Introduction

Prevention is the most effective strategy for controlling the spread of infectious diseases. Prevention through avoiding exposure is the best strategy for controlling the spread of sexually transmitted disease (STD). Behavior that eliminates or reduces the risk of one STD will likely reduce the risk of all STDs. Prevention of one case of STD can result in the prevention of many subsequent cases. Abstinence and sexual intercourse with one mutually faithful uninfected partner are the only totally effective prevention strategies. Proper use of condoms with each act of sexual intercourse can reduce, but not eliminate, risk of STD. Individuals likely to become infected or known to be infected with human immunodeficiency virus (HIV) should be aware that condom use cannot completely eliminate the risk of transmission to themselves or to others.

Efficacy

For the wearer, condoms provide a mechanical barrier that should reduce the risk of infections acquired through penile exposure to infectious cervical, vaginal, vulvar, or rectal secretions or lesions. For the wearer's partner, proper use of condoms should prevent semen deposition, contact with urethral discharge, and exposure to lesions on the head or shaft of the penis. For infectious agents spread from lesions rather than fluids, condoms may offer less protection because areas of skin not covered by the condom may be infectious or vulnerable to infection.

Laboratory and epidemiologic studies have provided information about the effectiveness of condoms in preventing STD. Laboratory tests have shown latex condoms to be effective mechanical barriers to HIV (1), herpes simplex virus (HSV) (2-4), cytomegalovirus (CMV) (5), hepatitis B virus (HBV) (6), Chlamydia trachomatis (2), and Neisseria gonorrhoeae (4). Latex condoms blocked passage of HBV and HIV in laboratory studies, but natural membrane condoms (made from lamb cecum), which contain small pores, did not (6-8). The experimental conditions employed in these studies may be more extreme than those encountered in actual use; however, they suggest that latex condoms afford greater protection against viral STD than do natural membrane condoms.

The actual effectiveness of condom use in STD prevention is more difficult to assess. It is difficult to determine if a user has been exposed to an infected partner or whether the condom was correctly used. However, several cross-sectional and case-control studies have shown that condom users and/or their partners have a lower frequency of gonorrhea, ureaplasma infection, pelvic inflammatory disease, and cervical cancer than persons who do not use condoms (9). Consistent previous condom use was associated with seronegativity during the 1- to 3-year follow-up period in a recent study of HIV antibody-negative heterosexual spouses of patients with acquired immunodeficiency syndrome (AIDS) (10). Another recent investigation of prostitutes in Zaire has also suggested a protective association between a history of condom use and HIV seronegativity (11).

Condoms are not always effective in preventing STD. Failure of condoms to protect against STD is probably explained by user failure more often than by product failure. User failure includes failure to:

1. use a condom with each act of sexual intercourse, 2) put the condom on before any genital contact occurs, and 3) completely unroll the condom. Other user behaviors that may contribute to condom breakage include: inadequate lubrication, use of oil-based lubricants that weaken latex, and inadequate space at the tip of the condom. Product failure refers to condom breakage or leakage due to deterioration or poor manufacturing quality. Deterioration may result from age or improper postmanufacturing storage conditions. No scientific data on the frequency or causes of condom breakage are available. Likewise, no data are available comparing the susceptibility to breakage of condoms of various sizes, thicknesses, or types, i.e., natural versus latex, lubricated versus nonlubricated, or ribbed versus smooth. Experimental methods need to be developed to test the factors associated with breakage. Such information is necessary to provide users with accurate instructions on proper condom use.

Quality Assurance

Since 1976, condoms have been regulated under the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. Within the Food and Drug Administration (FDA), the Center for Devices and Radiological Health is responsible for assuring the safety and effectiveness of condoms as medical devices. 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 its testing of condoms, FDA uses a water-leak test in which a condom is filled with 300 mL of water and checked for leaks. The FDA has also adapted its inspection sampling criteria to conform with the American Society for Testing and Materials Standard D3492-83 for latex condoms. FDA criteria and the industry acceptable quality level (AQL) for condoms specify that, in any given batch, the failure rate due to water leakage cannot exceed four condoms per thousand. Batches exceeding the specified rejection criteria are recalled or barred from sale. Among batches of condoms that have met the AQL, the average failure rate observed was 2.3/1,000.

As of February 1988, FDA had examined samples from 430 batches of domestically produced and foreign-made condoms. These examinations have resulted in the testing of over 102,000 condoms. In FDA's sampling methodology, the sample size is determined by the size of the batch of condoms introduced into the market, the inspection level, and the AQL. Approximately 38,000 domestically produced condoms from 165 different batches of condoms were tested. Nineteen of those batches (approximately 12%) had leakage rates of over 4/1,000 and failed the test. By contrast, approximately 21% of the 265 foreign-manufactured batches failed to meet AQL standards. Thus far, as a result of both FDA's sampling program and the manufacturers' quality assurance programs, four domestic manufacturers have conducted 16 condom recalls.

FDA samples foreign-made condoms before they are passed through U.S. customs. If two or more of a given foreign manufacturer's batches offered for import are found to have leakage rates of more than 4/1,000, future shipments from that manufacturer are automatically detained at the port of entry. Seven foreign firms are presently on this automatic detention list. FDA also has the authority to seize any lot that is found to be violative if the manufacturer or importer does not take appropriate action.

Use of Spermicides with Condoms

The active ingredients (surfactants) in commercially available spermicides have been shown in the laboratory to inactivate sexually transmitted agents, including HIV (9,12,13). Vaginal use of spermicides is associated with a lower risk of gonorrhea and chlamydial infection in epidemiologic studies of women (9,14). The use of spermicide-containing condoms may provide additional protection against STD in the event of condom leakage or seepage. However, the spermicidal barrier would no longer be in place if the condom breaks. If extra protection is desired, vaginal application of spermicide is likely to afford greater protection than the use of spermicide in the condom because a larger volume of spermicide would already be in place in the event of condom breakage. Neither the safety nor the efficacy of spermicides in preventing sexually transmitted infections of the anal canal or oropharynx has been studied.

Prevalence of Use

Recent studies suggest that condom use for STD prevention is increasing in selected populations but is still infrequent. In 1985, a sample of New York City male homosexuals reported a significant increase in condom use with both insertive and receptive anal intercourse after the respondents became aware of AIDS (15). In the year before learning of AIDS, the men used condoms an average of 1% of the time when engaging in insertive anal intercourse; in the ensuing year, 20% of respondents reported consistent condom use. In 1984, 39% of the men in a prospective study in San Francisco reported having anal intercourse; 26% of these men used condoms (16). In April 1987, 19% of the San Francisco respondents reported anal intercourse; 79% used condoms. The trends in condom use for STD prevention among heterosexual men and women are unknown. In a 1986-87 survey of female prostitutes in the United States, 4% reported condom use with each vaginal exposure (17).

Proper Selection and Use

The Public Health Service has previously made recommendations on reducing the risk of HIV infection through consistent use of condoms (18). Additional recommendations include a guideline for manufacturers published by FDA that recommends proper labeling of condoms to include adequate instructions for use (Center for Devices and Radiological Health, FDA; letter to all U.S. condom manufacturers, importers, and repackagers, April 7, 1987). Users can increase the efficacy of condoms in preventing infection by using a condom properly from start to finish during every sexual exposure. It is unknown whether brands of condoms with increased thickness offer any more protection for anal or vaginal intercourse than thinner brands. Even with a condom, anal intercourse between an infected individual and an uninfected partner poses a risk of transmitting HIV and other sexually transmitted infections because condoms may break.

The following recommendations for proper use of condoms to reduce the transmission of STD are based on current information:

1. Latex condoms should be used because they offer greater protection against viral STD than natural membrane condoms (7).

2. Condoms should be stored in a cool, dry place out of direct sunlight.

3. Condoms in damaged packages or those that show obvious signs of age (e.g., those that are brittle, sticky, or discolored) should not be used. They cannot be relied upon to prevent infection.

4. Condoms should be handled with care to prevent puncture.

5. The condom should be put on before any genital contact to prevent exposure to fluids that may contain infectious agents. Hold the tip of the condom and unroll it onto the erect penis, leaving space at the tip to collect semen, yet assuring that no air is trapped in the tip of the condom.

6. Adequate lubrication should be used. If exogenous lubrication is needed, only water-based lubricants should be used. Petroleum- or oil-based lubricants (such as petroleum jelly, cooking oils, shortening, and lotions) should not be used since they weaken the latex.

7. Use of condoms containing spermicides may provide some additional protection against STD. However, vaginal use of spermicides along with condoms is likely to provide greater protection.

8. If a condom breaks, it should be replaced immediately. If ejaculation occurs after condom breakage, the immediate use of spermicide has been suggested (19). However, the protective value of postejaculation application of spermicide in reducing the risk of STD transmission is unknown.

9. After ejaculation, care should be taken so that the condom does not slip off the penis before withdrawal; the base of the condom should be held while withdrawing. The penis should be withdrawn while still erect.

10. Condoms should never be reused. Condoms should be made more widely available through health-care

providers who offer services to sexually active men and women, particularly in STD clinics, family planning clinics, and drug-treatment centers. These same facilities should become more assertive in counseling patients on STD prevention. Recommendations for prevention of STD, including HIV infection, should emphasize that risk of infection is most effectively reduced through abstinence or sexual intercourse with a mutually faithful uninfected partner. Condoms do not provide absolute protection from any infection, but if properly used, they should reduce the risk of infection. Reported by: Center for Devices and Radiological Health, Food and Drug Administration. Div of Sexually Transmitted Diseases, Center for Prevention Svcs; AIDS Program, Center for Infectious Diseases, CDC.

References

1. Conant M, Hardy D, Sernatinger J, Spicer D, Levy JA. Condoms prevent transmission of AIDS-associated retrovirus (Letter). JAMA 1986;255:1706.

2. Judson FN, Bodin GF, Levin MJ, Ehret JM, Masters HB. In vitro tests demonstrate condoms provide an effective barrier against Chlamydia trachomatis and herpes simplex virus (Abstract 176). In: Program and abstracts of the fifth international meeting of the International Society for STD Research, Seattle, Washington, August 1-3, 1983.

3. Conant MA, Spicer DW, Smith CD. Herpes simplex virus transmission: condom studies. Sex Transm Dis 1984;11:94-5.

4. Smith L Jr, Oleske J, Cooper R, et al. Efficacy of condoms as barriers to HSV-2 and gonorrhea: an in vitro model (Abstract 77). In: Program and abstracts of the first Sexually Transmitted Diseases World Congress, San Juan, Puerto Rico, November 15-21, 1981.

5. Katznelson S, Drew WL, Mintz L. Efficacy of the condom as a barrier to the transmission of cytomegalovirus. J Infect Dis 1984;150:155-7.

6. Minuk GY, Bohme CE, Bowen TJ, et al. Efficacy of commercial condoms in the prevention of hepatitis B virus infection. Gastroenterology 1987;93:710-4.

7. Van de Perre P, Jacobs D, Sprecher-Goldberger S. The latex condom, an efficient barrier against sexual transmission of AIDS-related viruses. AIDS 1987;1:49-52.

8. Goldsmith M. Sex in the age of AIDS calls for common sense and 'condom sense.' JAMA 1987;257:2261-6.

9. Stone KM, Grimes DA, Magder LS. Personal protection against sexually transmitted diseases. Am J Obstet Gynecol 1986;155:180-8.

10. Fischl MA, Dickinson GM, Scott GB, Klimas N, Fletcher MA, Parks W. Evaluation of heterosexual partners, children, and household contacts of adults with AIDS. JAMA 1987;257:640-4.

11. Mann J, Quinn TC, Piot P, et al. Condom use and HIV infection among prostitutes in Zaire (Letter). Lancet 1986;316:345.

12. Hicks DR, Martin LS, Getchell JP, et al. Inactivation of HTLV/LAV-infected cultures of normal human lymphocytes by nonoxynol-9 in vitro (Letter). Lancet 1985;2:1422-3.

13. Rietmeijer CAM, Krebs JW, Feorino PM, Judson FN. Condoms as physical and chemical barriers against human immunodeficiency virus. JAMA (in press).

14. Rosenberg MJ, Rojanapithayakorn W, Feldblum PJ, Higgins JE. Effect of the contraceptive sponge on chlamydial infection, gonorrhea, and candidiasis: a comparative clinical trial. JAMA 1987;257:2308-12.

15. Martin JL. The impact of AIDS on gay male sexual behavior patterns in New York City. Am J Public Health 1987;77:578-81.

16. Research and Designs Corporation, Communication Technologies. Designing an effective AIDS prevention campaign strategy for San Francisco: results from the 3rd probability sample of an urban gay male community. San Francisco: Research and Designs Corporation, Communication Technologies, 1986.

17. Centers for Disease Control. Antibody to human immunodeficiency virus in female prostitutes. MMWR 1987;36:157-61.

18. Centers for Disease Control. Additional recommendations to reduce the sexual and drug abuse-related transmission of human T-lymphotropic virus type III/lymphadenopathy- associated virus. MMWR 1986;35:152-5.

19. Hatcher R, Guest F, Stewart F, et al. Contraceptive technology 1986-1987. New York: Irvington Publishers, 1987.

*This summary includes data presented at a conference entitled "Condoms in the Prevention of Sexually Transmitted Diseases" sponsored by the American Social Health Association, Family Health International, and the Centers for Disease Control and held in Atlanta, Georgia, February 20-21, 1987. The following consultants assisted in the formulation of these data and strategies: J Cohen, PhD, M Conant, MD, University of California; L Pappas, San Francisco AIDS Foundation, San Francisco, California. F Judson, MD, Disease Control Service and University of Colorado, Denver, Colorado. J Graves, M Rosenberg, MD, American Social Health Association; M Potts, MD, Family Health International, Research Triangle Park, North Carolina. P Harvey, Population Services International, Washington, DC. L Liskin, Johns Hopkins University, Baltimore, Maryland. M Solomon, Solomon Associates, Sudbury, Maine.

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