individuals, particularly adolescents and young adults, who may not know that products intended to prevent pregnancy are not necessarily effective for other purposes. Since 1987, FDA has strongly recommended that the labeling on latex condoms provide information regarding their effectiveness in preventing pregnancy and protecting users from STDs. Although the labeling for natural membrane condoms has stated that the products do not offer protection from STDs, such labeling has not been required for most other contraceptives. The labeling varies according to the type of contraceptive: ~ Oral contraceptives, Norplant, Depo Provera, and IUDs: This product is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. ~ Natural membrane ("lambskin") condoms: This product is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. In order to help reduce the risk of transmission of many STDs, including HIV infection (AIDS), use a latex condom. ~ Latex condoms: If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases. [This message is to appear on individual condom wrappers, as well as on the outer package.] FDA, in conjunction with the National Institutes of Health and the national Centers for Disease Control and Prevention, is currently reviewing the scientific literature to determine whether the labeling for other contraceptives, such as spermicides, cervical caps, diaphragms, and the newly approved female condom, should be changed as well. (FDA BULLETIN, Department of Health and Human Services, Food and Drug Administration, June 22, 1993.)